Templates and Forms


Please note, when uploading study documents in to the IRB system, a standard naming convention should be used for study documents such as Study Protocol_V1 and Main ICF_V2.


Protocol Templates

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Informed Consent Guidelines
Code of Federal Regulations
Title 45 Public Welfare
Department of Health And Human Services Part 46 Protection of Human Subjects
46.116 General requirements for informed consent
46.117 Documentation of informed consent

Glossaries Of Lay Terms
Glossary of Lay Terms (Medical terms in lay language, from Stanford)
Lay Language for Medical Terms (University of Kentucky)
Lay Terminology (North Shore Long Island Jewish Health System)
Simplification Guide to Medical Terms (University of Michigan)

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Procedure MG.O-004.03 Consenting Non-English Speaking Research Subjects outlines the procedures for obtaining and documenting informed consent for non-English speaking participants.

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) (new window)

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HIPAA Forms

For more information regarding HIPAA regulations click here.

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Progress Summary Templates

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Participant Notification Form

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External Team Member Form

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Responsible Participant Statement

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IRB Authorization Agreement 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.

*IAA forms are signed by the Institutional Official (IO) at each institution

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