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 Active Registry Management can include the annual PRS update.
Honest about NCTs
NCT assignment is up to ClinicalTrials.gov’s reviewers. BeaconCR’s Quality Review covers submission support, not assignment guarantee.
Public registration examples
Studies on the public record: NCT07511660, NCT07264166, and NCT07521384 — full registration with complete records and PRS account management.
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 Quality Review engagement 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