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IRB Submission Documents (Protocol Templates, Submission Forms, Consent Templates)
Submission to the HRPP for review of institutional requirements and IRB for review for the approval criteria may require different documents. Listed below are several templates to assist Investigators in creating and submitting their research protocols to the Yale IRB.
Listed below are several templates to assist Investigators in creating and submitting their research protocols to the Yale IRB:
- HRP-503D - Exemption Request Form
- HRP-503G - Not Human Subjects Template
- HRP-503H - Secondary Data Analysis Template
- HRP-593 - Humanitarian Use Device Template
- Medical Record Review Request Template
- Protocol Template: Devices
- Protocol Template: Investigational Drug
- Protocol Template: Observational Study of Individual or Group
- Protocol Template: Repository
- Protocol Template: Social Behavioral Research
- Yale HRP-503X Protocol for Expanded Access Programs (EAPs)
See also link to Protocol Builder which is a web-based application that offers over 10 different standardized protocol templates for investigator initiated biomedical and social behavioral research.
Listed below are several templates to assist Investigators in creating and submitting their research protocols to the Yale IRB:
Listed below are several templates to assist Investigators in creating informed consent document(s):
- Consent Glossary of preferred and required terms for consent forms
- Adolescent Assent
- Child Assent
- Compound Authorization and Consent Template Biomedical Research
- Compound Authorization and Consent Template Social Behavioral and Educational Research
- Consent Addendum
- Consent Template Social Behavioral and Educational Research
- Emergency Expanded Use Consent
- Information Sheet
- Parental Permission Form
- Video-Audio Consent