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. (n) „Zásady SKP“: Pokyn Mezinárodní konference pro harmonizaci E6 o správné klinické praxi v poslední ▇▇▇▇▇ 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.

  • 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.

  • 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.

  • The Investigator also must undertake to perform the study in accordance with ICH GCP Guideline E6 and applicable regulatory requirements and guidelines.

  • 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.

  • The 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 and International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6.

  • In carrying out its responsibilities under this Agreement and each CCLS, QLAB agrees to conduct its services in substantial compliance with all applicable laws, rules and regulations, including but not limited to the U.S. Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto, ICH GCP Guideline UK SI 2004; 1031 Part 2 where applicable and with the standard of care customary in the central laboratory industry.

Related to GCP Guideline

  • ECB €STR Guideline means Guideline (EU) 2019/1265 of the European Central Bank of 10 July 2019 on the euro short-term rate (€STR) (ECB/2019/19), as amended from time to time;

  • 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.

  • Poverty guidelines means the poverty guidelines for the 48 contiguous states and the District of

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