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115.2 Organization Policy on Protocol Record Retention Requirements for Investigators

August 2010

The Organization requires that investigators maintain research records for approved human subjects research protocols in accordance with federal and organizational requirements.  The data stored must be kept in a secure, protected manner in accordance with JHM IRB guidance as posted on the JHM IRB web site, or in accord with other JHU policies.  Requirements for specific types of research are noted below:

All Studies

HIPAA: Under the HIPAA Privacy Rule, subjects have the right to ask Hopkins for an accounting of certain disclosures of their identifiable health information for a period dating six years from the date of the last covered disclosure.  To ensure that Hopkins can meet this accounting requirement, the School of Medicine requires investigators to retain study records, along with records of all disclosures of study information, for the following time periods:

  1. At least 7 years after the last subject has completed his or her participation in the study, or
  2. The date of the last disclosure of identifiable health information from study records, if disclosures continue after all subjects have completed the study [45 CFR 164.528]. 

This requirement to retain study records and to account for disclosures also applies to research that involves the secondary use of medical records or other identifiable health information.

For research involving children

The School of Medicine requires study records to be retained (at a minimum) until the child subject reaches the age of 23.

Exceptions

Where questions have been raised regarding the validity of published data, investigators must preserve original data until such questions have been resolved to the satisfaction of the Institution and any involved government agencies.  The chief of each research unit must decide whether to preserve original data for a given number of years or for the life of the unit.

FDA Regulations

For Investigational New Drug (IND) research involving drugs, biologics, and other “test articles,” the FDA requirements must be met.  Sponsors and investigators must retain “records and reports required by this part for 2 years after a marketing application is approved for the drug; or if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and the FDA so notified” [21 CFR 312.61(c)].

For Investigational Device Exemption (IDE) research, the FDA requires the investigator or sponsor to maintain the records “for a period of 2 years after the latter of the following two dates:  The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol” [21 CFR 812.140(d)].



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