Conducting an NIH-Sponsored Clinical Trial? Find out more about the NIH Policy on Good Clinical Practice (GCP) training and what options are available to the Harvard LMA research community to satisfy the requirement for GCP training. The establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6. Does this apply to my study? This Policy applies to NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. is research study in which one or more human subjects are prospectively assigned to one or “a more (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”. See . NIH has also outlined some basic questions to help researchers determine whether they are conducting a clinical trial. These questions are: Is your research funded by NIH? Does the study involve human participants? Are the participants prospectively assigned to an intervention? Is the study designed to evaluate the effect of the intervention on the participants? Is the effect that will be evaluated a health-related biomedical or behavioral outcome? If the answer to all five questions is yes, then NIH considers your research a clinical trial. Here are some additional resources that you may find helpful: Frequently asked questions: Definition of Clinical Trial Case Studies: Who needs to take the training? All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials, including: Investigator: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
Conducting an NIH-Sponsored Clinical Trial? Find out more about the NIH Policy on Good Clinical Practice (GCP) training and what options are available to the Harvard LMA research community to satisfy the requirement for GCP training. The establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6. Does this apply to my study? This Policy applies to NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. is “a research study in which one or more human subjects are prospectively assigned to one or more (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”. See . NIH has also outlined some basic questions to help researchers determine whether they are conducting a clinical trial. These questions are: Is your research funded by NIH? Does the study involve human participants? Are the participants prospectively assigned to an intervention? Is the study designed to evaluate the effect of the intervention on the participants? Is the effect that will be evaluated a health-related biomedical or behavioral outcome? If the answer to all five questions is yes, then NIH considers your research a clinical trial. Here are some additional resources that you may find helpful: Frequently asked questions: Definition of Clinical Trial Case Studies: Who needs to take the training? All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials, including: Investigator: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
NIH-Clinical-Trial-Announcement_GCP-Final.docx