Description
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
GCP is one of the cornerstones of clinical research. It is therefore necessary for all those involved in clinical research to know the guidelines to work in this area.
In this video, Stefano Lagravinese, Scientific Director of CRO ClinOpsHub, and Federica Rossi, Quality Assurance Consultant, explain these extremely important guidelines according to the criteria dictated by TransCelerate Biopharma Inc.
Here is the course agenda:
- Summary of Good Clinical Practice (GCP)
- The principles of GCPs
- Investigator’s responsibility (Chapters 4.1 to 4.13)
What you'll learn
In this course Stefano Lagravinese, CEO of the CRO ClinOpsHub and Federica Rossi, will walk you through why and by who these guidelines were developed, the principles of ICH GCP (R2) and give you an in depth overview of the investigator responsibilities, tasks and related activities.
Who this course is for
Anyone interested in clinical research. In particular this course is suitable for study nurses, study coordinators, Investigators (PIs and Sub-Is) personnel involved in clinical research and assigned to a specific delegation log.
Requirements
None in particular.
Earn a certificate
Follow the course, take the simple quiz and earn a certificate to showcase what you learnt!
Course Curriculum
- Quality Control (2:36)
- Investigator's Responsibility (2:10)
- Adequate Resources (4.2) (1:37)
- Medical Care of Trial Subjects (4.3) (1:34)
- Communication with IRB-IEC (4.4) (1:48)
- Compliance with Protocol (4.5) Part 1 (0:24)
- Investigator Statement (signature page) (2:50)
- Compliance with Protocol (4.5) Part 2 (1:36)
- Investigational Product(s) (4.6) (1:17)
- Randomization Procedures and Unblinding (4.7) (0:46)
- Informed Consent of Trial Subject (4.8) (6:48)
- Vulnerable Subjects (1.61) (3:30)
- Informed Consent of Trial Subject (4.8) Part 2 (2:46)
- Records and Reports (4.9) (7:16)
- Progress Reports and Final Reports (4.10, 4.13) (2:00)
- Safety Reporting (4.11) (4:00)
- Early Trial Termination (4.12) and Course Conclusion (3:30)
- Final graded QUIZ
