ClinicalTrials.gov Protocol Registration and Results System
It is the responsibility of the Principal Investigator to ensure that registration, results reporting, and updating are performed within the specific timelines required by each applicable rule body for all new and ongoing clinical trials.
The Principal Investigator or designee is responsible for performing the following functions:
- Identify studies requiring registry in a publically accessible database;
- Request user account set-up within UNC organization account;
- Create records on ClinicalTrials.gov;
- Confirm accuracy of record content;
- Change ClinicalTrials.gov Record Status following edit completion to trigger release process;
- Ensure ClinicalTrials.gov notification emails are addressed within 15- and 25-day timelines (registration and results records, respectively);
- Maintain records on ClinicalTrials.gov in accordance with all regulatory and policy driven requirements;
- Notify the Office of Clinical Trials of receipt of any correspondence from an external agency regarding Final Rule (42 CFR Part 11) requirements, NIH policy requirements, ClinicalTrials.gov record: registration, results, and/or record maintenance requirements;
- Notify the Office of Clinical Trials within 30 days of an expected and 15 days following an unexpected Principal Investigator/Responsible Party personnel change. All changes in Study Official (Principal Investigator), their official title, and/or contact information must be updated in the ClinicalTrials.gov record within 30 days of the change.
The Office of Clinical Trials offers support, guidance, and assistance including user account set-up, clinicaltrials.gov record creation; record maintenance/updates, and results reporting.
Incoming new faculty or leaving faculty may need to transfer ClinicalTrials.gov records into or away from the University with them. The Office of Clinical Trials can assist with this as well.
Depending on the reason for registering and associated requirements, ClinicalTrials.gov Records consist of 1-3 sections: Protocol (initial registration record), Results, and Document Sections. The Protocol (initial registration) is the minimum registration requirement for those studies being registered to meet ICMJE and CMS rules. While permissible to enter results for such trials, it is not required. Records registered to meet Final Rule and/or NIH Policy requirements, must report results within ClnicalTrials.gov no later than 12 months of reaching the “Actual” Primary Completion. These studies must add and complete a results record and upload a protocol in Portable Document Format Archival (PDF/A) format. If the Statistical Analysis Plan (SAP) is included within the protocol, the protocol including SAP is the only item required for upload. However, if a stand-alone SAP exists, then it must be uploaded too. Each document must include a cover sheet indicating the Official Study Title, NCT number, and date of document.
- A study must have been submitted to an IRB for review prior to registry although actual approval is not required prior to ClinicalTrials.gov protocol record creation.
UNC’s IRB does not review the data registered for a given trial. Ultimate responsibility for record accuracy lies with the Principal Investigator (PI) although a preliminary quality control (QC) review is performed by UNC’s ClinicalTrials.gov account administrator before release to ClinicalTrials.gov where a separate QC review is conducted.
An individual user account must be established at ClinicalTrials.gov by the University Administrator for the study Principal Investigator (PI) and all designees requiring record access as user accounts should not be shared among users. To request a user account, send an e-mail to email@example.com or firstname.lastname@example.org providing the user’s name, department, telephone number, and e-mail address. The user account will be created within ClinicalTrials.gov the same day if at all possible, and usually within minutes of account set-up, the new user will receive an e-mail from ClinicalTrials.gov providing the login details and a temporary password.
The PI or the PI’s designee will complete the required record fields by entering study-specific details into the ClinicalTrials.gov website. The ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies definitions document is available from the Help ‘pull-down’ menu on the ClinicalTrials.gov/PRS Home page upon log in and is also accessible by using the ‘Definitions’ hyperlink found in each edit module. This document includes all of the registration recordʼs field definitions and can be used to identify which fields are (*) required, (*§) required if Study Start Date is on or after January 18, 2017, or ([*]) conditionally required.
When creating a new record, enter the 6-digit, hyphenated, IRB number (i.e., XX-XXXX) into the first entry field as the “Unique Protocol ID” since UNC has no overall protocol numbering convention. For those using a department or other protocol identifier, this can be entered into the Secondary ID field (found within the Study Identification section).
Once editing is complete and the ClinicalTrials.gov Record Status is changed from “In Progress” to “Entry Complete,” an automated system e-mail is sent to the University Administrator (Office of Clinical Trials) advising that the record is ready to review and edit (or facilitate editing), if necessary. Upon review completion, the administrator will then approve and release the record for review by ClinicalTrials.gov. Until this release occurs, no one outside of UNC can see the record (new registrations) or updated information (existing record edits). Once released, ClinicalTrials.gov will perform a system validation and QC review. For protocol records this usually occurs within 2 to 5 days of release. For records containing results, each review may take 30 or more days.
Additional registration and results reporting tools provided by ClinicalTrials.gov are available by clicking the ‘Help’ menu on the PRS homepage to better understand, prepare, and organize registration and results reporting. Included there are results data preparation checklists and simple results templates and examples.