Endpoint Training

The inability of investigators across multiple sites to uniformly assess and record clinically-defined endpoint parameters has been the bane of many clinical trials. For example, a rash that may appear to be ‘very red’ to one investigator may be only ‘slightly red’ to another. If the severity of redness is the primary endpoint for a study, there is a big problem. Assuring that endpoints are clearly defined and consistently scored is the primary objective of CAP’s training and education programs.

CAP provides a wide array of endpoint-focused training services all designed to minimize the risk of variability in the evaluation and capture of primary and secondary endpoint measures.  Comprehensive onsite training of endpoint assessors and study team members by CAP-certified site educators (all physicians, dentists, or nurses) has shown to be a key component in favorably affecting the uniformity and quality of study endpoint data, and far surpasses the impact and effectiveness of the typical training limited to investigator meetings. CAP reinforces training with numerous protocol and indication-specific tools including interactive DVDs, tip cards, customized presentations and handbooks. CAP can customize its endpoint training and education services to any protocol and budget for virtually any indication in which outcome measures are subjective (i.e., clinician-dependent).

Outcomes Management

CAP is the pioneer of study outcomes management to ensure endpoint quality throughout the study.  First, CAP utilizes its study-specific, source worksheets to ensure that critical endpoint measures, once assessed, are accurately captured and documented. Using these CAP worksheets, CAP continuously analyzes raw endpoint data from sites for accuracy and consistency. Assessment errors identified by CAP’s review result in prompt action to resolve issues long before data are monitored so that mistakes and errors can be addressed promptly. The CAP outcomes management process increases CRA audit efficiency, reduces the time to database lock at the close of the study, and markedly increases the accuracy of endpoint measurements. CAP's outcomes management program includes but is not limited to the following:

• Review data using traditional and computerized methods
• Provide real time analyses of data for troubleshooting purposes
• Discover inconsistencies and potential bias and suggest solutions
• Provide interim analyses of data for possible course correction, if necessary
• Ensure only trained individuals perform study assessments
• Determine when additional training is necessary
• Evaluate site and assessor performance and suggest improvement strategies
• Serve as facilitator for study site questions