NIH Clinical Trial Overview and Registration

NIH Clinical Trial

 

Clinical Trials Registration

 

GCP Training

 

Resources

 

Questions? Contact the OSPRI Compliance at composp@uccs.edu

NIH Clinical Trial Overview and Registration Requirements

 

In 2016, NIH launched a multi-faceted effort to enhance its stewardship over clinical trials.  The goal of this effort is to encourage advances in the design conduct, and oversight of clinical trials while evaluating the entire research enterprise to a new level of transparency and accountability. 

University of Colorado Colorado Springs (UCCS) faculty, staff, and students conduct a diverse array of human subjects research projects, including NIH funded projects that qualify as a clinical trial.  With this in mind, the Office of Sponsored Programs and Research Integrity (OSPRI) and the Institutional Review Board (IRB) at UCCS requires that all research that qualifies as a clinical trial meet the training and reporting requirements as set forth by the NIH for NIH-funded clinical trials.  The requirements can be found in in the “NIH Policy on Dissemination of NIH-Funded Clinical Trial Information” and the “Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials.” 

Additional information regarding training and reporting requirements can be found in the IRB Special Topics XXXII:  IRB Policy for NIH Funded Clinical Trial Compliance

Helpful Definitions:

  1. Clinical Trial: 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. (adapted from the Notice of Revised NIH Definition of “Clinical Trial”)
  2. Intervention:  With regards to NIH funded clinical trials, an intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  (adapted from the Notice of Revised NIH Definition of “Clinical Trial”)

Examples include:

  • drugs/small molecules/compounds;
  • biologics;
  • devices;
  • procedures (e.g., surgical techniques);
  • delivery systems (e.g., telemedicine, face-to-face interviews);
  • strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits);
  • treatment strategies;
  • prevention strategies;
  • and diagnostic strategies.

Depending on the study a non-UCCS (outside) IRB review may be required, please contact the IRB as soon as possible to explore the use of a non-UCCS IRB.

  1. Health-related biomedical or behavioral outcome:  With regards to NIH funded clinical trials, this is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. (adapted from the Notice of Revised NIH Definition of “Clinical Trial”)

Examples include:

  • positive or negative changes in physiological or biological parameters (e.g., improvement of lung capacity, gene expression);
  • positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers, reading comprehension and/or information retention);
  • positive or negative changes to disease processes;
  • positive or negative changes to health-related behaviors; and
  • positive or negative changes to quality of life.

Broad Interpretation

“Depending on how broadly one interprets … “to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”, this part of the clinical trials definition may include a wide range of basic behavioral and social science studies that manipulate an independent variable to observe a hypothesized modification of a behavioral process.”

Director, NIH Office of Behavioral and Social Sciences Research, October 18, 2016

NIH Might Consider Your Human Subjects Research to be a Clinical Trail

NIH Clinical Trials Image

Does your study…*

  • Involve one or more human subjects?
  • Prospectively assign human subject(s) to intervention(s)?
  • Evaluate the effect of intervention(s) on the human subject(s)?
  • Have a health-related biomedical or behavioral outcome?

If “yes” to All of the questions above, your NIH funded study is considered a clinical trial. 

*Unsure how to answer the questions? This tool can help. https://grants.nih.gov/ct-decision/

 

Clinical Trials Registration

 

All NIH-funded clinical trials are expected to register and submit results information to ClinicalTrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information" for competing applications and contract proposals submitted on or after 1/18/2017.

 

ClinicalTrials.gov is a public website designed by NIH and hosted by the National Library of Medicine. For reporting and compliance purposes with ClinicalTrials.gov, the Principal Investigator will be designated as the Responsible Party.

ClinicalTrials.gov registration and reporting requirements include the following:

  • Registration – The study must be registered on ClinicalTrials.gov within 21 days after the first subject is enrolled.  Registration information includes descriptive information, recruitment information, location and contact information, and administrative data.
  • Updates – The information in the clinical trial records must be updated at least once every 12 months.
  • Results – The study results must be reported on ClinicalTrials.gov within 1 year of the final collection of data.  Results information includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol and statistical analysis plan, and administrative information.

Note – The NTC number (or ClinicalTrials.gov identifier) received upon registration will need to be reported to the IRB once received.  The NTC number is a unique identification code given to each clinical study when it is registered on ClinicalTrials.gov.  Please submit the UCCS IRB protocol number and the NTC number to the IRB via email at irb@uccs.edu

GCP Training

 

Good Clinical Practice (GCP) Training Requirement

The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials.  NIH expects all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in GCP.  Additional information regarding the training are available at the Good Clinical Practice Training website

Resources