Clinical Study Initiation and Tools

NOTE: More information regarding clinical studies, including IRB and other research fees, can be found on the Office for Clinical Research website.

Clinical Trials at Emory Healthcare

Office of Quality Checklists

Clinical Research Key Points (CRKP) Summary and Sensitive Study Information

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.

Mandate Memorandum (PDF)

Study teams should submit the Clinical Research Key Points (CRKP) in eIRB.

The CRKP consolidates three previously separate forms:

  • Clinical Research Key Points
  • OoQ Clinical Research Readiness Checklist
  • EHC Nursing Clinical Research Preparedness Checklist

Study teams will now submit the CRKP electronically via eIRB for all clinical trials, including studies reviewed by WCG IRB.

Clinical Research Coordinators (CRC) will continue to submit the EML and Radiology Checklists, if applicable, directly to the OoQ. CRCs no longer have to obtain signatures from EML or Radiology prior to submission. EML and Radiology will sign approvals electronically.

Note: 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.

Clinical Trial Tools

These 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 the Clinical Trials Audit and Compliance page.

Cancer Studies

Winship Cancer Institute Resources

NOTE: Winship SOPs should be accessed via the Winship Cancer Institute website.

Winship Cancer Institute website

Cancer Therapy Evaluation Program (CTEP) Resources

For CTEP documents, see their Investigator Resources page.

Investigator Resources page