ICH E6

ICH E6 – Investigator (Chapter 4) (R2)

Upon completing this course, you will be able to define what an Investigator is and what their responsibilities are, discuss typical clinical research site requirements that an investigator is responsible for, provide examples of how the Investigator interacts with sponsors, regulators, and their IRB and identify the requirements and process for informed consent and assent.

CEU Credits: 0.1
Course Code: ELM-906
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Course Introduction
41 secs
What You'll Learn
31 secs
What an Investigator Does
10 secs
Clinical Trial Site Leaders
2 min 3 secs
Investigator Qualifications
44 secs
Staffing and Resourcing
10 secs
Common Site Research Stall
37 secs
Medical Oversight
1 min 47 secs
Knowledge Check
30 secs
IRB/IEC Engagement
1 min 17 secs
Compliance
10 secs
Failure to Comply
1 min 33 secs
IMP Management
57 secs
IMP Accountability
4 secs
Randomization and Blinding
1 min 53 secs
Informed Consent Overview
3 min 38 secs
Non-Therapeutic Trials
1 min 6 secs
Records and Reports
1 min 38 secs
Safety Reporting
1 min 28 secs
Trial Termination
28 secs
Final Report
19 secs
Conclusion
1 min 5 secs
What We Covered
23 secs

Test Your Knowledge

Results

Revision History

Author

Nick Cohen

GxP Quality Assurance Expert

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