- A summary of the Final Rule and NIH policy;
- A table comparing and contrasting the Final Rule and NIH policy;
- A summary of changes to clinical trial registration and results information data elements resulting from the Final Rule. In particular, see Table 3 (page 11 of 11) for more rapid data element update requirements;
- NIH ‘Clinical Trial’ definition;
- NIH Clinical Trial Definition Decision Tree;
- NIH Definition of Clinical Trial Case Studies;
- NIH Definition of Clinical Trial Frequently Asked Questions (FAQ).
Each document attached within the Protocol Registration and Results System (PRS) requires a cover sheet bearing the official study title, NCT number, and date of the document. This generic cover sheet template can be completed with the details for your IRB-approved protocol and Statistical Analysis Plan (SAP) documents. Use Adobe Acrobat to combine the two document files (cover sheet + document) and save in archivable PDF/A format (required) prior to upload into the CT.gov Protocol Registration and Results System (PRS).
If you have any questions about these requirements or need help registering or reporting results for your clinical trial, please contact: