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Page History
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- The submitter submits the trial. The trial has a processing status of Submitted.
- The CTRO Document Specialist performs validation on the Submitted trial:
- If the trial is not complete, the specialist sends a request to the submitter for information. The trial has a processing status of On Hold. When the CTRO receives the requested information, a Document Specialist takes the trial off hold. The trial's processing status returns to the previous status, which in this case would be Submitted.
- If the trial is not valid, the specialist rejects the submission. The trial has a processing status of Rejected.
- If the trial is complete and valid, the specialist accepts the submission. The trial has a processing status of Accepted.
- One or more CTRO Document Specialists perform abstraction on the Accepted trial, including administrative processing, scientific processing, and quality control. The trial has a processing status of Abstracted.
- The system sends the Trial Summary Report (TSR) of the Abstracted trial to the submitter. The trial has a processing status of Verification Pending.
- The submitter verifies the abstraction as per the TSR, and returns feedback to the CTRO within five business days after receiving the TSR.
The trial has a processing status of Abstraction Verified Response.Include Page Business Day Definition - Include v4.4 Business Day Definition - Include v4.4 - The CTRO Document Specialist decides, based on the feedback received, whether to restart administrative processing, scientific processing, or both for the trial (step 3).
- The CTRO Document Specialist completes the verification.
The following diagram illustrates diagrams illustrate the typical life cycle of a trial and the relationship between actions and processing statuses:
For more information, refer to Trial Processing Statuses and Amendment Process Life Cycle.