GCP Online Training for investigators

Quintiles is offering to investigational site staff the opportunity to attend an introductory Good Clinical Practice training online. Registration and attendance are granted free (no costs involved), the participant should only create an account (user ID = e-mail address and password) and start the training!

The training consists of 6 modules. Additionally, a separate module is giving an overview for the EU Clinical Trials Directives (which is recommended to investigators working in EU, too):

Introduction to Clinical Drug Development Process: ICH/FDA Good Clinical Practice for Clinical Trial Sites Module 1: Course Overview & Overview of ICH Good Clinical Practice Module 2: Clinical Investigator Obligations & Qualifications, Resources, IRBs/IECs Module 3: Subject Informed Consent & Protocol Compliance Module 4: Investigational Product, Randomization, and Unblinding & Source Documents and Case Report Form Completion Module 5: Safety Reporting, Financial Disclosure, & Study Closeout, Trial Termination, and Record Retention Module 6: Non-compliance, Scientific Misconduct and Fraud & Monitoring and Preparing for Audits and Inspections Module 7: The European Clinical Trial Directives (20/2001 & 28/2005)

Attendance to all modules is required and moreover, attendance to each module will bring the attendee to separate tests which finally will generate a certificate of completion. The program is flexible as it is not mandatory to perform all modules at once, it can be done sequentially depending on attendees availability; each module can be stopped, participant can log out and later on to log in and start from where has left it.

The modules can be attended in random order. The duration of modules differs from 30 minutes to 50 minutes (all 6 modules take about 4 hours to make it complete).

After each module the participant will need to pass an assessment (passing score is 75%). After passing the test, the participants will receive a Certificate of Completion (a sample is attached) which may be printed and filed as documentation of training (if failed, the test can be restarted).

These Certificates are given for each module, so completion of Introduction to Clinical Drug Development Process: ICH/FDA Good Clinical Practice for Clinical Trial Sites will be documented by 6 Certificates.

The link for accessing the website for attending the online training is: https://live.blueskybroadcast.com/bsb/client/CL_DEFAULT.asp?Client=6&PCAT=44&CAT=44

This link may be provided to any investigational site staff that is willing to receive a training in GCP! For any question you may have about this online course please contact the EEME L&D Members!