Jefferson Office of Human Research Protection

As part of the Quality Improvement Program, the OHR offers assistance in the creation and maintaining of study/regulatory and patient binders for clinical research studies. While the Quality Improvement Team is more than happy to meet with and assist any study personnel in their documentation methods, the OHR has provided all the tools needed to create your own binder. Documents for both study/regulatory and patient binders are provided on the link below.

The information provided covers the fundamental elements of initiating any oncology-related study at the SKCCC, from concept to activation. This will include the required committees and the sequence of committee reviews, key events that need to occur, and helpful checklists that will assist in making sure that all necessary activities have been completed prior to activation. The purpose of the study start-up process is to make sure that all oncology-related studies are being properly presented and discussed at all the required committees, and that the process of activating these studies is being done in an efficient and timely manner.

A list of resources for more information on federal guidance.