Recent industry reports note that Sponsors, IRBs, and the FDA are increasingly seeking documentation of GCP training of all members of the study team. Click here to read FDA's recent (May, 2007), draft Guidance about Investigator Supervision and Training of research personnel. To larger organizations and busy Investigators, the completion of GCP training can be time-consuming, costly, and impractical for today's clinical environment. It is our intent to change that.
Our Investigator GCP education course, Investigator GCP Training, Just Give Me The Bottom Line offers an efficient educational opportunity for Investigators. The course combines audio and visual delivery methods and the online version is presented via a unique learning management system with "tickle and tattle" technology.. which tracks documentation of training. The entire GCP course is comprised of 4 lessons and each lesson is approximately 30 to 40 minutes in length. The 4 course lessons include:
Overview of the Drug Development Process
Ethics and Human Subject Protection
Clinical Trials versus Routine Medical Care
Obligations of an Investigator
We believe our course offers unmatched quality as we utilize key Regulatory principles as well as industry best practices to help Investigators "learn the ropes" of industry-sponsored studies. We also use examples from FDA warning letters to further reinforce applicable learning objectives. A short test is completed at the end of each lesson and upon completion of each module, up to 2.5 AMA/PRA Category 1 continuing education Credits are available. The course will also assist in the preparation of any Investigator pursuing industry-certification.
Cost is $379 for up to three people and includes a certficate of GCP training (CMEs included) at no additional charge. Call 1-877-284-1815 for further details.
