A typical consultation we receive at AKRN Scientific Consulting is related to the essential documents required for planning, conducting and closing out clinical investigations in the medical device field. A detailed response is provided in the ISO 14155:2020, the ISO standard that specifies the general requirements for clinical investigation of medical devices for human subjects. Thus, to guide medical device manufacturers and sponsors, we have prepared a helpful article where we summarise the list of essential documents needed for clinical investigations.
First, essential documents refer to the necessary documentation to conduct a clinical investigation. Annex E of the ISO 14155:2020 lists the essential documents according to the stages of clinical investigations: prior, during, and after. The standard also details which documents may be retained by either the sponsor, the site, or both. Below, we have prepared a summary of the essential documents according to the ISO 14155:2020.
Essential documents prior to the clinical investigation
- Investigator’s Boucher (IB): This document describes the investigational device, including the instructions for device use.
- Clinical Investigation Plan (CIP): This document is the core of the clinical investigation. It describes the objectives as well as the investigation design and procedures. Moreover, it states the pre-specified analysis, methodology, organization and monitoring of the study.
- Case Report Form (CRF): A special document developed in order to capture the data for each enrolled subject in accordance with the CIP.
- Risk Assessment Forms (Adverse events form and Device deficiency form): Forms used to report the information regarding a device deficiency or adverse events that might occur during the clinical study.
- Informed Consent Form (ICF) and information for the subjects and advertisements: ICF is a writing form that includes all the procedures applied to the subjects. It should explain all the relevant aspects of the clinical investigation using non-technical language so that the possible subjects will be able to understand everything properly.
- Other documents:
- Regulatory Authority and Ethics Committee (EC) notifications, correspondence and approvals.
- Insurance certificates, financial agreements, and signed agreements between the principal investigator, sponsors, and external organization.
- List of investigation sites.
- CVs from the Principal investigators and other members of the investigating site team.
- Packaging labels, instructions for use and shipping records investigational device.
- Training records.
- Log of the principal investigator site team, which is a document that attributes the responsibilities to the different site investigation members. This document is commonly called the Delegation Log.
- Disclosure of conflict of interest.
- Normal values for the clinical laboratory test.
Essential documents during the clinical investigation
- Amendments in the CIP, IB or ICF, or CRF:: Any addition or modification in the essential clinical investigational documents should be documented and requires approval from the regulatory authorities and EC.
- Notices or approvals to regulatory authorities and EC of any amendments.
- Training records
- Signed informed consents
- Subject screening and identification log.
- CVs from any new member of the investigation site.
- Monitoring visit reports which summarize and verify the clinical site investigation compliance with the current regulation, CIP, and the Good Clinical Practices (GCP).
- Correspondence related to the clinical investigation
- CRFs, fully executed, which give evidence that data has been collected and verified by the principal investigator.
- Reports of adverse events, adverse device effects, and device deficiencies.
- Accountability records of the investigational device
- Updates on the normal values for clinical laboratory test.
Essential documents after the clinical investigation
- Investigational device accountability records
- Documents of investigational device return or disposal
- Close-out monitoring reports
- Notification of clinical investigation close-out to the regulatory authorities and EC.
- Sponsor’s statistical analyses and clinical investigational reports
- Completed subject identification log
Depending on the activities carried out in certain clinical investigations, further documentation might be required.
We acknowledge that preparing and filing all the essential documents required for a clinical investigation may be an exhausting and difficult task. Here at AKRN you can find support in preparing the essential documentation required to conduct your clinical investigation in compliance with the ICH Good Clinical Practices (GCP), ISO 14155, and applicable national and European regulations. Moreover, our clinical expert team can help you to design your clinical investigation successfully according to, the device type, stage, and characteristics.
Do not hesitate to contact us in case you might be interested in any of those services.
Other interesting articles
Please consider visiting the following article to get a perspective on the timelines to develop the essential documents, as well as the activities involved in a clinical trial.
Subject Matter Experts
Diana Posa, Pharm.D Associate Director Clinical Affairs LinkedIn
Elisa San Isidro, M.Sc. Clinical Study Manager