NIH Clinical Trial Overview and Registration
NIH Clinical Trial Overview and Registration
November 5, 2019
The Department of Health and Human Services has updated its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations. So, what does that mean? Essentially, as of November 5, 2019, FDA can now fine the responsible party $12,103 for a single adjudication, and then $12,103 per day after 30 days that the problem is not corrected for failing to submit required registration or results information to ClinicalTrials.gov for an Applicable Clinical Trial (ACT).
July 24, 2019
"This extension will last through September 24, 2021. During this extension period, NIH will continue implementation of initiatives launched in 2016 aimed at assuring that NIH and NIH-funded scientists maximize stewardship and transparency. However, delayed enforcement for BESH registration and results reporting will allow NIH to engage in further conversations with the BESH community to gain a deeper understanding of the scientific and technical needs to best facilitate (in a least burdensome way) registration and reporting of BESH studies while ensuring this information is scientifically useful."
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.
NIH Clinical Trial Overview
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.
NIH might consider your human subjects research to be a clinical trail. 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 you answer “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/
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”)
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”)
- drugs/small molecules/compounds;
- 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.
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”)
- 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.
Clinical Trials Registration
All NIH-funded clinical trials are expected to register and submit results information to ClinicalTrials.gov, as directed by 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.
Please note that 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 email@example.com.
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.
- Good Clinical Practice Training (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.)
- July 24, 2019 NIH extension of certain flexibilities for prospective basic experimental studies with human participants.
- National Institutes of Health, Office of Extramural Research - Frequently asked questions for NIH Clinical Trial Definition
- National Institutes of Health, Office of Extramural Research - NIH Definition of Clinical Trial Case Studies
- National Institutes of Health, Office of Extramural Research - NIH Clinical Trials for Grants and Contracts
- UCCS NIH Clinical Trial Awareness Flyer
Questions? Contact the OSPRI Compliance at firstname.lastname@example.org
Clinical Trials FAQ
Tips from UC Denver Anschutz's Clinical Research Support Center "ClinicalTrials.gov Tips of the Week."