Program records

Scientific and other technical records

Program reports: Retain programmatic/technical progress and final reports for at least three years after submission of the final report.

Projects that resulted in an invention or discovery: When an invention has resulted from the project, check with the Office of Technology Transfer for advice on retention of relevant records.

Scientific data: Retain the original data and all project records for at least three years after submission of the final report or award termination. Most such records are retained for many years. After the required retention period, the principal investigator/project leader may make the decision to retain the records or to discard them when the records are determined to be no longer useful for research or educational purposes.

Clinical study records

Corporate clinical study agreements include a provision specifying the required period of record retention for source documents, which may differ depending on the type of study and, ultimately, the success of the test product. The source (essential) documents must be maintained according to FDA regulations. The sponsor should notify UM and the investigator when the records are no longer required. The ICH Guidance for Industry - E6 Good Clinical Practice: Consolidated Guidance is a good resource regarding essential documents, retention, and audit.

For studies involving children, records are to be retained indefinitely.

Faculty transfers

Project records (data, etc.) generated at UMB are to be retained at UMB for at least the required retention period. The departing faculty member may take copies of these records.

Clinical study data must remain at UMB. Confidentiality provisions of the award as well as HIPAA regulations will generally prohibit the departing faculty member from retaining copies of these data.