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Good Clinical Practice - ICH Guidelines E6 R2

Course ID: 187460
Alison
Course Location
3-4 hours
Free

Course Content

Gain critical information about good clinical practice (GCP) in conducting safe clinical trials in this free course. Clinical research involving human subjects is a very sensitive matter requiring careful decision-making by those involved. The ICH guidelines to good clinical practice allow researchers to conduct clinical trials with the correct methodologies. By completing this course, clinical research aspirants can gain detailed insight into conducting fruitful clinical research while ensuring the safety of all those involved. ????

Course Details

Course CategoryHealth Care
Course TypeOnline Learning
Course QualificationCPD Certificate
Course Duration3-4 hours
Course FeeFree
Entry RequirementsLike all courses on the Alison Free Learning platform this is a free, CPD-accredited course. A Graduate can choose to buy a certificate or diploma upon successful completion of a course, but this is not required or necessary.

At Alison we believe that free education, more than anything, has the power to break through boundaries and transform lives.

Alison is the world’s largest free online empowerment platform for education and skills training, offering over 5000 CPD accredited courses and a range of impactful career development tools. It is a for-profit social enterprise dedicated to making it possible for anyone, to study anything, anywhere, at any time, for free online, at any subject level. Through our mission, we are a catalyst for positive social change, creating opportunity, prosperity, and equality for everyone.
Career PathIn This Free Course, You Will Learn How To
• Identify the role of ICH and the duties of its working groups
• Discuss GCP requirements regarding conducting a clinical trial
• Evaluate the team configuration of IECs and IRBs
• Recall the primary responsibilities and procedures of IECs and IRBs
• Define ICH's GCP requirements concerning communication with IRBs, and the responsibilities of trial conductors
• Discuss the method of taking consent from the trial's subjects
• Recognize GCP record-keeping requirements for a clinical trial
• Indicate the responsibilities of the trial's sponsors in financing the trial's subjects
• Recall how the sponsor will report any adverse events to the regulatory authorities
• Outline guidelines about trial protocols and subject treatment protocol
• Discuss the concept of good clinical practice
• Identify the importance of quality management and the role of a Clinical Research Organization
Course Code5445

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