Research published recently in Applied Clinical Trials indicated that investigators accredited through ACRP (Association of Clinical Research Professionals) had fewer protocol deviations . The authors suggested that pharma may want to consider using certified principal investigators (CPIs) going forward. Kudos to those investigators who have taken the time to prepare for and sit the exam. However, if studies are limited to certified investigators only, there would be insufficient investigators and sites in the short term to meet enrolment of the large number of trials in the pipeline.
Data Quality is Better
Behind every good investigator (certified or not) there is a research coordinator whose contribution is key to what makes a site successful. A good first step in reducing the number of protocol deviations would be the selection of sites where coordinators have completed ACRP accreditation.
A good research coordinator makes sure to schedule time with her principal investigator (PI) to discuss enrolment, review labs and review AEs. Documenting that they met, and action items taken, demonstrates PI oversight, something that Inspectors look for.
Membership of professional associations like ACRP and being a certified clinical research coordinator (CCRC) indicates to me that this person is committed to the research profession. Investigators should set that expectation for their staff and hold them to it.
If we set that expectation for research coordinators, pharma and CROs should ensure that the monitors/clinical research associates they hire are certified professionals or commit to getting certified within a specified time- period. At a minimum you should expect to see membership of a professional organization on their CVs. How else do independent contractors keep up to date with regulatory trends and changes in practice?
Outcomes are Better
Should investigators take the certification exam? Absolutely. That should be the goal for any site…that all staff, investigators, sub-investigators and research coordinators are certified research professionals. That certification differentiates that site from their peers and, based on studies conducted, that site will have fewer protocol deviations per subject, better quality data, and better FDA audit outcomes . An investigator could certainly make a strong case for being paid more per subject enrolled if he/she is certified!
Let’s start with the expectation that site personnel are certified professionals as are the clinical research associates who monitor the data. We should then encourage principal investigators to consider the benefits of certification and ‘join the club’. At the end of the day we all benefit. Clean data will mean studies can be completed faster, applications for approval can be submitted sooner and new drugs and devices reach the market in a timely manner.
 Vulcano, DM. (2012) CPI Certification as a predictor of Clinical Investigators’ Regulatory Compliance. Drug Inf
J 2012; 46(1):84 to 87. http://journals.sagepub.com/doi/10.1177/0092861511427862