NIH recently implemented enhanced efforts to help ensure information about clinical trials is widely available to the public. These efforts include the “Final Rule” (42 CFR Part 11), which clarifies and expands the legal requirements for registration and results submission of clinical trials of FDA-regulated products, as well as a complementary policy requiring all NIH-funded clinical trials (including those not covered by the regulations) to be registered and have results submitted to ClinicalTrials.gov. Attendees of this session will gain a better understanding of these requirements. They will also be given an overview of registration and results reporting to ClinicalTrials.gov, an introduction to the Protocol Registration and Results System (PRS) Guided Tutorials, and a brief update on modernization efforts currently underway at ClinicalTrials.gov.
Note: Individual studies may need to meet requirements not covered in this presentation. These include but are not limited to policies detailed in the following links: [ Ссылка ], [ Ссылка ], and [ Ссылка ].
