Created 03/07/2017Revised 10/05/2017Administratively Revised 4/30/2019 Washington University Education in Good Clinical Practices I. PurposeII. PolicyIII. Definition of a Clinical TrialIV. ApplicabilityV. Educational RequirementsVI. FrequencyVII. Effective DateVIII. Frequently Asked Questions I. Purpose Washington University in St. Louis is committed to assuring the safety, integrity and quality of clinical trials as part of its mission to foster excellence in […]
Reporting Results on Clinicaltrials.gov
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
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Study Termination Visit
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Sponsor CRO Audit
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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).