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Lead Researcher Recordkeeping Responsibilities

Overview

The Office of Research (OR) maintains an official protocol file for each study to meet the University's regulatory obligations for record keeping. The IRB staff is not responsible for maintaining study documents for the researchers, or for providing copies of official documents to research staff. Keeping accurate and complete protocol records is the responsibility of the Lead Researcher.

Records Retention Requirements

Effective April 1, 2020:

In accordance with UC Office of the President policy, research records must be retained for 10 years after the end of the calendar year in which the research is completed unless otherwise specified in the award agreement. 

If research involves the investigation of FDA regulated products: Information/biospecimens must be retained for two years after an approved marketing application. If approval is not received, the information/biospecimens will be kept for 2 years after the investigation is discontinued and the FDA is notified per FDA sponsor requirements.

For more information on UCOP Retention and Disposition Requirements as of October 2018, visit their web page to view the matrix.*

*While signed consent forms are not considered an IRB administrative record for the purposes of this matrix, OHRP and FDA regulations require that signed consent form documents must be retained for a minimum of three years past the completion of a study. If a research study accesses protected health information (PHI) and is covered under the Health Insurance Portability Accountability Act (HIPAA) policy, consent forms are to be retained for a minimum of six years after the completion of a study.

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