Templates and Forms

Translation Service: Chris Elznic, Client Success Manager, chris@ad-astrainc.com, Office number: +1 301.408.4242 Ext. 106, Ad Astra Inc., 8701 Georgia Ave Suite 808, Silver Spring, MD 20910, www.ad-astrainc.com (new window)

Protocol Templates

  • Biomedical Protocol Template
    • Must be used for investigational drugs, medical devices, special diets, radioactive materials, or other biomedical interventions or interactions
  • Social and Behavioral Template
    • Must be used for all Social and Behavioral Studies; such as, surveys, interviews, focus groups, behavioral interventions, and educational practices
  • Site Supplement Protocol Template
    • Must be used when GU is the IRB of record and the main protocol is a sponsor provided protocol

Code of Federal Regulations
Title 45 Public Welfare
Department of Health And Human Services Part 46 Protection of Human Subjects

Glossaries Of Lay Terms

Guidance for obtaining and documenting informed consent of subjects who do not speak English can be found at the OHRP website.


PLEASE NOTE: Along with the implementation of the new IRB system and associated documents, the HIPAA Authorization form has been incorporated into the ICF template. There is no longer a need for a separate HIPAA Authorization Form unless otherwise instructed due to special circumstances. 

For more information regarding HIPAA regulations click here.

Progress Summary Templates

Participant Notification Form

External Team Member Form

Responsible Participant Statement

IRB Authorization Agreement (IAA) Forms

For more information regarding the request to act as the IRB of Record (reviewing on the behalf of other participating sites), deferral of IRB oversight to another institution (relying site or ceded review), and/or reliance agreements (IAAs and IIAs), please click here.

Radiation Safety Forms