You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
FDA announced the availability of a new Draft Guidance Document for industry entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.”
Topics: New FDA Draft Guidance, clinicaltrials.gov
A well-controlled clinical trial is much like a well controlled experiment. They are both rooted in the cornerstone of the scientific method. What exactly is a clinical trial? According to clinicaltrials.gov, “In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, for example, diet.” In the 21 CFR 314.126, the FDA lays out regulations as to what makes an “Adequate and Well-Controlled study” as one that has:
Clinicaltrials.gov is a database of clinical research trials being conducted both in the United States and internationally and is intended to be a resource for patients and researchers alike. Housed by the United States National Library of Medicine, clinicaltrials.gov currently has postings for over 257,000 clinical studies that are being conducted in over 200 countries. On January 18, 2018, the “Final Rule for Clinical Trials Registration and Results Submission” will go into effect. This rule provides further clarification on the “What, How, and When” of clinical trial reporting requirements.
Topics: Clinical Studies, FDA, clinicaltrials.gov