Created 06/2009 All studies, other than Phase I studies, that are interventional*, include a drug, device, or biologic, have at least 1 site in the U.S., and were ongoing after 9/27/07 MUST report results of the trial on clinicaltrials.gov. Investigators are required to report results within 12 months of the primary completion date** of the […]
Training
Download the Training Template (DOC).
Study Termination Visit
Download the Study Termination Visit Template (DOC).
Sponsor CRO Audit
Download the Sponsor CRO Audit Template (DOC).
Reporting Unanticipated Problems, SAEs, and Adverse Drug/Device Events
Download the Reporting UPs, SAEs, and Adverse Drug/Device Events Template (DOC).
Preparation and Handling of Laboratory Samples
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Patient Recruitment
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Monitoring Visits
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Management of Source Documents and Case Report Forms
Download the Management of Source Documents and Case Report Forms Template (DOC).
IRB Approval
Download the IRB Approval Template (DOC).