How does your company assess the performance of clinical research associates to ensure quality and safety standards are consistently upheld?
Conducting clinical drug and device trials to collect the data necessary to make decisions regarding the safety and efficacy of investigational products is crucial. Prior to being released in the market, however, the investigational product will require substantial proof. Clinical research associates (CRAs) have the enormous responsibility to ensure that subject safety is protected, the clinical data provided is accurate and verifiable and that the investigational product is handled per federal regulations and guidelines. So what standards do we use to determine CRA competency?
CRA competency is defined as observable attributes that contribute to performing clinical trial tasks within a measurable standard. Previous perceptions were that experience correlates to increased quality (e.g. CRA 1 vs. Senior CRA), however, I have seen junior CRAs outperform senior CRAs in certain monitoring categories.
Previously, CRA competency was measured solely based physical on-site visits to clinical research sites. This approach lacked consistency in identifying and reporting quality issues in a reproducible fashion. Unfortunately, the person conducting the competency assessment may not be trained and the variability of others conducting competency assessment without training made it challenging for CRAs to gain traction or momentum in increasing their skill set with different expectations for each competency assessment. In order to optimize consistency, competency assessors should all be trained the same way and use the same collection tools to gather the necessary information.
CRAs have a unique opportunity to interact with investigators and clinical research colleagues across the globe who have many different backgrounds, languages and cultures. CRAs should understand some of the cultural differences that exist across the globe, in particular having knowledge of local laws and regional perceptions on healthcare. For example, addressing a specific health issue for women in India may not be the same for women that are receiving healthcare for the same illness in the United States.
Competency Assessors
Assessors should not re-create the monitoring as it is impossible to check all data points a CRA has monitored. Assessors should narrow their focus on key variables to verify critical primary/secondary endpoints, safety data and investigational product (right dose/right subject). Assessors should look for evidence of a “state of control,” meaning the study is being conducted in compliance with the protocol and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP) regulations.
What Should the Assessor Assess?
The following monitoring categories should be considered when conducting assessments:
- Informed consent/assent
- Study conduct and procedures
- Principal Investigator Oversight
- Data recording/privacy and source verification
- Investigational medicinal product (IMP)
- Regulatory submissions and approvals
- Essential documents
- Study personnel/training
It is everyone’s responsibility in clinical research to own quality, including all activities that support quality; sharing solutions and integrating best practices should be the standard. Assessors should consider that each CRA is unique and will require a different approach in order for a competency visit to be successful. Other monitoring categories (than mentioned above) should be considered when preparing for a competency assessment.
- Delegation of authority log
- Potential fraud
- Confidentiality
- Subject safety
- Serious adverse effects (SAE)/Adverse effects (AE) identification and reporting
- Query writing and response,
- Electronic data capture (EDC) – Source documentation verification metrics
- Good Documentation Practices (GDP)
- ICH/GCP
- Electronic medical records access
- Relationship building
- Presentation skills
- Technical skills
- Scientific concepts
- Electronic systems such as Trial Master File (e-TMF), Clinical trial management system (CTMS) and web portals
- Laboratory supplies
- Site specific equipment to conduct the study (electrocardiogram (ECG), computerized tomography (CT) scan, Pulmonary function tests
- ALCOA+C (attributable, legible, contemporaneous, original and accurate)
- Root cause analysis
- Soft skill training
- Cultural differences
The competent assessor should do their research and discuss the CRAs performance with the project manager and/or line manager to understand which monitoring areas the assessor should narrow their focus to.
Types of Assessments
1. Physical On-Site Assessment: This is where an assessor physically visits the site and CRA to conduct the assessment.
Pros: An assessor can see the CRA in real-time to provide guidance and training while building a relationship.
Cons: Assessors may have not all received the same training, cost of visiting a site (airfare, hotel, car rental), the time it takes to write the assessor’s report, preparation time could be as much as 8-12 hours.
2. Remote Assessments: The CRA will provide the assessor with various critical documents (scanned) to the assessor for review.
Pros: Time to prep for the visit is significantly reduced, travel and related expenses not required.
Cons: Adds additional workload on CRA to scan documents to assessor. CRA does not get to meet assessor in person.
3. Web Based Assessments: Companies have developed web-based online assessments that replicate clinical subject casebooks. CRAs will be able to identify deficiencies and document findings (queries) for review.
Pros: No prep time, no travel costs, no report writing.
Cons: Time to take the online exam (4-8 hours), CRA does not get to meet the assessor in person.
Summary
Once a CRA has been identified to participate in an assessment, the assessor should follow a rigorous preparation regimen to enhance the assessment experience for the CRA. All assessors should be trained the same way and use the same collection tools to ensure consistency in the assessment process. The digital world can provide many opportunities to enhance the assessment process if done correctly. Web-based assessments can easily support the CRA assessment process at greatly reduced time and costs. Consider using video chat, e.g. FaceTime, Skype, to augment the personal experience.
CRAs must take responsibility to own quality at their respective sites. Web-based assessment programs can be an indispensable tool that supports continuous process improvement and paves the way for quality performance from CRAs.
Want to learn more about assessing CRA performance? Contact Actalent now.