EDC is Now – The Changing
pharmafile | January 5, 2011 | Feature | Research and Development |
Clinical research is rapidly moving toward the electronic environment as more han half of all studies are conducted utilizing EDC, and this number is on the rise globally. With the development and deployment of EDC platforms, the role of the
CRA is changing. No longer is the scope of responsibility limited to protocol adherence and source document verification. It has grown to encompass input on eCRF design, creation of supporting documents such as Monitoring and eCRF Completion Guidelines, and the ability to remote monitor.
The CRA has become a key influence for site staff in understanding and performing their responsibilities within EDC, creating the increased need for CRAs to understand all aspects of EDC systems. The role of the CRA must expand to meet the needs and growth of Electronic Data Capture. EDC is now.
Input from the CRA is critical during the early stages of the database design process. Protocol adherence, ensuring correct terminology, logical order of assessments and ease of data entry are crucial components to site compliance. CRAs have a broad understanding of the study protocol as well as the tasks necessary for a successful workflow. Their input during eCRF creation is instrumental in reducing or preventing errors in data collection. This potentially decreases the need for database or eCRF amendments throughout the study.
Confirming time and event structures, verifying eCRF placement, and double checking data points and code lists all become key areas that fall within the new scope of responsibility. Due to the increased workload during a database build, the ability to enlist the CRAs’ participation in screen review meetings and User Acceptance Testing (UAT) allows the opportunity to resolve issues not previously recognized upfront during a paper study.
The CRA has become an instrumental resource for both Clinical and EDC design. Many supporting documents are required for clinical trials to be successful. The creation of these documents should include the perspective of the monitor as they are the first line of resource for the site user. Most EDC platforms allow supporting documents to be housed along with the study database making them available for electronic access during data entry. A clear, concise eCRF completion Guideline which is readily available can eliminate queries associated with data entry format or compliance. A clinical trial is only as successful as the quality of the data entered. It has become crucial for CRAs to understand both the study team and site activities within EDC to effectively increase this data quality.
Monitoring guidelines must be expanded to include specific tasks and duties which encompass both remote monitoring and in-house data review. For the benefits of EDC to be evident, an EDC study must be treated as EDC and not paper. The ability to access real time global data, create and answer queries remotely in a timely manner,
cross check screening and enrollment logs, and observe data trends is a huge step in the growth of technology. The capability to create on demand reports and track global metrics is becoming a requirement by sponsors in clinical trials. Tasks and resources need to be realigned and allocated appropriately to gain the full benefits from EDC. Efficient remote monitoring throughout an EDC study provides an increase in effectiveness and faster data cleaning which leads to decreased time from the last visit to database lock. With an EDC study, system edit checks are programmed to supply the site with instant notification of potential data entry errors at the point of first entry. In paper studies, the majority of data cleaning occurs during the periodic monitoring visits and closer to database lock by the data manager. EDC allows for both the CRAs and data managers to validate and review data in a timelier manner. By treating EDC studies appropriately, project teams allow the system functions and benefits to be utilized to provide ongoing data cleaning within the study workflow. System edit checks will fire immediately upon the site entering and saving eCRFs, and CRAs will have the opportunity to remotely review and correct or comment on data trends. This allows for early identification of protocol deviations and detection of data entry errors. Time can be spent more productively and the time allocation and/or number of monitoring visits may potentially be decreased.
Training is a key component to the success of an EDC study. All users (both site and project team) should be familiar with the tasks associated for their role within the study. The CRA becomes a key influence for the site staff in understanding and performing their task within EDC. CRAs must master not only their duties within EDC, but also become experts at those system functions applicable to site personnel (data entry, data change, query resolution and electronic signatures). Being the first line of resource in a site’s quest for help, CRAs must rise to the challenge and meet the ever growing need for clinical and technology resources. The role of the CRA must expand to incorporate new responsibilities and tasks created by Electronic Data Capture. EDC is now!
Tina Pagos Gene Filipp
