Research Roundtable: ClinicalTrials.gov FAQ — Results Reporting (Part 2)
Published May 13, 2024
Part two in a series of articles highlighting frequently asked questions to comply with results reporting for ClinicalTrials.gov includes guidance on the Quality Control review process, protocol and statistical analysis plans, and appendices. (See part one here.)
ClinicalTrials.gov has an extensive FAQ section ranging from general to investigation-specific. Many of these questions frequently arise not only at the University at Buffalo but also at many other institutions that are part of the Clinical Trials Registration and Results Reporting Taskforce. See additional ClinicalTrials.gov FAQs here.
How long does the Quality Control review process take?
After the Responsible Party releases (submits) information to ClinicalTrials.gov, the information undergoes a manual quality control review to identify possible errors, deficiencies, or inconsistencies that are not detected automatically during data entry. The Responsible Party will be notified of any issues that need correction, usually within a few days after release of the protocol information. Review of records with results is prioritized for the studies that appear to be Applicable Clinical Trials (ACT) or are NIH-funded and can take up to 30 days or longer. The review process for non-ACTs and studies that are not funded by NIH can be lengthier.
Is a protocol and statistical analysis plan (SAP) required to be submitted?
The regulations require a copy of the protocol and SAP (if not included in the protocol) to be submitted as part of clinical trial results information. The Responsible Party may redact names, addresses, and other personally identifiable information, as well as any trade secrets and/or confidential commercial information.
If there is more than one IRB-approved version of a consent form, how many must be posted?
The Revised Common Rule requires that the version of the consent document that is posted must a) be IRB-approved and b) have been used to enroll a participant in the clinical trial. The version of the consent that should be posted is the most recent IRB-approved version that was used to enroll a participant.
Are appendices required to be included in the uploaded study protocol?
ClinicalTrials.gov considers the protocol appendices that contain a “description of the clinical trial, including objective(s), design, and methods,” and any “relevant scientific background and statistical considerations,” to be part of the full protocol and as such they must be included with the uploaded protocol.
When posting a protocol with many add-on sub-studies, which version of the protocol should be posted?
Post the version of the protocol that was originally approved and is relevant to the study at hand. If sub-studies answer the same research questions, register under the originally approved protocol. If sub-studies are clearly different from the main study, each sub-study should be registered separately in ClinicalTrials.gov.
How can I get ClinicalTrials.gov help at UB?
For UB assistance with ClinicalTrials.gov registration and reporting requirements, contact the UB ClinicalTrials.gov team (UBClinicalTrialsgov@buffalo.edu) or ClinicalTrials.gov Protocol Registration and Results System (PRS) Administrators Lynn Jagodzinski (lynnjago@buffalo.edu), CTSI Clinical Research Regulatory Administrator, and Urmo “Mo” Jaanimägi (uj@buffalo.edu), CTSI Quality Assurance Specialist.
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