Clinical Trials Records - Investigator

Records that document research data and documentation gathered or created in the course of Phases I, II, or III of a clinical trial sponsored by an institution outside the University. Records may include case reports, study protocol and amendments, patient care data, objectives and purpose of the study, selection criteria, clinical procedures, FDA records, serious adverse events reports, study design and other documentation relating to study protocols. Does not include materials also maintained in official patient medical record.

Category

Research

Retention Period

Retain for a period of ten years after the submission of the final report and closeout procedures on the research project for which the clinical trials records were prepared or termination of the study, unless a longer retention period is specified by Emory policy, the sponsor, funding source, or regulation. Retain pediatric, vitro studies or research involving pregnant women for twenty-five years after the submission of the final report and closeout procedures on the research project for which the clinical trials records were prepared or termination of the study, unless a longer retention period is specified by Emory policy, the sponsor, funding source, or regulation. Records should be sent to the sponsor unless the sponsor in writing specifies that the records can be destroyed.

Disposition Instructions

Confidential destruction is required. Paper must be shredded, pulped, or incinerated; electronic records must be overwritten or the storage media physically destroyed. Deletion of information in computer files or on electronic storage media is not sufficient.

Last Updated: December 31, 2008