ProtocolForge — Decentralized Trial Builder

Start from a registered trial

Paste a ClinicalTrials.gov NCT id. Fields are mapped onto this builder's vocabulary; outcomes are matched to home measurement sources.

Protocol Metadata

Study Title

Short Title

Version

Sponsor Organization

Principal Investigator

PI Credentials

Trial Type

Estimated Enrollment

Phase

Registry keywords (one per line)

Duration (days)

Hypothesis

Primary Hypothesis

Secondary Hypotheses (one per line)

Study Design

Allocation

Blinding

Control

Study Arms

Eligibility Criteria

Age Min

Age Max

Sex

Inclusion Criteria (one per line)

Exclusion Criteria (one per line)

Decentralization Resolver

Fully Decentralized100/100

Every intervention and outcome resolves to ship-to-home, local pickup, at-home kit, or in-app fulfilment. No required in-person site visits.

Regulatory & budget

2 blockers4 major

Supplement studied for a disease endpoint: Dietary nitrate (beetroot juice concentrate)
Supplement studied for a disease endpoint: Nitrate-depleted beetroot placebo

Per participant$679

Total (150 enrolled)$199,485

IRB Acceptance Score

80/100

Blockers (2)

Consent reading level ≤ 8th grade
No consent/risk narrative drafted yet
Fix: Simplify flagged sentences in the informed consent form (AI-assisted)
Risk/benefit narrative includes quantified risk
Risk/benefit narrative lacks quantified risk estimates
Fix: Add incidence data from evidence pipeline to risk assessment

Consent reading level ≤ 8th gradehigh
No consent/risk narrative drafted yet
Risk/benefit narrative includes quantified riskhigh
Risk/benefit narrative lacks quantified risk estimates
Supplement does not make disease-treatment claimcritical
Data safety monitoring plan presenthigh
Vulnerable population safeguardshigh
Placebo justified where standard of care existsmedium
Primary endpoint has MCID / poweringmedium
Decentralized identity verification addressedhigh
Remote consent process describedhigh
Shippable intervention has stability/handling notemedium
AE reporting pathway for remote participantshigh