Protocol Templates

Which Protocol Template and Protocol checklist should I use?

For multisite studies where Emory is not the lead site (industry-sponsored or otherwise):

  • Use our Supplement to Sponsor Protocol Template. Upload this supplement plus the study-wide protocol in the smartform.
    • This supplement template was updated with select revisions on September 6, 2024 to align with the updated Biomedical Protocol Template. The latest template version is titled SUPPLEMENT-24-09; however the prior version dated 01/30/23 may also be accepted at this time.
  • Exception: studies that will be reviewed by an external IRB should follow the guidance on this page instead. See that page for guidance on whether Emory would rely on an external IRB, as well.

For all other studies:

  • Use our Biomedical Protocol Template if your study involves biomedical/health-related research and includes clinical procedures, drugs, devices, or tests (except for sociobehavioral studies with procedures limited to minimal, non-invasive sampling methods or simple blood draw/venipuncture). 
    • Studies created in eIRB on or after October 1, 2024 are required to use the latest protocol template. The IRB will accept templates stamped with "BIOMED-24-09" or a more recent date. The latest version available is stamped with "BIOMED-24-10"
  • Use our Sociobehavioral Protocol Template (including the embedded checklist) if your study involves interviews, surveys, focus groups, or behavioral interventions. This latest template version is dated 1/30/2023.
  • Use our Chart Review Protocol Template (including the embedded checklist) for studies involving solely a review of medical charts. If your study involves solely the review of charts at CHOA, submit to the CHOA IRB instead. This latest template version is dated 1/30/2023.
  • Use our Registry, Repository, or Database Protocol Template(including the embedded checklist) for projects creating a registry, biospecimen repositories, or databases created, even if partially, to conduct research projects in the future. If this registry, repository, or database will only include data or biospecimens from CHOA participants, submit to the CHOA IRB instead. This latest template version is dated 1/30/2023.
  • Use our Secondary Data/Biospecimen Analysis Protocol Template (including the embedded checklist) for studies that are solely using previously collected data or biospecimens. This latest template version is dated 1/30/2023.
  • If you are using a Humanitarian Use Device for treatment purposes, use our HUD for Treatment Use template. 

Winship Cancer Institute

Studies taking place at the Winship Cancer Institute should use the Winship Clinical Protocol Template. Please contact the Meegan Barrett, Protocol Writer, at meegan.barrett@emory.edu with any questions about the template. Note that the Biomedical Protocol Checklist will also be required for clinical trials conducted at the Winship Cancer Institute. 

Guidance Information

  • NIH Protocol building tool for Phase 2 or 3 IND/IDE Trials: Highly encouraged to refer to this when submitting NIH grants for these types of studies. Ensure that you are covering all these elements when creating your protocol using our templates. If NIH requires you to use their template, you will be required to create a Supplement to Sponsor Protocol Template with your protocol.

Please remember:

  • Grant applications are not acceptable in lieu of protocols

  • Sponsor-developed multisite protocols are acceptable, but when Emory IRB is reviewing for our site, we also need the "Supplement to Sponsor Protocol".

  • To ensure that all the required sections are considered and added to the protocols, you must complete the embedded protocol checklist. 
  • Please do not copy/paste into your own word document because this will remove the headers/footers/version dates.
  • Please always use the latest protocol version which you can find on this page.