Clinical Study Initiation and Tools
Clinical Trials at Emory Healthcare
Office of Quality Checklists
- All required forms are available on the Office for Clinical Research website
Clinical Research Key Points (CRKP) Summary and Sensitive Study Information
Studies on or after 7/1/2011 must submit a CRKP if conducted in an EHC facility. See criteria below:
- Any clinical research or a clinical trial conducted in an EHC facility including all hospitals, TEC, and ESA clinics
- Any clinical trial/research or expanded access with a drug or device
The Clinical Research Key Points provides 24-hour emergency contact information for the study team to ensure patient safety. It also contains clinically relevant research information for our healthcare partners providing clinical care to our patients/research subjects. The CRKP specifies to EHC Nursing their specific responsibilities/requirements within the context of the clinical trial/research as well as providing access to additional details about the research if needed. Find the mandate memorandum here. If the information in the CRKP Summary changes during the life of a study, submit a modification to the IRB with the revised CRKP Summary.
- Letter on Sensitive Studies - describes Emory's policy on when study information may be withheld from the medical record
- Request for Sensitive Study Status Worksheet - to be placed in eIRB
Clinical Trial ToolsThese tools were created in cooperation with the Clinical Trials Audit and Compliance Office (CTAC) and the Emory Office of Compliance for use by Investigators and their study teams. These are optional templates and may be freely modified to meet the needs of individual departments or trials. Find these tools posted on this webpage.
Winship Cancer Institute Resources
NOTE: Winship SOPs should be accessed via the Winship Cancer Institute website.
Cancer Therapy Evaluation Program (CTEP) Resources
For CTEP documents, see their Investigator Resources page.