ACRP GCP Courses Recognized for Good Clinical Practice by TransCelerate Biopharma

The Association of Clinical Research Professionals (ACRP) is pleased to announce that TransCelerate Biopharma, Inc. now recognizes completion of any one of three ACRP professional development courses devoted to the international quality standard for Good Clinical Practice (GCP) as evidence of required GCP training for site-based researchers involved in clinical trials sponsored by TransCelerate member firms.

GCP, especially as interpreted in the International Conference on Harmonization (ICH) guidelines, encompasses an effort through quality assurance and inspections to enforce tighter guidelines on ethical aspects of human rights in clinical studies. The GCP-related courses highlighted by TransCelerate and already available in a self-paced, online format through ACRP (see www.acrpnet.org/gcptraining) include:

• Good Clinical Practice: An Introduction to ICH GCP Guidelines
• GCP for the Experienced Investigator: Reducing Risk and Avoiding Common Inspection Findings
• GCP for the Experienced CRC: Partnering with Your Investigator to Reduce Risk and Avoid Common Inspection Findings

This announcement follows up on TransCelerate's decision in January to recognize certification through the Certified Clinical Research Coordinator (CCRC®) and Certified Physician Investigator (CPI®) programs of ACRP's affiliate, the Academy of Clinical Research Professionals, as evidence of GCP training (see

www.acrpnet.org/PDF/ACRPTransCeleratePressReleaseFINAL.pdf

).

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 or researchers that completed any of the three GCP related courses as listed above 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.

"Being recognized by TransCelerate is a great achievement for ACRP and offers several advantages to our members, who now have more opportunity to focus on the actual conduct of clinical trials instead of having to use valuable time and resources sitting in redundant GCP training," says Esther Daemen, ACRP Director of Professional Development. "Through completion of ACRP's high-quality GCP courses, clinical trial stakeholders can be assured that researchers have the required knowledge to perform accordingly, making additional courses obsolete."