Employed by Pharmaceutical, Biotech and Medical Device organizations, Clinical Research Associates (CRAs) play a vital role in the conduct of clinical research trials around the globe. An organization's ability to objectively evaluate CRA core monitoring competencies and develop suitable remediation strategies is imperative for ensuring quality monitoring.
No qualified degree or comprehensive certification exists for CRAs. The co-monitoring visit approach for evaluating individual CRAs is a costly, inconvenient, variable and subjective method of evaluating core monitoring competencies. Most organizations lack a targeted training and re-testing program to ensure the deficiencies identified in the co-monitoring visit are addressed and remediated.
CRA Assessments offers web-based simulated site monitoring visits, targeted training and comprehensive metrics. Our solutions are cost-effective, easily accessible, consistent and objective. CRA Assessments' goal is to give organizations the ability to evaluate core monitoring competencies and to remediate deficiencies across their entire CRA population.
What I liked in the simulation was that the documentation was very realistic including investigators' and patients' handwriting. The design of the two windows for opening documents was also very good and contributed for the realistic situation at sites. There were enough issues to find, not all of them so evident. There was enough time and the pause option was also well designed.
What I appreciate in the assessment are that the essential documents are present in the assessment, and you really have to go through all those documents in order to verify the CRF against the source documents, and also that they are in compliance with the protocol. The assessment would indeed benefit those companies who will want to evaluate their CRAs if they are already ready to conduct monitoring visits on their own, and I would really recommend that they use the program.
Sr. CTL, USA
I think this assessment is a great tool and would be helpful in providing some information/confirmation about my CRAs’ abilities and attention to details.
CRA, New Zealand
Overall the simulations were really interesting and cover all the parts of monitoring I consider important. I have recently become involved in training trainee CRAs and modules like these would be very useful in assessing how their training is going.
My general impression of the assessment is very positive: I felt like I was performing a real monitoring. In every section I found all documents necessary to perform required activities.
I want to congratulate with you and your team for the assessment. It's really well done in my opinion: structured, detailed but still user-friendly.