Mastering ICH Good Clinical Practice E6 (R2)

The following Mastering ICH Good Clinical Practice E6 (R2) educates healthcare providers on the ICH guidelines for good clinical practice (GCP). The three major milestones associated with ICH good clinical practice include the Nuremburg Code, Declaration of Helsinki, and the Kefauver-Harris Amendments. Additionally, there are other guidelines that are important to this practice that are further outlined within this course. Also, the course goes into detail about the history of ICH GCP.

What you will learn:

• Ethical principles underpinning the ICH GCP guidelines
• Responsibilities and expectations for all parties involved in clinical trials
• Critical aspects of clinical trial design
• The process of obtaining informed consent from trial participants
• Best practices for conducting clinical trials in accordance with the ICH GCP guidelines
• The importance of accurate data collection
• Processes for ongoing trial monitoring

Details

Course length: 1 hour. CME: 1

Languages: American English

Key features: Audio narration, learning activity, and post-assessment.

American Medical Compliance is accredited by the Accreditation Council for Continuing Medical  Education (ACCME) to provide continuing education to physicians. Our Continuing Medical Education (CME) program is committed to enhancing the knowledge, skills, and professional performance of healthcare providers to improve healthcare outcomes. Through high-quality educational activities, we aim to address the identified educational gaps to support the continuous professional development of our medical community. American Medical Compliance designates this activity for a maximum of 1 AMA PRA Category 1 Credits. Physicians should only claim this credit for their complete participation in this activity.

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Ethical Considerations of Clinical Trials

While there are other texts in research ethics that had an impact on the ethics of clinical trials, the Declaration of Helsinki is extremely respected within research ethics and GCP. Furthermore, the Declaration of Helsinki is a respected institution and one of the most prominent texts in research ethics, having been revised five times and clarified twice since its inception in 1964. Its guardian, the World Medical Association, recently requested further revisions. There have been numerous changes to the documents over time. This is especially as working with human subjects has changed drastically over the last few decades.

GCP Training Requirements

The GCP policy expects investigators and clinical trial staff to retain documentation of their training, and as needed, provide it to the National Institute of Health upon request. Additionally, the policy expects investigators and clinical trial staff to maintain their training through refresher courses on these topics every 3 years. With the help of American Medical Compliance, your healthcare and clinical trial staff can stay up to date on their GCP training requirements. To learn more about the requirements associated with research ethics and good clinical practice, click the button below.