History and Principles of ICH GCP: Good Clinical Practice

Learn the History and Principles of Good Clinical Practice which is a unified standard for conducting clinical trials
Free tutorial
Rating: 4.5 out of 5 (33 ratings)
452 students
1hr 13min of on-demand video
English

Principles of ICH Good Clinical Practice (GCP)
History and Evolution of ICH Good Clinical Practice (GCP)
Key facts about the Declaration of Helsinki
Importance of GCP and its 13 Core Principles

Requirements

  • Any individuals that are interested in acquiring knowledge about ICH GCP

Description

ICH GCP certification is essential for all those working in the field of clinical research. This module introduces GCP and helps you understand the role and goals of the International Council for Harmonization (ICH) and the principles of Good Clinical Practice (GCP). We describe the roles of members of a team working on a clinical trial. We set out the documentation that must be created and maintained. We specify the responsibilities of trial sponsors, clinical investigators and monitors. We explain the rationale and execution of the informed consent process, and discuss issues that arise in practice.

International Conference on Harmonization -Good Clinical Practice (Food and Drug Administration guideline)

  • ICH GCP is a unified standard to facilitate the mutual acceptance of clinical data by the mutual acceptance of clinical data by the regulatory authorities.

  • ICH GCP is an international standard for designing, conducting, recording and reporting trials that involve participation of human subjects.

  • This standard provides public assurance that the rights, safety, and well-being of trial subjects are protected Consistent with the Consistent with the Declaration of Helsinki Declaration of Helsinki

The responsibility for GCP is shared by all of the parties involved, including : –

  • sponsors

  • investigators and site staff

  • contract research organizations (CROs )

  • ethics committees

  • regulatory authorities regulatory authorities

  • research subjects

Who this course is for:

  • Pharmacy students
  • Working Professionals in Clinical Research, Pharmacovigilance or Clinical Data Management
  • Life science graduates
  • Doctors
  • Nursing graduates
  • Paramedical staff

Instructor

Leading training Centre in Healthcare
Jehangir Centre for Learning
  • 3.9 Instructor Rating
  • 118 Reviews
  • 2,591 Students
  • 4 Courses

Jehangir Centre for Learning (JCL) is a division of Jehangir Clinical Development Centre (JCDC) which is a leading clinical research centre in India.

JCL is a leading healthcare education and training institute since 2008. JCL with a vision of spreading quality education in healthcare offers a wide range of educational and training programs.

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