The PI is responsible for the collection, management, maintenance and retention of research data accumulated under a research project.  The University must retain research data in sufficient detail and for an adequate period of time to enable appropriate responses to questions about accuracy, authenticity, privacy and compliance with laws and regulations governing the conduct of the research.  It is the PI's responsibility to determine what records need to be retained to comply with sponsor requirements.  PIs should adopt an orderly system of data organization and should communicate the chosen system to all members of a research group and to the appropriate administrative personnel, where applicable.  Particularly for long-term research projects, PIs should establish and maintain procedures for protection of essential records in the event of a natural disaster or other emergency.

Research data must be archived for a minimum of three years after the final project close-out, with original data retained wherever possible.  Some sponsors require a longer period of retention.  Some circumstances may require a longer period of retention such as:

• Data that must be kept for as long as necessary to protect intellectual property and complete patenting and licensing procedures for inventions resulting from the work;
• If any charges regarding the research arise, such as allegations of scientific misconduct, conflict of interest, or allocable an allowable costs, data must be retained at least until such charges are fully resolved; and
• If a student is involved in the research, data must be retained at least until the student's degree is awarded or it is clear that the student has abandoned work on the project.

Clinical Trials with a FDA Investigational New Drug Application (IND) must also comply with federal regulations (21 CFR 312.57 and 21 CFR 312.62) that apply to investigational drug records, investigator financial interest records and patient case histories.  Both regulations require retention of records and reports for the longest of:

1.   A period of two years following the date on which the results of the clinical investigation are submitted to the FDA in support of an application for a research Investigational New Drug Number or Investigational Device Exemption or marketing permit;

2.   A period of two years following the date on which an application for a research or marketing permit (in support of which the results of the clinical investigation were submitted to the FDA) is approved by the FDA; and

3.   A period of two years after the investigation is discontinued and FDA is notified of that fact.