Close out plan

Failing to conduct all necessary close out activities in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s), can put a site out of compliance.

Close-out is, therefore, integral to the quality control of a clinical trial and is designed to ensure all necessary documents are in place and complete, as a trial may be inspected in the future.

Generally, site close-out visits are performed by the Clinical Trial Monitor or Clinical Trial Coordinator. Here are some of the tasks involved during this step:

Prepare site for closure

To prepare for the site closure:

• check the trial’s SOPs and institutional requirements. Delegation logs will state who has been delegated by the Principal Investigator to perform the close-out duties
• review the site file or trial master file (if single site) to ensure all documentation is in accordance with ICH GCP 8.4. Ensure documentation such as delegation and screening logs and case report forms are completed
• ensure appropriate final disposal of investigational product.

Data Cleaning and Lock

Data cleaning involves recognising any errors in the data, such as incorrect or duplicate data, and correcting and updating them. This should have been outlined in the data management plan, which recognises institutional and regulatory requirements. Data cleaning occurs during the closeout stage before the final data transfer.

Site closure

Following review of the trial’s documentation, disposal of investigational product and the site’s data cleaning and lock. The site can now be closed. The sponsor must be notified of the trial site’s closure.

Trial reports

Complete the trial safety profile involves systematically collecting, analysing, and documenting all safety-related data from a clinical trial to evaluate the safety of the investigational product. The trial close-out report should be submitted to the Human Research Ethics Committee (HREC). It should include a summary of the study outcomes and ensure that the trial was conducted in compliance with ethical standards and regulatory requirements.

Trial closure

A notification should be sent to the Sponsor that all sites are closed for TGA notification. Then, you can update your trial status to closed in the trial registry (i.e. ANZCTR, clinicaltrials.gov).

Archiving

After the trial close out, the PI is responsible for ensuring all hard and electronic copies of site and trial master files are archived, as per institutional SOPs, data management plan and the approved protocol.

Destruction of essential documents

Destruction dates must be clearly identified on archived documentation and any biological samples being stored along with appropriate contacts for retrieval. Refer to institutional and regulation guidelines for data destruction; however, there is generally a minimum of 15 years of retention prior to destruction.