ICH-GCP: Introduction to Good Clinical Practice

5/5
133
GCP

Duration :

2.5

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course : 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

Good clinical practice can be seen as a general framework ensuring that all stakeholders will be respected, listened to, taken into account, and accountable in the complex process of discovering new medical treatments, whether they be investigative drugs, improved treatments or medical devices. Compliance with GCP principles is required by regulatory authorities (FDA, EMA) in many countries for the authorization of clinical trials and the validation of their data.

This module introduces GCP. Our expert discusses the role and goals of the ICH (International Council for Harmonization) and the principles of GCP. Our expert describes the roles of members of a team working on a clinical trial. She sets out the documentation that must be written and validated. She defines the responsibilities of trial sponsors, clinical investigators and monitors. She explains the rationale and execution of the informed consent process, and discuss issues that arise in practice.

 

Curriculum:

 

Lesson 1: Why do we need Good Clinical Practice ? 

 

Lesson 2: Concern about the safety of drugs

 

Lesson 3: Ethical Principles

 

Lesson 4: The four phases of Clinical Research

 

Lesson 5: International Council for Harmonization

 

Lesson 6: Principles of ICH GCP

 

Lesson 7: Code of Federal Regulations

 

Glossary

 

Evaluation

Author:

patricia kay
Dr. Patricia Kay
Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She worked as Clinical Research Associate at Pfizer, GSK, AstraZeneca and she takes part in many startups boards.

Reviews:

5/5
133
USD: United States (US) dollar ($)

$48.00 $60

Buy now
This course includes:
Full lifetime access
Updated content every month
Certificate of completion

GxP-Training Benefits

$48.00

$48.00

Frequently bought together

Good Clinical Practice GCP

$48.00
$60

We might have this course but it's not displayed online. Please type your email and we will get back to you within 24h

No video yet for this course