ICH Good Clinical Practice E6 (R2)
We are pleased to announce that as of January 1st, 2018 this course has been updated to incorporate additional information from the latest International Conference on Harmonisation E6 (R2) Guidelines for GCP and re-named ‘ICH Good Clinical Practice E6 (R2)’ to reflect this update. Please take the revised version of this course for the latest updates and to gain the required certification.
Prof. Arzu Kanik, PhD
Accreditation & CME MedicReS 6 MACMEC
Venue MedicReS Campus Vienna
The good clinical practice provides a framework of principles which aim to ensure the safety of research participants and the integrity and validity of data. This short course aims to provide the researcher with the basic principles of GCP and how these principles can be applied practically in the research setting. The course is aimed at all those involved in clinical research.
Upon completion of this course, you will have an understanding of:
* Why GCP is necessary for clinical research professionals * Historical development of GCP * The responsibilities of the clinical research professionals
* How GCP should be adopted in the conduct of good clinical research * How to be a good clinical researcher with MedicReS BeGMR Use and reproduction of BeGMR e-learning materials:These e-learning materials are owned by MedicReS.
You are free to share or adapt this material but you must attribute it to MedicReS using the link www.medicres.org.
* Why Good Clinical Research and Good Clinical Researcher * The Role of Institutional Review Boards/ Independent Ethical Committees * Informed Consent Documents and Patient Education * Confidentiality & Privacy * Participant Safety & Adverse Events * Quality Assurance * Developing Research Protocol * Documentation & Record-Keeping * Clinical Research Misconduct * Roles & Responsibilities * Recruitment & Retention * The Drug Development Process
Users are required to complete a test following each lesson. To receive a GCP certificate, all test must be completed with at least 80% accuracy. Upon successful completion of all quizzes, the user will be given access to the MedicReS GCP Certificate of Completion. Within MedicReS, certification there no expires dates.
Services included in the registration fee
- Full conference & workshop participation
( one day )
- E-PICOS intelligence and interactive biostatistics software
- BeGMR online education program
Accreditation & CME Certificate