Clinical trials do not succeed without effective documentation.
In fact, “proper documentation is critical to the success of a clinical study [and] every aspect of the study must be documented,” write pharmacologists Dinesh M. Gangoda and Nirzarini N. Shah. This documentation includes site visit reports, which give a contemporaneous account of key details observed during the site visit they record.
A single clinical trial can generate many site visit reports. Clinical trial regulations require certain details in these reports to be consistent; if documents do not match, questions may arise. Automating site visit reports can help ensure key details align, allowing site visitors to focus on the day’s tasks.
How Automated Site Visit Reports Improve Your Clinical Trial Efforts
Site visit reports provide essential information about the operation of a clinical trial. According to the Commission on Dental Accreditation (CODA), successful site visitors generate reports that:
- Provide an objective evaluation of the facts.
- Collect and analyze essential data.
- Give accurate insights into the site’s operation, strengths, and weaknesses.
- Maintain confidentiality standards.
To perform these tasks, site visit reports need to be clear, complete, and accurate. Several challenges can interfere with these demands, especially when site visit reports are not automated.
Many site visit reports contain duplicate information. The location of a site, tasks completed, and similar information may be identical across multiple site visit reports generated at different times during a clinical trial. An automated site visit report system can populate this information directly from clinical trial documents, ensuring its consistency and saving your teams the effort of re-entering it at every site visit.
Data entry errors introduced through typos in retyping information are just one risk to the integrity and quality of clinical trial data. Current FDA guidance recommends examining clinical trial plans at the design stage to “identify the critical data and processes necessary” to evade a number of risks, from exposing patient information to undermining the quality of data collected. Automation can help reduce certain risks, allowing clinical trial teams to focus on critical issues such as protecting patients’ personal health information.
Tools for Automating Site Visit Reports
Quality of data collected in site visit reports is a key concern for clinical trial teams and for federal regulatory bodies, note Claire G. McHugh and fellow researchers in a March 2023 article in Osteoarthritis and Cartilage Open. The restrictions of the COVID-19 pandemic spurred clinical trial teams not only to implement virtual or decentralized clinical trial tools but also to meet the challenges of generating clear, complete, and accurate site visit reports in these remote settings.
One way clinical trial teams rose to the challenge is by embracing the digital tools needed to automate aspects of site visit reports. Anju’s Clinical Trial Management System (CTMS Master) leverages automation to help your clinical trial teams submit more complete, efficient site visit reports.
CTMS Master allows clinical trial teams to:
- Set up site visit reports quickly. Teams can maintain standard templates in CTMS Master for a range of purposes, including site visit reports and site correspondence. These templates can be tailored as needed for individual studies while maintaining a consistent and familiar interface.
- Automate document management. CTMS Master automates document placeholders, sends automatic updates for expiring documents, and facilitates easy drag and drop uploading of documents directly into the eTMF structure.
- Improve site visit reports with integrated automation. CTMS Master’s integrated site visit report tool uses automated workflow features to eliminate duplicate data entry — saving each team time and eliminating the risk of accidentally introducing data errors during reentry.
- Provide tailored access for each user. CTMS Master allows administrators to assign access based on user roles. Users can access site visit calendars, rely on site visit reports populated from study details, and use automated workflow and report generation to generate effective, accurate insights and share that information with stakeholders.
The traditional method of using paper clinical trial site visit reports introduced the risks of accidental errors through data re-entry, confusion in workflows and scheduling, and other challenges. Automated site visit reports help reduce or eliminate these issues. They allow clinical trial teams to focus on the critical tasks and topics before them each day, confident that their documentation has the necessary support to be clear, complete, and accurate.
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