Children’s Oncology Group Therapeutic Trials Team

Starting Your Study

The sponsor of the trial will provide the relevant study materials to the Emory investigator. When the trial is investigator-initiated, the Emory investigator will need to obtain the written information on the drug/device and is responsible for the development of the written protocol and informed consent forms. The investigator must develop the informed consent form by using the Informed Consent Template on the Emory IRB website. This template contains required language and the IRB stamp placeholder. If the sponsor provides the investigator with a sample informed consent form, the investigator will need to incorporate the required Emory language and IRB stamp placeholder from the IRB Informed Consent Template.

There may be multiple approvals required for your clinical trial. Please see Appendix 1 at the end of this guidance to determine which committee approvals are necessary for your clinical trial.

Study Start Up Checklist

  1. Obtain study material from sponsor; if investigator-initiated, obtain written material on the drug/device and develop the written protocol. Note: If the sponsor requires you to sign a confidentiality disclosure agreement (CDA) prior to sending you the study material, submit the CDA to the Office of Sponsored Programs for approval before signing it.
  2. Identify study personnel
  3. Decide which Emory approvals you need to obtain (see CTAC Guidebook Appendix 1) and complete applications
    • IRB submission via eIRB for Emory IRB or Form A/B for Western IRB (Visit the Institutional Review Board for WIRB eligibility requirements)
    • OCR submission for studies with billable items and services
    • OSP submission via EPEX for grants and contracts
    • ORC submission for all sponsor-investigator studies from Winship Cancer Institute
    • COI submission via eCOI
    • Radiation safety, if applicable
    • Biosafety, if applicable
    • IDS submission, if applicable. If studies are already routed through OCR, OCR will initiate the contact to IDS.
    • Emory Healthcare Office of Quality Checklist
    • Grady Office of Grant Administration. Seek financial clearance for all studies using Grady as a site.
    • Application of the Form 1572

    Note: If changes to protocol or other study material occurs during IRB submission and before approval submit the revised documentation to OCR and OSP as well to eliminate waiting time in approvals.

  4. After IRB approval seek the following approvals, if applicable:
    - Grady Research Oversight Committee  (GROC)
    - Veterans Affairs Research Development Committee (VA R&D)
  5. Ensure proper institutional credentialing and training of study personnel (see Chapter 2 of the CTAC Guidebook)
  6. Document study-specific training for each study personnel
  7. Complete the Form FDA 1572 (drug studies) or Investigator Agreement (device studies)
  8. Develop or complete the Delegation of Authority (DOA) log with specific study tasks delegated from the PI