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Before you begin your review and validation of submitted trial data, open or print the protocol, IRB, consent, and/or other trial-related documents so that you can compare trial details in the document(s) to those displayed in Protocol Abstraction. For instructions, see Editing and Replacing Documents . To facilitate the comparison, you can view and print the Trial Summary Report (TSR), which contains all data as submitted via CTRP Registration. For instructions, see Accessing Trial Summary Reports . How to Validate Submitted Trials
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Protocol and IRB documents are required for all Complete trials. Ensure that all required documents have been submitted and that these documents include information required for abstracting trials. For example, the informed consent document must be included in the Protocol document or submitted in a separate file. A summary of the protocol is required for all Abbreviated trials. How to Validate Trial-Related Documents
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Ensure that the relationships between statuses and dates follow the rules provided in the tables and diagrams that follow.
How to Review Trial Status Details
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Validating Funding
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How to Validate Funding Details
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For Complete trials, ensure that no duplicate IND/IDE records were registered. If a duplicate exists, use the Protocol document to verify which record is correct. If you are unable to determine the correct record, you may contact the trial submitter to request verification. How to Review Trial Funding Details
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How to Validate Trial Details
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These instructions pertain to complete trials that require XML documents for submission to ClinicalTrials.gov. How to Validate Regulatory Information
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Ensure that the following information is complete and accurate:
How to Validate Participating Sites
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