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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
