In your role as trial owner (original submitter or current owner), you can amend only Complete trials. The trials you own are listed when you use the Search My Trials feature. Refer to Searching for Trials. In addition to rules provided in Registering New Trials, the following rules apply to amendments:
- You can create a new NIH grant record only if you can provide all of the following details:
- Funding Mechanism
- NIH Institution Code
- Serial Number
- NCI Division/Program
- You can not change the following existing information:
- NCI trial identifier number
- NIH grant number
- IND/IDE serial number
- The following list is the minimum set of required documents that must be submitted with each amendment:
- Protocol document.
- IRB approval document.
A change memo document or protocol highlighted document:
A change memo is a document that contains a summary of changes as compared to the original, or last amended, trial submission.
A protocol highlighted document is a document that has been marked up, with or without using a Track Changes feature.
List of participating sites and contact information (for multi-site trials, if not included in the protocol document).
Informed consent (if not included in the protocol document) and only when there are documented changes to the consent.
When you are submitting an amendment, we recommended that you provide any additional documents that you think will be useful to the CTRO for reviewing and processing the amendment document.
A trial may have more than one owner. Review the recorded information carefully to see if another owner has modified the trial.
