Interventional Research
The NIH definition of a clinical trial is: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”.
The NIH definition of a clinical trial is: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”.
An intervention, according to the NIH, is "Both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes".
Clinical trials can be either uncontrolled, with no control group for comparison, or controlled. In controlled trials, participants can be randomly assigned to an intervention or control group (randomized clinical trial) or specifically allocated to an intervention or control group (non-randomized).
Click on the link below for guidance determining if your study is a Clinical Trial, Basic Experimental Study involving Humans (BESH) or Observational study involving humans.
Interventional Protocol Templates
For interventional research, you should use one of the following two templates:
- Interventional Drug/Device Trial Template: For studies involving drugs or devices.
Protocol Template For Interventional Drug/Device Clinical Trials Only
- Behavioral and Social Science Research Template: For studies involving behavioral or social science interventions.
Protocol Template For Behavioral And Social Science Research
Both templates follow the NIH/FDA template and comply with ICH GCP standards.
Addendum Templates for multi-site protocols
If you are participating in a multi-site study where another entity has written the protocol, you should use the NIH Protocol Addendum Template to address the specific NIH information. This addendum should accompany the primary protocol in your submission to the NIH IRB.
NIH Protocol Addendum Template When NIH Is The Reviewing IRB
If you are writing a protocol that will be a multi-site study, provide the following protocol addendum template to any participating site (pSite) that is relying on the NIH IRB. After the reliance agreement is in place, the pSIte should submit this to the NIH IRB.