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 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.

Examples of Good Clinical Practice in a sentence

The MEB has been assured that the bioequivalence study has been conducted in accordance with acceptable standards of Good Clinical Practice (GCP, see Directive 2005/28/EC) and Good Laboratory Practice (GLP, see Directives 2004/9/EC and 2004/10/EC).
This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Institutional research policies and procedures.
In obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirement(s), and should adhere to Good Clinical Practice (GCP) and to ethical principles that have their origin in the Declaration of Helsinki.
Prior to trial initiation, sites are evaluated by Merck personnel to assess the ability to successfully conduct the trial.3. Site Monitoring/Scientific IntegrityTrial sites are monitored to assess compliance with the trial protocol and general principles of Good Clinical Practice.
The RMS has been assured that the bioequivalence study has been conducted in accordance with acceptable standards of Good Clinical Practice (GCP, see Directive 2005/28/EC) and Good Laboratory Practice (GLP, see Directives 2004/9/EC and 2004/10/EC).

More Definitions of Good Clinical Practice

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;

Good Clinical Practice or “GCP” means the then-current good clinical practice applicable to the clinical Development of any Licensed Product under Applicable Laws, including the ICH guidelines and U.S. 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. 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” - clinical practice as set out in:

Good Clinical Practice or “GCP” means the ICH ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

Good Clinical Practice means using standards, practices, methods and procedures conforming to the Law, the Duty of Candour (Appendix M) and relevant Clinical Guidelines including those set out in the Service Specifications 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

Filter & Search

Related Definitions