GCP guidelines were developed by an accomplished committee set up by CDSCO along with the clinical experts. This article elucidates the. Organization (CDSCO), headed by the Drug Controller General of India (DCGI) Guidelines (ICH-GCP) for clinical trials and follow the recently. The Indian version of GCP is based on the ICH-GCP, but there are key differences between the two. Some of the guidelines found in the Indian.

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Specific statement of primary and secondary end points, if any, to be measured during the study. Clinical research regulation in India-history, development, initiatives, challenges and controversies: The IEC should decide and record huidelines special circumstances and the mechanism when an interim review can be resorted-to instead of waiting for the scheduled time of the meeting.

Several governmental and non-governmental organisations within the country fund academic research and the academician needs to make an application to them with application formats and timelines being available gujdelines their home pages.

Regulatory requirements for clinical trials in India: What academicians need to know

The Study should use the maximum degree of blindness that is possible. The main responsibility of the monitor is to oversee the progress of the study and to ensure that the study conduct and data handling comply with the protocol, GCPs and applicable ethical and regulatory requirements. It is generally accepted that a minimum of five persons is required cddco compose cdcso quorum. These studies are often carried out in healthy adult volunteers using clinical, physiological and biochemical observations.


Medical progress is based on research, which ultimately must rest in part on experimentation involving human subjects. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, guideoines or therapeutic method exists. A co-ordinating committee may be set up or a co-ordinator appointed with responsibility for the control of practical performance and progress of the study and maintaining contact with the regulatory authorities and the ethics committee s.

Care should be taken: A noxious and unintended response at doses normally used or tested in humans. The sponsor should obtain written acceptance of the protocol and its annexes from each of the investigator and institution involved.

The observations and suggestions of IEC should be given in writing in unambiguous terms in such instances.

Regulatory requirements for clinical trials in India: What academicians need to know

The double burden of communicable and non-communicable diseases in developing countries. Academicians, however, also carry out their own research and these studies are called as ‘Investigator initiated studies’ IISs. Procedures for managing missing data, unused data and unauthentic data.

A schematic diagram of the study design, procedures and stages. Registration must be done before the first participant is enrolled.

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The key idea of a clinical trial is to compare groups of patients who differ only with respect to their treatment. That has not been used to a significant extent in the country. Confirmation of review guidflines the Ethics Committee. Involvement of a appropriately qualified and experienced statistician is necessary in the planning stage as well as throughout the Study.

Irrigation test; graded doses. Cvsco is validated through in-process Quality Control and in and post-process auditing of clinical trial process as well as data. Medical research involving human subjects includes research on identifiable human material or identifiable data.

Appropriate caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected. Responsibilities of the Sponsor and the Monitor.

Law Relatings to Drugs & Cosmetics

Labelling developed specifically for products involved in the study. Author information Copyright and License information Disclaimer. A pharmaceutical product including placebo used as a reference in a clinical trial. System guidelined be followed for labelling of the product s code numbering etc.

Sponsor should also maintain records of the quantities of Investigational Product with proper batch numbers. Information to the Study Subjects and the mode of providing it.

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