Clinical Investigations & IDE Toolkit
FDA IDE applications, clinical investigation plans, IRB submissions, adverse event SOPs, monitoring plans, and final study reports — built for the way FDA reviews them.
What You Get
IDE Application Structure Guide (21 CFR Part 812)
Complete framework for structuring an Investigational Device Exemption application. Covers all required IDE sections: report of prior investigations, investigational plan, description of device, monitoring procedures, labeling, IRB information, and investigator agreements. Includes FDA reviewer expectations for each section and common deficiency patterns.
Clinical Investigation Plan (CIP) Template
Comprehensive clinical investigation plan template aligned with FDA 21 CFR Part 812 and ISO 14155:2020. Structured sections for study objectives, design rationale, subject selection criteria, procedures, statistical analysis plan, adverse event definitions, stopping rules, and data management plan.
IRB/IEC Submission Checklist
Complete checklist for Institutional Review Board (FDA) and Independent Ethics Committee (EU) submissions. Covers required documents, consent form elements, protocol requirements, device information, investigator qualifications, and the expedited review criteria that can accelerate approval timelines.
Adverse Event and Unanticipated Device Effect Reporting SOP
Complete adverse event reporting procedure covering FDA 21 CFR 812.150 and ISO 14155 requirements. Includes definitions (SAE, SADE, UADE), reporting timelines (5-day, 10-day), MDR reportability decision algorithm, IRB notification requirements, and the documentation chain from site to sponsor to FDA.
Clinical Site Monitoring Plan
Risk-based monitoring plan template for clinical investigation oversight. Covers site qualification, initiation, routine monitoring, and close-out visits. Includes monitoring checklists for data verification, informed consent review, protocol compliance, and investigational device accountability. Structured for both on-site and remote monitoring approaches.
Final Clinical Study Report Template (FDA/ICH E3)
Structured final study report template aligned with ICH E3 guidance and FDA expectations for IDE study completion. Covers study synopsis, background, objectives, methods, results, safety analysis, discussion, and conclusions. Pre-formatted for 510(k), PMA, and De Novo submissions as clinical evidence documentation.
Why It Works
IDE-ready application structure
The IDE application guide maps directly to 21 CFR Part 812 requirements with FDA reviewer expectations noted throughout — so your application is structured the way FDA reads it.
ISO 14155 and FDA aligned CIP
The clinical investigation plan satisfies both FDA and EU investigational requirements simultaneously — reducing rework when you need to run parallel investigations.
Adverse event reporting built for pressure
The AE reporting SOP includes decision trees for the 5-day vs 10-day vs annual reporting calls — the decisions that matter when an SAE occurs at a site at 11pm.
From the Field
"Clinical investigations are where device companies lose months — either because the IDE is deficient or the study design won't support the submission. These templates reflect what FDA actually approves, not what textbooks say."
"The adverse event SOP and monitoring plan alone would have saved us a full quarter on our last IDE study. Having the FDA reporting timeline decision tree is the piece most sponsors get wrong under pressure."
FAQ
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 structure 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. The IRB checklist covers both FDA IRB and EU IEC requirements.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use and customization for your specific investigation.
Ready to get started?
6 templates. Instant access. Built for regulated medical device clinical programs.
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