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How do I comply with Good Clinical Practices (GCP)?

Good Clinical Practices( GCP ) are regulations and guidelines which set minimum standards for clinical trials. They are designed to accomplish two primary purposes:

  • to ensure the quality and integrity of data obtained from clinical testing, and
  • to protect the rights and welfare of clinical subjects.

After convictions of fraud among investigators and the deaths of study volunteers in IRB -approved Clinical Trial , intense scrutiny on all key figures involved in Clinical Research in the last decade has caused investigators, regulatory agencies and sponsors of research to develop standards for the conduct of clinical trials. Many IRBs will require investigators to fulfill GCP training requirements in the form of a class or on-line test. Contact your local IRB for more information.

Every investigator conducting human subjects research is responsible for ensuring the safety and rights of participants in studies. The investigator has an obligation to:

  • Obtain and maintain appropriate training to assume responsibility for proper conduct of the trial.
  • Maintain a list of properly qualified persons to whom the investigator has delegated duties.
  • Ensure that all persons assisting with the study are adequately trained with respect to the protocol, investigational procedures or products and their duties.
  • Ensure that protocols conform to ethical and scientific standards and that the study is conducted according to the protocol.
  • Ensure that the process for obtaining consent is done in an ethical manner within regulatory standards.
  • Support the safety monitoring process.

The International Conference on Harmonization has developed Guidelines for Good Clinical Practices, ethical and scientific standards for designing, conducting, recording and reporting trials in human subjects.

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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