When ICH GCP E6 (R1) was introduced in the year 1996, clinical trials were largely paper-based, and spreadsheets were widely used as the manual computation and compilation tool for managing various trial processes. 

Now almost two and half decades later, with industry’s adoption of revised ICH GCP E6 (R2) guidelines which recommend greater use of technology solutions, we have witnessed improved and efficient management of many aspects of clinical trial operations. One such area that has benefitted from automation is how the sponsors today ensure site compliance to regulations and protocol adherence through interim on-site visits and perform the aftermath of resolving monitoring visit findings – the so-called “Action Items”. 

The Action Items

The To-Do lists received by clinical trial sites from clinical research associates (CRAs) are commonly referred to as “open issues” or “action items”. 

Action items are identified either during routine site monitoring visits (SMV’s) or remote monitoring and are those that cannot be immediately resolved and require a follow-up. CRAs along with clinical site staff work together to address and resolve these issues in a time-bound manner. In an ideal scenario, action items are resolved by the next monitoring visit. Since time to resolution is important, CRA normally brief the site team regarding the issues so that they can get started before the formal SMV follow-up letter arrives. However, this does not happen all the time and few action items are carried forward over subsequent monitoring visits, despite the best collaborative efforts to resolve them. These are invariably clubbed with new action items and the list goes on and on and on…

The Traditional approach to Action Item Management

Traditionally, the Sponsor/CROs have been spending a lot of time and energy conducting site monitoring visits and capturing data that reflects due diligence in reporting clinical site compliance. CRAs are used to writing lengthy and elaborate SMV reports and issue follow-up letters to sites enumerating visit findings and all action items that need to be resolved on time. The show does not end here. Effective site monitoring requires rigorous follow-up to ensure that all open issues are properly addressed, closed and documented. The task of remembering and tracking action items is daunting not only for the CRA but also for the clinical research coordinator (CRC) who are both juggling between multiple studies and numerous other trial emergent day-to-day issues.

Efforts toward Effective Action Item Management

Until recently, CRAs utilized different methods to record and track action items such as 

• Enter on notepad or notebook paper to be transcribed later
• Write action items directly in a paper-based monitoring report
• Create action item logs
• Use a spreadsheet wizard
• Use a siloed project management software 

The common metrics which are tracked are

• Date of creation of the action item
• Action Item description
• Assigned to detail
• Timeline for completion
• Action Item Status – Open, Closed

CRAs perform the mundane tasks of going through the paper-based SMV reports, and action item log/spreadsheet regularly to track the action items until completion. This further involves on and off communication with clinical sites to confirm not only the completion status but also to verify that the action item is resolved accurately. 

Moving towards Efficient Action Item Management

Fortunately, cloud-based Clinical Trial Management Systems (CTMS) monitoring solutions provides a more efficient tool to address these dat­ed approaches to action item management. CTMS system has not only replaced the standard and passive trackers but also comes with enhanced reporting capabilities that dynamically and automatically identify trends and measures site performance to compliance, thus, providing valuable insights to make meaningful operational decisions. 

This new age solution can query SMV reports on multi-variable matrices, integrate and normalize all relevant data and extract information, as required. User-friendly visualizations that incorporate charts and graphs simplify the ability to identify trends and measure performance in real-time. 

Metrices to Measure       

Here is an exhaustive list of features that can help a user holistically manage site/sponsor compliance to open item management – 

• Configure and design monitoring visit checklists/questionnaire/report form fields to categorize and capture action items. Automate generation of trackable action items based on CRA responses to form field questions.
• Create dashboard visualization of all action items – timepoint of creation, assigned to, description, the timeline for completion and open versus closed status between monitoring visits.
• Ensure record level traceability by linking action items to originating SMV report.  

• Integrate action item information to the subsequent SMV report, if still open, to provide continuity and transparency between visits. 
• Auto-assign or delegate action item tasks to responsible parties. Include instructions and due dates for completion.
• Deploy an alert mechanism to send email notifications to assigned team members of action item workflow events including but not limited to aged action items, escalations for resolution, analysis for recurrent issues and problem-solving to prevent reoccurrence.
• Link action items to applicable protocol deviations, AE/SAEs, note to file (NTF) or corrective and preventive action (CAPA) reports for issues raised and resolved through an integrated task completer – anticipating and closing automatically the action items based on relevant entries you make. For example – SAE resolution date, IRB acknowledgment of protocol deviation, completion of the pending training module, etc. shall automatically mark the action item complete when cross-linked to the same.
• Link action item reports across visits and sites for reporting and analyzing quality trends for site compliance.
• Create a risk-based site quality indicator dashboard based on targeted action items categorization and threshold. Identify the outliers i.e. sites which fall outside the threshold values and proactively establish processes to minimize those risks.

Conclusion

Action items that go unresolved may pose a risk to subject safety and data integrity. They may leave the site and the sponsor at risk for being out of compliance with the protocol, SOPs, IEC policies, GCP guidelines, and applicable regulations. Smart and efficient CTMS solutions that use strategy, technology, and design to efficiently manage action items can help sponsors not only achieve quality and compliance but also minimize risk and cost at the same time.

Octalsoft’s cloud-based, mobile-enabled CTMS provides a comprehensive platform for planning your trials, efficiently managing them, and bringing studies to successful conclusion. Please contact us for an online demo