PRS submission support for eligible studies.
When your study is eligible for ClinicalTrials.gov registration, BeaconCR helps assemble the Protocol Registration and Results System (PRS) submission. We support the submission process — we do not guarantee acceptance, NCT assignment, or publication timing.
What we do
- PRS eligibility check based on FDAAA 801, NIH policy, and ICMJE
- PRS record drafting — required and recommended fields
- Outcome measure formatting per PRS conventions
- Eligibility criteria formatting
- Site information and contact-list preparation
- Submission coordination with the responsible party
- Post-submission revision support
- Annual update preparation when registry stays active
- Results-section preparation (when results are due)
- Refusal-to-publish reason management when required
Key features
Eligibility comes first
Not every observational study qualifies. BeaconCR runs an eligibility check before drafting so we don’t prepare a submission that will not be accepted.
Responsible party clarity
Every PRS submission needs a responsible party (sponsor or sponsor-investigator). BeaconCR helps determine which applies and prepares the submission accordingly.
Field-level QA
Required and recommended fields are reviewed for PRS-style language before submission. Reviewers see fewer revision requests.
Annual updates handled
Once a study is registered, BeaconCR’s $119/month Active Registry Management can include the annual PRS update.
Honest about NCTs
NCT assignment is up to ClinicalTrials.gov’s reviewers. BeaconCR’s $499 Quality Review covers submission support, not assignment guarantee.
No misleading claims
We never imply that a study has a pending NCT until ClinicalTrials.gov confirms one.
ClinicalTrials.gov registration support is bundled into the $499 Quality Review for eligible studies. For studies that aren\u2019t eligible, BeaconCR can still help organize the registry — it just doesn\u2019t go on the public record.
Begin Quality Review