Why We Need Competency Guidelines
Variance is the enemy of quality. The ad hoc manner in which we hire and train CRCs is failing to improve quality in clinical research conduct, as clearly evidenced by the persistence of negative FDA and global regulatory agency findings. We are also failing those at the front lines of clinical research by leaving them without consensus guidance on what we expect from them in terms of knowledge, skills, and attributes necessary to perform their jobs effectively, and how they can grow in their careers. We hope these guidelines will provide CRCs with the support they need while improving operational quality and trial outcomes for all stakeholders in the clinical research enterprise.
How the Guidelines Were Developed
Developed by a task force of diverse industry representatives, the guidelines directly map to Version 2.0 of the Harmonized Core Competency Framework developed by the Joint Task Force (JTF) for Clinical Trial Competency (More Info).
Through extensive vetting—along with review and comments from ACRP’s Workforce Innovation Steering Committee—the guidelines were developed to provide the most far ranging set of competencies required by the broadest set of CRCs working across different types of clinical studies (investigational products, therapeutic areas and indications). In essence, we have attempted to create a robust library of competency guidelines from which individual organizations can select and choose those that are most relevant for the job roles and levels within their companies.
In all cases, efforts were made to translate the exact JTF competency statements into meaningful, practical, and measurable statements (including a combination of knowledge assessments and other behavioral descriptors). It should be noted that:
- Many tasks that CRCs are required to perform can be more easily mapped to the competency statements, whereas in other cases interpretation was required to apply the intent of the competencies and relate these to the typical roles of the CRC.
Several assumptions and caveats were also applied:
It is ACRP’s hope that this initial set of guidelines serves as a strong foundation from which diverse organizations across the globe can adapt to their specific institutional guidelines.
Inevitably, modifications will be required to accommodate different types of sites (e.g., academic health centers, dedicated research facilities, site networks and other models), across different regions, countries, and local ethical and regulatory requirements. We recognize that this will be a work in progress and the guidelines will undergo many iterations once they are in more widespread use.
Forthcoming editions will provide links to ACRP training programs that can be accessed to close any competency gaps, recommendations for creating competency-based job descriptions, performance assessment tools, and more.
How You Can Get Involved
We are eager to hear how you have applied and adapted these guidelines, and welcome all comments and suggestions that can be incorporated into future versions.
Please email Beth Harper, ACRP Workforce Innovation Officer, at email@example.com, to share your feedback.