Good Clinical Practice definition

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.

Good Clinical Practice means using standards, practices, methods and procedures conforming to the Law and exercising that degree of skill and care, diligence, prudence and foresight which would reasonably and ordinarily be expected from a skilled, efficient and experienced clinical services provider and a person providing services the same as or similar to the Services at the time the Services are provided including assigning a Consultant to each Service User who will be clinically responsible for the Service User at all times during the Service User’s care by the Provider;

Good Clinical Practice means a set of detailed ethical and scientific quality requirements for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials ensuring that the rights, safety and well-being of subjects are protected, and that the data generated in the clinical trial are reliable and robust;

Examples of Good Clinical Practice in a sentence

• The Study shall be performed in accordance with the terms and conditions of the Protocol, the terms of this Agreement, the generally accepted standards of Good Clinical Practice and all applicable laws and regulations governing the conduct of this Study in Czech Republic, including but not limited to the ICH GCP and the Declaration of Helsinki, and all other applicable legislation.

• Where the clinical trial is to be undertaken under this Agreement, Afrigen shall comply with ICH GCP principles outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice guidelines as laid down in the “ICH Topic E6(R1)” and set out at xxxx://xxx.xxx.xxx/products/guidelines/efficacy/article/efficacy-guidelines.html, as amended from time to time.

• Documentation of all IRB/EC approvals and of the IRB/EC compliance with the ICH harmonised tripartite guideline E6(R2): Good Clinical Practice will be maintained by the site and will be available for review by the sponsor or its designee.

• All study procedures were conducted in accordance with the Guidelines for Good Clinical Practice and ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

• Confirmation and documentation of any training (Human Subjects Protections, Good Clinical Practice, etc.) for UW team members.

More Definitions of Good Clinical Practice

Good Clinical Practice means using standards, practices, methods and procedures conforming to the Law and using that degree of skill and care, diligence, prudence and foresight which would reasonably and ordinarily be expected from a skilled, efficient and experienced clinical services provider, or a person providing services the same as or similar to the Services, at the time the Services are provided, as applicable Guidance means any applicable local authority, health or social care guidance, direction or determination which the Authority and/or the Provider have a duty to have regard to including any document published under section 73B of the NHS Act 2006 Immediate Action Plan means a plan setting out immediate actions to be undertaken by the Provider to protect the safety of Services to Service Users, the public and/or Staff Indirect Losses means loss of profits (other than profits directly and solely attributable to the provision of the Services), loss of use, loss of production, increased operating costs, loss of business, loss of business opportunity, loss of reputation or goodwill or any other consequential or indirect loss of any nature, whether arising in tort or on any other basis Issuing Party means the Party which has issued a Contract Query Notice JI Report means a report detailing the findings and outcomes of a Joint Investigation Joint Investigation means an investigation by the Issuing party and the Receiving Party into the matters referred to in a Contract Query Notice Law means:

Good Clinical Practice or “GCP” means the current good clinical practice applicable to the clinical Development of the Product under applicable law including without limitation the ICH guidelines, or in the event such standards are less stringent than the current U.S. Good Clinical Practice, then “Good Clinical Practice” or “GCP” shall mean current U.S. Good Clinical Practice.

Good Clinical Practice or “GCP” - clinical practice as set out in:

Good Clinical Practice means the 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 MHLW, EMA and other organizations and governmental agencies in Major EU Countries to the extent such standards are not less stringent than United States Good Clinical Practice.

Good Clinical Practice means the 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 EMA and other organizations and governmental agencies in Major EU Countries to the extent such standards are not less stringent than United States Good Clinical Practice.

Good Clinical Practice means the current good clinical practice applicable to the clinical Development of Licensed Product under applicable Law, to the extent such standards are not less stringent than the U.S. current good clinical practice, including the ICH guidelines.

Good Clinical Practice or “GCP” shall mean any and all laws, rules, regulations, guidelines and generally accepted standards and requirements regarding the ethical conduct of clinical trials, including without limitation the U.S. Code of Federal Regulations (“CFR”) Title 21, ICH GCP Guidelines E6(R1), current step 4 version, dated 10 June 1996, as amended from time to time, national legislation implementing European Community Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, European Community Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards to investigational medicinal products for human use.