5 Aspects of Device Clinical Study Close-Out

Clinical Trials

A clinical study process that is often underappreciated is close-out. Regardless if the study was completed or halted prematurely, the close-out process is a required final step for the sponsor to ensure compliance.

1. Monitoring Close-Out Visit

The monitoring close-out visit is intended to ensure the proper data and documents are accurate and complete. During the visit, any outstanding queries and action items are resolved. Product reconciliation is performed by comparing the product accountability log at the site with the sponsor’s ship log and other records of product use, disposal, and return. The monitor will also review the record retention requirements and other investigator close-out obligations with the investigational site personnel.

2. Data and Document Archive

After the data have been verified with the source documents and queries are resolved, the database is locked so that no changes can be made. If missing data points remain after monitoring, an explanation should be included, which can be included in a note-to-file or memo.

In addition to data, essential documents in the investigator file and sponsor’s trial master file should be prepared for archival. Good Clinical Practice includes a list of the essential documents that should be retained in the investigator/institution file and the sponsor trial master file. Records should be retained according to applicable regulations. For example, records from a clinical study conducted under an FDA IDE must be maintained for two years after the investigation is complete (or terminated) or if it is no longer needed to support a submission (21 CFR 812.140.d).

3. Regulatory and IRB/EC Close-out Notification

Depending on the regulatory, institutional review board (IRB)/ethics committee (EC) requirements, they may need to be notified or approve study close-out. For example, the FDA requires notification within 30 working days of completion or termination of significant risk device studies (21 CFR 812.150.b.7).

4. Clinical Study Report

The clinical study or clinical investigation report summarizes the conduct and results of a study. The IRB/EC and relevant regulatory body may have timeline and content requirements for this report. For example, the final report for FDA IDE studies is due from the sponsor to the IRB within six months of study completion or termination (21 CFR 812.150.b.7). ISO 14155 Annex D outlines the various aspects that should be included in this report. The International Council for Harmonisation (ICH) developed a guidance on clinical trial reports.

5. Updating Public Database

If the study was registered in a public database such as ClinicalTrial.gov, the study should be updated to reflect the status accordingly. Results may be required to be posted within one year of the completion of the primary outcome measure (see ClinicalTrials.gov’s requirements and guidelines). This includes administrative and scientific information such as participant flow, baseline characteristics, outcome measures and statistical analyses, and adverse events.

Need support with your study close-out? MED offers a variety of clinical trial services and is a full-service CRO. We have over 40 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries.

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