Primary sources: ClinicalTrials.gov Results Data Element Definitions and How to Submit Your Results.
Use the Results Quality Control Review Criteria for the current review path. Protocol registration information follows a separate record workflow.
Start with one review set
Identify the person who can answer each results question, the version of the results materials being reviewed, and the study record that will be updated. Results preparation often spans participant accounting, analysis outputs, and safety information. A clear review set makes it easier to send a question to the right owner before a field is entered.
Keep study facts and record wording together during this review. Do not assume that a protocol-era statement answers a results question. The official results definitions distinguish the results record from protocol registration information.
Use four connected review areas
- Participant flow. Check that the periods, milestones, and groups describe how participants moved through the study. Resolve differences with the responsible study team before treating a table as final.
- Baseline characteristics. Confirm that the groups and analyzed population are understandable in context. Where the population differs from another table, use the official definitions to decide what explanation is needed.
- Outcome measures. Review the measure title, time frame, groups, and reported data together. An outcome table is easier to review when the measure and its time frame are specific to the data being shown.
- Adverse events and caveats. Bring the supporting safety information and any limitations into the same review. If the team cannot explain an apparent inconsistency, resolve it before submitting the results record.
Turn the review into a clean handoff
Use a short decision list for open questions: the field or table, the supporting source, the content owner, and the next action. This is not a substitute for the receiving system’s review. It is a way to avoid carrying an unresolved issue from one results area into another.
When a result requires interpretation, open the current ClinicalTrials.gov definition rather than applying a local convention. The official submission guidance and quality-control criteria remain the source for record decisions.
What this guide does not decide
This guide does not determine whether results are due, whether a study meets a legal or policy requirement, study quality, or whether ClinicalTrials.gov will accept a record. It is a preparation guide for a focused review before submission.