Clinical Trials
Definitions
Clinical trial definitions and study requirements may be different, depending on associated agencies. Registration with the following agencies (FDA, NIH, ICMJE) is a separate requirement in addition to IRB approval.
Applicable Clinical Trial (ACT) is a term used in the Food and Drug Administration Amendments Act (FDAAA) to designate interventional studies of drugs, biologics and devices for which information must be submitted to the Clinical Trial Registry Data Bank.
- An applicable device clinical trial is either:
- (1) a prospective clinical study of health outcomes comparing an intervention with a device subject to sections 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); or
- (2) a pediatric post market surveillance of a device as required under section 522 of the Food, Drug, and Cosmetic Act.
- An applicable drug clinical trial is a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of FDAAA.
ClinicalTrials.gov provides a checklist to help determine if your study is considered an ACT.
NIH Clinical Trial Definitions capture more phases than those considered for Applicable Clinical Trials. NIH defines Clinical Trials as 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.
NIH Clinical Trials include:
- Studies with healthy participants
- Phase 1 trials of FDA-regulated drugs and biological products
- Small feasibility studies of FDA regulated device products
- Studies with no comparison group (placebo or control)
- Studies designed to assess the pharmacokinetics / safety of an investigational drug
- Studies where only one aim or sub-aim meets the clinical trial definition
For more guidance, please review the NIH Clinical Trial Definition and assess your study with the NIH Clinical Trial Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?
The International Committee of Medical Journal Editors requires clinical trial registration for studies published in member journals. ICMJE has adopted the World Health Organization’s definition of clinical trials: “Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
Health related interventions include:
- Drugs/pharmaceuticals
- Surgical procedures
- Devices
- Behavior treatments
- Dietary interventions
- Process-of-care changes
The ICMJE requires that registration occur before the first instance of data collection and that publication be within 12 months of the final instance of data collection.
Registration through ClinicalTrials.gov satisfies the ICMJE requirement, however, investigators are recommended to discuss all requirements through their potential member journal before data collection commences.
Registration Requirements for ClinicalTrials.gov
Registration on ClinicalTrials.gov is required if a study meets any of the following:
- A Food and Drug Administration (FDA) regulated applicable clinical trial (ACT)
- NIH-funded clinical trial
- Planned publication in an International Committee of Medical Journal Editors (ICMJE) member journal
Account Establishment FAQs
User accounts are established by the PRS administrator at the site where the trial is registered. PIs can reach a PRS administrator for Purdue by contacting irb@purdue.edu.
Note: IRB approval and training in Good Clinical Practices (GCP) is required prior to registration for all studies.
Start by utilizing the resources found on the ClinicalTrials.gov website, including the Protocol Registration Data Element Definitions and Expanded Access Data Element.
See https://clinicaltrials.gov/ct2/help/for-manager for resources.
At Purdue the Responsible Party should be listed as the Principal Investigator (PI). PIs should review the expectations associated with this role on the ClinicalTrials.gov registration materials.
Required Training
Investigators and study personnel who are responsible for study coordination, data collection and data management are required to complete training in Good Clinical Practice (GCP). To fulfill the training requirements, Purdue utilizes the CITI Program. The GCP training courses differ from those required for other training (i.e. Human Subjects Research, Responsible Conduct of Research). It must be renewed every three years. See the Training page for more information.
The IRB may also request evidence of prior training or certification for biomedical procedures conducted as part of a research protocol (e.g., placement of IVs or drawing of blood) or a plan for training, supervision, and monitoring for required skills.
Principal Investigators are ultimately responsible for leading the research teams and confirming proper training and valid credentials or experience.
Consent Form Requirement for Clinical Trials
You are required to use the following language in the consent documents for all studies that are clinical trials. Please do not alter or change this language.
“A description of this clinical trial will be available on the Clinical Trials website, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.”
Required Informed Consent Language for NIH clinical trials and non-ACTs:
“This trial will be registered and may report results on www.ClinicalTrials.gov, a publicly available registry of clinical trials.”