GCP Guideline definition

GCP Guideline the International Conference on Harmonization E6 Guideline on Good Clinical Practice as set out in the latest version of CPMP/ICH/135/95. (h) „zásady SKP“: Pokyn Mezinárodní konference pro harmonizaci E6 o správné klinické praxi v poslední xxxxx CPMP/ICH/135/95.
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GCP Guideline means the Committee for Proprietary Medicinal Products (CPMP)/lnternational Conference on Harmonisation (ICH) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted with annotation by the TGA, or its replacement.
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GCP Guideline means the Committee for Proprietary Medicinal Products (CPMP)/International Conference on Harmonisation (ICH) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted with annotation by the TGA. GST means tax that is payable under the GST Law and imposed as goods and services tax.
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Examples of GCP Guideline in a sentence

  • Subject to clause 9, the Institution will allow regular monitoring visits in accordance with the GCP Guideline, access for the purposes of audit and as required by Regulatory Authorities or as specified in the Protocol and permit access to the Essential Documents (including original records), Study records, reports, other Study related materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor.

  • Subject to clause 9, the Institution will allow regular monitoring and scheduled audit visits in accordance with the GCP Guideline and as required by Regulatory Authorities or as specified in the Protocol and permit access to the Essential Documents (including original records), Study records, reports, other Study related materials and its Personnel as soon as is reasonably possible upon request by the CRG, Regulatory Authority, Reviewing HREC or any third party designated by the CRG.

  • Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

  • The parties must comply with, and conduct the Study in accordance with the following, in the following order of precedence: the Protocol; any condition of the Reviewing HREC; any requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities; additionally as applicable: the GCP Guideline; and the NHMRC National Statement on Ethical Conduct in Human Research (2007) or its replacement, and any other relevant NHMRC publication or guideline that relates to clinical trials.

  • Regulations Any relevant legislation, codes or guidelines directly or indirectly related to the conduct of the Trial including but not limited to (as applicable) the Clinical Trials Directive 2001/20/EC and its transforming legislation in the relevant countries of the European Union, the ICH GCP Guideline (“ICH-GCP”), and/or any other relevant applicable legislation, codes or guidelines issued by any Regulatory Authority.

  • Subject to clause 9, the Institution will allow regular monitoring and scheduled audit visits in accordance with the GCP Guideline and as required by Regulatory Authorities or as specified in the Protocol and permit access to the Essential Documents (including original records), Study records, reports, other Study related materials and its Personnel as soon as is reasonably possible upon request by the CRIG, Regulatory Authority, Reviewing HREC or any third party designated by the CRIG.

Related to GCP Guideline

  • Program Guidelines means any and all GLO-approved documents reflecting specific rules and regulations governing the implementation of the Program.

  • Treasury guidelines means any guidelines on supply chain management issued by the Minister in terms of section 168 of the Act;

  • Modification Guidelines has the meaning provided in Section 2.1(a) of this Single Family Shared-Loss Agreement.

  • Federal poverty guidelines means the poverty guidelines published annually in the federal register by the United States department of health and human services under its authority to revise the poverty line under section 673(2) of subtitle B of title VI of the omnibus budget reconciliation act of 1981, 42 USC 9902.

  • Investment Guidelines means the investment guidelines adopted by the Board, as amended from time to time, pursuant to which the Adviser has discretion to acquire and dispose of Investments for the Company without the prior approval of the Board.

  • Design Guidelines means the Fernkloof Estate architectural design guidelines to control all aspects of design and landscaping of any development within the Fernkloof Estate dev elopment, as amended from time to t ime in terms of the constitution of the MPOA or as required by the Council , a copy of the current draft which i s av ailable for inspection at the offices of the Association;

  • Risk-Based Capital Guidelines means (i) the risk-based capital guidelines in effect in the United States on the date of this Agreement, including transition rules, and (ii) the corresponding capital regulations promulgated by regulatory authorities outside the United States implementing the July 1988 report of the Basle Committee on Banking Regulation and Supervisory Practices Entitled "International Convergence of Capital Measurements and Capital Standards," including transition rules, and any amendments to such regulations adopted prior to the date of this Agreement.

  • Procurement Guidelines means the “Guidelines: Procurement under IBRD Loans and XXX Credits” published by the Bank in May 2004 and revised in October, 2006.

  • Consultant Guidelines means the “Guidelines: Selection and Employment of Consultants by World Bank Borrowers” published by the Bank in May 2004 and revised in October 2006.

  • Guidelines means the Instructions to Authors available on the Xxxxxxx Science website, as well as the Aims & Scope applicable to the relevant Xxxxxxx Science publication). Xxxxxxx Science’s nominated service provider, Xxxxxxx Science, offers English language support services which Assignor may elect to utilise in respect of the Work by completing the applicable box in Schedule 1: Details of the Work. The provision of such services by Xxxxxxx Science shall be subject to Xxxxxxx 2 [v.122016] Science’s prevailing terms and rates relating to such type of optional support.

  • Guideline means a written statement of regulatory intent or policy for the information and guidance of licensees, issued by the Regulator, or by any other relevant person determined and advised to licensees by the Regulator;

  • Operating Guidelines means the guidelines for the creation and redemption of Units of a class as set out in the schedule to each Participation Agreement as amended from time to time by the Manager with the approval of the Trustee, and where applicable, with the approval of HKSCC and the Conversion Agent, and following consultation, to the extent reasonably practicable, with the relevant Participating Dealers subject always, in respect of the relevant Operating Guidelines for a Participating Dealer, any amendment being notified in writing by the Manager in advance to the relevant Participating Dealer. Unless otherwise specified, references to the Operating Guidelines shall be to the Operating Guidelines for the relevant Sub-Fund applicable at the time of the relevant Application.

  • Anti-Corruption Guidelines means the “Guidelines on Preventing and Combating Fraud and Corruption in Projects Financed by IBRD Loans and XXX Credits and Grants”, dated October 15, 2006.

  • Rating Agency Guidelines means the Fitch Guidelines and any Other Rating Agency Guidelines as they exist from time to time.

  • Consulting Guidelines means the Guidelines on the Use of Consultants by Asian Development Bank and its Borrowers (2010, as amended from time to time);