To prepare a study record:
- Register the study in CTRP. For information and instructions, refer to Getting Started with Registration in the NCI CTRP Registration User's Guide.
- New trial submissions are reviewed during the validation process. Protocol abstraction is performed by the CTRO immediately after validation. Refer to the below diagram for CTRP Trial Processing Life Cycle.
(Stephanie: Do you think we can/should include the screenshot above from the CTRO SOP on this page?)
The study must be fully abstracted, and the abstracted study must be verified by the Submitter prior to accrual being reported to CTRP. If the CTRO requests more information about the study once the study is registered, respond in a timely manner to facilitate the abstraction process. - For Complete studies the overall status must include an open status (i.e. overall trial and PS are active).
- Participating sites must include an open/recruiting study status before initial accrual can be loaded. Open/recruiting statuses include the following:
- Active
- Available
- Enrolling by Invitation
- Temporarily Closed to Accrual
- Temporarily Closed to Accrual and Intervention
- Temporarily Not Available
Note
When reporting accrual via Batch Upload and REST Services, ensure the accrual reporting type is properly set on the study(ies). Accrual records reported with a different accrual reporting type than what is on the study record will be rejected. To update the accrual reporting type for all studies other than Complete Non-Interventional, a request must be submitted to the CTRO (NCICTRO@mail.nih.gov) for approval. Center's can change the default accrual reporting type on Complete Non-Interventional studies within the Accrual application, as long as accrual has not been reported. Once accrual has been reported, a request will need to be submitted to the CTRO to change the accrual reporting type to Partial Subject.
