Release--CCRC and CPI Certification Recognized for Good Clinical Practice by TransCelerate BioPharma

Alexandria, Va.—The Association of Clinical Research Professionals (ACRP) has learned that TransCelerate Biopharma, Inc., now recognizes certification through the Certified Clinical Research Coordinator (CCRC®) and Certified Physician Investigator (CPI®) programs of ACRP's affiliate, the Academy of Clinical Research Professionals (the Academy), as evidence of Good Clinical Practice (GCP) training.

This exciting development means that TransCelerate's membership of pharmaceutical and biotechnology companies with research and development (R&D) operations, including 17 major firms to date working together to create efficiencies within the clinical trials process, will save time and resources by not requiring CCRCs and CPIs involved in their trials to complete redundant GCP training for each and every new study team they join. TransCelerate launched in 2012 to advance innovation in R&D, identify and solve common R&D challenges, and further improve patient safety with founding members AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Lilly, Pfizer, Roche, and Sanofi.

According to various laws, regulations, and/or standard operating procedures across the global clinical research enterprise, every study coordinator, principal investigator (PI), and sub-investigator must complete some basic level of GCP training for each trial on which they work. They also are typically required to "re-do" a more intensive GCP training every two years (sometimes more often). Thus, PIs or coordinators working at sites running multiple trials likely have to complete GCP training for each one.

"As you can imagine, this is a time-consuming chore for coordinators and PIs; it is expensive for sites and sponsors to develop the training or provide time for staff to take the training; and it duplicates efforts and documentation over and over again," says Morgean Hirt, ACA, director of certification for ACRP. "Now, TransCelerate member companies are standardizing and recognizing each other's GCP training courses. By furthermore recognizing that the Academy's rigorous certification process for CCRCs and CPIs provides a solid grounding in the tenets of GCP for research involving human volunteers, much training time and effort will be saved when these companies undertake their own studies and when they engage in cooperative research projects with one another."

In other words, any clinical research professional who has a current CPI or CCRC designation will be able to use that as evidence that retaking GCP training is not necessary if they are working on a trial for one of the TransCelerate companies. This highlights the tangible value of certification through the Academy's programs, which have produced more than 28,500 certificants in more than 60 countries since 1992 (including the CPI, CCRC, and Certified Clinical Research Associate [CCRA®] programs) and also have been accredited independently through the National Commission for Certifying Agencies (see www.acrpnet.org/PDF/NCCA_Accreditation.pdf and www.acrpnet.org/PDF/CPI_Accreditation.pdf).