When to Close the Study

When IRB Approval Expires (under Manage the Study)

Study Closure

Data Analysis after Study Closure

Clinicaltrials.gov Study Results

Study Record Management

When to Close the Study

The Principal Investigator can close the study:

  1. When all human studies activity is finished. All the following must be concluded: subject recruitment, study participation, and follow-up; collection and analysis of data containing any subject identifiers are completed.

  2. When the study sponsor, if any, officially confirms that the study is closed or the study site is closed. Investigators must provide the IRB with documentation of study closure by the sponsor.

Study Closure

The Principal Investigator should complete the Research Report form reporting that all human studies activities are concluded. In addition, the investigator should submit an electronic copy of the abstract updated to reflect end of study, to irb@llu.edu. The IRB number must be referenced in the subject heading.

For Clinical Studies:

CTC Closure Notifications

CTC Financial Reconciliation

Data Analysis after Study Closure

Can data analysis continue after a study has been closed with the IRB?

Yes, if subject identifiers and/or links to identifiable data have been destroyed. At the close of formal study activities involving subjects and data collection, investigators should consider when subject identifiers may safely be destroyed (i.e., identifiers are no longer required for scientific or regulatory purposes). The remaining data or tissue samples may then be used for secondary analysis and will not be considered human subject research.

Removing subject identifiers may not sufficiently address Privacy (HIPAA) issues since the data may still contain some of the data elements that are protected under the HIPAA privacy rules. Research data with any HIPAA identifiers (download) may NOT be removed from the institution without approval of the Privacy Officer and the IRB.

Clinicaltrials.gov Posting of Study Results

If an investigator is the “responsible party” as defined in FDA regulations, he/she is responsible for posting study results to clinicaltrials.gov within a year of completing data collection. See link for further information. PRS Information: U.S. Public Law 110-85.

Study Record Management

Investigators will maintain documentation and record-keeping as required by applicable law and institutional policy. This responsibility includes storage of confidential data in a secure manner that assures only authorized personnel will have access.

How long should study records be stored?

See the attached chart for the appropriate retention period.

Investigators are responsible for retaining the records of all IRB-approved projects for a minimum of 3 years (but see next paragraph) after completion of the research or publication.

There are factors that require many records be kept for longer than 3 years. HIPAA requirements mandate covered entities retain required documentation for six years from the date of its creation or the date when it last was in effect, whichever is later (45 CFR 164.316(b)(2)). Research conducted under an IND or IDE should not be destroyed without the permission of the sponsor since it can take many years to get a product to market through the FDA process. In addition, records subject to litigation should not be destroyed even if the records retention schedule would otherwise allow it. Investigators are also advised to ascertain the retention requirements of their certification, licensing, and/or professional bodies, as appropriate; since these bodies may have stricter requirements.

Where should study records be stored?

Records must be stored in a LLU-approved, secured location. Initially, the records are kept in the department or institute for easy access. Older records may be transferred to the Archives department, Del Webb Memorial Library. Label the stored material with: name of investigator, state who may access the data and when the data may be destroyed.

The FDA may audit records at any time during this period of time and records must be available.