$347 — Premium Tier

Clinical Investigations & IDE Toolkit: FDA Part 812 + ISO 14155 Templates

Clinical Investigations and IDE Toolkit — IDE application guide, clinical investigation plan, IRB checklist, adverse event SOP, site monitoring plan, and final study report template.

Get the Toolkit — $347

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What's Included

IDE Application Structure Guide (21 CFR Part 812)
Clinical Investigation Plan Template (ISO 14155:2020)
IRB/IEC Submission Checklist
Adverse Event and UADE Reporting SOP
Clinical Site Monitoring Plan
Final Clinical Study Report Template (ICH E3)

Benefits

IDE application guide maps directly to 21 CFR Part 812 sections FDA reviews
CIP template satisfies both FDA and EU investigational requirements simultaneously
AE reporting SOP includes 5-day vs 10-day vs annual reporting decision trees
Final study report pre-formatted for 510k, PMA, and De Novo submissions

Is This For You?

This toolkit is designed for teams facing these challenges:

IDE application deficient on first submission delaying study start
Clinical investigation plan missing ISO 14155 required elements
Adverse event reporting timelines unclear under pressure
Final study report not structured for FDA submission integration

Who This Is For

RA leads managing IDE submissions and clinical strategyClinical affairs directors overseeing investigational studiesRegulatory consultants supporting sponsor IDE applicationsClass III device manufacturers planning pivotal studies

Frequently Asked Questions

When is an IDE required?

An IDE is required for significant risk device studies involving human subjects. Non-significant risk devices require IRB approval but not an FDA IDE. The IDE application guide includes the NSR/SR determination framework.

Can these templates be used for EU clinical investigations?

Yes. The Clinical Investigation Plan template is aligned with both FDA 21 CFR Part 812 and ISO 14155:2020, which is the standard used for EU MDR clinical investigations.

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Ready to Get Started?

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

Get the Toolkit — $347

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