You are a principal investigator, sub-investigator, study coordinator within clinical research; or other staff; then you need to comply with the International Council of Harmonisation Good Clinical Practice (ICH-GCP) guideline, including the recently released ICH-GCP E6 (R2) Addendum 2016 . Authorities as well as scientific journals imply compliance to ICH-GCP for all research with human subjects. This international standard is specifying conduct, performance, monitoring, documentation and reporting of the results of clinical research. Without training, or without experience in clinical trials, you might not fully grasp what it means to work according to GCP. This e-learning will give you the training as required by most of the European Regulators.
This 3 hours course will allow professionals, active in clinical research, to understand GCP-roles of everyone involved. All GCP-duties of the investigator and his/her team according to chapter 4 of ICH-GCP will be elucidated. In addition, the implementation of GCP is explained and illustrated using examples from practice. You will receive hands-on information about mandatory elements such as approval for clinical trials, informed consent, safety reporting and trial specific documentation. You will learn to link your clinical research tasks with ICH-GCP requirements.
Note that the complete and most recent 2016 version of the ICH-GCP is covered by this training. Secondly, our ICH-GCP training meets all the Criteria for ICH GCP Investigator Site Personnel Training as identified by TransCelerate BioPharma, which makes this course recognized by most of the sponsors.
All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.
Course timeAt your own pace; the course will remain available online for you for 3 months after you register for it.---------------------- Course Credits: 3 hours
Who should attend
Medical Doctors looking to participate in, or conducting Clinical Trials. Sub-investigators, study coordinators and other staff involved in clinical trials.
- Introduction to ICH-GCP for all involved stakeholders
- ICH-GCP and the 13 responsibilities of the investigator and his /her staff
- Being qualified, taking responsibility and having oversight
- Obtaining informed consent, the right way
- Knowing and following the protocol
- Controlling the investigational products
- Safety reporting characteristics
- Source documents and trial specific documents
Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.
- Comprehend the overall ICH-GCP requirements
- Understand the responsibilities of a Medical Doctor within clinical trials
- Know what, why and how clinical trial duties are to be performed and documented
- Be prepared for audits/inspections
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (8)
- Study and Site Management (2)
- Data Management and Informatics (4)
- Leadership and Professionalism (2)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained