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- 98% of people completing this module said they would recommend it to their colleagues
- Over 80% gave an overall assessment of this module of 7/10 or better
- Over 80% said that this module met their expectations to a level of 7/10 or better
Overview
ICH GCP E6 guidelines provide the basis for the conduct of clinical trials and therefore it is important that Investigators have an understanding of ICH GCP requirements.
The primary audience for this module is any Investigator involved in the set up, conduct or reporting of a clinical trial. This module will also provide the standard principles required to satisfy the regulatory requirements and meet the exacting standards of clinical research.
The course was designed to increase subject knowledge for Investigators. It does not cover ICH GCP in great depth, but is designed to enhance Investigators skills of ICH GCP by means of consequence learning.
By the end of this module the learner will know the requirements of the Investigator under ICH GCP. Its aim is not so much to explain what the ICH GCP guidelines are, but instead to explore why it is vital to strictly adhere to them.
The programme is clear and simple in design and gives full instructions for use.
Learning objectives
By the end of this course, you will be able to…
- Describe ICH GCP requirements and their impact on the role of the Investigator
- Implement appropriate strategies for ensuring adherence to the protocol and communication with the Ethics Committees
- Demonstrate an awareness of the key requirements of the guidelines; informed consent, drug accountability, maintaining records and reports
- Effectively communicate and implement procedures for safety reporting
Certification & CPD
At the end of the course you can complete a 20 question,
multiple choice exam, which will test you on the subject matter of the
module. The pass mark for the exam is 75%, but you can take the exam as
many times as you like.
On passing the exam you will have the option of printing
out a certificate which will certify your successful completion of the
course.l
