Document Retention and Disposal

Document Retention

What

Clinical research documents and data must be retained in accordance with ISMMS policies, federal regulations and the requirements of the study sponsor/funding agency.

Industry Sponsored Trials

Records must be retained for the length of time outlined in the contract with the sponsor.

ISMMS Data Retention Policy

Per Mount Sinai institutional policy, research data that supports any publication must be kept at least Six (6) years after the date of publication. (Source: Faculty Handbook Data Retention Policy and Graduate School Student Handbook)

Use the longest retention period when the Mount Sinai policy differs from that of the funding organization. Contracts may specify different time periods; any contractual obligation for longer retention would supersede any other retention policies.

Data produced through funded research that does not support a publication must be retained according to the funder policy.  For example, per Section 8.4.2 of the NIH Grants Policy Statement, grantee institutions are required to keep the data for 3 years following closeout of a grant or contract agreement.

Questions

Contact Research Compliance.

Document Storage

Data Storage

For Data Storage and Management information, refer to the Mount Sinai Information Technology page.

Records Management

For Records Management information, refer to the Mount Sinai Information Technology page.

Document Disposal

When

Industry Sponsored Studies – Once the contractual and regulatory document retention requirements have been met, contact the study sponsor to obtain written approval before disposing of Human Research records.The study team must ensure data disposal is compliant with the institutional regulations as outlined below.

How

Paper Records – Contact Research Compliance.

Questions

Contact Research Compliance.

Research 411 Portal

Still Need Help?