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  1. Register the study in CTRP. For information and instructions, refer to Getting Started with Registration in the NCI CTRP Registration User's Guide.
  2. 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.
    Image Removed
    (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.that abstraction verified before accrual can be submitted 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.
  3. For Complete/Protocol studies, the overall trial status history must overall trial status history must include an open/recruiting status(i.e. overall trial and PS are active).
  4. A Participating A Participating site's status history must 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


Info
titleNote

When reporting accrual via Batch Upload and REST Services, ensure the accrual reporting type is properly set on the study(ies) SW:  Set where?in the CTRP Accrual application. 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  Centers 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.