In some cases, you may be required to upload documents to ClinicalTrials.gov. These include:
The study Protocol and Statistical Analysis Plan (SAP)(often included in the protocol) - Required if results are required. Must be posted when results are posted
The Informed Consent Form - Required for federally-funded clinical trials IRB approved on or after January 21, 2019. Must be posted after enrollment closes but within 60 days of the last study visit by any subject.
To post documents to ClinicalTrials.gov, follow these instructions.
1) First, you will need to convert your document(s) to a PDF/A format.
2) Next, log in and open the record (your username is your email. the organization is "UColorado").
3) The record will open to the Record Summary Page. Scroll down the page to the Upload Documents section, and click "Open".
4) Click the "+ New Document" button.
5) Click "Continue", if prompted.
6) Select the Document Type and enter the Document Date.
The date must be included on the first page. If your document has a version date AND an IRB approval date on the first page, use the IRB approval Date.
7) Click "Choose File" and browse for your document. Remember to select the version that you saved as a PDF/A (this will still be a .pdf file type).
8) Click "Upload" to upload your document.
9) Don't forget to go back to the Record Summary page and click the green "Entry Complete" button when done!
