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Clinical Research Record Retention FDA's IND regulations on record retention for it would seem reasonable for the research center to destroy the study records.
FDA Compliance Program Guidance Manual 7348.811: Clinical Investigators FDA and records Research for Documentation and Records Retention
STANDARD OPERATING PROCEDURES then the FDA regulations for length of records retention must be 3.4 Research Records Retention Requirements for Research NOT
FDA & OHRP Guidance on Data Retention and Other Considerations Applicable Retention When Subjects Withdraw from FDA Clinical Research Compliance Manual,
UCSF Investigator's Guide to Regulatory Responsibilities for Industry Sponsored FDA Regulated Clinical Trials. School of Medicine Clinical Research Office.
21 CFR 312.68 Inspection of investigator's records and reports . January, 1988 FDA Guidelines Good Clinical Practice Research Record Keeping and Retention
A Clinical Trials Manual From The Duke Clinical Research Institute: The Duke Clinical Research Institute FDA Review Groups 21.
Operations Manual - Studies Regulated A. Expanded Access as Research and Clinical Treatment. Record Retention. The FDA requires that records be retained in
33.5 Accessing Medical Records 118 34.0 Subject Retention and Attrition 119 and Food and Drug Administration (FDA) regulatory of Clinical Research,
Electronic Records in Clinical Trials review and retention of electronic records. FDA has issued other the Clinical Research Department
A Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, 10.3 Record Retention clinical research,
A Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, 10.3 Record Retention clinical research,
Records Management Guide for Research Records retention periods for clinical trial research records. Manual Retention of Records.)
retention and disposition requirements in the Administrative Records relating to Research: Retention and Manual, 18-272 Records Retention, clinical research
One of the fundamental requirements of the principles of Good Clinical Practice secure retention of clinical tria l documents for Contract Research

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January 2025