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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The investigator should keep a confidential list of names of all Study Subjects allocated to each study. Author information Copyright and License information Disclaimer.

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

Responsibilities of the Sponsor and the Monitor. Academic guidelinws, clinical trials, compliance, India, regulations. Anaesthesia as a speciality straddles several diverse disciplines that include various branches of surgery and medicine as well as critical care and pain management among others. All observations and findings should be verifiable, for the credibility of the data and to assure that the conclusions presented are correctly derived from the Raw Data. Tests for identification of the active ingredient and method of its assay.

Precise description of methodology of the proposed research, including intended dosages and routes of administration of drugs, planned duration of treatment and details of invasive procedures if any. Procedures for handling and processing records of effects and adverse guidelijes to the product s under study. Drugs and Cosmetics Act. However, only through good manufacturing practices GMP can the end products reach the stage of utilization by society. Essential Documents are those documents which individually and collectively allow the evaluation of the conduct of a study and the quality of the data generated.

These studies see Appendix I, Sch. The drug should be administered throughout the last third of pregnancy and then through lactation and weaning.

All Protocol Amendments should be agreed upon and signed by the persons who were the signatories to the Protocol.

The IB also provides background material to support the clinical management of the study subjects. These may be carried out at one or two centres. The systems should be designed to permit data cdsc in such a way that the data changes are documented and there is no deletion of data once it has been entered. The reports of completed clinical trials shall be submitted by the applicant duly signed by the investigator within a stipulated period of time. Until the guidelines are formulated and implemented by this regulatory Authority clinical trials with biomedical devices should be approved on case to case basis by committees constituted for the specific purpose.


Plans cvsco publication of results – positive or negative – while maintaining the privacy and confidentiality of the study participants.

This is provided that these studies are not intended for generating data to make a regulatory submission. The clinical pharmacological including pharmacodynamic and pharmacokinetic effects. References to the literature and data that are relevant to the study and that provide background for the study.

Repeated or Chronic use. Investigator should check whether the subject s so identified could be included in the study according to the protocol. The objective of QC is to avoid exposure of study subjects to unnecessary risks guiddelines to avoid false conclusions being drawn from unreliable data.

Specifications of safety parameters. The refusal of a patient to participate in a study must never gcl with the patient-physician relationship. Informed Consent in Non-Therapeutic Study: Examples of such instances are research involving children, pregnant and lactating women, vulnerable subjects and those with diminished autonomy besides issues pertaining to commercialisation of research and international collaboration.

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

Obligations of investigators regarding informed consent: For this reason, a medically qualified person should generally participate in the editing of an IB, but the contents of the IB should be approved by the disciplines that generated the described data.

When the application is for clinical trials only, information covered in item 2. Open in a separate window. It also states the conditions under which the study shall be performed and managed. Compensation in a clinical trial is needed both when death occurs or when there is clinical trial-related injury. Type and duration of the follow-up of the subjects after adverse events. An already approved drug that is now proposed to be used in a different dosage, different dosage form, a new route or a new indication.


Obligation of the sponsor to pay. These studies are usually limited to centres and carried out by clinicians specialized on the concerned therapeutic areas and having adequate facilities to perform the necessary investigations for efficacy and safety. The protocol should include the following: The committee has the right to monitor ongoing trials. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.

Ideally, the studies should begin and end simultaneously at all institutions. The physician should fully inform the patient which aspects of the care are related to the research. Per law, it is mandatory that all clinical research that falls under the ambit fdsco Schedule Y complies with the necessary requirements.

It ensures that the studies are implemented and reported in such a manner that there is public assurance that the data are credible, accurate and that the rights, integrity and confidentiality of the subjects are protected. Some research populations are vulnerable and need special protection.

Phase I trials are usually carried out by investigators trained in clinical pharmacology and having the necessary facilities to closely observe and monitor the subjects. B – Conduct of the clinical trial Conduct of the clinical trial The investigator must ensure that clinical trials are conducted as per the rules outlined below[ 13 ] In compliance yuidelines an EC and a DCGI approved protocol. A noxious and unintended response at doses normally used or tested in humans.

Medical research involving human subjects includes research on identifiable human material or identifiable data. The IB should contain the following sections, each with literature references where appropriate: Do clinical trials conducted in India match its healthcare needs? The number of animals required for these studies, i.

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