Glossary, CRG, NHLBI, NIH

Good Clinical Practices( GCP

Good Clinical Practice (GCP)
ethical and scientific standards for designing, conducting, recording and reporting trials in human subjects. The International Conference on Harmonization has developed Guidelines for Good Clinical Practices. See also Good Clinical Practice in FDA-Regulated Clinical Trials.

) 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)
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).

-approved Clinical Trial

Clinical Trial
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

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.

)

, intense scrutiny on all key figures involved in Clinical Research

Clinical Research
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.

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

Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction

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.

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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Home » Clinical Research Guide» Management» How do I comply with Good Clinical Practices (GCP)?
CRG Home Contracts Overview What is clinical research? What is the role of NIH and NHLBI in clinical research? What are the Project Officer's responsibilities in clinical research? What is the role of the Principal Investigator/Institution in clinical research? Application How can I find funding opportunities (RFAs, RFPs and PAsG)? What do I need to know before submitting a clinical research application? Am I a new investigator and what if this is my first NIH application? Which NHLBI staff can help me? Is my study considered clinical research? Is my study observational or interventional? What is the best award mechanism for my clinical research proposal? What if my project exceeds $500,000 in direct costs in any given year? Where can I get help with writing the application? What must I include in "Protection of Human Subjects"? How and when do I submit my application? Review What happens to my grant after submission? Who will review my application and when? Did the reviewers like my application? What is a summary statement and what does it mean? What if I don't agree with the review? Funding How do I know if I am funded? Who needs human subjects protection training? Who approves my data monitoring plan? What is a Certificate of Confidentiality and do I need one? How do I develop consent forms and who reviews them? Are there ethical concerns and conflicts of interest I must consider? Do I need IRB, IEC or REB approval? What other approvals are needed? How do I track recruitment of research participants? My study involves Medicare or third party support. My study involves foreign grants and contracts. How do I register my study? When can I begin enrolling participants? Management How do I comply with Good Clinical Practices (GCP)? How do I manage changes to my grant? How do I report amendments, suspensions and terminations? Must I obtain continuing review from the IRB? Who should monitor subject recruitment/retention? How do I report adverse events? How is data quality monitored? What if I wish to add extra sites or studies to my project? How do I manage my budget and when are reports expected? What is HIPAA and how do I abide by the requirements ? Study Closure Tools & Training Glossary	How do I comply with Good Clinical Practices (GCP)? Good Clinical Practices( GCP Good Clinical Practice (GCP) ethical and scientific standards for designing, conducting, recording and reporting trials in human subjects. The International Conference on Harmonization has developed Guidelines for Good Clinical Practices. See also Good Clinical Practice in FDA-Regulated Clinical Trials. ) 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) 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). -approved Clinical Trial Clinical Trial 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 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. ) , intense scrutiny on all key figures involved in Clinical Research Clinical Research 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. 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 Human Subject Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction 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. 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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How do I comply with Good Clinical Practices (GCP)?