New Final Guidance from FDA: the Certification Form (FDA Form 3674)
Notice to all Sponsor-Investigators:
2009, the FDA published the final Guidance titled 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.
This form is your binding agreement to register your trial and download your trial data to clinicaltrials.gov
FDA recommends that a certification (FDA Form 3674) accompany the following types of applications and submissions (including resubmissions):
Therapeutic Biologic Applications
New! How to Register and Upload Data in clinicaltrials.gov
Download this helpful presentation: the guidance on how to register and download your data.
Questions? Contact Virina De Jesus, CT.gov Administrator, Sr. CRC, CTSC (email@example.com)
Step-by-Step: How to input your information into clinicaltrials.gov
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, Denise Owensby to get your account established (firstname.lastname@example.org). 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.
What do I put in this section?
3). Unique Protocol ID: 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.
For questions about this process please refer to the CTSC Clinical Trials website http://www.ucdmc.ucdavis.edu/clinicaltrials/ClinicalTrialsGov/clinicaltrialsgov.html or contact Denise Owensby (email@example.com), or Virina DeJesus (firstname.lastname@example.org) for assistance.
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.
NIH Guidance on ClinicalTrials.gov Registration Requirements
ClinicalTrials.gov Protocol Registration System