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
Institutional Review Board (IRB) -approved Clinical Trial
a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC).
Clinical Trial , intense scrutiny on all key figures involved in Clinical Research
A clinical trial is a controlled experiment, conducted in human beings, that is designed to evaluate and/or compare the effects of specific regimens or strategies on one or more pre-specified health outcomes in a defined population over a defined period of time. (Clinical Trials: Phase I
Phase I Clinical Trial
testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
, Phase II
Phase II Clinical Trial
study in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
, Phase III
study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.
, Phase III(as defined by NIH)
Phase III(as defined by NIH)
is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials.
, Phase IV
Phase IV Clinical Trial
studies done after an intervention has been marketed to monitor its effectiveness in the general population and to collect information about any adverse effects associated with widespread use.
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.
patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects.
Every investigator conducting human subjects
Human Subject research is
responsible for ensuring the safety and rights of participants
in studies. The investigator has an obligation to:
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102
and full 45 CFR 46
or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
- 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