REGISTRY SNAPSHOT: Clinical Trial Register of Singapore
Knowing which countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial…
Topic
Clinical Disclosure Reporting
REGISTRY SNAPSHOT: Central Committee on Research Involving Human Subjects (CCMO)
Knowing what countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial…
Questions answered on FDA’s draft guidance on civil money penalties for ClinicalTrials.gov
The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on civil monetary penalties of up to $10,000 per day for failing to…
VIDEO: Clinical Trial Disclosures; More Transparency in the Future
Ed Miseta, Editor of Clinical Leader, interviews Joe Archer, Associate Director of Trial Disclosure Services at DIA 2013. Archer discusses clinical trial disclosures, why they are important to…
Clinical Trial Disclosure: More “FDA” Needed in Past and Present Acts
Federal mandates calling for transparency of clinical trial information have been in place in the United States since 1997, but a recent move will finally give the current…
Clinical Disclosure Reporting: Are You Prepared to Meet the Expanding Requirements?
A group of House Democrats led by Congressman Edward Markey (D-Mass.) on Aug. 2, 2012 introduced the Trial and Experimental Studies Transparency (TEST) Act of 2012 (H.R. 6272),…