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

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.

• Letter on Sensitive Studies (PDF) - describes Emory's policy on when study information may be withheld from the medical record
• Request for Sensitive Study Status Worksheet (DOCX) - to be placed in eIRB

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.