Compliance with Clinicaltrials.gov Requirements
Title VIII of the Food and Drug Administration Amendments Act (FDAAA), Public Law 110-85, contains section 402(j), provisions of which require that clinical trials information is to be submitted to the clinical trials data bank, also known as www.ClinicalTrials.gov. This bank is established and maintained by the National Institutes of Health (NIH). The purpose of Title VIII is to provide a means for ensuring that the public has access to information about clinical trials, and provides a mechanism for the public to learn about the results of those trials.
The following INVESTIGATOR-INITIATED studies may need to be registered :
- Any study under IND/IDE.
All investigator-initiated studies under IND/IDE are required to sign the Certification (FDA Form 3674 ). This is your binding agreement to register your trial and download your trial data to clinicaltrials.gov. For more details see the final FDA Guidance "Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007."
- Any study not conducted under IND/IDE but involving drug or device
- Studies that intend to publish in an ICMJE journal (International Committee of Medical Journal Editors). The ICMJE clinical trial registration policy requires prospective registration of all interventional clinical studies, but does not require results reporting for registered trials. In June 2007 the ICMJE adopted the WHO’s definition of clinical trial: “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 any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.
The NIH encourages registration and results reporting for all NIH-supported clinical trials, regardless of whether or not they are subject to FDAAA
|FDAAA - a law||ICMJE - voluntary||Medicare Claims Submission|
|What to register||Applicable Clinical Trials||Any human subject project that prospectively assigns human subjects to intervention or comparison groups to study cause and effect relationship between a medical intervention and a health outcome||Qualifying Clinical Trials (may include Phase I)|
|When to register||At trial initiation (no later than 21 days of enrollment of the first subject); update at least every 12 months||Prior to first subject enrollment||Before patient care claims are submitted|
|Results Reporting||Required for applicable trials||not required||not required|
|If non-compliant||Public notice; NIH funds withheld; FDA sanctions, civil monetary penalties (up to $10,000/day)||cannot publish in select journals (just about all of the important ones)||not required|
The Centers for Medicare and Medicaid Services (CMS) issued a Transmittal requiring new mandatory reporting of the clinicaltrials.gov clinical trial number (also known as NCT#) on all hospital and professional claims for related items/services. Effective January 1, 2014, it will be mandatory to report the clinical trial number on claims for items/services provided in all clinical trials that are qualified for coverage.
In order for the NCT# to correctly appear on the claims, the study teams need to type the number in the corresponding field of the BRIDGE.
ClinicalTrials.gov Protocol Registry System Instructions, Specific to University of California, Davis.
1. It is the study Sponsor’s responsibility to register the trial with ClinicalTrials.gov.
- If you wrote the study protocol (Sponsor Investigator-Initiated, you are considered the study Sponsor
- If the study protocol was sent to you by an industry sponsor, then the industry sponsor will have the responsibility to register the trial.
- If industry is supplying a drug or device for your study, but you are the author of the study, then it is your responsibility to register your trial.
- If you have received grant funding to conduct a clinical trial then you, as the awardee, are considered the Sponsor for that trial.
2. In order to establish user access, you must have a UC Davis email address and a UC Davis telephone extension.
3. In order to register your clinical trial with ClinicalTrials.gov you will need to request User access. Please contact the UC Davis ClinicalTrials.gov Administrator, Virina De Jesus, Sr. CRC, CTSC, to get your account established. You will be assigned a User ID. UC Davis has an established Organization Account for all UC Davis investigators to register under. DO NOT request an Individual Account or another Organizational Account on the clinicaltrial.gov website.
4. Once you are assigned a User ID, you will receive an email from ClinicalTrials.gov with your temporary password. Click on the link in the email to get to the ClinicalTrials.gov Protocol Registry System Log-In page: https://register.clinicaltrials.gov/
5. Login Page:
- Organization: UCaliforniaDavis (NO SPACES-Case Sensitive)
- User Name: as it was assigned to you in your notice from PRS
- Password: enter your temporary password
1) Under the “User Account” section, click on “Change Password". Please change your temporary password to one that you will be able to remember.
2) Read the Quick Start Guide in the “Help” section. For additional help, there is also a User’s Guide and Data Element Definitions which explains each type of entry.
3) Unique Protocol ID: MUST use the IRB number assigned to this protocol (e.g., 123456). You don’t need to put the numerical suffix on this number. DO NOT enter a new listing for each renewal year.
4). ClinicalTrials.gov ID: Leave this blank – It will be assigned by ClinicalTrials.gov once the listing is approved in the registry. (usually takes 2 – 5 working days)
5). FDA Regulated Intervention: If subjects are being given any drug (investigational or already approved) this answer is YES. If the study involves an investigational Device this answer is YES. If the study involves any Biologicals or vaccines, this answer is YES.
6). Secondary ID: this can be a grant number or some other study number that is frequently referred to for this protocol. DO NOT enter IRB number with numerical suffixes.
7). Section 801 Clinical Trial: Does this trial qualify as an “Applicable Clinical Trial” under the regulations? (See Data Element Definitions in Help menu: #2 US FDA Info.)
8). Responsible Party: This will be Sponsor, Principal Investigator or Sponsor-Investigator.
|Sponsor:||Only entered by study Sponsor or in some cases for consortium trials|
|Principal Investigator:||Need to include PI Name, Official Title, & Affiliation Institution|
|Sponsor-Investigator:||Fields will automatically populate with PI Name & UCaliforniaDavis|
|For Existing Studies||When you enter ClinicalTrials.gov to update an existing entry, you will see a WARNING message stating: “Responsible Party has not been entered.” Below this will also be an “NOTE” stating: “Responsible Party was entered in the old format as: John Doe, MD, University of California, Davis.” You need to change the definitions as described above. The old Responsible Party data elements will continue to show in the listing until you enter information in the new format. Your study will not be affected.|
IMPORTANT: Previously, the UC Davis Clinicaltrials.gov Administrator, was able to approve and release the registry listing and updates to ClinicalTrials.gov. Under the new process, the Investigator must Approve and Release the record for QA review and processing by ClinicalTrials.gov. The investigator does this by selecting:
Next Action: Approve [click Approve], and then, Next Action: Release [click Release]
The investigator must be listed on the pull-down Access List on the same screen. The pull-down includes the list of all user names within the current ClinicalTrials.gov PRS organization. The investigator name must be selected from this pull-down list. If the name is not listed, the investigator must establish access as a “User” by contacting the UC Davis PRS Administrator.
9). Review Board:
|Board Name:||UC Davis Institutional Review Board|
|Board Affiliation:||University of California, Davis
|Business Address:||IRB Administration
University of California, Davis
2921 Stockton Blvd., CTSC Bldg.
Sacramento, CA 95817
|United States:||Institutional Review Board|
|AND (for drug studies) United States:||InFood and Drug Administration|
10). Record Verification Date: This is the date you enter information into this listing. ANY TIME you change information in this listing, or go in to check it, CHANGE THIS DATE TO THE CURRENT MONTH YEAR. YOU ARE REQUIRED TO REVIEW THE LISTING AT LEAST EVERY 6 MONTHS.
11). Study Start Date: Month Year first enrolling study subjects
12). Study Primary Completion Date: Month Year last study subject data is collected for the Primary Outcome Measure
13). Study Completion Date: Month Year last study subject data is collected for all Outcome Measures.
14). Accepts Healthy Volunteers? If the eligibility criteria require subjects to have some type of medical condition then this answer is NO. If subjects may be enrolled who DO NOT have any medical conditions, but will be given the investigational intervention as a study CONTROL subject, then the answer is YES.
15). Study Official: This should be the PI
16). Location: Where the study will take place. You must list a contact name/phone with this. You will also be asked what the recruiting status is at this location.
Basic Results are required to be entered into the registry within 12 months of the Primary Completion Date.
Some DO’s and DON’Ts
DON'T enter a study twice. DON'T enter a study each time the IRB renewal goes through –it’s the same study – if there are amendments/modifications and it changes the information in the listing, then DO go in and change the info in the listing using edit buttons. (and remember to change the Record Verification Date again!!).
DO look at the Record Log section for notes/information regarding the listing. Sometimes these come from the Protocol Registration System Quality Control/Quality Assurance group. DO call or email if you have a question. Questions? Contact Virina De Jesus, Sr.CRC, CTSC, 916-703-9174; email@example.com