Transparency in Trial Registration: Completing PRS Records Accurately
Plan PRS access, protocol fields, outcome definitions, quality control and record updates using official ClinicalTrials.gov guidance.
Why prospective registration matters
Prospective registration makes the research question and primary outcomes visible before results are known, reducing selective reporting and supporting transparency. Legal, policy and journal requirements vary, so the responsible party must verify which rules apply.
PRS access
Records are submitted through the Protocol Registration and Results System. Investigators generally obtain an account through their organisation's PRS administrator. Define the responsible party and update responsibilities early.
Prepare consistent protocol information
Gather titles, sponsor information, design, masking, interventions, eligibility, enrolment, locations and recruitment status. Outcome measures need a specific measure, metric, method and time frame—for example, change from baseline in a 0–10 pain score at week 12.
Quality control and updates
ClinicalTrials.gov QC checks clarity and consistency; it is not ethics or scientific approval. Resolve comments in the relevant fields. Keep recruitment status, sites, contacts, protocol changes and results current.
References
Accessed 20 June 2026.