Additional Resources
- Brief CT.gov Registration Highlights
- 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. Note: 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)
- Generic Cover Sheet Template. 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 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).