07/19/2023
Photo by Scott Graham on Unsplash
Posting Applicable Clinical Trials and expanded access on ClinicalTrials.gov was first required in the Food and Drug Administration Amendments Act of 2007 (FDAAA). The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands on the regulatory requirements and procedures for submitting registration and results posting to ClinicalTrials.gov. Applicable Clinical Trials (APT) are those that meet the requirements under 42 CFR 11.22(b), and a checklist and elaboration tool is available to assist with the determination. APT include certain drug, biologic, or medical device clinical trials and observational studies conducted in the United States or its territories. Studies other than APT may be submitted voluntarily, for example Phase I studies.
The National Library of Medicine (NLM) maintains the ClinicalTrials.gov website as a transparent database of study records for 1) patients and health care providers, and 2) researchers. Recently, the NLM launched a modernized ClinicalTrials.gov website to improve user experience including 1) improvements in searching for, viewing, and downloading the data, and modernized 2) Protocol Registration and Results System (PRS) used to submit data to the website. The classic view will remain available until 2024. If users have questions, they can review the FAQ on the transition document HERE.
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- The Clinical Pathways Team
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