Clinical Investigation Procedure
Plan, conduct and close out a medical device clinical investigation with an editable procedure and related study documents. The download includes a clinical investigation plan and report form, investigator brochure, site initiation and monitoring forms, informed consent material and guidance for case report forms.
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Supplied as seven editable Microsoft Word documents (the procedure and six supporting documents) in a digital download.
Clinical investigation planning, conduct and close-out
The procedure covers sponsor and investigator responsibilities, ethical and regulatory planning, the clinical investigation plan, site selection and initiation, monitoring, source records and data handling. Later sections address deviations and adverse events, decisions to suspend or terminate an investigation, and the documents needed for close-out and the final report. Teams can use its sequence to assign ownership and maintain a traceable investigation file from planning through reporting.
Standards and frameworks addressed: ISO 14155:2026; MDR EU 2017/745; ISO 13485:2016.
The plan, report and investigator brochure documents described above are included with this Clinical Investigation Procedure download. They are also available as separate standalone listings: Clinical Investigation Plan, Clinical Investigation Report and Investigator Brochure.
Related documents for this workflow
Use the standalone investigation plan when defining a study. Medical Device Clinical Investigation Plan (CIP) | ISO 14155:2026.
Use the standalone investigation report to document its results. Medical Device Clinical Investigation Report | ISO 14155:2026.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Clinical Investigation Documents: Plan, Investigator Brochure and Report for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This document is also included in Clinical Evaluation Procedure Bundle. Explore the bundle for the related documents.
