{"id":95,"date":"2019-01-02T10:47:27","date_gmt":"2019-01-02T15:47:27","guid":{"rendered":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/?page_id=95"},"modified":"2023-11-01T15:24:48","modified_gmt":"2023-11-01T15:24:48","slug":"domains","status":"publish","type":"page","link":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/framework\/domains\/","title":{"rendered":"Domains and Leveled Core Competencies"},"content":{"rendered":"

[vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/2″][vc_column_text]<\/p>\n

WHAT ARE DOMAINS AND LEVELED CORE COMPETENCIES?<\/h2>\n

The JTF Core Competency Framework is made up of 8 Competency Domains which are broad categories of knowledge, skills, and attitudes necessary for conducting clinical research.<\/p>\n

Click here<\/a> for information about how to reference the JTF Framework.[\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”1435″ img_size=”medium” alignment=”center”][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]Within each Domain are specific competency statements which are expressed at a Basic, Skilled and Advanced level.<\/p>\n

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  1. Fundamental (\u201cCan perform the task\/and or exhibit the knowledge at an essential or fundamental level; may require some coaching or supervision\u201d)<\/li>\n
  2. Skilled (\u201cCan perform task or skill independently, consistently, accurately, and has a moderate level of expertise. Efficient and high-quality work; able to independently navigate resources and uses tools well\u201d), and<\/li>\n
  3. Advanced (\u201cDemonstrates advanced skills and knowledge and the ability to teach, coach, or supervise others. Consistently applies critical thinking and problem solving\u201d<\/li>\n<\/ol>\n

    [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]For each of the 47 Leveled Competency statements an example is provided of how the competency may be implemented in a clinical research environment. Translations<\/a> of the JTF Framework can be accessed and downloaded in various languages.\u00a0 Additional translations are in progress.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]<\/p>\n

    Learn more about the competency domains and statements below.\u00a0Please click on \u201c+\u201d for each category below to view.<\/h3>\n

    [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”149″][\/vc_column][vc_column width=”5\/6″][vc_column_text el_id=”domain1″]<\/p>\n

    Domain 1: Scientific Concepts and Research Design<\/h2>\n

    Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials<\/em>[\/vc_column_text][vc_tta_accordion color=”white” gap=”1″ active_section=”0″ no_fill=”true” collapsible_all=”true”][vc_tta_section title=”1.1 Apply Principles of biomedical science to investigational product discovery and development and health-related behavioral interventions” tab_id=”1546448728496-2f92f60e-b7b5″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Recognize<\/b> the need to apply scientific principles to discovery and development of biomedical investigational products and health-related behavioral interventions\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
    \n<\/td>    		B1. Apply <\/b>scientific principles when implementing a clinical or behavioral study
    \n
    \n<\/td>    		C1.\u00a0Plan <\/b>biomedical research according to scientific principles<\/td>\n<\/tr>\n
    A2. Explain<\/strong> the basic scientific principles that should be applied during development of biomedical investigational products and health-related behavioral interventions\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/td>B2. Implement<\/b> data collection according to scientific principles and based on protocol design<\/td>C2.\u00a0 Develop<\/b> a data management plan according to scientific principles.<\/td>\n<\/tr>\n
    Example:<\/strong> When reviewing a clinical research protocol, researcher describes the objective and scientific techniques used to design and implement biomedical research. <\/td>Example:<\/b> When given a clinical research protocol, researcher differentiates what principles could affect how the data should be collected and implement best practices accordingly.<\/td>Example:<\/b> Given a clinical research protocol and data collected, the researcher evaluates the findings to assess results via a scientific framework.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”1.2 Identify Scientific Questions that are Potentially Testable Clinical Research Hypotheses” tab_id=”1546896034545-25797df5-a331″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Articulate<\/b> the purpose of the study<\/td>B1. Identify <\/b> the research hypothesis in a study protocol<\/td>C1. Develop <\/b>a protocol that appropriately includes
    \ndistinct research activities and standard of care<\/td>\n<\/tr>\n
    A2.\u00a0 Describe<\/strong> the importance of the study<\/td>B2. Identify<\/b> endpoints (primary and secondary) that will be used in data analyses to measure outcomes<\/td>C2. Align<\/b> parameters for collecting data on endpoints with objectives <\/td>\n<\/tr>\n
    Example:<\/strong> Identifies the following elements in selected study protocols: Study title, Key purpose of the study, Why this study is important to be done, Who the specific population for the study is<\/td>Example:<\/b> When given a study protocol, describes and classifies the objectives and associated safety and efficacy endpoints that will be used to test the hypothesis and identify assessments (clinical, social\/ behavioral, or economic) that will be used to measure endpoints. <\/td>Example:<\/b> Develops presentations to educate others on the scientific feasibility and conduct of the study to ensure quality collection of endpoints for hypothesis testing. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”1.3 Identify the Elements and Explain the principles and Processes of Designing a Clinical Study” tab_id=”1546896085511-c111300a-b011″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify<\/b> the key elements of a clinical study protocol<\/td>B1. Review<\/b> a clinical study protocol to ensure all needed elements are included<\/td>C1. Evaluate <\/b>the clinical study design and make adjustments<\/b> to the processes as needed<\/td>\n<\/tr>\n
    A2. Describe<\/strong> the general process of clinical study protocol development<\/td><\/td>C2. Develop<\/b> protocols as applicable to the therapeutic area<\/td>\n<\/tr>\n
    A3. Recognize<\/strong> the basic differences between the various types of clinical studies<\/td><\/td>C3.\u00a0 Evaluate<\/b> strengths and weakness of study designs and explain these to others<\/td>\n<\/tr>\n
    <\/td><\/td>C4.\tDevelop <\/b>specific strategies for considering culture and region\/country when designing and conducting studies in multiple regions<\/td>\n<\/tr>\n
    Example:<\/strong> When given a clinical study protocol, identifies the inclusion and exclusion criteria for a set of mock participants.<\/td>Example:<\/b> When given a clinical study protocol, identifies missing, incomplete or inappropriate features. <\/td>Example:<\/b> When given a clinical study protocol that has misalignment between the measures and objectives, researcher appropriately modifies the protocol. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”1.4 Maintain awareness of new technologies, methodologies and techniques which enhance the conduct, safety and validity of the clinical study” tab_id=”1546896127560-852c6dbb-e49f”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Recognize <\/b>the utility of new technologies and techniques which may facilitate the conduct of a clinical study<\/td>B1.\tIdentify and apply <\/b>new technologies and techniques which enhance the quality, conduct and safety of the clinical study <\/td>C1.\tPerform <\/b>data-driven decision-making process, and integrate<\/b> new technologies and techniques into the development and conduct of clinical studies <\/td>\n<\/tr>\n
    <\/td>B2.\tImplement <\/b>training programs relating to new technologies and techniques that enhance the conduct, safety, and validity of the clinical study<\/td>C2.\tDesign and optimize<\/b> training programs for clinical study staff which incorporate new technologies and techniques<\/td>\n<\/tr>\n
    Example: <\/b>Demonstrates ability to work on appropriate electronic clinical platforms which utilize mobile devices or the internet to manage study conduct.<\/td>Example:<\/b> Leads a team that is able to utilize tools and appropriate data capture methods such as electronic clinical outcome assessments (eCOA) to increase the quality of data collected.<\/td>Example: <\/b>Analyzes reported data and implements modifications by utilizing data from different sources such as a Clinical Trial Management System (CTMS) relating to measurable Key Performance Indicators (KPIs). <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”1.5 Critically analyze clinical study results” tab_id=”1583339088748-40ab180f-f2c2″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1.\tIdentify <\/b>the study results<\/td>B1.\tCompare and assess <\/b>the level of quality of results associated with study reports and publications<\/td>C1.\tAssess<\/b> the potential for application of findings <\/td>\n<\/tr>\n
    A2.\tDescribe<\/b> the relevance of the results to the research question<\/td>B2.\tUnderstand<\/b> descriptive and exploratory data analysis<\/td>C2.\tIdentify<\/b> trends and anomalies within the clinical study data<\/td>\n<\/tr>\n
    Example: <\/b>When given study reports, paraphrases and summarizes the study results.<\/td>Example: <\/b>When given two publications researching the same topic, researcher compares and contrasts what could have affected how the data from the two could be interpreted.<\/td>Example: <\/b>Conducts pharmacovigilance assessments of collected data and generates queries to close data gaps.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”253″][\/vc_column][vc_column width=”5\/6″][vc_column_text el_id=”domain2″]<\/p>\n

    Domain 2: Ethical and Participant Safety Considerations<\/h2>\n

    Encompasses care of patients, aspects of human subject protection, and safety in the conduct of a clinical trial<\/em>[\/vc_column_text][vc_tta_accordion color=”white” active_section=”0″ no_fill=”true” collapsible_all=”true”][vc_tta_section title=”2.1 Differentiate between standard of care and clinical study activities” tab_id=”1548259137906-85cdc383-151f”][vc_column_text]\n\n\n\n\t\n\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced<\/th>\n<\/tr>\n<\/thead>\n
    A1. Explain<\/b> that a clinical study is unconfirmed research and not accepted standard of care<\/td>B1. Demonstrate<\/b> the importance of conducting clinical trial activities as per the protocol<\/td>C1. Develop <\/b>a protocol that appropriately includes distinct research activities and standard of care<\/td>\n<\/tr>\n
    Example: <\/b>Explains to a study participant that procedures that are part of the protocol are not necessarily standard of care.<\/td>Example: Explains<\/b> to clinical staff the timing of a research blood draw versus standard blood draw timing for the shift. <\/td>Example: <\/b>Appropriately distinguishes between activities that should be billed to insurance versus incorporated into sponsored cost.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”2.2 Define the concepts of “clinical equipoise“ and “therapeutic misconception“ as they relate to the conduct of a clinical study” tab_id=”1548259172871-6f500670-b307″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Recognize<\/b> that clinical equipoise and therapeutic misconception are fundamental ethical principles and concerns that underlie clinical research<\/td>B1. Explain<\/b> the rationale of clinical equipoise and therapeutic misconception, and can demonstrate comprehensive knowledge and understanding of how they may impact patient understanding<\/td>C1. Act <\/b>as an expert resource to potential study participants and staff in their understanding of clinical equipoise and therapeutic misconception <\/td>\n<\/tr>\n
    Example: <\/b>Identifies and discusses the two comparators in a controlled clinical trial and why each has been selected.<\/td>B2. <\/b> Consistently apply<\/b> knowledge of clinical equipoise and therapeutic misconception during the course of the study<\/td>Example: <\/b>Leads the development of an in-service training by interpreting study protocols in relation to clinical equipoise and therapeutic misconception. <\/td>\n<\/tr>\n
    <\/td>B3. Recognize, interpret, and seek<\/b> assistance where required to address participant concerns regarding therapeutic misconception or clinical equipoise<\/td><\/td>\n<\/tr>\n
    <\/td>Example: <\/b>Identifies during ICF process whether the potential participant truly understands the study is research and does not have a predictable outcome.<\/td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”2.3 Apply relevant national and international principles of human subject protections and privacy throughout all stages of a clinical study” tab_id=”1548259189947-ac2c9ce8-d167″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Explain<\/b> the importance of complying with global guidelines and recommendations, as well as local regulations regarding the safety, wellbeing, and rights of all subjects participating in a clinical trial anywhere <\/td>B1. Critically appraise and implement<\/b> within a clinical study protocol, the principles of human subject protection and privacy<\/td>C1. Supervise <\/b>the implementation of activities required to protect a clinical study participant\u00b4s privacy, safety, well-being, and rights in a clinical trial being conducted in any region<\/td>\n<\/tr>\n
    Example: <\/b>Identifies examples of autonomy, justice and beneficence in the recruitment and consent process for a clinical protocol<\/td>Example: <\/b> Designs recruitment strategies that ensures inclusion of all appropriate populations. <\/td>C2. Respond <\/b>to questions posed by a regulatory body (e.g. IRB.IEC) regarding the methods by which a clinical study protects the privacy and safety of participants<\/td>\n<\/tr>\n
    <\/td><\/td>Example: <\/b>Explains to an IRB\/IEC the plans for ensuring participant confidentiality for a clinical study being submitted for review. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”2.4 Explain the evolution of the requirement for informed consent from research participants and the principles and content of the key documents that ensure the protection of human participants in clinical research” tab_id=”1548259210246-a5b9dd91-a5d9″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify<\/b> the historical events which have led to the development of the current informed consent regulations<\/td>B1. Recognize<\/b>the critical nature of communicating the potential risks or hazards, as well as the benefits of a clinical study, using terminology and a manner that is understandable by the potential study participants during the informed consent process<\/td>C1. Implement <\/b>processes and control measures to ensure human subject protection regulations requirements are met across studies<\/td>\n<\/tr>\n
    A2. Identify<\/b> the key documents that ensure the protection of human participants in clinical research (Declaration of Helsinki, Belmont Report, CIOMS, Nuremberg report, ICH guidelines, Investigators Brochure, product label, etc.)<\/td>B2. Apply <\/b>knowledge of the key doctrines and tenets for the regulations and guidelines coupled with available safety information when drafting an informed consent document for a clinical study<\/td>C2. Evaluate <\/b>the informed consent document in relationship to the study protocol to assure that it not only meets current regulations and guidelines but also provides the information needed for a potential study participant to make an informed decision regarding their participation in the study<\/td>\n<\/tr>\n
    Example: <\/b>Identifies and explains the three principles of the Belmont Report and the difference between FDA regulations and ICH GCP guidelines.<\/td>Example: <\/b> Composes the informed consent document for a clinical study and includes the potential risks and benefits in an understandable manner for the study participants.<\/td>Example: <\/b>Serves as an effective member of an IRB to ensure human subject protection.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”2.5 Describe the ethical issues involved when dealing with vulnerable populations and what additional safeguards should be in place for those populations” tab_id=”1548259225859-7fc18b47-09bc”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify<\/b> which populations are considered vulnerable<\/td>B1. Accurately apply<\/b>the appropriate safeguards with research participants<\/td>C1. Evaluate <\/b>a study protocol to identify whether population is properly protected or additional safeguards are needed<\/td>\n<\/tr>\n
    A2. Understand<\/b> that regulations are in place to protect vulnerable populations<\/td>B2. Anticipate <\/b>situations when research participants may be considered vulnerable<\/td>C2. Create <\/b>strategies to engage vulnerable populations in research studies to allow them to make the best decision<\/td>\n<\/tr>\n
    Example: <\/b>Understands these groups as being vulnerable: children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons and accurately describe additional safeguards in place for each group.<\/td>Example: <\/b> Applies knowledge of vulnerable populations to the subject consent process and identifies vulnerabilities and applies safeguards for participant protection.<\/td>C3. Evaluate<\/b> unique situations that affect participation of vulnerable patients<\/td>\n<\/tr>\n
    <\/td><\/td>C4. Evaluate <\/b>whether vulnerable populations require special considerations from IRBs or regulatory authorities<\/td>\n<\/tr>\n
    <\/td><\/td>Example: <\/b>In a community research study of vulnerable populations, develops strategies that would protect participants during recruitment and retention. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”2.6 Evaluate and apply an understanding of the relevant ethical issues and cultural variation as it applies to the commercial aspects of the clinical research and investigational product development process” tab_id=”1548259648695-dad9c63c-3b96″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Recognize<\/b> the cultural variations which exist when conducting multi-regional clinical trials for new investigational product development<\/td>B1. Compare and contrast<\/b>the ethical principles guiding clinical research across different global regions (e.g., ICH guidelines vs. FDA regulations, other country regulations)<\/td>C1. Assure <\/b>that clinical trials incorporate concepts which recognize varying cultural perspectives and ethical issues across regions<\/td>\n<\/tr>\n
    A2. Explain<\/b> the concept of cultural competency and how it relates to the conduct of clinical research in diverse population groups<\/td>B2. Examine <\/b>the pros and cons of conducting clinical trials in low and middle-income countries and differentiate the potential types of exploitation and benefits that populations in these countries may face in the conduct of a global clinical trial<\/td>C2. Develop strategies <\/b>to select clinical trial sites that appropriately balance the need to provide equal access to potential treatments<\/td>\n<\/tr>\n
    Example: <\/b>Serves as a contributing member of a global medicines development team.<\/td>Example: <\/b> Recommends that clinical studies will only be conducted where the relevant infrastructure exists (e.g. cold chain storage) and in regions where the products will be marketed.<\/td>Example: <\/b>Researcher designs a global medicine development program that considers the health needs of potential participants and ensures post trial access to investigational product. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”2.7 Explain why inclusion, exclusion, and other criteria are included in a clinical protocol to assure human subject protection” tab_id=”1548259721266-134c13d9-a9f9″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Recognize<\/b> the eligibility criteria for study participants (e.g., that include and exclude subjects) based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions that allows the research team to determine whether the subjects can take part in the study safely<\/td>B1. Articulate<\/b> the necessity for a homogeneous patient population (based on criteria defined in the protocol) and the need for consistency in protocol recruitment<\/td>C1. Develop and edit <\/b>eligibility criteria for new protocol development <\/td>\n<\/tr>\n
    A2. Determine<\/b> potential eligibility of study participants for a non-complex study (e.g., registries, survey studies)<\/td>B2. Describe <\/b>the implications of deviations from inclusion\/exclusion criteria on data quality and study validity and how results can be generalized to the public<\/td>C2. Explain <\/b>the rationale for choosing inclusion and exclusion criteria based on evidence or previous experience <\/td>\n<\/tr>\n
    Example: <\/b>Identifies the inclusion and exclusion and eligibility criteria from a set of sample cases for an upcoming clinical study.<\/td>B3. Develop<\/b> study materials (e.g., guidance documents, recruitment plans) to ensure appropriate application of inclusion\/exclusion criteria<\/td>Example: <\/b>Performs an eligibility risk-assessment and risk mitigation plan for new clinical trials and corrective and preventive action strategies for deviations found during routine site audits. <\/td>\n<\/tr>\n
    <\/td>B4. Determine<\/b> potential eligibility of study participants for complex studies (e.g., biomedical or interventional)<\/td><\/td>\n<\/tr>\n
    <\/td>Example: <\/b> During a study audit, identifies deviations from eligibility guidelines, describes potential consequences, and discusses the required next steps. <\/td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”2.8 Summarize the principles and methods of distributing and balancing risk and benefit through selection and management of clinical study subjects” tab_id=”1548259797077-0cc57926-ffbc”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Recognize<\/b> the eligibility criteria for study participants (e.g., that include and exclude subjects) based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions that allows the research team to determine whether the subjects can take part in the study safely<\/td>B1. Implement<\/b> the processes (e.g., inclusion\/exclusion, study procedures, adverse event identification and documentation, continuation of the study) that appropriately balance risk and benefit<\/td>C1. Develop <\/b>the processes (e.g., inclusion\/exclusion, study procedures, adverse event identification and documentation, continuation of the study) that appropriately balance risk and benefit <\/td>\n<\/tr>\n
    Example: <\/b>Identifies known and potential clinical risks associated with a clinical protocol and applies ongoing risk assessment activities during study visits with participants. <\/td>Example: <\/b> Identifies key risk and benefit components that belong in a Strategic Recruitment and Retention plan or in an Informed consent. <\/td>C2. Illustrate <\/b>the risk and benefits principles and methods while designing and\/or providing oversight through the selection and management of clinical study subjects<\/td>\n<\/tr>\n
    <\/td><\/td>Example: <\/b>Independently constructs a protocol, informed consent, and\/or recruitment and retention plan that incorporates the principles and methods of distributing and balancing risks and benefits. <\/td>\n<\/tr>\n
    <\/td><\/td><\/td>\n<\/tr>\n
    <\/td> <\/td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”317″][\/vc_column][vc_column width=”5\/6″][vc_column_text el_id=”domain3″]<\/p>\n

    Domain 3: Investigational Products Development and Regulation<\/h2>\n

    Encompasses knowledge of how investigational products are developed and regulated<\/em>[\/vc_column_text][vc_tta_accordion color=”white” active_section=”0″ no_fill=”true” collapsible_all=”true”][vc_tta_section title=”3.1 Discuss the historical events that precipitated the development of governmental regulatory processes for investigational products” tab_id=”1547840253443-6f98c937-3a80″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify<\/b> the key historical events that took place which influenced the current regulatory environment that exists today (both FDA and internationally)<\/td>B1. Demonstrate<\/b> an understanding of current events that have influenced guidelines and regulatory processes with regards to FDA regulations and guidelines as well as those on a global scale<\/td>C1. Predict and\/or construct <\/b>adaptation plans for the new releases of existing regulations and ICH Guidelines<\/td>\n<\/tr>\n
    Example: <\/b>Understands why the inclusion and exclusion criteria for women of childbearing potential sometimes exists in a clinical study.<\/td>Example: <\/b> Locates and describes FDA\u2019s guidance on genomics in clinical research. <\/td>C2. Support <\/b>cross-functional team efforts, provide teaching to internal staff, investigators, and other stakeholders about pending or current guidance or regulations, such as the documentation about training planned for updated ICH E6<\/td>\n<\/tr>\n
    <\/td><\/td>Example: <\/b>Creates a risk-based monitoring plan for a new clinical trial to ensure compliance with FDA regulations and ICH GCPs. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”3.2 Describe the roles and responsibilities of the various institutions participating in the investigational products development process” tab_id=”1547840457750-72a6ea6b-d62f”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify<\/b> differences between responsibilities of investigators, sponsors, CROs and regulatory bodies<\/td>B1. List <\/b> specific roles and responsibilities for each of the institutions participating in the investigational products development process, (investigators, sponsors, CROs and regulatory bodies)<\/td>C1. Evaluate <\/b>the study protocol to determine the need for collaboration between various institutions\/organizations <\/td>\n<\/tr>\n
    A2. Demonstrate<\/b> understanding of the role of IRBs in approving protocols, assessing risk, and determining exemptions<\/td>B2. Recognize<\/b> the scope of responsibilities of monitoring organizations like Research Pharmacy, Data Safety Monitoring Boards<\/td>C2.\tDefine<\/b> the roles and responsibilities and manage the relationships<\/b> between the stakeholders (including patients, participants, and advocates) to assist in the design and conduct of clinical research <\/td>\n<\/tr>\n
    Example: <\/b>Describes the role of an investigator as described in FDA 1572 and the delegation of responsibilities from sponsor to a CRO.<\/td>Example: <\/b> Explains the information required and processes used by the IRB in approving protocols, assessing risk, and determining exemptions.<\/td>Example: <\/b>Assesses the need and develops a request for proposal for hiring a CRO to conduct monitoring activities for a multicenter trial. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”3.3 Explain the investigational products development process and the activities which integrate commercial realities into the life cycle management of medical products” tab_id=”1547840503548-6aad6134-21d7″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Understand <\/b> concepts, major elements and objectives of investigational products development life cycle management process for investigational products<\/td>B1. Interpret and execute <\/b> the concepts, major elements, and objectives of investigational products development life cycle management process for medical products<\/td>C1. Evaluate <\/b>an established or create a strategic investigational products development and life cycle management plan <\/td>\n<\/tr>\n
    Example: <\/b>Has a basic understanding of the drug development and approval process and recognizes the need to obtain approval from the FDA to market the investigational products in US. Maintains site\u2019s IP tracking log at, CRFs, and is familiar with IB or Device Manuals.<\/td>Example: <\/b> Uses the FDA website to determine whether a clinical study using investigational products requires an IND or IDE or letter of exemption. <\/td>C2. Coordinate <\/b>an IP development plan with regulatory authorities <\/td>\n<\/tr>\n
    <\/td><\/td>C3. Distinguish<\/b> between the regulatory approval processes for drugs, biologics and medical devices<\/td>\n<\/tr>\n
    <\/td><\/td>Example: <\/b>Develops and formulates a request for orphan drug designation for a new investigational product. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”3.4 Summarize the legislative and regulatory framework that supports the development and registration of investigational products and ensures their safety, efficacy and quality” tab_id=”1547840544988-f5cebad4-df0c”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Describe <\/b> how to access the appropriate regulatory guidance that applies to the development and registrations of IMPs, and the clinical trials process required to register such products in their geographical location. (US-FDA, Europe-EMeA, UK-MHRA)<\/td>B1. Describe and apply <\/b> federal (US, EMA, or other) regulatory laws and guidance during the performance of complex clinical research operations. <\/td>C1. Provide oversight and train <\/b>others in relation to the relevant authority and associated regulatory frameworks, including how these harmonize with ICH GCP Guideline, the approved study protocol, and sponsor study related SOPs to ensure the safety and rights of study participants<\/td>\n<\/tr>\n
    A2. Demonstrate<\/b> basic knowledge of Human Subjects Protection and ICH GCP Guideline<\/td>B2. Interpret<\/b> the requirements of ICH GCP Guideline, the approved study protocol and sponsor study related SOPs. <\/td>C2. Monitor <\/b>the progress and assure that conduct of studies at site meets local, national and global regulatory frameworks, and support others to meet such requirements in the conduct of trials<\/td>\n<\/tr>\n
    <\/td><\/td>C3.\tDevelop and facilitate<\/b> the implementation of Safety Risk Management plans<\/td>\n<\/tr>\n
    Example: <\/b>Accesses the relevant guidance in their country for: Informed Consent, Drug Development and approval, IRBs\/ECs, Conflict of interest, Investigator responsibilities, Sponsor responsibilities <\/td>B3. Execute <\/b>the development or editing of study related SOPs, reports, and \/ or submission for the relevant regulatory approval of the study.<\/td>Example: <\/b>Produces training guides, documentation, and checklists to enable study delivery staff to ensure that the relevant regulatory framework is adhered to in relation to specific studies. <\/td>\n<\/tr>\n
    <\/td>Example: <\/b> Describes how regulations and guidance are applied in harmony with ICH GCP requirements, Health Research Authority approvals processes, Research Ethics Committee Approvals and through the comprehensive recording of study related conduct through the maintenance of an investigator site file.<\/td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”3.5 Describe the specific processes and phases that must be followed for the regulatory authority to approve the marketing authorization for a medical product” tab_id=”1547840585287-a777d3f4-0dde”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Describe <\/b> the specific activities and purposes of preclinical and clinical research and how they contribute to the filing of an IND and an NDA\/CTA\/BLA<\/td>B1. Actively participate <\/b> in the implementation of Phase 1-3 clinical trials<\/td>C1. Appraise <\/b>the potential and resources required for successful implementation of a preclinical or clinical research protocol <\/td>\n<\/tr>\n
    A2. Recognize <\/b> how Phase 1-3 data contributes to the filing of an IND and NDA<\/td>B2. Differentiate <\/b> between the purposes of the IND, NDA, BLA and each phase of clinical development and the relationship of research questions answered at each phase<\/td>C2. Supervise <\/b>the development, clinical planning and implementation of a preclinical or clinical research protocol intended to contribute to a regulatory submission (e.g., IND, BLA, NDA) or clinical program<\/td>\n<\/tr>\n
    Example: <\/b>Participates in the collection of documents necessary for submission of an NDA.<\/td>Example: <\/b> Uses the investigator brochure to understand and anticipate what types of potential safety risks might be associated with a clinical trial. <\/td>Example: <\/b>Analyzes data and makes a go\/no-go decision after Phase I data are analyzed. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”3.6 Describe the pre- and post- approval safety reporting requirements of regulatory agencies” tab_id=”1547840755670-cc0bba41-d7cc”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify <\/b> the differences between adverse event reporting requirements for studies pre- and post- marketing approval <\/td>B1. Assess <\/b>the occurrence and coordinate with investigator on classification of adverse events during the conduct of a clinical trial<\/td>C1. Identify and interpret <\/b>safety data (e.g., safety signals or data from surveillance systems) <\/td>\n<\/tr>\n
    A2. Understand <\/b> the reporting requirements for different types of adverse events <\/td>B2. Complete and submit <\/b> adverse event reports, according to appropriate requirements and timeline<\/td>C2. Monitor and teach <\/b>others to compare and contrast safety reporting requirements that may differ by region<\/td>\n<\/tr>\n
    <\/td><\/td>C3.\tDevelop and facilitate <\/b>the implementation of Safety Risk Management plans<\/td>\n<\/tr>\n
    Example: <\/b>Identifies adverse events that meet the criteria to be labeled \u2018serious.\u2019<\/td>Example: <\/b> Identifies, classifies, and codes an adverse event using source documentation and an appropriate coding dictionary.<\/td>Example: <\/b>Serves as the point of contact for both pre- and post-approval safety reporting issues and collaborates with others when responding to questions from regulatory agencies with regards to safety reporting.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”3.7 Appraise the issues generated and the effects of global expansion on the approval and regulation of medical products” tab_id=”1547840781372-fd448cea-96f8″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Recognize <\/b> that different national regulations may affect the medical product approval process<\/td>B1. Compare <\/b>regional regulations and how their differences could impact the conduct of trials or the review of medical product approvals<\/td>C1. Develop and implement <\/b>strategies for the conduct of multi-regional clinical trials<\/td>\n<\/tr>\n
    <\/td><\/td>C2. Develop and implement <\/b>global strategies that optimize the required review and approval of a marketing application<\/td>\n<\/tr>\n
    <\/td><\/td>C3. Analyze <\/b> the resources necessary to gain approval for medical products in multiple countries<\/td>\n<\/tr>\n
    Example: <\/b>Recognizes that GCP must be honored in multi-site trials, but that other national regulations may differ.<\/td>Example: <\/b> When conducting a study in Japan, applies appropriate strategies to include the correct number of Japanese nationals as part of your study population, as required by the Japanese regulatory agency. <\/td>Example: <\/b>Knows that a regulatory application in another country may necessitate significantly more resources than a similar application in the US and provides multiple solution alternatives to address barriers to approval of medical products with strategies in alignment with international harmonization efforts (e.g., ICH, EU. WHO).<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”318″][\/vc_column][vc_column width=”5\/6″][vc_column_text el_id=”domain4″]<\/p>\n

    Domain 4: Clinical Study Operations (Good Clinical Practice)<\/h2>\n

    Encompasses study management (adverse event identification and reporting, post-market surveillance, and pharmacovigilance), and handling of investigational product.<\/em>[\/vc_column_text][vc_tta_accordion color=”white” gap=”1″ active_section=”0″ no_fill=”true” collapsible_all=”true”][vc_tta_section title=”4.1 Explain how the design, purpose, and conduct of individual clinical studies fit into the goal of developing a new intervention” tab_id=”1547841890308-445d2e7e-7e74″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify <\/b> the link between developing a new intervention and the interrelated trial goals and design by reading and comprehending a clinical trial protocol<\/td>B1. Review and comment <\/b>on trial protocols to ensure the links between the objective of developing a new intervention and the related trial goal and design is accurate<\/td>C1. Design <\/b>a clinical trial independently to ensure an accurate link between the goal of developing a new intervention and the trial goal<\/td>\n<\/tr>\n
    Example: <\/b>Identifies the study protocol methods for avoiding selection bias in a clinical study so that the results are considered reliable and valid.<\/td>B2. Provide input and share ideas<\/b>, proactively and reactively, on trial design<\/td>C2. Train, supervise, and coach <\/b>junior trial designers<\/td>\n<\/tr>\n
    <\/td>Example: <\/b> Reviews and provides substantive editorial comments for a clinical study protocol during its initial development. <\/td>Example: <\/b>Independently designs a feasible clinical trial per applicable regulatory requirements, within budget, to provide proof of unbiased safety and efficacy. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][vc_column_text]link to table[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”4.2 Describe the roles and responsibilities of the clinical investigation team as defined by Good Clinical Practice Guidelines” tab_id=”1547841890355-28899f3d-c08d”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Describe <\/b> basic principles of GCP<\/td>B1. Describe <\/b>how GCP principles are incorporated into clinical research<\/td>C1. Apply <\/b>GCP Guidelines to the conduct of clinical research<\/td>\n<\/tr>\n
    A2. Describe<\/b> own role and is aware of roles of others in the site clinical investigation team as set forth by the institution or organization, regulations and GCPs<\/td>B2. Describe <\/b>roles and responsibilities of IRB and sponsors as set forth in federal regulations and GCPs<\/td>C2. Review and assess <\/b>all roles in the clinical investigation team<\/td>\n<\/tr>\n
    A3. Understand<\/b> the concepts of delegation of authority and scope of practice<\/td>B3. Perform<\/b> role in accordance with GCP guidelines<\/td>C3. Supervise <\/b>clinical investigation team members<\/td>\n<\/tr>\n
    Example: <\/b>Clearly articulates own role responsibilities and describes limits of one\u2019s role in the performance of clinical study activities.<\/td>Example: <\/b> Accurately identifies and reports situations when clinical investigation team members are not able to fulfill responsibilities and who to contact for support. <\/td>C4. Perform audits<\/b> of clinical research performance to ensure compliance with GCPs<\/td>\n<\/tr>\n
    <\/td><\/td>Example: <\/b>Assembles, supervises and manages an appropriate investigational team for multiple clinical research studies <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”4.3 Evaluate the design, conduct and documentation of clinical studies as required for compliance with Good Clinical Practice Guidelines” tab_id=”1547841890376-7309003e-91a8″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Following training, describe <\/b> how the ICH Good Clinical Practice Guidelines are incorporated into the design of a research protocol, the procedures followed during the conduct of a clinical study and the collection of data relating to the study<\/td>B1. Successfully participate <\/b>in the implementation of a clinical research protocol and assure<\/b> that, with minimal supervision, the ICH Good Clinical Practice Guidelines are being followed during the conduct of research procedures and the collection of data<\/td>C1. Ensure <\/b>that the operationalization of a clinical research study complies with ICH Clinical Practice Guidelines<\/td>\n<\/tr>\n
    Example: <\/b>Describes the concepts contained in the Declaration of Helsinki and how they are incorporated into clinical protocols and implemented during research on human subjects to ensure ethical and quality standards are maintained.<\/td>Example: <\/b> Leads a team that is generating and collecting data in a clinical research protocol in a manner that ensures the conduct, reporting and recording of the clinical study is occurring utilizing internationally accepted guidelines.<\/td>C2. Appropriately resolve <\/b>any compliance related issues which arise during the conduct of the clinical study<\/td>\n<\/tr>\n
    <\/td><\/td>C3. Ensure <\/b>that the personnel conducting the study are appropriately trained<\/td>\n<\/tr>\n
    <\/td><\/td>Example: <\/b>Assesses and ensures that ICH GCP compliance is maintained throughout the conduct of a clinical research study and when appropriate mentor and train individuals in the ethical and quality concepts required during the conduct of a clinical research study.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”4.4 Compare and contrast the regulations and guidelines of global regulatory bodies relating to the conduct of clinical studies” tab_id=”1547841890398-0c586f2b-fd1b”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Describe <\/b>the role of global regulatory bodies in the conduct of clinical studies<\/td>B1. Assist <\/b>in the identification of country-specific regulations which apply during the conduct of a clinical study<\/td>C1. Create <\/b>processes and procedures to determine feasibility for global studies<\/td>\n<\/tr>\n
    A2. Identify<\/b> the various global regulatory agencies and their respective country-specific regulations<\/td>B2. Apply <\/b>current processes and procedures for the global regulatory agency application requirements for clinical studies<\/td>C2. Determine and schedule <\/b>the proper regulatory application requirements and timeframes for study applications<\/td>\n<\/tr>\n
    A3. Recognize<\/b> the differences in the global regulation of drugs, biologics, and medical devices<\/td>Example: <\/b> Applies knowledge of local and global regulations in performing initial feasibility studies for the conduct of global multicenter clinical studies. <\/td>C3. Provide mentoring and educate <\/b>others on the global regulatory landscape with respect to the identification of potential clinical sites and the initiation and conduct of clinical studies<\/td>\n<\/tr>\n
    Example: <\/b>Identifies the differences between the regulations and guidelines in the US and Europe for the development and marketing of investigational medicinal products.<\/td><\/td>Example: <\/b>Establishes workflows that promote optimal planning for future clinical study applications, data-sharing and clinical sample acquisition for a global multicenter clinical trial.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”4.5 Describe appropriate control, storage and dispensing of investigational product” tab_id=”1547841890421-c78d7814-3fa3″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Understand <\/b>that investigational products require specific control, storage and dispensing<\/td>B1. Articulate <\/b>the specific procedures and elements for control, storage and dispensing of investigational product<\/td>C1. Develop <\/b>SOPs that include specific procedures and elements for control, storage and dispensing of investigational product<\/td>\n<\/tr>\n
    A2. Identify and follow <\/b>existing Standard Operating Procedures for control, storage, and dispensing of IP<\/td>B2. Determine <\/b>deviations in the process of handling study medication and report \/solve the issue<\/td>C2. Develop <\/b>CAPAs when issues in the handling of study medication are detected in order to avoid further deviations<\/td>\n<\/tr>\n
    Example: <\/b>Locates and applies an SOP for the receipt, storage and usage of investigational product for a clinical study at the clinical research site.<\/td>Example: <\/b> When given a variety of scenarios, implements maintenance of proper environmental storage conditions, security, inventory control, and IP accountability (ordering, receipt, inventory, disposal, transfer) to ensure adequate and safe supplies for clinical study participants. <\/td>Example: <\/b>Performs audits, generates CAPAs and adjusts SOPs for the management of investigational products according to FDA regulations and GCPs. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”4.6 Differentiate the types of adverse events (AEs) that may occur during clinical studies and explain the identification process and reporting requirements to IRBs\/IECs, sponsors and regulatory authorities” tab_id=”1547841890442-f6eba1ea-daa5″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Recognize <\/b>the differences between the different types of adverse events<\/td>B1. Differentiate <\/b>the reporting timelines and requirements for an SAE and SUSAR across various international guidelines (e.g., FDA, EMA, ICH, etc.)<\/td>C1. Critique <\/b>the SUSAR reporting requirements across various agencies and entities and formulate new recommendations to enhance the harmonization of reporting requirements <\/td>\n<\/tr>\n
    A2. Recognize <\/b>when an SAE occurs during the conduct of a clinical trial and report it within the appropriate time frame per the regulatory regulations<\/td>B2. Execute <\/b>the reporting of an SAE to the appropriate entity (sponsor, regulatory agency, IRB\/IEC) based on their respective role (e.g., investigator, CRA, sponsor)<\/td>Example: <\/b>Investigates the impact of a lack of harmonization of SUSAR reporting requirements on the timeliness of reporting in a global clinical trial and constructs a new SOP to govern reporting requirements for their organization. <\/td>\n<\/tr>\n
    Example: <\/b>Applies accurate classification of adverse events from sample cases (AE, SAE, Serious and Unexpected AE, Adverse Drug Reaction, etc.)<\/td>Example: <\/b> Demonstrates an ability to recognize and report an SAE to the appropriate entity within the appropriate time frame during the conduct of a clinical trial.<\/td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”4.7 Describe how global regulations and guidelines assure human subject protection and privacy during the conduct of clinical studies” tab_id=”1547841890463-34601116-66e5″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Understand <\/b>that human research subjects are entitled to protection and privacy and that global regulations are in place to protect research subjects during the conduct of clinical studies<\/td>B1. Apply <\/b>appropriate protection and privacy safeguards when conducting clinical studies<\/td>C1. Create <\/b>strategies to protect human research subjects and guard their privacy in clinical studies<\/td>\n<\/tr>\n
    A2. Locate <\/b>the specific regulations associated with the protection and privacy of human research subjects<\/td>B2. Report <\/b>situations when human research subjects may require protection and privacy<\/td>C2. Evaluate <\/b>whether protection and privacy strategies are appropriate<\/td>\n<\/tr>\n
    Example: <\/b>Accurately describes safeguards for human research subject protection and privacy in global, national and local regulations and guidelines.<\/td>B3. Recognize<\/b> the existing global regulations and local rules which differ among countries regarding to protect human research subjects and their privacy<\/td>C3. Develop and implement<\/b> a global investigation strategy with global and local regulations to protect human research subjects and their privacy<\/td>\n<\/tr>\n
    <\/td>Example: <\/b> Describes study visit activities, and identifies actions required for subject protection and privacy appropriate for the regulatory body and regulation for different countries (e.g., CFR (FDA, US), EU directive and regulation (EMA, EU), J-GCP (PMDA, Japan), C-GCP (CFDA, China) and guidelines for privacy protection for research participants.<\/td>Example: <\/b>Plans a new clinical study that includes a comparison of local, national and international health care settings, norms and ethnicities that may impact human subject protection and privacy. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”4.8 Describe the role and process of monitoring a clinical study” tab_id=”1547842217792-5c429a12-6132″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Recognize and understand <\/b>the rationale for clinical monitoring and the appropriate regulations and ICH guidance that applies<\/td>B1. Employ and implement <\/b>the clinical monitoring plan to complete monitoring tasks\/activities<\/td>C1. Lead <\/b>the monitoring effort by mentoring others in the planning and conduct of monitoring site visits<\/td>\n<\/tr>\n
    A2. Adhere to <\/b>the monitoring plan and applicable standard operating procedures<\/td>B2. Address <\/b>complex monitoring issues with minimal supervision or guidance<\/td>C2. Oversee <\/b>the creation and planning of study-specific monitoring plans that assure sufficient resources are allocated to ensure timely review of data while maintaining established standards for study participant safety and data integrity<\/td>\n<\/tr>\n
    A3. With guidance and oversight, perform<\/b> monitoring tasks per the monitoring plan and inform others when confronted with issues not detailed in the monitoring plan<\/td>B3. Provide guidance<\/b> to others to resolve simple and moderately complex monitoring issues<\/td>Example: <\/b>Creates clinical study monitoring plans, provides leadership, mentoring and guidance to ensure all monitoring activities and workflows are in compliance and are \u2018audit-ready\u2019 <\/td>\n<\/tr>\n
    Example: <\/b>Participates in local QA audits of clinical studies in preparation of a CRO monitoring visit.<\/td>Example: <\/b> Applies prospective risk-based approaches to ensure quality data and rapid and accurate responsiveness to clinical monitoring queries.<\/td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”4.9 Describe the role and purpose of clinical study audits” tab_id=”1547842236962-fc0aac6d-c9e9″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Describe <\/b>the steps taken to prepare for an audit\/inspection<\/td>B1. Distinguish <\/b>between scope of audits conducted by sponsors, IRB and regulatory authority<\/td>C1. Supervise <\/b>preparation for an audit\/inspection conducted by a sponsor or regulatory authority<\/td>\n<\/tr>\n
    A2. Name <\/b>the entities which have authority to conduct audits<\/td>B2. Identify <\/b>research components inspected during a clinical study audit<\/td>C2. Develop <\/b>policies and SOPs in response to audit\/inspection findings<\/td>\n<\/tr>\n
    A3. Locate and explain <\/b> the federal regulations governing audits and inspections<\/td>B3. Distinguish<\/b> between routine and for-cause audits and inspections<\/td>Example: <\/b>Given an audit report, creates a comprehensive CAPA plan to respond to audits\/inspections, and develop appropriate SOPs. <\/td>\n<\/tr>\n
    Example: <\/b>Assists with preparation for clinical study audits and understands roles of the team during an audit.<\/td>Example: <\/b> Given a clinical study protocol, classifies and categorizes the specific information and sources of data required by auditors and inspectors.<\/td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”4.10 Describe the various methods by which safety issues are identified and managed in clinical studies” tab_id=”1547842252304-4649e495-dd53″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Understand <\/b>that safety is a central issue in clinical trials and that lack of safety oversight can jeopardize participants in numerous ways<\/td>B1. Execute <\/b>safety reporting within required timelines through appropriate channels<\/td>C1. Anticipate <\/b>possible safety issues during the clinical study implementation<\/td>\n<\/tr>\n
    A2. Recognize <\/b>the tools and processes implemented in a clinical trial to protect participants<\/td>B2. Classify <\/b>safety issues and report them to regulatory authorities and IRBs<\/td>C2. Institute <\/b>measures to minimize risks<\/td>\n<\/tr>\n
    A3. Remember <\/b>to report suspicious activities or events which might compromise safety<\/td>B3. Implement <\/b> international guidelines and requirements across relevant agencies (e.g., FDA, EMA, ICH, etc.) <\/td>C3. Critique and improve<\/b> monitoring and pharmacovigilance plans <\/td>\n<\/tr>\n
    Example: <\/b>Identifies safety issues, risk mitigation and action plans for diabetic patient who are required to be fasting for a lengthy study visit. <\/td>B4. Relate <\/b> safety issues according to monitoring and pharmacovigilance plans<\/td>C4. Recommend and conduct<\/b> safety training for study teams<\/td>\n<\/tr>\n
    <\/td>Example: <\/b> Generates SOPs for the handling of safety hazards in the clinical research site and detecting and reporting adverse events.<\/td>Example: <\/b>Example: Develops a CAPA plan and staff training for monitoring findings of under-reported adverse events.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”319″][\/vc_column][vc_column width=”5\/6″][vc_column_text el_id=”domain5″]<\/p>\n

    Domain 5: Study and Site Management<\/h2>\n

    Encompasses content required at the site level to run a study (financial and personnel aspects). Includes site and study operations (not encompassing regulatory\/GCPs)<\/em>[\/vc_column_text][vc_tta_accordion color=”white” gap=”1″ active_section=”0″ no_fill=”true” collapsible_all=”true”][vc_tta_section title=”5.1 Describe the methods used to determine whether to sponsor, supervise or participate in a clinical study” tab_id=”1547842280557-ea3bfd57-fa0b”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Demonstrate <\/b>a basic understanding of baseline determinants of new study selection process at a research site<\/td>B1. Provide <\/b>input and guidance in the study selection process, including the ability to assess financial and logistical feasibility of conducting a study at the research site<\/td>C1. Guide <\/b>study selection on a program or institutional level <\/td>\n<\/tr>\n
    A2. Understand <\/b>the purpose of pre-site evaluation visits<\/td>B2. Assist in organizing and conducting<\/b> pre-site visits<\/td>C2. Defend <\/b>study selection decision-making, including determination of scientific validity and value; favorable risk\/benefit ratio, and operational (logistical and financial) feasibility<\/td>\n<\/tr>\n
    A3. Participate <\/b>in virtual or face-to-face pre-site visits <\/td>B3. Assist in estimating <\/b> budgets for a potential study<\/td>C3. Lead<\/b> the negotiation, creation of tools, guidance documents, and policies to guide the decision-making process in study selection and participation<\/td>\n<\/tr>\n
    Example: <\/b>Given a new potential protocol, understands study-related needs in order to be able to do the study at the site, including availability of a specific study population. <\/td>Example: <\/b> Completes a feasibility assessment checklist for a new potential study, including preliminary budget estimates. <\/td>Example: <\/b>Creates a study feasibility tool for use throughout department and evaluate assessments to make recommendations<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”5.2 Develop and manage the functional and operational efficiencies and personnel resources necessary to conduct a clinical study” tab_id=”1547842280604-a02bca20-23de”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify <\/b>the component parts of a clinical trial budget<\/td>B1.\tCritique <\/b>and recommend changes to proposed business plan, budgets, timelines, outsourcing requirements, and amount\/type of personnel necessary to conduct a clinical study<\/td>C1.\tDevelop, monitor, and manage<\/b> the business strategy (e.g. budget, timeline, outsourcing plan, and\/or personnel resources) to conduct a clinical study<\/td>\n<\/tr>\n
    A2.\tTrack <\/b>functional tasks for external partners. <\/td>B2.\tMonitor <\/b>milestones (e.g., clinical and financial) and identify trends or risks during study execution<\/td>C2. Analyze <\/b>trends and implement mitigation plans<\/td>\n<\/tr>\n
    <\/td>B3.\tOrganize and process <\/b>outsourcing requirements and reporting (bid defense, proposal development, vendor selection, metrics, financial management and reports)<\/td>C3. Manage<\/b> personnel that is assigned to the clinical study<\/td>\n<\/tr>\n
    <\/td><\/td>C4.\tLead<\/b> the vendor selection and management process<\/td>\n<\/tr>\n
    Example: <\/b>Organizes study visits and requisite labs using correct requisition and account numbers for the study and is able to track and reconcile those documents.<\/td>Example: <\/b> Analyzes a study budget to ensure all requirements of the protocol are included. <\/td>Example: <\/b>Generates amendments to a study budget and milestone timeline to reflect new requirements for an amended protocol and to address unforeseen cost issues for the conduct of a clinical study. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”5.3 Describe the management and training approaches to mitigate risk to improve clinical study conduct” tab_id=”1547842280630-e2578bf6-626f”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify <\/b>the mechanisms used in a research study that have been put in place to mitigate risk<\/td>B1.\tMonitor <\/b>the effectiveness of the Quality\/Risk Management Plan <\/td>C1.\tDefine <\/b>key performance indicators necessary for the clinical studies and incorporate them into the study specific Quality\/Risk Management Plan <\/td>\n<\/tr>\n
    A2. Understand<\/b> how risk assessments are conducted for clinical study operations and patient safety<\/td>B2. Implement <\/b> risk mitigation steps as defined in the plan and develop a strategy to educate others on its content and application<\/td>C2.\tDevelop and deliver<\/b> both generalized and study-specific Quality\/Risk Management Plan training programs <\/td>\n<\/tr>\n
    A3.\tProvide <\/b>critical data points and\/or generate reports that relate to the risk management plan<\/td><\/td>C3.\tInterpret <\/b>internal quality assurance data on key performance indicators and strategize to mitigate risk through a corrective and preventive action (CAPA) plan<\/td>\n<\/tr>\n
    Example: <\/b>Articulates potential reasons why a key performance indicator might be compromised (e.g., study participants not completing study visits within the protocol-defined study window) and operations that might ensure lowest risk of occurrence.<\/td>Example: <\/b> Analyzes reports and implement defined risk mitigation steps when key performance indicators have been triggered.<\/td>Example: <\/b>Analyzes and reports quality audit findings, presents them as discussion topics for mitigation strategies during staff meetings and\/or incorporates them as part of quality management training programs to ensure staff understand how a QMS applies to a clinical study.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”5.4 Develop and implement strategies to manage participant recruitment, retention, compliance and track study activities.” tab_id=”1547842280652-548207f6-daf5″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Articulate <\/b>expected recruitment and retention rates<\/td>B1. Interpret <\/b>subject recruitment and retention tracking data to determine if changes are needed<\/td>C1. Innovate <\/b>solutions to recruitment and retention challenges incorporating key ethical considerations.<\/td>\n<\/tr>\n
    A2. Identify and use <\/b> tools, strategies, and procedures for implementation and tracking of participant recruitment and retention <\/td>B2. Develop <\/b>basic methods for capturing and reporting on recruitment and retention<\/td>C2.\tPropose <\/b>different recruitment tools specific to regulatory requirements of each region \/ country<\/td>\n<\/tr>\n
    A3. Describe<\/b> local and international regulatory requirements that impact the use of different recruitment tools<\/td>B3. Apply <\/b>local and international regulatory requirements to the use of different recruitment tools<\/td><\/td>\n<\/tr>\n
    Example: <\/b>Identifies documents and systems used to track recruitment and retention of participants. <\/td>Example: <\/b> Creates a recruitment plan that addresses the needs of the study population with regards to age, gender, distance, and develops participant fliers for IRB submission that will aid in recruitment.<\/td>Example: <\/b>Given a scenario of a study with fledgling recruitment or retention, the researcher creates innovative solutions that are evidence-based, clearly address the specific needs of hard-to-reach\/engage populations. The solution includes plans for frequent review of the success of the strategies <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”5.5 Identify the legal responsibilities, liabilities and accountabilities that are involved in the conduct of clinical studies” tab_id=”1547842280680-71cf5c60-d2ae”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Organize and maintain <\/b>study regulatory and grants\/contracts documents for regulatory and institutional compliance audits<\/td>B1. Organize and appropriately process <\/b>contracts, materials transfer agreements, budgets, indemnification agreements, confidentiality agreements and conflict of interest reporting. <\/td>C1. Monitor <\/b>systems and collaborate with institutional bodies to ensure compliance with legal and ethical requirements in the conduct of clinical research at the organization.<\/td>\n<\/tr>\n
    A2. Understand<\/b> purpose of study legal materials including: contract, budgets, indemnification, confidentiality disclosure agreements, conflict of interest reporting and IRB approvals in a compliant study site<\/td>B2. Develop and\/or follow <\/b>SOPs that mitigate legal risks in conducting clinical trials<\/td>C2. Develop and critique <\/b>risk mitigation strategies, associated action plans and issue resolution <\/td>\n<\/tr>\n
    Example: <\/b>When asked by an investigator to obtain samples in the freezer to ship to another investigator for a lab-based research project, researcher at the Fundamental Level knows to seek additional advice to ensure that a materials transfer agreement is in place before making the shipment.<\/td>Example: <\/b> Reviews an informed consent form to ensure that indemnification language in the Clinical Trial Agreement is in line with indemnification statements in the protocol and informed consent form and institutional policy.<\/td>C3. Negotiate<\/b> legal contracts (including budgets), confidentiality agreements, and conflict of interest documents<\/td>\n<\/tr>\n
    <\/td><\/td>Example: <\/b>Serves on a conflict of interest board for an institution<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”5.6 Identify and explain the specific procedural, documentation and oversight requirements of principal investigators, sponsors, CROs and regulatory authorities that relate to the conduct of a clinical study” tab_id=”1547842280708-d1c21fe1-b54c”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify <\/b>the regulations and guidelines that describe the requirements that apply to principal investigators, sponsors, CROs, and regulatory authorities in the conduct of clinical research<\/td>B1. Understand and articulate <\/b>applicable regulations and accurately follow established processes in place to ensure compliance<\/td>C1. Apply <\/b>advanced understanding of regulations and ability to accurately interpret regulatory guidance and mentor others in the translation of regulations into everyday practice.<\/td>\n<\/tr>\n
    A2. Describe<\/b> roles of the site team members, including PI; sponsor, CRO, institution and FDA<\/td>B2. Describe <\/b>the various team roles (Sponsor, PI) and their responsibilities in the compliant conduct of clinical research.<\/td>C2. Create <\/b>strategies, policy and procedures to ensure regulatory compliance at a departmental or institutional level<\/td>\n<\/tr>\n
    Example: <\/b>Catalogues and files all regulatory documents, including informed consent forms and recruitment materials necessary for an IRB submission.<\/td>B3. Describe <\/b>the impact of compliance on the safe and ethical conduct of clinical research studies<\/td>C3. Organize and manage <\/b> regular study-related meetings with study staff and the principal investigators.<\/td>\n<\/tr>\n
    <\/td>Example: <\/b> Processes an IRB submission for a new clinical trial.<\/td>Example: <\/b>Generates a delegation of authority log that clearly delineates staff roles in conducting a study according to levels of responsibility and scope of practice. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”5.7 Identify, organize, analyze and report project performance for comprehensive management of a clinical study” tab_id=”1583340940308-e31cbc55-cd68″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1.\tIdentify <\/b>stages of project management (e.g. Identify, Plan, Implement, Monitor\/Control, Close)<\/td>B1.\tIdentify <\/b>critical project success factors for tracking, analysis, and reporting for clinical research project performance<\/td>C1.\tImplement <\/b>project adjustments and influence future project selection and execution, based on analysis of prior performance<\/td>\n<\/tr>\n
    A2.\tMonitor and report<\/b> critical project success factors or milestones<\/td>B2.\tCompile and analyze, and make recommendations<\/b> relating to clinical research project performance<\/td>C2.\tOversee the development of project content<\/b> across project plans<\/td>\n<\/tr>\n
    Example: <\/b>Identifies the basic principles of project management (e.g., scope or deliverables) and relates them to the requirements of a clinical research project.<\/td>Example:<\/b> Defines and develops critical and relevant Key Performance Indicators (KPIs) and metrics for a dashboard presentation.<\/td>Example: <\/b>Shares best practices (e.g., lessons learned) across multiple projects to establish a scalable organizational knowledge base to improve current and future projects by utilizing project performance metrics.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”320″][\/vc_column][vc_column width=”5\/6″][vc_column_text el_id=”domain6″]<\/p>\n

    Domain 6: Data Management and Informatics<\/h2>\n

    Encompasses how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database<\/em>[\/vc_column_text][vc_tta_accordion color=”white” gap=”1″ active_section=”0″ no_fill=”true” collapsible_all=”true”][vc_tta_section title=”6.1 Describe the role and importance of statistics and informatics in clinical studies” tab_id=”1547843620397-7143fafa-35f3″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Understand <\/b>the basic purpose of statistics and informatics as applied in clinical studies (e.g., randomization, sample size, adverse events, analysis, results)<\/td>B1. Perform <\/b>randomization activities to ensure accurate designation of new study participants<\/td>C1. Develop <\/b> a statistical analysis and data management plan for a clinical study<\/td>\n<\/tr>\n
    Example: <\/b>When reviewing a protocol and case report form, recognizes the data points that are associated with analysis of safety and efficacy endpoints.<\/td>B2. Describe <\/b>the statistical requirements to answer the study question (hypothesis) in a study protocol<\/td>Example: <\/b>Develops and annotates a case report form for a clinical trial that will ensure accurate data collection in keeping with the study protocol.<\/td>\n<\/tr>\n
    <\/td>Example: <\/b> Generates descriptive statistics to illustrate enrollment and safety data in a study for a staff meeting presentation.<\/td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”6.2 Describe the origin, flow, and management of data through a clinical study” tab_id=”1547843620421-81a300df-a9c0″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Describe <\/b>the basic concepts of clinical data management.<\/td>B1. Apply <\/b>all aspects of the clinical data management plan (CDMP) to an active clinical study with regards to the flow of data from the site to the clinical database as well as the flow of data from other sources, for example laboratory electronic uploads, EMR transfers, etc.<\/td>C1. Create <\/b> the clinical data management plan for a clinical study<\/td>\n<\/tr>\n
    A2. Identify<\/b> the various sources of data that contribute to a clinical study and can distinguish the different industry standards to be used in their handling.<\/td>B2. Manage <\/b>queries and recommend whether the flow and quality of the clinical data meets the standards set in the CDMP.<\/td>C2. Analyze and modify<\/b> standard operating procedures, when necessary to accommodate the inclusion and implementation of new technology in the data management process or new industry-wide initiatives (e.g. data transparency and clintrials.gov requirements or the MRCT initiatives on data sharing, etc.).<\/td>\n<\/tr>\n
    Example: <\/b>Understands the purpose and scope, as well as the process workflow defined in a data management plan.<\/td>Example: <\/b> Performs an analysis of the data flow from various sources (e.g., Esource, third-party sources, etc.) to ensure clean data transfers per predefined specifications.<\/td>C3. Educate and mentor<\/b> others concerning their role and responsibility in the conduct and management of clinical data across each aspect of the clinical research enterprise.<\/td>\n<\/tr>\n
    <\/td><\/td>Example: <\/b>Participates at an investigator meeting to review the clinical data management process and the responsibilities each PI and site has in the process. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”6.3 Describe best practices and resources required for standardizing data collection, capture, management, analysis, and reporting” tab_id=”1547843620435-f6269bd2-c828″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify and apply <\/b>standard and best practices for data management in clinical research. <\/td>B1. Implement <\/b>industry, federal and GCP accepted standards and best practices for data management in a clinical study.<\/td>C1. Develop <\/b> a data management plan for a clinical study that includes standardized plans for data collection, data capture, data management, data analysis, and data reporting that use industry-accepted standards or best practices.<\/td>\n<\/tr>\n
    A2. Identify<\/b> documents and resources related standards and best practices associated with the collection, data capture, data management, data analysis, and data reporting in clinical research.<\/td>B2. Perform <\/b>data management activities across clinical studies from creation of protocol specific source documents, collection and entry of data and performing quality audits<\/td>Example: <\/b>Develops an annotated CRF for a specific study according to the data management plan for that study.<\/td>\n<\/tr>\n
    Example: <\/b>When given standardized scenarios, the researcher identifies a standard or best practice (for data collection, capture, management, analysis, and reporting).<\/td>Example: <\/b> Collects and enters data into new electronic data collection forms with timeliness, accuracy and low query rates.<\/td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”6.4 Describe, develop, and implement processes for data quality assurance” tab_id=”1547843620462-899bc82e-5968″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify and understand <\/b>processes that assure data quality.<\/td>B1. Independently ensure <\/b>compliance with data quality related SOPs<\/td>C1. Create\/define <\/b> data quality related SOPs or study-specific procedures for the conduct of a clinical trial. <\/td>\n<\/tr>\n
    A2. Recognize <\/b> whether individual pieces of data collected in a clinical study are attributable, accurate, complete and verifiable from the source data.<\/td>B2. Provide <\/b>input and share ideas, pro- and reactively, related to data quality and the related processes.<\/td>C2. Advise <\/b>the data management team on data quality related processes that impact the clinical trial team, ensuring a smooth and constructive collaboration and communication between both.<\/td>\n<\/tr>\n
    Example: <\/b>Enters and corrects data from a source document into an electronic data collection form.<\/td>Example: <\/b> Suggests a change in an eCRF design to a sponsor to help avoid recurrent queries.<\/td>C3. Train<\/b> trial staff on data quality related procedures and provide oversight and support in cases of doubt or risk for non-compliance.<\/td>\n<\/tr>\n
    <\/td><\/td>Example: <\/b>Generates an eCRF that complies with data quality standards defined by the institution or company.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”321″][\/vc_column][vc_column width=”5\/6″][vc_column_text el_id=”domain7″]<\/p>\n

    Domain 7: Leadership and Professionalism<\/h2>\n

    Encompasses the principles and practice of leadership and professionalism in clinical research<\/em>[\/vc_column_text][vc_tta_accordion color=”white” gap=”1″ active_section=”0″ no_fill=”true” collapsible_all=”true”][vc_tta_section title=”7.1 Describe and apply the principles and practices of leadership, management and mentorship in clinical research” tab_id=”1547844219073-b5a5ecb3-989f”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Display <\/b>professionalism in the workplace, in attire, attitude, work-ethic, self-motivation and quality products<\/td>B1. Assist <\/b>others with various aspects of study management using effective communication methods and documentation<\/td>C1. Serve <\/b> in leadership roles in the research department<\/td>\n<\/tr>\n
    A2. Identify <\/b> the leadership structure of the organization<\/td>B2. Train and mentor <\/b>Fundamental Level staff<\/td>C2. Train and mentor <\/b>new staff members and team members, including performance management<\/td>\n<\/tr>\n
    A3. Locate, comprehend, and adhere to<\/b> the standard operating procedures in the research department<\/td>B3. Demonstrate <\/b>effective time management and organizational skill when managing multiple research related projects<\/td>C3. manage<\/b> multiple complex study operations<\/td>\n<\/tr>\n
    A4. Demonstrate <\/b>initiative and team cooperation in performing research duties<\/td>Example: <\/b> Plans and conducts a protocol implementation meeting.<\/td>C4. Set <\/b>strategic planning goals and objectives for study performance<\/td>\n<\/tr>\n
    Example: <\/b>Arrives at work on time, articulates information in a succinct and appropriate manner both verbally and in writing, and seeks guidance or directions where he\/she has questions.<\/td><\/td>Example: <\/b>Manages study teams and develops budgets and assists with contracts for clinical research projects.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”7.2 Identify ethical and professional conflicts associated with the conduct of clinical studies and implement procedures for their prevention or management” tab_id=”1547844219141-8a80aab1-e5a6″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Explain <\/b>the nature and historical instances of ethical and professional conflicts which occur in the conduct of clinical research<\/td>B1. Recognize, implement, and manage <\/b>the procedures in a clinical research study which minimize the risks of ethical and professional conflicts<\/td>C1. Assess <\/b> the risk of ethical and professional conflicts inherent in a clinical study<\/td>\n<\/tr>\n
    A2. Describe <\/b>the procedures which are implemented to prevent ethical conflicts and support risk management strategies<\/td>B2. Implement <\/b>risk management strategies within their role responsibilities<\/td>C2. Develop <\/b>strategies and policies to implement and manage risk of ethical and professional conflicts across a project team as well as functional domains<\/td>\n<\/tr>\n
    Example: <\/b>Describes how the concepts within historical documents (e.g., of the Nuremburg Code, the Declaration of Helsinki, the Belmont Report and the CIOMS International Ethical Guidelines for Research Involving Human Subjects) concerning research ethics are integrated into a clinical research protocol.<\/td>Example: <\/b> Organizes and implements the procedures (such as participant recruitment strategies and informed consent) which are included in a clinical research protocol that mitigate ethical and professional risks to clinical trial integrity and contributes to risk management planning for a study team.<\/td>Example: <\/b>Appraises the potential risks (both ethical and professional) inherent in the conduct of a clinical research study and develops the framework for risk management for a department or project team.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”7.3 Identify and apply the professional guidelines and codes of ethics that apply to the conduct of clinical research” tab_id=”1547844219174-198489f9-e282″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Recognize <\/b>the key documents which make up the foundation of the regulations that ensure clinical studies are conducted ethically and in a professional manner<\/td>B1. Apply <\/b>professional and ethical regulations and international guidelines in each facet of clinical research<\/td>C1. Evaluate, and modify <\/b> when required, internal policies and procedures to ensure that the organization\u2019s code of ethical conduct is in compliance with local law\/regulations and\/or international guidelines<\/td>\n<\/tr>\n
    A2. Identify and understand <\/b>the meaning of ethical and professional behaviors found in both federal regulations and international guidelines addressing ethical conduct in clinical studies.<\/td>B2. Demonstrate <\/b>through actions and documentation of tasks during the conduct of clinical research an understanding of how appropriate procedures and processes assure professional and ethical conduct throughout clinical research<\/td>C2. Mentor (educate) and provide guidance <\/b>to all study team and staff members concerning internal processes and procedures which ensure that all aspects of clinical studies are conducted within the bounds of ethical conduct.<\/td>\n<\/tr>\n
    Example: <\/b>Identifies the key regulations and guidelines in FDA and ICH documents that ensure ethical conduct in clinical studies.<\/td>Example: <\/b> In day-to-day activities and tasks, demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures, regulations, and guidelines.<\/td>Example: <\/b>Ensures all local and global regulations and guidelines are reflected in standard operating procedures and processes by adapting any established procedures, processes, or workflows to reflect any new or updated regulations and\/or guidelines (e.g. training documentation)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”7.4 Describe the impact of regional diversity and demonstrate cultural competency in clinical study design and conduct” tab_id=”1547844219201-e9c97371-54aa”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Describe <\/b>why it is important to incorporate strategies that account for regional and cultural diversity in the conduct of clinical research<\/td>B1. Apply <\/b>regional\/country and cultural considerations during study design and conduct<\/td>C1. Develop specific strategies <\/b> or methods for considering culture and region\/country when designing and conducting studies in multiple regions\/countries<\/td>\n<\/tr>\n
    A2. Classify <\/b>examples of potential impact that are related to diversity or cultural competency<\/td>B2. Incorporate <\/b>the appropriate regulatory requirements during the implementation of multi-country trials<\/td>C2. Validate <\/b>that regulatory requirements are incorporated into the study design for multi-country trials<\/td>\n<\/tr>\n
    Example: <\/b>Suggests strategies to address diversity and cultural competence for a diverse set of potential participants in a clinical study, including age, ethnicity, race, and gender and religion<\/td>Example: <\/b> Recognizes cultural and diversity issues when developing a research idea into a global clinical study.<\/td>Example: <\/b>Proposes specific strategies that can be employed in each region\/country to ensure cultural and regional appropriateness when initiating a new clinical study.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”322″][\/vc_column][vc_column width=”5\/6″][vc_column_text el_id=”domain8″]<\/p>\n

    Domain 8: Communications and Teamwork<\/h2>\n

    Encompasses all elements of communication within the site and between the site and sponsor, CRO, and regulators. Understanding of teamwork skills necessary for conducting a clinical trial.\u00a0<\/em>[\/vc_column_text][vc_tta_accordion color=”white” gap=”1″ active_section=”0″ no_fill=”true” collapsible_all=”true”][vc_tta_section title=”8.1 Describe the importance of team science and methods necessary to work effectively with cross-functional, multidisciplinary and inter-professional research teams, which may include external partners” tab_id=”1547844408482-e7c00d94-0ed4″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Describe and understand <\/b>the importance of an interdisciplinary team and the values each member can bring to clinical studies <\/td>B1. Identify and facilitate <\/b>the activities of the key contacts essential to ensuring effective team operations during a clinical study<\/td>C1.\tMentor <\/b>others regarding how to work best on a multi-functional\/matrix clinical study team.<\/td>\n<\/tr>\n
    A2. Identify and recognize <\/b> each member of the team and their respective roles and responsibilities and understand that communications within a clinical study team is vital to the success of the study<\/td>B2. Demonstrate<\/b> an understanding of the cross-functional team in developing a communication plan<\/td>C2. Establish <\/b>the core infrastructure of the clinical study team and ensure effective and efficient communication and teamwork<\/td>\n<\/tr>\n
    <\/td>B3.\tProvide<\/b> team members and stakeholders with timely status reports<\/td>C3. Incorporate <\/b>multidisciplinary skills into research teams<\/td>\n<\/tr>\n
    <\/td>B4.\tDemonstrate<\/b> interpersonal skills (e.g. negotiating, influencing, resolving conflict)<\/td>C4.\tResolve team related<\/b> issues and evaluate<\/b> outcome of solutions <\/td>\n<\/tr>\n
    Example: <\/b>Understands the professional roles and clinical practice domains of all members of the clinical study team.<\/td>Example: <\/b> Demonstrates the ability to perform the day-to-day operational activities critical to running an effective team (e.g. setting up meetings, developing a communications plan, identification of key contacts both within the team and outside of the team).<\/td>Example: <\/b>Creates study teams and establishes an operational workflow to implement study team communication, cross-training, ensures training documentation is maintained, and provides guidance when needed in order for them to optimize their effectiveness.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”8.2 Discuss the relationship and appropriate communication between Sponsor, CRO and clinical research site.” tab_id=”1547844408565-da622e39-b895″][vc_column_text]\n\n\n\n\t\n\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Understand and describe <\/b>the relationships and appropriate communication channels between regulators, sponsors, CROs and research sites<\/td>B1. Apply <\/b>appropriate professional communication practices in written and verbal interactions with other parties in order to maintain legal, ethical, and productive relationships during the conduct of a research study<\/td>C1. Establish and maintain <\/b> productive long-term relationships with all participating parties across the research enterprise to sustain efficient, effective and sustainable clinical trials currently and in the future<\/td>\n<\/tr>\n
    Example: <\/b>Demonstrates appropriate written and oral communication between stakeholders in the clinical research operation<\/td>Example: <\/b> Develops proactive written and oral communication that addresses team related challenges that could impact study execution so that mutually agreed upon solutions can be developed to address the challenges.<\/td>Example: <\/b>Anticipates the needs of all parties participating in the research enterprise and serves as a communication mediator when difficult situations arise that have had previous unsatisfactory results.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”8.3 Effectively communicate the content and relevance of clinical research findings to colleagues, advocacy groups and the non-scientific community” tab_id=”1547844408613-5c885dd9-81c0″][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Explain <\/b>the structure and contents of a scientific publication.<\/td>B1. Relate <\/b>the content and value of clinical research studies to colleagues and the non-scientific community through professional presentations and other verbal and written means<\/td>C1. Design <\/b> reports for scientific and non-scientific communities which interpret and explain clinical trial data and appraise the significance of clinical study reports<\/td>\n<\/tr>\n
    A2. Identify and utilize <\/b> reliable sources of information which communicate clinical research findings to the scientific and non-scientific communities<\/td>Example: <\/b> Writes lay summaries of research studies for a journal club or to potential patient populations.<\/td>C2. Facilitate <\/b>the awareness and further understanding of clinical research protocols and their results to colleagues, advocacy groups and the non-scientific community<\/td>\n<\/tr>\n
    Example: <\/b>Explains the scientific underpinnings of a clinical trial in terms that can be understood by the non-scientific community.<\/td><\/td>Example: <\/b>Communicates outcomes of a clinical research study to sponsors, colleagues and the non-scientific community.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”8.4 Describe the components of a traditional scientific publication.” tab_id=”1547844408642-a802a1c0-0fae”][vc_column_text]\n\n\n\n\t\n\n\t\n\t\n\t\n\t
    Fundamental Level<\/th>Skilled Level<\/th>Advanced Level<\/th>\n<\/tr>\n<\/thead>\n
    A1. Identify <\/b>the component parts of a scientific publication and the general purpose of each part<\/td>B1. Describe <\/b>the methods for a study that has been published and appreciates the basis for the conclusions made from the results obtained. <\/td>C1. Navigate, appraise, and assess <\/b> the content of all component parts within a traditional scientific publication and communicate a both detailed understanding to staff<\/td>\n<\/tr>\n
    A2. Comprehend<\/b> that a traditional scientific publication describes the outcomes of a research study in a structured and ordered format to contribute to generalizable knowledge and evidence-based practice<\/td>B2. Search<\/b> the literature using key terms to find articles on specific subjects<\/td>C2. Describe <\/b>the relationship of the findings from a clinical study to the relevant human population and current practice context<\/td>\n<\/tr>\n
    Example: <\/b>Reviews and discusses a published study associated with an ongoing clinical study protocol.<\/td>B3. Explain<\/b> the difference between a primary source and a secondary source when citing the professional literature<\/td>C3. Write and edit<\/b> manuscripts as well as apply varying journal citation styles when formatting a manuscript<\/td>\n<\/tr>\n
    <\/td>Example: <\/b> Composes an abstract for a publication or professional presentation accurately citing the literature using primary source data (e.g., able to trace a secondary source back to the originating primary source). <\/td>Example: <\/b>Given the results of a clinical study, generates and edits a manuscript and\/or responds to editorial comments and suggestions in order to develop a final and accepted professional publication. <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1649425354630{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #d8d8d8 !important;border-left-style: solid !important;border-right-color: #d8d8d8 !important;border-right-style: solid !important;border-top-color: #d8d8d8 !important;border-top-style: solid !important;border-bottom-color: #d8d8d8 !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_column width=”1\/4″][vc_single_image image=”1707″ alignment=”right”][\/vc_column][vc_column width=”3\/4″][vc_column_text]<\/p>\n
    \u00a9 2020 MRCT Center. This work is licensed under a CC BY-NC-SA 4.0 license<\/a> that allows it to be shared or adapted for noncommercial purposes, with appropriate attribution.<\/i><\/h5>\n

    [\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"

    [vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/2″][vc_column_text] WHAT ARE DOMAINS AND LEVELED CORE COMPETENCIES? The JTF Core Competency Framework is made up of 8 Competency Domains which are broad categories of knowledge, skills, and attitudes necessary for conducting clinical research. Click here for information about how to reference the JTF Framework.[\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”1435″ img_size=”medium” alignment=”center”][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]Within each Domain are specific competency […]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":11,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-95","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/wp-json\/wp\/v2\/pages\/95"}],"collection":[{"href":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/wp-json\/wp\/v2\/comments?post=95"}],"version-history":[{"count":3,"href":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/wp-json\/wp\/v2\/pages\/95\/revisions"}],"predecessor-version":[{"id":2512,"href":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/wp-json\/wp\/v2\/pages\/95\/revisions\/2512"}],"up":[{"embeddable":true,"href":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/wp-json\/wp\/v2\/pages\/11"}],"wp:attachment":[{"href":"https:\/\/dev.mrctcenter.org\/clinical-trial-competency\/wp-json\/wp\/v2\/media?parent=95"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}