Date: November 27, 2017
PI Name: Marianne Woods
Study #: HIRB00006654
Study Name: "Creating, Training, and Implementing the Safety Reporting Processes for a Research Organization’s New Clinical Trials Program"
Date of Review: 11/27/2017
Date of Approval: 11/27/2017
The Homewood IRB reviewed the information provided for the above-mentioned project and has determined that this research does not qualify as federally-regulated human subjects research, and therefore does not require IRB approval. This determination has been made with the understanding that the proposed research either (a) does not involve a systematic research investigation designed to develop or contribute to generalizable knowledge, or (b) does not collect identifiable private data about a human participant.
You may proceed with the study at any time. No further communications with the HIRB are necessary unless the procedures in your project are changed in such a manner that would require IRB review or approval.
Please keep this message in your files for future reference. Thank you for contacting the Homewood IRB about this research and for providing the requested information to make this determination. Your cooperation is greatly appreciated.
Study Team Members:
Angelica Medina