Good Clinical Practices Guidelines definition

Good Clinical Practices Guidelines means Good Clinical Practices Guidelines issued by Central Drugs Standards Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India;
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Good Clinical Practices Guidelines means the Good Clinical Practices Guidelines for conduct of clinical studies in India, formulated by the Central Drugs Standard Control Organisation and adopted by the Drugs Technical Advisory Board;
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Examples of Good Clinical Practices Guidelines in a sentence

  • Central Drugs Standard Control Organization- Good Clinical Practices, Guidelines for Clinical Trials on Pharmaceutical Products in India.

  • The Ethics Committee shall review and accord approval to a Clinical trial, Bioavailability and Bioequivalence study protocol and other related documents, as the case may be, in the format specified in clause (B) of Table 1 of the Third Schedule of New Drugs and Clinical Trials Rules, 2019 and oversee the conduct of clinical trial to safeguard the rights, safety and wellbeing of trial subjects in accordance with these rules, Good Clinical Practices Guidelines and other applicable regulations.

  • The members of the Ethics Committee shall follow the provisions of these rules, Good Clinical Practices Guidelines and other regulatory requirements to safeguard the rights, safety and well-being of trial subjects.

  • I am familiar with the internationally recognized and national guidelines of internationally accepted Good Clinical Practices Guidelines adopted by the Authority and understand the responsibilities and obligations of the clinical trial monitor within the context of this trial.2. I have notified the Authority of any aspects of the above with which I do not or which I am unable to, comply.

  • Good Clinical Practices- Guidelines for Clinical Trials on Pharmaceutical Products in India.

  • When you become a customer of a Gentrack Customer, the Gentrack Customer may disclose or provide us with access to your personal information so that we can provide billing and data hosting support to the Gentrack Customer.

  • Monitors will be trained on study protocol, study procedures, administrative and regulatory procedures, monitoring guidelines (including handling of Adverse Events), Operating Procedures related to their activities and Good Clinical Practices Guidelines.

  • The College voluntarily applies the International Conference on Harmonization Good Clinical Practices Guidelines (ICH-GCP) to certain types of human subject research conducted under itsHRPP.

  • Changes made while conducting the research which are notifiable and which require the approval of the ethical committee and the permission of the General Directorate are specified in accordance with the Good Clinical Practices Guidelines.

  • The members of the Ethics Committee shall follow the provisions of all the rules, Good Clinical Practices Guidelines and other regulatory requirements to safeguard the rights, safety and well-being of trial subjects.

Related to Good Clinical Practices Guidelines

  • Good Clinical Practices means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Part 50, 54, 56, 312, 314, 320, 812, and 814 and (ii) “Good Laboratory Practices” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58.

  • Good Clinical Practice or “GCP” means the then current standards for clinical trials for pharmaceuticals, as set forth in the ICH guidelines and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by the European Union and other organizations and governmental agencies in countries in which a Licensed Product is intended to be sold to the extent such standards are not less stringent than the ICH guidelines.

  • Clinical practice guidelines means a systematically developed statement to assist

  • Good Laboratory Practices or “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory standards in jurisdictions outside the United States, as they may be updated from time to time).

  • Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Good Laboratory Practice or “GLP” means the applicable then-current standards for laboratory activities for pharmaceuticals (including biologicals) or vaccines, as applicable, as set forth in the Act and any regulations or guidance documents promulgated thereunder, as amended from time to time, together with any similar standards of good laboratory practice as are required by any Regulatory Authority having jurisdiction over the applicable activity.

  • Good Industry Practices means the practices that would be adopted by, and the exercise of that degree of care, skill, diligence, prudence and foresight that reasonably would be expected from, a competent contractor in the international oil and gas industry experienced in performing work similar in nature, size, scope and complexity to the Work and under conditions comparable to those applicable to the Work, where such work is subject to, and such contractor is seeking to comply with, the standards and codes specified in the Contract or (to the extent that they are not so specified) such national or international standards and codes as are most applicable in the circumstances, and the applicable Law.

  • Prudent Electrical Practices means those practices, methods, standards and equipment commonly used in prudent electrical engineering and operations to operate electrical equipment lawfully and with safety, dependability and efficiency and in accordance with the National Electrical Safety Code, the National Electrical Code and any other applicable federal, state and local codes provided, however, that in the event of a conflict, the applicable federal, state or local code shall govern.

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • Generally accepted standards of medical practice means standards that are based upon: credible scientific evidence published in peer-reviewed medical literature and generally recognized by the relevant medical community; physician and health care provider specialty society recommendations; the views of physicians and health care providers practicing in relevant clinical areas and any other relevant factor as determined by statute(s) and/or regulation(s).

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • New Jersey Stormwater Best Management Practices (BMP) Manual or “BMP Manual” means the manual maintained by the Department providing, in part, design specifications, removal rates, calculation methods, and soil testing procedures approved by the Department as being capable of contributing to the achievement of the stormwater management standards specified in this chapter. The BMP Manual is periodically amended by the Department as necessary to provide design specifications on additional best management practices and new information on already included practices reflecting the best available current information regarding the particular practice and the Department’s determination as to the ability of that best management practice to contribute to compliance with the standards contained in this chapter. Alternative stormwater management measures, removal rates, or calculation methods may be utilized, subject to any limitations specified in this chapter, provided the design engineer demonstrates to the municipality, in accordance with Section IV.F. of this ordinance and N.J.A.C. 7:8-5.2(g), that the proposed measure and its design will contribute to achievement of the design and performance standards established by this chapter.

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Good Industry Practice means standards, practices, methods and procedures conforming to the Law and the degree of skill and care, diligence, prudence and foresight which would reasonably and ordinarily be expected from a skilled and experienced person or body engaged in a similar type of undertaking under the same or similar circumstances.

  • Quality Standards means the quality standards published by BSI British Standards, the National Standards Body of the United Kingdom, the International Organisation for Standardisation or other reputable or equivalent body, (and their successor bodies) that a skilled and experienced operator in the same type of industry or business sector as the Contractor would reasonably and ordinarily be expected to comply with, and as may be further detailed in the Specification.

  • standards of generally recognised accounting practice means an accounting practice complying with standards applicable to municipalities or municipal entities as determined by the Accounting Standards Board

  • PJM Regional Practices Document means the document of that title that compiles and describes the practices in the PJM Markets and that is made available in hard copy and on the Internet. PJM Region Installed Reserve Margin:

  • GMPs means all good manufacturing practices under Title 21 of the United States Code of Federal Regulations, as amended from time to time.

  • ISO-NE Practices means the ISO-NE practices and procedures for delivery and transmission of energy in effect from time to time and shall include, without limitation, applicable requirements of the NEPOOL Agreement, and any applicable successor practices and procedures.

  • Specifications and Standards means the specifications and standards relating to the quality, quantity, capacity and other requirements for the Project Highway, as set forth in Schedule-D, and any modifications thereof, or additions thereto, as included in the design and engineering for the Project Highway submitted by the Contractor to, and expressly approved by, the Authority;