Protocol Templates

Which Protocol Template and Protocol checklist should I use?

Use our Biomedical Protocol template which includes the checklist if your study involves clinical procedures or tests (except for behavioral studies where the only collected sample is obtained via a non-invasive method, for example, saliva for cortisol tests).  Last Version 1/19/2022

Use our Supplement to Sponsor Protocol template which includes the checklist for studies that are industry-sponsored and industry-initiated, or when we are one of the sites in a multisite study we are not leading. You will be required to attach these forms plus the main protocol from the sponsor to the submission. Last Version 1/19/2022

Use our Sociobehavioral Protocol Template which includes the checklist if your study involves interviews, surveys, focus groups, or behavioral interventions. Last Version 1/19/2022

Use our Chart Review Protocol Template which includes the 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. Last Version 1/19/2022

Use our Registry, Repository, or Database Protocol Template which includes the 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. Last Version 1/19/2022

Use our Secondary Data/Biospecimen Analysis Protocol Template which includes the checklist for studies that are solely using previously collected data or biospecimens.  Last Version 1/19/2022

If you are using a Humanitarian Use Device for treatment purposes, use our HUD for Treatment Use template. 

Winship Cancer Institute

Use the Winship Clinical Protocol Template and our Biomedical Protocol Checklist 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 is IRB of record, we also need the "Supplement to Sponsor Protocol".

  • Emory Investigator-initiated protocols: You must use the relevant template.

  • To ensure that all the required sections are considered and added to the protocols, you must submit the appropriate checklist with each protocol. If you used our previous version of the protocol templates that had restrictions, you are no required to use the checklist. If you are modifying your protocol and use the new templates, you will be required to attach the checklist the first time you submit your protocol to the IRB.