Accessibility by Design (AbD) Toolkit is Released

May 4, 2023

The Accessibility by Design (AbD) in Clinical Research Toolkit is now available here. The AbD toolkit was developed with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders in clinical research.

On May 4th, the MRCT Center held a webinar in which Dr. Willyanne DeCormier Plosky presented the background, structure, and key themes of the AbD Toolkit. Invited speaker Cecile González-Cerimele shared lessons learned as a family caregiver during clinical trials, a leader in the planning and conducting of clinical research, and a member of the EnAble employee resource group at Eli Lilly. Duke Morrow could not attend but shared, via moderator Dr. Barbara Bierer, his lived experience as a person with a disability, trial participant, and [community] IRB member. “Any researcher must put aside any knowledge they have learned academically and accept the lived experience of the participants.”

The MRCT Center welcomes your feedback on the AbD Toolkit. Please send suggestions, additional tools and resources, and concerns to mrct@bwh.harvard.edu. We look forward to continuing to work together with people with disabilities, their allies, study teams, sites, and sponsors to further the inclusion of people with disabilities in clinical research.

The MRCT Center Glossary As A Global Standard For Plain Language: Announcing A Collaboration With CDISC

Clinical research is essential for the discovery of new treatments and medical interventions that advance public health and medicine. Yet clinical research is complex, and scientific concepts are often complicated to explain. Several organizations have developed health- and disease-specific glossaries, which are often technical or intended for scientific stakeholders. Even glossaries developed for the general public are more focused on medicine and health, not research.

As a result, the MRCT Center developed a comprehensive and publicly available plain language glossary of clinical research terms and procedures—built collaboratively with patients, caregivers, and other clinical research industry stakeholders. Today we announce a collaboration between the MRCT Center and CDISC to sustain and expand the potential of this resource to provide standardized and harmonized plain language options for the technical language that is often used in participant-facing documents and materials.

Dr. Barbara Bierer, MRCT Center Faculty Director, enthusiastically endorsed the partnership. “Expanding access to the MRCT Center’s plain language glossary will advance health literacy, giving patients and their caregivers the resources they need to make informed decisions about their participation in clinical research.”

“Clear communication is essential to the success of research and the development of new treatments and therapies that people need,” said Rhonda Facile, VP, Partnerships and Business Development, CDISC. “CDISC is pleased to collaborate with the MRCT Center on this important initiative to advance health literacy.”

The resource will be governed via the robust CDISC Standards Development Process that invites input from the public broadly, expanded and sustained through the MRCT Center patient-centered consensus process, maintained and made freely available by both organizations working together to ensure the content’s quality. The plain language definitions developed for the MRCT Center Clinical Research Glossary will be included as a CDISC standard starting in 2023, and as such, will go through a public review process.  Click here to complete the March 2023 public review.

Please join the MRCT Center team for a webinar on April 5, 2023 from 11 AM – 12 PM EDT. Click here to register.

About CDISC

Clinical Data Interchange Standards Consortium is a non-profit organization that develops and advances data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a robust framework for generating accessible clinical research data. Driven by the belief that the true measure of data is its impact, CDISC convenes a global community of research experts representing a range of experiences and backgrounds to harness the collective power to drive more meaningful clinical research.

Template Data Sharing Governance Tools Released

In order to maximize the interoperability of anonymized data and reduce the contractual barriers and administrative burden(s) of data sharing, the MRCT Center developed three harmonized governance tools as part of the PCORI Open Science Pilot Project.

The resulting tools, which include a Template Data Contributor Agreement (DCA), a Template Data Use Agreement (DUA), and a Template Data Sharing Section of an Informed Consent Form (ICF), are intended to ease the implementation of data sharing among organizations that fund clinical research.

Standardizing Informed Consent Templates and Data Sharing Agreements

Revised ICF and DUA templates available.

Standardizing Informed Consent Forms (ICFs) and Data Use Agreements (DUAs) across multiple sponsors may considerably streamline the data sharing process.

A multi-stakeholder working group at the MRCT Center released revised ICF and DUA templates at the March Data Transparency Conference. The revised DUA template provides legal text for a data sharing agreement between a recipient institution and a supplying institution. The ICF provides suggested text for prospectively informing participants on how broadly their data will be shared and with whom. Further comments on these documents are welcome and can be sent to MRCT@harvard.edu.

Learn More about the ICF Template for trials with external sponsors  and the ICF Template for trials with no external sponsors.