Introduction

In brief, the research closure procedure only requires an administrative review, as long as the researcher has fulfilled all of the following closure submission requirements:

1. Recruitment of research subjects has closed
2. Data collection has been completed
3. All subjects have undergone the research procedures
4. Data analysis has been completed
5. Personal data information (PII) has been deleted

If there is an indication of a Non-Compliance report or Unanticipated Problems and Adverse Events on the closure application, KEP will review the closure application in accordance with the Non-Compliance review or Unanticipated Problems and Adverse Events review.

I. Research Closure Submission

A. Submission Type and Submission Time

a. Closure of research that has expired

Research closure submissions must be made within a maximum of one cycle before the expiration date of the research approval.

Example: A researcher wants to apply for research closure for a study whose KEP approval expires on April 4, 2023, therefore the researcher must apply for research closure no later than the March 2023 cycle.

B. Voluntary closure of research

The research closure form must be submitted to KEP within 30 days of completion or termination of all research activities. Voluntary research closure submissions can be made outside of the KEP monthly cycle.

C. Closure Submission Documents

Researchers must send the following documents to KEP to apply for research closure:

• Request for Research Closure Form
• Complaint / adverse event report documents that have not been reported to KEP (if any)
• Other supporting documents

Documents are sent to the email address kep@lpem-febui.org with the subject: Research Closure Request – (protocol number)