Is GCP part of ICH?
GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
What is ICH-GCP in clinical research?
ICH-GCP (International Conference on Harmonisation – Good Clinical Practice) To avoid any malpractices and overcome inconsistencies in clinical trial, the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued these guidelines.
What is ICH-GCP R2?
ICH E6(R2) adds more about document control, specifying that the sponsor should not have exclusive control of case report form (CRF) data submitted by the investigator, and that the investigator/institution should have control of all their own essential documents before, during, and after the trial.
What is ICH GCP R2?
What is ICH GCP in clinical research?
What are the 3 main principles of GCP?
Subject’s Rights, Safety, and Bell-Being. ICH GCP Principle 3 states that the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
What are the GCP guidelines?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.
What is the primary purpose of the ICH?
A primary purpose of the ICH is to: Minimize the need for redundant research. The ICH GCP Guidelines: Set standards for the design, conduct, monitoring and reporting of clinical research.
Which are the main guidelines of ICH?
The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories.
- Quality Guidelines.
- Safety Guidelines.
- Efficacy Guidelines.
- Multidisciplinary Guidelines.