Guest Column | November 28, 2023

5 Habits For Ship-Shape Source Data

By Kaitlin Bova, senior manager, R&D Quality, Moderna

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What comes to mind when you hear audit or inspection? Stress, anxiety, intimidation, chaos… But with good documentation practices, you are always inspection ready. ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate + Complete, Consistent, Enduring, and Available) is the foundation of good documentation practices. By following these guidelines, we can ensure the integrity of the data generated in a clinical trial. Data is the most important deliverable of a clinical trial and is what health authorities use as basis for new product approvals. Most site staff working in clinical research have heard of ALCOA+, but what does this mean for daily work at the site level? As an auditor and clinical quality study representative, I frequently work with sites to improve source documentation and have identified five practical ways to ensure site teams are meeting ALCOA+ standards. When source data is ship shape, audits and inspections will be smooth sailing.

1. Design Smart Source Documents

Stress the importance of your sites designing smart source documents to ensure the sites are set up for success. Not only should the source clearly document the data required in the study database, but it should be user-friendly to ensure contemporaneous and accurate documentation. Sites should involve those who will work on the study in the design to ensure the source worksheets are fit for purpose. Source worksheets should support processes at the site; for example, if one staff member takes vital signs and confirms any medication changes and another staff member then takes a blood sample, there could be two sections created in the source so that each team member can quickly identify the documentation required for their activities and sign off on their source entries independently. Finally, ensure that monitors carefully review source worksheets to ensure the source closely matches the protocol and study database requirements and there are appropriate places for those completing the documentation to sign and date to ensure the source is attributable.

2. Always Document In Source In Real Time

Site staff are busy and may be pulled in multiple directions at any given time. It is often tempting for staff to perform study activities and then wait until later to document in source, perhaps using sticky notes or other scrap paper to quickly jot down patient data. However, contemporaneous documentation in source is essential to data integrity. To best support your site teams, go beyond simply reminding them to document in real time. Have monitors ensure site processes support contemporaneous documentation and the appropriate staff have access to the source when they are conducting study activities. For example, if staff need to answer subject calls after hours, consider having a dedicated resource to stay on-site with access to the source to avoid staff taking calls remotely without access. Electronic source can greatly improve staff access to source as multiple people can access a subject’s chart simultaneously. If a site uses eSource, consider if staff have access in each area where clinical trial activities will occur through either laptops, mobile workstations, or several stationary workstations.

3. Sign And Date Every Entry

A reviewer should be able to easily reconstruct a series of activities based on the documentation. A signature and date are essential to demonstrating who completed the activity and when for both regularly scheduled study visits and ad hoc contact with subjects or other team members. Also consider where in source the time must be recorded to document compliance to the protocol and good clinical practice, such as documentation of informed consent and the start of screening procedures and any protocol required procedures occurring on the same day such as blood draws and IP administration. Updates and changes occur frequently, and original documentation ensures the source is enduring and the sequence of events is easily understood in several years’ time. If monitors cannot easily reconstruct a series of events from source alone (i.e., how a new adverse event was identified), they should review the site’s documentation practices and re-educate staff on the importance of contemporaneous and attributable source. Some site staff may feel that frequent updates in source makes the source cluttered. However, when done in a legible manner, contemporaneous and attributable documentation ensures a clear picture of the activities of a clinical trial.

4. Perform Regular Quality Checks  

Encourage sites to implement a source quality review, especially for complex documentation or fast-paced studies. Whether it’s a quick self-review or a peer review, taking time to review documentation immediately after it is captured allows for any missed data or clarifications to be handled promptly. The quality review could be implemented for key documents such as the informed consent and inclusion/exclusion criteria or a daily review of source completed that day. Remember, any quality review completed or corrections made should also be documented with a signature and date. Implementing a quality review step is often an effective corrective action to monitoring and audit findings, especially for documentation errors with informed consent.

5. Be Transparent About Protocol Deviations

Site staff and participants are human and, despite everyone’s best efforts, deviations will occur in the study. To protect the integrity of the study data, the site should clearly document any deviations in source and report as appropriate to the study sponsor. Specifically, sites can consider implementing a protocol deviation log to document deviations they identify and prompt PI review of the deviations and IRB reporting requirements. Further, the site-level log will help site staff identify and promptly address any trending areas of noncompliance. The monitor should review the deviations identified by the site in addition to any deviations the monitor identifies and ensure the site log matches the deviations documented in the sponsor’s database.

Clinical studies are completed to generate key data to support new products, and everyone working on the clinical study must do their part to ensure the integrity of the data generated. Building a strong foundation for your team and sites in good documentation practices helps to ensure your success in every study.

About The Author:

Katie Bova has worked in R&D Quality at Moderna for over three years. In her role as senior manager, R&D Quality, she serves as a clinical quality representative, working closely with clinical development teams to manage quality issues and conducting GCP site, process, and study audits. Katie also leads the issue management program for Moderna clinical study teams including design and maintenance of the electronic quality management system (eQMS) workflows, training development and end user support, and oversight of quality issue records. Katie earned her Pharm.D. at Ohio Northern University and completed a fellowship in Clinical Quality Assurance at Novartis as part of the Massachusetts College of Pharmacy and Health Sciences Pharmaceutical Industry Fellowship Program.