GCP Guideline definition

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 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)/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

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

  • The Qualified Investigator must ensure compliance with the Regulations and the GCP Guideline from every person involved in the conduct of the clinical trial at the site.

  • The investigator must undertake to perform the study in accordance with ICH GCP Guideline E6 (1996), EU Directive 2001/20/EC and its updates, and applicable regulatory requirements and guidelines.

  • In the ICH GCP Guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29).

  • 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.

  • The study sponsor and any third party to whom aspects of the study management or monitoring have been delegated will undertake their assigned roles for this study in compliance with all applicable industry regulations, ICH GCP Guideline E6 (1996), EU Directive 2001/20/EC and its updates, as well as all applicable national and local laws and regulations.

  • This trial must be conducted in compliance with the protocol, ICH GCP Guideline (E6), international ethical principles derived from the Declaration of Helsinki and Council for International Organizations of Medical Science (CIOMS) guidelines, and applicable local laws and regulations.

  • The investigator must undertake to perform the study in accordance with ICH GCP Guideline E6 (1996), EU Directive 2001/20/EC, and applicable regulatory requirements and guidelines.

  • The study sponsor and any third party to whom aspects of the study management or monitoring have been delegated will undertake their assigned roles for this study in compliance with all applicable industry regulations, ICH Good Clinical Practice (GCP) Guideline E6 (1996), EU Directive 2001/20/EC and its updates, as well as all applicable national and local laws and regulations.

  • 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.

Related to GCP Guideline

  • 2%/25% Guidelines has the meaning set forth in Section 13.

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

  • Applicable Guidelines means the policies of the Bank governing the selection and Contract award process as set forth in this RFP.

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

  • Fitch Guidelines means the guidelines, as may be amended from time to time, in connection with Fitch’s ratings of the VMTP Shares.

  • 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 approved by the Board, a copy of which is attached hereto as Exhibit A, as the same may be amended, restated, modified, supplemented or waived pursuant to the approval of a majority of the entire Board (which must include a majority of the Independent Directors).

  • Valuation Guidelines means the valuation guidelines adopted by the Board, as may be amended from time to time.

  • 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;

  • Effluent limitation guideline means a regulation published by the Administration under Section 304(b) of the CWA to adopt or revise effluent limitations.

  • 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;

  • Credit Guidelines means the policies of Credit Acceptance, relating to the extension of credit to automobile, light-duty truck, minivan and/or sport utility dealers and consumers in respect of retail installment contracts for the sale of automobiles, light-duty trucks, minivans and/or sport utility vehicles including the policies for determining creditworthiness of such dealers and consumers and otherwise relating to the extension of credit to dealers and consumers and the maintenance of installment sale contracts, as in effect on the Cut-off Date and as amended from time to time in accordance with the Basic Documents or in accordance with Applicable Law, attached hereto as Exhibit H.

  • 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.

  • Program Guide The Residential Funding Seller Guide for mortgage collateral sellers that participate in Residential Funding's standard mortgage programs, and Residential Funding's Servicing Guide and any other subservicing arrangements which Residential Funding has arranged to accommodate the servicing of the Mortgage Loans.

  • 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.

  • Environmental Guidelines means the environmental guidelines and occupational health and safety standards of the World Bank Group as in effect on [Bid Date].

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

  • Swiss Guidelines means, together, the guideline “Interbank Loans” of 22 September 1986 (S-02.123) (Merkblatt “Verrechnungssteuer auf Zinsen von Bankguthaben, xxxxx Xxxxxxxxx Xxxxxx sind (Interbankguthaben)” vom 22. September 1986), the guideline “Syndicated Loans” of January 2000 (S-02.128) (Merkblatt “circular letter No. 46 of 24 July 2019 in relation to syndicated credit facilities (Kreisschreiben Nr. 46 "Steuerliche Behandlung von Konsortialdarlehen, Schuldscheindarlehen, Wechseln und Unterbeteiligungen”" vom Januar 200024. Juli 2019), the guideline S-02.130.1 in relation to money market instruments and book claims of April 1999 (Merkblatt vom April 1999 betreffend Geldmarktpapiere und Buchforderungen inländischer Schuldner), the guideline “Bonds” of April 1999 (S-02.122.1) (Merkblatt “circular letter No. 47 of 25 July 2019 in relation to bonds (Kreissschreiben Nr. 47 "Obligationen”" vom April 199925. Juli 2019), the circular letter No. 34 “Customer Credit Balances” of 26 July 2011 (1-034-V-2011) (Kreisschreiben Nr. 34 “Kundenguthaben” vom 26. Juli 2011), the circular letter No. 15 of 3 October 2017 (1-015-DVS-2017) in relation to bonds and derivative financial instruments as subject matter of taxation of Swiss federal income tax, Swiss Federal Withholding Tax and Swiss Federal Stamp Taxes (Kreisschreiben Nr. 15 “Obligationen und derivative Finanzinstrumente als Gegenstand der direkten Bundessteuer, der Verrechnungssteuer und der Stempelabgaben” vom 3. Oktober 2017), the practice note 010-DVS-2019 of 5 February 2019 published by the Swiss Federal Tax Administration regarding Swiss Withholding Tax in the Group (Mitteilung-010-DVS-2019-d vom 5. Februar 2019 - Verrechnungssteuer: Guthaben im Konzern); all as issued, and as amended or replaced from time to time, by the Swiss Federal Tax Administration or as substituted or superseded and overruled by any law, statute, ordinance, regulation, court decision or the like.

  • DOL Guidance means the Department of Labor (DOL) Guidance entitled: “Guidance for Executive Order 13673, ‘Fair Pay and Safe Workplaces’”. The DOL Guidance was initially published in the Federal Register on August 25, 2016, and significant revisions will be published for public comment in the Federal Register. The DOL Guidance and subsequent versions can be obtained from www.dol.gov/fairpayandsafeworkplaces.

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

  • Credit Policy means the “New Jersey Infrastructure Bank Credit Policy,” as adopted by the Board of Directors of the I-Bank and as further amended and supplemented from time to time.