The Importance of ICH GCP
The Importance of ICH GCP:
The ICH GCP is a harmonized standard that protects the rights, safety, and welfare of human subjects eliminating their exposure to investigational products, improve the quality of data, and speed up the marketing of new drugs.
Fig 1: Good clinical practice and ICH
Good clinical practice (GCP) is an international ethical and good quality standard for the design, conduct, performance, monitoring, recording, analysis, and reporting of clinical trials. A good clinical practice course aims to prepare researchers to conduct clinical trials with human participants. Ensure the credibility of clinical trial data. The objective of this ICH GCP is to provide unified data for European Union, Japan, and the USA to facilitate the mutual acceptance of clinical data by regulatory authorities of jurisdiction. Good clinical practitioners of the European Union, Japan, Canada, the USA, Australia, and the World Health Organization establish the guideline for clinical trials and these guidelines should be followed, when intended to represent the clinical trial data to regulatory authorities.
Table 1: Reason for GCP
Since the development of ICH GCP guidelines, the scale, complexity, and cost of clinical trials have increased. This guideline offers a new opportunity to increase activity and focus on relevant activities. Therefore, these guidelines have encouraged the implementation of an improved and efficient approach to design, conduct, oversight, perform, monitor, record, and analyze the clinical trials to ensure human subject protection reliability of trial results.
There are thirteen core principles of ICH GCP,
• Keep ethical principles in mind while conduction clinical trials.
•Before initiating the trial, foreseeable risk, and benefits of it, are calculated. Continue it only if anticipated benefits are more than risk.
• The right, safety, and wellbeing of the trial subject are the most important consideration and should prevail over the interest of science and society
• Clinical trials should be scientifically sound and describe detailed information about it.
• The medical care given, and the medical decision made on behalf of the subject should be the responsibility of a qualified physician\dentist.
• Everyone involved in conducting a trial should be qualified by education, training, and experience to perform his/her task.
•There must be a service of freely given informed consent for every individual
• All information from clinical trials should be handled and recorded in an accurate way
• The confidentiality of record that could recognize the subject should be protected respecting the privacy of the subject
•The implemented System must have a procedure that ensures the quality of every aspect of the trial.
Fig 3: Principles of ICH GCP
There has been a rapid expansion of clinical trials in developing countries in the past few decades. The rapid increase in clinical trials in developing countries has raised concerns regarding the rights of participants and research ethics. Informed consent is a required part of all clinical researches. It is also an article part of the process. The ICH GCP informed consent guidelines have suggested adding 20 informational items in the Informed Consent Form. Informed consent form from several therapeutic areas includes information on cardiovascular disease, women’s health, etc.
Explore These Courses for Enhanced Learning:
Training of pharmacovigilance staff who will work on computer systems. To deepen your knowledge, check out the Pharmacovigilance Certification.
The topic of the training should cater to job requirements, providing detailed education for pharmacovigilance employees. Consider the comprehensive Pharmacovigilance Certification.
For new employees, overcoming geographical differences in training is crucial. Online courses like the Advanced Clinical Research Project Manager Certification and the Medical Monitor Certification are excellent resources.
Interested in coordinating clinical research? The Clinical Research Coordinator course provides essential training.
Explore the role of a Clinical Research Associate with the CRA course.
For those involved in international health care compliance, the ICH-GCP course offers critical guidelines and practices.
Assist in clinical trials more effectively by undertaking the Clinical Trials Assistant Training.
Physicians aiming to become principal investigators can benefit from the Advanced Principal Investigator Physician Certification.
References:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4936070/ - Comparison of good clinical practice compliance and readability ease of the informed consents between observational and interventional clinical studies in the Emirates
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3097692/ - The importance of Good Clinical Practice guidelines and its role in clinical trials
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4923807/ - Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2794015/ - Good Clinical Practice Research Guidelines Reviewed, Emphasis Given to Responsibilities of Investigators: Second Article in a Series
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4629715/ - Good clinical practice in clinical interventional studies
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1884182/ - Good clinical practice: a nuisance, a help or a necessity for clinical pharmacology?