$247 — Standard Tier

Medical Device Clinical Ethics & IRB Toolkit: Human Subjects Research Templates

Medical Device Ethics and IRB Toolkit — IRB application template, informed consent form, protocol amendment procedure, adverse event reporting to IRB, continuing review, and IRB closure request.

Get the Toolkit — $247

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What's Included

IRB Application Template (FDA 21 CFR Part 56 + 45 CFR Part 46)
Informed Consent Form Template (21 CFR 50.25 Required Elements)
Protocol Amendment Submission Template
Adverse Event and Unanticipated Problem Reporting to IRB Template
Continuing Review Application Template
IRB Study Closure Request Template

Benefits

IRB application covers all required elements under 21 CFR Part 56 and Common Rule
Informed consent template includes all 8 required elements plus 6 additional elements under 21 CFR 50.25
Protocol amendment template covers impact assessment and continuation justification
AE/unanticipated problem report template meets IRB reporting timeline requirements

Is This For You?

This toolkit is designed for teams facing these challenges:

IRB returning application as incomplete due to missing required elements
Informed consent form missing required FDA disclosure elements
Protocol amendments submitted without adequate impact assessment causing IRB hold
Adverse event reporting to IRB untimely or missing required information

Who This Is For

Clinical research coordinators preparing IRB applicationsRA leads managing regulatory compliance for clinical investigationsSponsors conducting first-in-human medical device studiesResearch teams at academic medical centers conducting device studies

Frequently Asked Questions

Is IRB approval required for all medical device clinical studies?

IRB approval is required for all research involving human subjects conducted under an FDA-regulated investigation. This includes IDE studies and any clinical investigations used to support FDA submissions.

What format are the documents?

All documents are editable Word templates.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $247

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