ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Clinical studies are registered on ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System (PRS).
Registration with ClinicalTrials.gov will ensure increased awareness of interventional and observational clinical trials sponsored by NIH, other federal agencies, private industries and nonprofit organizations. ClinicalTrials.gov offers information about those studies that are currently open for recruitment as well as those that are no longer recruiting study participants.
Click here for Clinicaltrials.gov fast facts.
Some trials must be registered by law, and other trials must be registered based upon other factors such as ICMJE requirements.
Why should I register?
- Required by law. Section 801 of the Food and Drug Administration (FDA) Amendments Act mandates the registration with ClinicalTrials.gov of certain clinical trials of drugs (including biological products) and medical devices subject to FDA regulations for any disease or condition. For details, see http://prsinfo.ClinicalTrials.gov.
- Required for journal publication. The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication of research results generated by a clinical trial (http://www.icmje.org).
The following link provides helpful information and clarification: FDAAA Clinicaltrials.gov Registration FAQ
The checklist, below, will also help determine if you are responsible for registering your clinical trial in the ClinicalTrials.gov system using the Protocol Registration System (PRS).'
1. This is an “applicable clinical trial.” (Federal law requires that applicable clinical trials should be registered. However, many medical journals require registration as a condition of publication.)
Applicable Device Clinical Trials:
- Clinical study of health outcomes with an FDA approved Investigational New Device (IDE) against a control in human subjects. (Device subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act.) Feasibility studies or tests of prototype devices where the primary outcome relates to feasibility and not to health outcomes are excluded.
- Pediatric postmarket surveillance as required under section 522 of the Federal Food, Drug, and Cosmetic Act
Applicable Drug Clinical Trials:
- A controlled clinical investigation, other than a phase I trial, of drugs or biological products subject to Food and Drug Administration (FDA) regulation.
FDAAA Definition of Applicable Clinical Trials: http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf
2. I am the sponsor or responsible party for this clinical trial.
Sponsor - a person who initiates a clinical investigation (IND or IDE holder).
Responsible party – the principal investigator if so designated by a sponsor, grantee, contractor, or awardee.
The investigator must be responsible for conducting the trial and have access to and control over the data with the right to publish the results.
If unsure, contact your funding agency to determine the responsible party.
3. This trial is ongoing as of December 26, 2007 or any date thereafter.
- An ongoing trial has one or more patients enrolled and the final subject has not been examined or received an intervention for the purposes of final data collection.
4. I have checked the ClinicalTrials.gov website and my study is not registered.
If items 1-4 are true, you must register your clinical trial in the ClinicalTrials.gov system.
Other reasons your study should be registered on the Clinicaltrials.gov website.
Certain Journals require registration at Clinicaltrials.gov for publication: ICMJE Clinical Trials Registration
- ICMJE Clinical Trial Registration FAQ: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
- Effective July 1, 2008, the ICMJE revised its policy of June, 2005.The new policy requires the registration of all clinical trials including Phase I and pharmaco-kinetic trials. ICMJE defines clinical trials as: Any human research project that prospectively assigns human subjects to an intervention or comparison group to study the relationship between a medical intervention and a health outcome.
Certain funders may require registration: NIH Clinical Trials Registration: NIH FDAAA FAQ
The NIH encourages registration of all clinical trials whether required under the law or not. The NIH defines clinical trials as:
- As a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.
Who is the UMMS institutional contact for Clinicaltrials.gov?
For UMMS questions:
Teresa Sousa, MSN, CCRC, CIP, RN
Quality Improvement Manager, Clinical Research
Human Research Protection Program
Email - Teresa.Sousa@umassmed.edu
Tel - 508-856-1960
For Clinicaltrials.gov system issues: https://clinicaltrials.gov/ct2/manage-recs/faq#howtocontact
When Do Basic Trial Results Need to be Posted?
- Posting basic study results is mandatory.
- Basic results posting is required for applicable clinical trials of FDA-approved drugs and cleared devices.
- Submission of results is required within twelve months after primary endpoint completion date.(date final subject was examined or received an intervention).
Who Should Report Results?
- Under FDAAA 801, the “responsible party” is required to report results information. The term responsible party is defined as follows:
- The study sponsor (eg, the holder of an investigational new drug application/investigational device exemption or grantee); or
- The PI responsible for conducting the study, analyzing the data, and publishing the results, if designated by the sponsor.
What are the potential consequences of not registering on clinicaltrials.gov?
- Criminal and civil penalties can be imposed for non-compliance to FDAAA 801.
- Principal Investigators may receive Public Notices for non-compliance.
- NIH funds can be withheld for non-compliance.
- Principal Investigators may receive monetary penalties for failure to register or update protocol records within the required timelines.
- Penalties of up to $10,000 for the first occurrence and up to $10,000 a day for protocols that are 30 days past due may be issued.
Who is the “responsible Party” and what are the obligations?
- The responsible party for Investigator Initiated protocols is the Principal Investigator.
- If a Principal Investigator leaves the university they are still the “Responsible Party” and must complete the record.
- Only the “Responsible Party” has access to release the protocol record into the CT.gov public database.
When must registration occur?
- The ICMJE (International Committee of Medical Journal Editors) requires registration of all interventional studies in a database prior to the first patient being enrolled for publication in their journals.
- All Applicable clinical trials must be registered within 21 days of enrollment of the first subject.
When and who should report results?
- Submission of results is required within twelve months after primary endpoint completion date (date final subject was examined or received an intervention).
- Under FDAAA 801, the “responsible party” is required to report results information.
You must update the record at the following intervals.
- Every 6 months for studies actively enrolling participants
- Annually for studies closed to enrollment and pending data results
- Within 30 days of a change in study status or any significant changes to the protocol record for example; eligibility changes, study design and outcomes.