If your research fits the clinical trial definition it must be registered.
Clinicaltrials.gov is the most well-known repository for information on clinical trial research in the world and the University of Waterloo requires all clinical trials be registered on this registry.
How to register a study on clinicaltrials.gov:
- Heather Root, Senior Manager, Research Ethics has been set up as the Protocol Registration and Results System (PRS) Administrator for all registrations.
- The Primary Investigator (PI) named on the research ethics application is the person responsible for registering the clinical trial and setting up the initial protocol record.
- Registration must be done within three weeks of the first participants being contacted.
- PDF version outlining the steps for registering.
Things to remember when registering:
- When logging in, the institutional name is UWaterloo.
- Email addresses provided within the protocol record should be official Waterloo email addresses.
- The Senior Manager will serve as the “responsible party” for the registration as required by clinicaltrials.gov. The protocol record should indicate this.
- The PI is to be named as the “owner” of the registration and is responsible for updating the records on clinicaltrials.gov every 6 months as required and ensuring that all required information has been completed and submitted.
Steps in registering:
- Any researcher who wishes to register a protocol on clinicaltrials.gov, needs to send an email to Heather Root, Senior Manager, Research Ethics which identifies:
- the name of the PI who will be the “owner” of the record,
- the owner‘s UWaterloo email, and
- the owner’s phone number.
- The Senior Manager, who is the PRS Administrator, will set up the researcher as a user using the “create a new user” option on the main menu.
- The system will automatically create a new user ID (first initial last name).
- The PI “owner” will receive an email from clinicaltrials.gov confirming that they have been set up and sending them a password which can then be used to create the research protocol record.
- The PI is responsible for creating a protocol record.
- A clinical trial is registered in the ClinicalTrials.gov system by creating a "protocol record".
- Click on the "Create" link under Protocol Records on the Main Menu and fill in a series of data entry screens as appropriate.
-
A
couple
of
specific
requirements:
- The “sponsor” should be the University of Waterloo.
- Additional funding agencies or institutions can be indicated as collaborators.
- In the section on “review board” indicate either the Human or Clinical Research Ethics Board as appropriate. These are the official names of the research ethics boards.
- Send the required signed copy of the “Certificate of Ethic Acceptability” by email as a PDF to approval@clinicaltrials.gov or send a hard copy. Clearly indicate the institution name and protocol ID so the certificate can be matched to the protocol record.
- In the field “Data Monitoring Committee” indicate “NO” unless your research involves NIH funded research for which such a committee would be required.
- The record verification date will be the original date on which the record was created.
-
Studies
can
be
registered
either:
a)
before
you
have
received
ethics
clearance
or
b)
after
you
have
received
ethics
clearance.
- If you opt for a), in the section of the record called “Review Board”, choose the status “approval, pending” (assuming you will have submitted your application for ethics review first) and leave blank the approval number. Then once you have an approval number you can go into the record and add the approval number. You would select “not yet recruiting” under the overall status section. A copy of your ethics clearance certificate should be sent to ClinicalTrials.gov to the email address on their site (per 7. above this can be a PDF).
- If you opt for b) then you can complete all of the sections of the record at that time. They still need a copy of your certificate.
- The ORE# should be used as the protocol record ID#.
- Once you have completed the record, click on complete.
- An email will then be sent to the Senior Manager to advise that the record has been completed.
- The Senior Manager will then review the record, approve it and then release the record to clinicaltrials.gov. At that time the information is available to the public.
- Records may take from 2 to 5 days to be made available to the public after they are released.
- The “owner” must maintain the currency of the record at least every 6 months during the life of the protocol. The record verification date should be changed at that time to the date of the review and/or update of the record.
Please note the following instructions from the clinicaltrials.gov website:
To avoid duplicate or invalid registration of your study, check the following before proceeding with registration:
Section 801 studies may only be registered by the Responsible Party. If this is an applicable clinical trial as defined by US Public Law 110-85, Title VIII, Section 801, ensure that your organization is the Responsible Party as defined by the law before registering the study.
IND/IDE studies may only be registered by the IND/IDE holder. If the study is subject to US Food and Drug Administration regulations, under an Investigational New Drug (IND) Application or Investigational Device Exemption (IDE), ensure that your organization is the IND/IDE holder before registering the study.
For NIH-funded studies, coordinate with the relevant Institute or Center. If this is a US National Institutes of Health (NIH) funded study, registration should be coordinated with the sponsoring NIH Institute or Center to avoid duplicate registration.
Multi-site studies are NOT registered by individual sites. If this is a multi-site study it must be registered only once, by the sponsor (primary organization that oversees implementation of study and is responsible for data analysis) or its designated principal investigator (PI).
Coordinate with all collaborators before registering. If the study has multiple collaborators, contact the other organizations to confirm that the study has not already been registered and to notify them that your organization, as sponsor or its designated PI, is registering the study.
Refer to the ClinicalTrials.gov Review of Protocol Submissions document for a description of items evaluated by ClinicalTrials.gov after protocol information is submitted.
Tip: Data is saved as each screen is filled in, so that you can "Quit" at any time, saving the record for later completion using the "Modify" instructions provided below.
Mark the protocol record as "Complete" - After filling in the last data entry screen, the "Edit Protocol" screen appears with all of the information provided. Review the information for accuracy and completeness, and address "ERROR" messages, if any. "Alert" messages should also be addressed (and must be for trials that are not under U.S. FDA IND/IDE application).
When the record is ready, simply click on the "Next Action: Complete" link near the top of the Edit Protocol screen. Your PRS Administrator will "Approve" and "Release" the record for publication on the ClinicalTrials.gov web site.The record should be available on the site within 2-5 business days of release by the administrator.
EXCEPTION: If you are designated as the Investigator and Responsible Party for a record, you have the authority (and responsibility) to Approve and Release the record even if you are not an administrator. Use the Next Action links in the Edit Protocol screen for these steps at the appropriate times. More information on Responsible Party is accessible from the Sponsor data entry screen.
Modify a protocol record - Once created, a protocol record can be modified at any time. Click on the "Modify" link under Protocol Records on the Main Menu. A selection list of all records owned by you appears, with status information for each record. Click on the "Edit" link next to the record that you wish to update. The Edit Protocol screen appears. Use the "Edit" links on the left to modify the desired portion(s) of the record.
When a record that is currently completed, approved or released is modified, the record status is automatically reset to "In progress". Remember to mark the record as Complete when finished editing. Your PRS Administrator will approve and release the modified record as described above.
Keep protocol records up to date - Protocol records for active trials should be reviewed and modified as needed at least every 6 months. Pay special attention to recruiting status and contact information, as the accuracy and timeliness of this information is extremely important to patients and health care professionals. Update the record's verification date (via the Edit Protocol screen) to confirm that the record has been reviewed.
Check for problems - Use the Problems link on the Main Menu to identify critical issues, such as records that need attention from your PRS Administrator or records that are missing information required by U.S. Public Law 110-85 (FDAAA).