GCP definition

GCP means good clinical practices, which are the then-current standards for Clinical Trials for pharmaceuticals, as set forth in the FD&C Act or other Applicable Law, and such standards of good clinical practice as are required by the Regulatory Authorities of Europe and other organizations and governmental authorities in countries for which the applicable Licensed Agent or Product is intended to be Developed, to the extent such standards are not less stringent than United States standards.

GCP or “Good Clinical Practices” means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures promulgated by the EMA or other Regulatory Authority applicable to the Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

GCP means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable to the testing of the Compounds.

Examples of GCP in a sentence

• If Pathos elects to license the records, it will be permitted to transfer the files from the Pathos GCP Instance into its own cloud repository subject to (i) Tempus’ express written consent (such consent not to be unreasonably withheld), and (ii) the terms and conditions set forth herein.

• Deviations from this protocol, regulatory requirements and/or GCP must be recorded and reported to the Sponsor prior to database lock.

• Tempus will control the Pathos GCP Instance, but Pathos will cover all associated costs of the GCP cloud repository for Pathos, [***].

• Lo Sperimentatore principale deve consegnare tutte le Schede Raccolta Dati (Case Report Forms-CRF) correttamente compilate, secondo termini e modalità previsti dal Xxxxxxxxxx xxxxx sperimentazione e dalla normativa applicabile, in formato cartaceo o elettronico, e comunque con tempestività come da GCP, entro i termini previsti dal Xxxxxxxxxx xxxxx sperimentazione.

• Suspected Serious Breach means suspicion by any of the Parties of GCP non- compliance with the Protocol, GCP and/or of the Regulation or other applicable requirements caused by the Institution and/or Principal Investigator that is likely to affect to a significant degree the safety or rights of any Study Subject or the reliability and robustness of the data generated in the Study, including suspicion of fraud or misconduct.

More Definitions of GCP

GCP means current Good Clinical Practices as specified in the United States Code of Federal Regulations, at the time of testing, and all FDA and ICH guidelines, including the ICH Consolidated Guidelines on Good Clinical Practices.

GCP means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable to the testing of the Products.

GCP means the applicable then-current ethical and scientific quality standards for designing, conducting, recording, and reporting Clinical Trials as are required by applicable Regulatory Authorities or Applicable Law in the relevant jurisdiction, including, in the United States, Good Clinical Practices established through FDA guidances, and, outside the United States, Guidelines for Good Clinical Practice – ICH Harmonized Tripartite Guideline (ICH E6).

GCP means the then current “good clinical practices” as such term is defined from time to time by the FDA, EMA or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise, as applicable.

GCP means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures promulgated by the EMA or other Regulatory Authority applicable to the Territory, as such standards, practices and procedures may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

GCP means the General Conditions of Purchase contained in this section.

GCP means, as to the United States and the European Union, applicable good clinical practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices as then in effect in the United States or the European Union.