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
immediatelyafter 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?) SW: no, I do not. This page is not about the registration process/lifecycle/internal processes.
The study must be fully abstracted, and the abstracted study must be verified by the Submitter prior to accrual being reported to CTRP. SW: this is not accurate. The submitter doesn't have to verify the abstraction, as if there is no response after 5-business days after the TSR is sent, the system applies a verified processing status. Please go back to the previous wording. 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/Protocol studies, the overall trial status history must include an open/recruiting status
(i.e. overall trial and PS are active). - A Participating site's status history 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
When reporting accrual via Batch Upload and REST Services, ensure the accrual reporting type is properly set on the study(ies) SW: Set where?. 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 or Summary accrual.