01 Aug ‘Voice of the Clinical Research Professional’ Heard in Comments Submitted to FDA on DCTs
Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S. Food and Drug Administration (FDA) in response to the agency’s recent draft guidance on DCTs.
Following the release of some initial reactions to the draft guidance in May, volunteer members of ACRP’s DCT Think Tank Regulatory Working Group and other subject matter experts, including the ACRP Content Committee and ACRP Fellows, took a closer look at how FDA worded its document on “Decentralized Clinical Trials for Drugs, Biological Products, and Devices—Guidance for Industry, Investigators, and Other Stakeholders.” Read more…