Clinical Trials Registration
Step-by-Step Instructions

1. Determine If Your Clinical Trial is Covered by These Rules

Food and Drug Administration (FDA) Registration Requirements
International Committee of Medical Journal Editors (ICMJE) Registration Requirements
Differences between FDA Requirements and ICMJE Requirements
UW-Madison Registration Instructions and Guidance (PDF)

Additional Information

**NEW** Guidance on Clinical Trial Registration if You are Planning to Patent an Invention

Food and Drug Administration (FDA) Information Page
Food and Drug Administration Amendments Act (FDAAA) of 2007
International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration FAQ’s
National Institutes of Health (NIH) Guidance on New Results Database

2. Determine If You Must Register Your Trial

 

NOTE:  All Industry-sponsored trials must be registered by the sponsor.  UW investigators should not register any industry-sponsored trial in clinicaltrials.gov.  Contact the Office of Research Policy if you have a question about this.

A University of Wisconsin Principal Investigator is responsible for registering a clinical trial at clinicaltrials.gov when:

• The trial is investigator-initiated;
• The trial is federally sponsored [however, in an NIH-sponsored multisite trial, registration is the responsibility of the grantee];
• The PI is the holder of an approval from the FDA for an investigational new drug (IND) or investigational device exemption (IDE)  [conversely, if the PI is not the holder, the trial should be registered by the holder of the IND or IDE];
• A non-industry sponsor has declined to register [if this occurs please contact the Office of Research Policy].

If a PI is responsible for registration, the PI may designate an individual to register his/her protocols and complete registration information.  However, it is ultimately the responsibility of the PI to assure that registration occurs and the accuracy of the information entered.

3. Determine Your Registration Contact

The University of Wisconsin is already registered as an institution at ClinicalTrials.gov and has appointed ClinicalTrials.gov administrators to assist UW investigators or their designees in establishing their Protocol Registration System accounts. Investigators or their designees should contact the appropriate UW ClinicalTrials.gov administrator listed below for assistance with protocol registration requirements and other guidance information.  The ClinicalTrials.gov administrators are also responsible for releasing information that has been entered by the investigator into the ClinicalTrials.gov system and for following up on ClinicalTrials.gov inquiries.

• For all cancer-related protocols, contact Shari Zeldin, UW Comprehensive Cancer Center @ (608) 263-8403 or swzeldin@uwcarbone.wisc.edu

• For all other protocols, contact Tina Graber, Office of Clinical Trials @ (608) 265-6506 or tmg@clinicaltrials.wisc.edu

4. Request a User Name and Password

To request a user log on name and temporary password, send an email message to your assigned UW ClinicalTrials.gov administrator:

swzeldin@uwcarbone.wisc.edu (all cancer-related protocols)

tmg@clinicaltrials.wisc.edu (all other non-UWCCC protocols)

Include in the message your name, telephone number, and email address.

You will receive a reply to your email with a login name and a temporary password which will allow you to register your protocol(s).

5. Go to the ClinicalTrials.gov Website

 

A. Complete the login fields

In the “Organization” field, type “UWisconsin”

B. Change Password

On the Main Menu page under “User Account,” follow the instructions to change your temporary password as soon as possible. Refer to the “User’s Guide” link for additional information.

The “User” is responsible for entering the information about the trial, ensuring that the information is correct, and updating the information in a timely manner.

C. Study Description

On the Main Menu page, under “Protocol Record”, click "Create" and complete the study description template.

Note that the ClinicalTrials.gov-required fields are marked with a red asterisk (*) and the FDA-required fields are marked with a green FDAAA. Taken together, these data elements represent the requirements for an adequate registration. If you do not complete these fields, your trial may not be considered "fully registered." Note also that each field of the template is labeled and linked to a definition; however, several fields are potentially confusing and should be completed as follows:

• Organization’s Unique Protocol ID: Use the UW IRB number.
• Sponsor: Enter “University of Wisconsin” (even though the UW may not be the actual trial sponsor.
• Collaborators: Sponsorship can be clarified by entering the actual sponsor’s name. For unsponsored research, either leave the field blank or enter "None".
• Record Verification Date: Enter the date on which you complete and submit the template.
• Conditions: Use the MeSH controlled vocabulary (link provided in the conditions field). If you don’t, ClinicalTrials.gov staff is likely to delete your term and choose one of their own.
• Keywords: Use the MeSH controlled vocabulary (link provided in the keywords field). If you don’t, ClinicalTrials.gov staff is likely to delete your term and choose one of their own.

D. PI Review and Approval

If the User is not the PI, the User must ensure the PI has reviewed and approved the information before submitting.

E. Submit

Submit the completed, PI-approved, template (note: you will receive a warning message if required fields are incomplete; complete the missing information and re-submit). The completed template will go to the UW administrators listed above.

F . Periodic Updates

The PI or designee is responsible for periodic updates to the study record, e.g., for study-specific changes such as recruitment status and protocol revisions (see below for more instructions). The PI or designee is also responsible for verifying the study record once every 12 months.  

6. Complete Periodic Updates, As Needed

Please note that anytime you access your trial information to perform updates or review information, MAKE SURE TO update the “Record Verification Date” field.

• Recruitment status change: If recruitment status changes you must submit an update noting such within 30 days of the change in recruitment status

• Completion of trial: If the clinical trial has completed, you must submit an update noting such within 30 days of the completion of the trial

• Other changes: If any of the information you submitted has changed, you must submit an update of those changes at least once every 12 months (see above bullets for deadlines associated with changes in recruitment or trial completion).  The update must include the dates of any such changes. 

• If no changes: If no changes have been made in the proceeding 12 months, you still must go in to the record and update the “Record Verification Date” field and resubmit the protocol for release by the clinicaltrials.gov administrator.

7. Submit Results of the Study

The PI responsible for registering a trial must also submit information on basic results. 

Such information must include for each applicable clinical trial for an approved drug or for a cleared or approved device the following elements:

• Demographic and baseline characteristics of the patient sample, including the number of patients who dropped out of the trial and the number of patients excluded from the analysis;
• Primary and secondary outcomes, including the results of scientifically appropriate tests of the statistical significance of such outcome measures;
• Point of contact for scientific information about the trial results; and
• Whether there exists an agreement between the sponsor and the PI that restricts in any manner the ability of the PI, after completion of the trial, to discuss or publish the results of the trial.

The information described above generally must be submitted not later than 1 year after the earlier of :

• The estimated completion date of the trial (that projected at the outset of the study); or
• The actual date of completion.

For more information, go to: http://prsinfo.clinicaltrials.gov and scroll down to the bottom of the page to the link entitled: “Basic Results” Data Element Definitions.

8. Submit Information on Adverse Events

 Effective September 27, 2009, adverse events must be part of results reporting and include:

• A table of anticipated and unanticipated serious adverse grouped by organ system, with number and  frequency of such event in each arm of the clinical trial; and

• A table of anticipated and unanticipated adverse events not included in the table described above that exceed a frequency of 5% within any arm of the clinical trial, grouped by organ system, with number and frequency of such event in each arm of the clinical trial.

 

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