MRCT Center and Medable Launch Toolkit for Decentralized Clinical Trials
Medable and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) have announced a toolkit for Institutional Review Boards (IRBs)/Ethics Committees (ECs) to standardize decentralized clinical trial (DCT) ethics review. The toolkit provides a common framework, tools, and best practices for uniform ethical review and approval and provides a roadmap for the ethical conduct of DCTs.
A task force consisting of Advarra, MRCT Center, Medable, FDA, Office for Human Research Protection (OHRP), ethics committees, sites, patients, and patient advocates collaborated for more than 18 months to create the new DCT IRB/EC Toolkit. It encompasses 13 guides (organized around three themes of people, data collection, and data oversight)—addressing each common element of a DCT. These range from eConsent, eCOA/ePRO, wearable devices, remote telehealth visits, and more.
Reference
MRCT Center and Medable Launch First, Comprehensive IRB/EC Review Toolkit for Decentralized Clinical Trials. (2023, June 20). Business Wire.
Telemedicine Considerations When Conducting Decentralized Clinical Trials
January 14th 2025Compliance with state telemedicine requirements is imperative, as not only will most clinical trial sponsors contractually require such compliance, but non-compliance may also subject the practitioner to licensure violations and liability.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
