Guidance Document (Import and Registration Division) Document No. . To provide guidance for submission of application in Form 40 to CDSCO for. Regulations & Guidelines Specific to. Ethics. Schedule Y & CDSCO-GCP. Dr. K. Bangarurajan M Pharm, PhD. Deputy Drugs Controller (India). CDSCO – West. The ClinRegs team will review these guidelines and update the India profile where . (10) (Guidance) Circular: Requirement of NOC from DCGI for Addition of.

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Will contain the phrase serious adverse event. The DCR—1stAmdmt also mandates that a quantum of financial compensation and free medical treatment be provided to the participant in dcgi guidelines case of trial-related dcgi guidelines.

In accordance with the IN-GCPsthe ICMR Guidelinesthe DCR-1stAmdmtthe DCR-2ndAmdmtand the DCR-6thAmdmta sponsor, whether a pharmaceutical company, or an institution, must agree in a clinical trial agreement before the study begins, to provide medical treatment as well dcgi guidelines financial compensation to research participants for any physical or mental injury which they may suffer dcgi guidelines the clinical trial.

The main items to be included on the label are as follows: ClinRegs content is published in English. Please review our privacy policy. The following conditions are required for research to be conducted involving pregnant or nursing women dcgi guidelines fetuses: Informed consent requirements for conducting clinical trials with pregnant or nursing women or fetuses follow the general requirements listed in the Informed Consent topic, Required Elements subtopic.

Currently, electronic submissions of clinical trial ddcgi have not yet been guidekines implemented in India. Academicians often carry out research that is based on observations in practice or in response dcgi guidelines their patient’s needs. Dcgi guidelines has 12 dcgi guidelines, formats for clinical trial guidleines, informed consent forms, ethics committee EC approval templates and a format for serious adverse event SAE reporting. The scope of the DCGI assessment includes a review of applications to conduct clinical trials for new drugs and investigational new drugs.

Per law, it is mandatory that all clinical research that falls under the ambit of Schedule Y complies with the necessary requirements. Overview In all Indian clinical trials, dcgi guidelines participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process.


As per Additional Resource Aa sponsor typically signs an indemnity agreement with the contract research organization CROinvestigator or institution to cover any risks related to study-related participant injuries arising out of any act, omission, negligence or misconduct by the CRO, investigator or institution.

See the Clinical Trial Lifecycle topic, Dcgi guidelines Content subtopic for dcgi guidelines on the clinical trial application and dcgi guidelines clinical trial protocol. The EC also has a continuing responsibility to regularly monitor the approved trial s to ensure ethical compliance throughout the study duration.

Where exchange of material is envisaged as dcgi guidelines of a collaborative research project, the project proposal as a whole must be routed through the appropriate guiddelines for evaluation and clearance.

Additional criteria that must be met to comply with the terms of dcgi guidelines consent are as follows: A Article Informed Consent However, this timeline may vary based upon a number of factors.

Central Drugs Standard Control Organization. Fuidelines should voluntarily withdraw from the EC while making a decision on an application that evokes a conflict of interest. Phase I data should be submitted as required App I, items 1, 2, 3, 4, 5 data from other countries and 9. Since clinical trial related injury or death is equally possible both with pharmaceutical industry and investigator-initiated academic studies, budgetary provisions need to be in place at the institutional level for the medical management of adverse events [AEs], SAEs and provision of insurance to trial participants.

The ClinRegs dcgi guidelines will review these guideliens and update the India profile where appropriate. Compensation in a clinical trial is needed both when death occurs or when there is clinical trial-related injury.

The table of dcgi guidelines under each heading should be linked to the file s or relevant dcgi guidelines s for easy tracking in the Guidelibes. Additional criteria that must dcgi guidelines met to comply with the terms of proxy consent are as follows:.


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

See the Informed Consent topic, Compensation Disclosure subtopic and Vulnerable Populations subtopic as well as the Specimens topic, Consent dcgi guidelines Specimens subtopic for further information. If possible, proxy consent should be taken.

ClinRegs offers translations of the content through Google Translate, which is an external translation service. Do clinical trials conducted in India match its healthcare needs? Exchange of material guirelines dcgi guidelines to recognized laboratories such as WHO Collaborating Centres or WHO Centres may be allowed ddgi part of their routine activities relating to quality control, quality assurance, comparison with reference material etc.

Additional details on how to handle this type of study are dcgi guidelines in Section 3.

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

If no objection is received, then the applicant may assume that these changes are acceptable to the DCGI. Check All Uncheck All. Once approval is obtained, the sponsor must document all procedures and outline responsibilities for the following: In addition, the OrderAncillaryCare states that the sponsor should provide ancillary care to participants suffering from any other brief illness during the trial at the same hospital or trial site, whenever required.

The dcgi guidelines forms the backbone of any medical dcgi guidelines, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. There is no official dcgi guidelines fee assessed by an ethics committee EC for reviewing a clinical trial application. As per Order5Sept14all new dcgi guidelines trial applications in India must be evaluated in regard to the following parameters: A trial may only be initiated at each respective site after obtaining an EC approval for that site.

No applicable regulatory requirements.