Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov.
ClinicalTrials.gov is a registry and results database of clinical studies of human participants conducted around the world. The site is intended to provide to the public easily accessible, reliable information about clinical trials on a wide range of diseases and conditions.
Registration of clinical studies is required by law. Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires the Responsible Party (the Principal Investigator) to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices. The International Committee of Medical Journal Editors also requires registration in order to publish research results generated by a clinical trial. Failure to register can result in refusal to publish results, loss of NIH grant funding and civil penalties. Detailed information can be found at https://clinicaltrials.gov/ct2/manage-recs/fdaaa.
FDAAA 801 requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. The International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.
In order to access the system, you will need to contact the UBC administrator for your institution to have a ClinicalTrials.gov user account set up:
- Children’s & Women’s Hospitals: Nur Eisma
- Vancouver Coastal Health (including UBC Hospital): Susan O’Neil
- UBC Vancouver campus, Providence/St. Paul’s Hospital, BC Cancer Agency: Carolyn De Melo
- UBC Okanagan campus: Lisa Shearer
Once a user account has been set up, you will receive an automatic confirmation email from the site that will contain your user name and password.
Studies are registered using the Protocol Registration and Results System (PRS). To access the system, go to https://register.clinicaltrials.gov. The Organization name is UBColumbia.
In addition to the tips provided below, be sure to visit ClinicalTrials.gov for detailed instructions and resources to assist with registering your study – the Submit Studies page and Frequently Asked Questions page are particularly helpful. As you go through the data entry pages, refer to the “Help” and “Definitions” links for useful page-specific information and guidelines. Questions can be directed to email@example.com. Also, see the Tips + Reminders and Common Errors To Avoid sections below.
Page: Study Identification
- The Organization’s Unique Protocol ID should be the UBC ethics application ID (eg, H17-xxxxx). The official title should match the title listed on your ethics approval. Once your protocol has been approved by PRS staff, they will assign it an 8-digit NCT number.
Page: Study Status
- The Record Verification Date is the date on which the Responsible Party (PI) last verified the clinical study information in the entire ClinicalTrials.gov record for the clinical study, even if no additional or updated information is being submitted. This date should be updated at least every 12 months for studies that are not yet completed.
- For grant-funded clinical trials, the Responsible Party should be the Principal Investigator, provided he or she is responsible for conducting the trial, has access to and control over the data from the trial and has the right to publish the results of the trial.
- The Sponsor should be The University of British Columbia.
- Collaborators are not individuals in this case, but organizations providing support, including funding, design, implementation, data analysis and reporting.
Once you select the Board Status from the drop-down menu, you will be asked to provide information about the research ethics board reviewing the study. The board affiliation is the University of British Columbia. Copy and paste the contact details for the relevant REB:
University of British Columbia Clinical Research Ethics Board
Room 210, Vancouver General Hospital Research Pavilion
828 West 10th Avenue
Vancouver, BC V5Z 1L8
University of British Columbia Children’s and Women’s Research Ethics Board
A2-136, 950 West 28th Avenue
Vancouver, BC V5Z 4H4
University of British Columbia Providence Health Research Ethics Board
Providence Health Care Research Institute
10th Floor - 1190 Hornby Street
Vancouver, BC V6Z 2K5
604-683-2344 ext 63496
University of British Columbia B.C. Cancer Agency Research Ethics Board
BC Cancer Agency
Fairmont Medical Building, Suite 902
750 West Broadway
Vancouver, BC V5Z 1H8
University of British Columbia Behavioural Research Ethics Board
#102, Technology Enterprise Facility III
6190 Agronomy Road
Vancouver, BC V6T 1Z3
- There can only be one record owner, but he or she can allow others to edit the study by managing the Access List from the Record Summary page. The completed record can only be approved and released for review by the PI (the Responsible Party).
- Once released, every record undergoes review by PRS staff. If corrections are needed, the record owner will receive an email alert and the problems will be noted on the online record. The record will need to be corrected, completed, approved and released again for secondary review by PRS staff.
- Records must be updated every time a change occurs – pay particular attention to ensuring that the study status, timelines and enrolment information are current.
- The Record Verification Date must be updated at least every 12 months, even if no changes have occurred
- For complete timelines/deadlines for updates to study records, refer to https://prsinfo.clinicaltrials.gov/FinalRuleChanges-16Sept2016.pdf (Table 3)
- Results information must be submitted, generally within 12 months after the primary completion date (date that the final subject was examined or received an intervention for the purpose of collecting data), regardless of whether the drug, biological, or device products under study have been approved, licensed, or cleared for marketing by the FDA.
- Only records that are still being created can be deleted. Once published on ClinicalTrials.gov, they cannot be deleted, even after the study has been completed.
- Acronyms and abbreviations should be spelled out fully for first use
- Do not use personal pronouns (eg, use “The investigators” rather than “We.”)
- Check for spelling errors prior to submitting record (there is a Spelling link on the Protocol entry screen to help identify any errors)
- Time frames provided in the Outcome Measures section must be specific (eg, "1 day" or "up to 24 weeks")
- Any errors noted in red font must be corrected
- After the record has been marked as Complete, the Responsible Party (PI) must then Approve and Release in order to submit it for review
For more information on registering clinical trials, please review the UBC Clinical Research Ethics Board Guidance Note 16: Research Databases and Registries and visit ClinicalTrials.gov.
Note: Click here to learn about the important changes to NIH policies & procedures related to human subjects research, and how they affect the grant application process.
On January 18, 2017, revisions to the requirements for clinical trials registration and results submission came into effect per the US Department of Health and Human Services’ recently issued Final Rule and the NIH’s complementary policy. All institutions are required to be in full compliance with the Final Rule by April 18, 2017.
The Final Rule clarifies and expands requirements for submitting clinical trial registration and results information to ClinicalTrials.gov in accordance with Section 801 of the Food and Drug Administration Amendments Act of 2007. A summary of the changes implemented via the Final Rule can be found here. In addition to the current DHHS consequences for non-compliance, which include civil monetary penalties, the NIH’s policy states that failure to submit all required registration and results information could jeopardize future grant funding.