Simplify ClinicalTrials.gov registration and results reporting with ORA

Investigators running investigator-initiated clinical trials (IITs) at UCLA can get hands-on support with ClinicalTrials.gov registration and results reporting through the CTSI Office of Regulatory Affairs (ORA). ORA handles the technical and regulatory work that keeps a study compliant, so study teams can spend less time navigating the Protocol Registration System (PRS) and more time on their research.

These services support research transparency and regulatory compliance by providing expert ClinicalTrials.gov registration and results reporting that reduces administrative burden, saves investigators time, and ensures research findings are accessible to participants, clinicians, and the broader scientific community.

ORA offers three services:

• ClinicalTrials.gov Protocol Registration. ORA performs registration entries in the Protocol Registration System (PRS) in compliance with the Protocol Registration Quality Control Review Criteria, and provides updates and verification as needed throughout the study (minimum annually).
• ClinicalTrials.gov Results Reporting, Option 1. ORA provides fillable tables or lists specifying the required results data. The study team completes and returns them by email, and ORA performs the data entry and responds to reviewer comments, with input from the PI or statistician as needed.
• ClinicalTrials.gov Results Reporting, Option 2. ORA meets with the PI or statistician over one or two Zoom sessions to (1) explain PRS data entry requirements for results reporting, (2) guide them through the data entry process for results reporting and statistical analyses (if applicable), (3) review and provide feedback prior to submission on entries likely to violate review criteria. 

Fees

Fees are charged per study as a required pass-through cost.

• ClinicalTrials.gov Protocol Registration ($1,500)
• Results Reporting, Option 1 (ORA performs data entry) ($2,500)
• Results Reporting, Option 2 (ORA guides your team) ($1,000)

When to reach out

The best time to engage ORA is early, both before and during your study.

"An NCT number is just the starting line, not the finish line, for compliance," says Elaine Cooperstein, MS, CCRP, RAC-US, UCLA's Clinical Trials Government Liaison. "ClinicalTrials.gov requires continuous maintenance throughout the life of a study and beyond. Securing that initial identifier does not equal lasting compliance, and staying proactive is vital to protect our participants, our data integrity, and our institutional funding."

Outcome measures are where she sees teams stumble most often. "Waiting until a study is complete to revise outcome measures is a critical mistake," Cooperstein says. "At that stage, altering them triggers major red flags around data integrity and selective reporting. Front-loading that planning before the trial concludes is essential to comply with transparency requirements."

How to get started

Want to know how to request support for your study? Contact the CTSI Office of Regulatory Affairs through ResearchGo to get started.