A-Z Index  |  MCG Home  |  Site Search 

back to: Human Assurance Committee 

Previous Section  |  Table of Contents  |  Next Section

Informed Consent Document Templates

SECTION 17

Protocol Termination or Completion

At study termination or completion, a timely final report must be submitted to the Human Assurance Committee (HAC). It must include the number of enrolled, discontinued and completed subjects, and the number of signed informed consent forms in the investigator's files for the entire project. An HAC Form 111, Final Study Report, must be utilized.  If the study is industry sponsored, a copy of the sponsor termination letter should accompany the HAC Form 111 if utilized when the termination occurs during the approved project period.  The HAC Form 107, Clinical Study Status Report (CSSR), may be used if the termination coincides with the approval expiration date.  A phone call or e-mail message is inadequate to terminate a study.  Refer to section 16 for additional information on completing the HAC Form 107.  The completed form should be submitted to CJ-2103.

A study may not be terminated if subjects are in follow-up or if data are still being analyzed.

Sample Guidance Statement for the summarization report section:

"Twelve medical records were reviewed.  The data was gathered and protected as per the Description of Research Proposal.  The poster presentation was made at the July meeting of National Principal Investigators.  The study is now complete."

NOTE:  This is a suggestion to assist the investigators.  Please be as informative as possible.  Use of this guide does not guarantee that the termination request will be approved by the Human Assurance Committee.  This is a guide only.  If there are any questions, please contact Michelle Christiano, CCRC, CIP,  Director, at 706-721-1480.

Previous Section  |  Table of Contents  |  Next Section
 

OHRP  |  Research  |  Medical College of Georgia

Please email comments, suggestions, or questions to:

February 21, 2007