IRB Guidance: Post Project Procedures & Data Retention
This page addresses steps to be taken at the end of a study and maintaining research records.
When active data collection and data analysis activities have ended for a project, there are still a number of requirements and responsibilities for the Principal Investigator listed on the study.
After a study has concluded, research data must be retained at UW-Madison 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. It is the responsibility of the Principal Investigator to determine what needs to be retained under this policy.
Principal Investigator Responsibilities:
- The leadership of the scientific/technical aspects, and compliance with administrative aspects of the research;
- Creation of an orderly system of data organization, access, and retention. Must communicate the chosen system to all members of a research group and to the appropriate administrative personnel; and
- The stewardship and retention of research data as well as determinations concerning access to and appropriate use of data.
While the federal regulations governing human subjects research require the retention of research records for three years after the study is closed, the UW-Madison policy on records retention directs Principal Investigators to retain data for seven years. Research data must be archived for a minimum of seven years after the final project close-out, with original data retained whenever possible.
Records will normally be retained in the unit where they are produced. Research records must be retained on the UW-Madison campus, or in facilities under the auspices of UW-Madison, such as on UW-Madison servers or UW Box.
Investigator records are considered the official research file. The IRB office maintains copies of documents sent to the investigator, but these are not considered to be the official record. It is the Principal Investigator’s responsibility to maintain adequate documentation of research procedures/process. In the case of a request to review a research record file, an audit for example, all information must be readily available to be reviewed by the appropriate entity or individual in a reasonable manner.
Study team files may consist of, but are not limited to, the following documents:
- Protocol application;
- Consent forms;
- Any submissions to the IRB;
- Responses from the IRB for initial approval, changes, and continuing review;
- Other correspondence with the IRB including reports unanticipated problems and noncompliance;
- Correspondence with sponsors;
- Other study instruments such as surveys, questionnaires,
- Interview recordings and transcripts;
- Data sets and analyses of data.
See End of a Study