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