Monday, 21 May 2018

CLINICAL TRIAL & 13 Principles of ICH GCP

In Clinical Trials to achieve Quality readiness one needs to understand the Principles of Good Clinical Practices. GCP has been well defined in EU Directive 2001/20/EC, under Clause 2 of Article 1, which discusses about scientific quality requirements for designing and conducting clinical trials.

The data obtained from Clinical trials should be credible as well Clinical trials should protect the rights, safety and wellbeing participating subjects as per National Research Act and Belmont Report, to ensure the authenticity of data and protection of human subjects The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) created Good Clinical Practices in the year 1996, which eventually became mandatory to be followed in the year 2004 for conducting trials on all Investigational Medicinal Products (IMP).

Principles of GCP are summarized as follows

1.Clinical Trials should be conducted as per Declaration of Helsinki, which provides ethical guidelines on human experimentation.
2.Before the initiation of clinical trial, the risks for subject and society should be weighed against its anticipated benefits. 
3.The safety and rights of the participating subjects should considered with utmost importance over the benefits of trial. 
4.Clinical information and non-clinical information on the investigational medical product should be adequate to support the trial.
5.Specifics of clinical trials should be well defined and explained in Protocol
6.Protocol should be approved by Institutional review board (IRB)/independent ethics committee (IEC), following which clinical trial should be conducted in compliance with Protocol. 
7.During the trial, qualified physician would be responsible for the well the being of the subject 
8.The staff conducting the trail should be qualified in education, training and experience to perform task allocated to them.
9.Prior to the clinical trial signed informed consent should be obtained from the subject
10.To allow accurate reporting, interpretation and verification of clinical trial data, measures to and record and maintain the data should be sought out.
11.The records identifying the confidentiality of subject should be protected in respect to privacy and confidentiality regulations.
12.The Investigational medicinal product in Clinical Trials should be manufactured as per Good manufacturing practices (GMP) and should be used in accordance to the protocol. 
13.Quality systems should be maintained to ensure quality in Clinical Trials.

Reference: GCP 13 Principles
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