Once you are finished collecting data and following up on participants you have enrolled, it’s time to close your project.
Study Closure Report.
A Hartford HealthCare Study Closure Report form and final report must be submitted to close out a research study. This is done when the human subject component is complete. This is necessary so that the HRPP office knows the project is over, and they no longer need to track the project. It also prevents any further notifications related to the project from being sent to you. This form should be completed via the HHC iRIS system and the final report should be attached to the form prior to submission to the IRB. One the study has been closed no further research related activity may occur, including analysis of data for the purpose of publications and presentations.
Please note: The IRB will not review new research applications if the investigator has not completed the required termination form for another study.
Research Data/File Storage
Data collected during the life of your project must remain on file and be accessible for a certain amount of time after your project officially ends. The HRPP office should communicate this information to you when the process your closure report.
Data Storage Requirements
- OHRP Requirements
45 CFR 46 requires research records to be retained for at least 3 years after the completion of the research.
- HIPAA Requirements
Any research that involved collecting identifiable health information is subject to HIPAA requirements. As a result records must be retained for a minimum of 6 years after each subject signed an authorization.
- FDA Requirements
Any research that involved drugs, devices, or biologics being tested in humans must have records retained for a period of 2 years following the date a marketing application is approved 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. Please note - this length of time can be much greater than 2 years. You should receive written confirmation from the sponsor and/or FDA granting permission to destroy the records. (21CFR312.62.c)
If you have any questions about these requirements or the review process, please contact us 860.972.2893 or [email protected].