Clinical Investigation Documents: Plan, Investigator Brochure and Report
Clinical investigation documentation serves different readers at different stages. The plan defines the study before it begins, the investigator brochure communicates relevant device information, and the report accounts for the completed investigation. A controlling procedure coordinates responsibilities and conduct across the study.
Keep the study definition consistent
Identify the device and configuration, rationale, objectives, endpoints and study population. Align the plan with monitoring arrangements, data collection and analysis methods. The investigator information should describe the device, relevant existing evidence and risks in terms useful to study personnel. Check consistency whenever study documents are revised.
Prepare for reporting while the study is planned
Define how deviations, adverse events, missing information and changes will be recorded and assessed. The final report should explain the actual conduct, participant information, results and limitations. Assess results against the objectives without concealing changes or departures that affect interpretation. Applicable authorization, ethics and reporting obligations must be assessed for the particular study and jurisdiction.
Practical checklist
Identify the study and device versions.
Align objectives, endpoints and analysis.
Check consistency across study documents.
Define monitoring and deviation records.
Plan reporting and required approvals before conduct.
Example
If a device configuration changes during a study, the plan, investigator information and eventual report need a coherent account of which participants used which configuration and how the change affects analysis.
Common mistakes
Avoid treating an investigator brochure as a study plan or copying a planned analysis into the report without explaining what was actually performed. Each document should answer the questions appropriate to its role.
Choose the relevant A.P. Lyon documents
Use the clinical investigation procedure to coordinate study planning, conduct, monitoring and close-out.
Use the CIP document to define the prospective study design, objectives, endpoints, population and follow-up.
Use the standalone investigator brochure for device information, existing evidence, risks and anticipated benefits.
Use the investigation report document to present completed methods, results, deviations and analysis.
Review the product page, document previews and any content list before choosing. Adapt the selected documents to your device, processes and applicable requirements; the organization must generate and review its own implementation evidence.
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