Registering a Study on ClinicalTrials.gov

• The UCSF PRS Registration User Guide provides institution-specific guidance for UCSF.
• The Common Errors page highlights frequently identified errors, explains why they occur, and provides recommendations for correcting them before submitting or updating a ClinicalTrials.gov record.
• The ClinicalTrials.gov PRS Registration Guided Tutorial should be completed before starting a new study record and offers step-by-step instructions and guidance for completing the record modules.
• The PRS Quality Control Criteria document includes examples of acceptable and unacceptable record content, including outcome measures.
• The PRS User's Guide and Data Element Definitions documents provide additional guidance and definitions.

• All fields should be complete.
• All fields should be accurate.
• All fields should be in lay language, where possible.

If the UCSF investigator holds an IND or IDE: the IND or IDE holder must be listed as the Responsible Party as the Sponsor-Investigator. The Record Owner must update the record, mark “Entry Complete”, approve the record, and release to PRS.

If there is no IND or IDE: UCSF must be listed as the Responsible Party and as the Sponsor. Record Owners should only update the record and mark “Entry Complete” for the UCSF Regulatory Support Team to review, approve, and release to PRS.

The purpose of the ClinicalTrials.gov outcome measures module is to report summary quantitative results by group for enrolled participants. Outcome measures must clearly and accurately describe what will be measured and reported.

Each outcome measure must represent a single variable with a single unit of measure, a description of what will be measured, and have outcome-neutral language (e.g., “change” must be used instead of “improvement,” “decrease,” etc.).

NOTE: exploratory outcome measures do not need to be listed, only primary and secondary outcome measures require reporting.

Titles

Each title must be brief but descriptive, specific, and unique, conveying what will be measured and reported as data for the study. For change measures, the title must specify that a change will be measured over time. PRS does not permit the use of general titles such as “Safety,” “Feasibility,” or “Pharmacokinetics.”

Descriptions

Use the description field to include any additional information about the measure, such as how the measure will be taken, relevant definitions, criteria, and the method of assessment. When a score on a scale will be reported, include the unabbreviated scale title, how the reported score is calculated, the minimum and maximum values, and whether higher scores mean a better or worse outcome.

Time Frames

The time frames must be the specific time point at which the outcome will be measured from the perspective of a single participant from baseline (the time of enrollment) or the duration of time of assessment of the participant. Change measures must specify two time points for which the change is being measured (e.g., baseline and 8 weeks). If an outcome measure will be reported at multiple time points, each time point must be entered as a separate outcome measure. (Dose escalation studies are an exception, see example below.)

Examples of acceptable outcome measures