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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.
MRCT Center and Medable Launch First, Comprehensive IRB/EC Review Toolkit for Decentralized Clinical Trials. (2023, June 20). Business Wire.