Project Close Out

Data Retention

The retention of research data at Case Western Reserve University is based upon the University Policy on the Custody of Research Data.

Data Retention Responsibilities

Both the university and Principal Investigator (PI) have responsibilities and rights concerning access to, transfer of, use of, storage and maintenance of research data. 

Case Western Reserve shall retain research data in sufficient detail and for an adequate period of time to enable appropriate responses to questions about accuracy, authenticity, primacy and compliance with laws and regulations governing the conduct of the research.

Principal Investigator Responsibilities:

1.  Serve as the custodian of research data, unless agreed on in writing otherwise and the agreement is on file with the University, and is responsible for the collection, management, and retention of research data.
2. Comply with terms of sponsored project agreements regarding data retention and storage. See specific guidelines below.
3. Archival of  research data for not less than three years after the final grant close-out or after publication resulting from the project, whichever occurs last, with original data retained whenever possible.
4. Determine and utilize reasonable and prudent methods of archiving, using University information technology resources where possible.
5. Where applicable take appropriate measures to protect confidential information. 
6. Ensuring that appropriate security policies and procedures are followed for data derived from animals, human subjects, recombinant DNA, etiological agents, radioactive materials, and the like.
7. To enable the University to meet its responsibilities related to custody of research data, the PI is obligated, upon appropriate request, to make all data available for review by the University, its officials or bodies, the external funding agency, journals in which data are published, or other external regulatory agencies. This obligation continues even after the PI leaves the University.
8. Be aware of additional circumstances that may justify longer periods of data retention. 
   1. Retaining data as long as necessary to protect any intellectual property resulting from the work.
   2.  If any charges regarding the research should arise, such as allegations of scientific misconduct or conflict of interest, data shall be retained until such charges are fully resolved.
   3. If the data involved constitute part of a student’s work toward a degree, they shall be retained at least until the degree is awarded or the student has abandoned the degree program.

Data Retention Guidelines

Research data should be retained in sufficient detail to enable appropriate responses to questions about accuracy, authenticity, primacy and compliance with laws and regulations governing the conduct of the research.

Data should be stored in an orderly system.

The PI should establish and maintain procedures for the protection and management of essential records.

Additional Data Retention Guidelines

• For federal funding projects this is a minimum of three (3) years from the date of submission of the final expenditure report to the funding agency or the date of study closure with the IRB, whichever is longer.If the research is conducted pursuant to a contract or agreement, data must be retained in accordance with the contract or agreement.
• For studies subject to HIPAA, signed HIPAA authorization forms (or if using a combined informed consent and HIPAA authorization form, the signed informed consent/authorization) must be retained for a minimum of six (6) years from the date it was obtained.
• For studies conducted under an IND, records must be retained for two (2) years after approval of a marketing application for the drug for the indication for which it is being investigated or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.
• For studies conducted under an IDE or HDE, records must be retained during the investigation and for a period of two (2) years after the latest of either: 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, a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification submission, or a request for De Novo classification.
• For research subject to VA regulations, records, including codes or keys linking subject data to identifiers, must be retained for six (6) years following the federal fiscal year end (September 30th) after the study has been closed by the VA.
• If the research involves intellectual property, data must be kept for as long as may be necessary to protect any intellectual property claims resulting from the work.
• If any charges regarding the research arise, such as allegations of misconduct in research or financial conflict of interest, data must be retained until such charges are fully resolved.
• If the research is being conducted by a student, data must be retained at least until the degree is awarded, or it is clear that the student has abandoned the work.

Data Destruction

PIs must destroy research data when required by laws, regulations, or other agreements, on or before a specified deadline, and follow the applicable process for destroying research data. 

The following is a rough guideline for destruction of data. Please contact [U]Tech for additional information.