1) Core principles

Standards are designed to protect the scientific record while keeping submissions usable for journals, ethics boards, institutions, and the public.

• Prospective registration: register before first participant enrollment whenever feasible.

• Public accessibility: core study metadata is searchable and citable.

• Accuracy and completeness: submitters are responsible for truthfulness and sufficient detail.

• Auditability: material updates are recorded with timestamps and reasons.

2) Minimum required data set

Every record must include enough information to identify the study, understand methods, and interpret prespecified outcomes.

• Administrative: title, sponsor, principal investigator, contact, countries and sites.

• Rationale: background and objective (and hypothesis where applicable).

• Design: study type, setting, allocation and masking (if relevant), comparator, timeline, target sample size.

• Participants: eligibility criteria, age range, key exclusions, recruitment status.

• Intervention or exposure: clear description, timing, and dose or procedural detail where relevant.

• Outcomes: primary and secondary outcomes with timepoints and measurement instruments or definitions.

• Ethics: approval status or exemption, consent approach, privacy considerations.

• Identifiers: protocol IDs and external registrations (if any).

3) Outcome clarity requirements

Outcomes must be specific enough to prevent ambiguity and selective reporting.

• Measurable: outcomes must be quantifiable or clearly defined.

• Time-bound: include timepoints (for example, 30 days, 6 months, 1 year).

• Instrument-linked: name instruments or definitions (for example, PROM name, radiographic definition).

• Aligned: ensure outcomes match the design and population, and are consistent across versions.

4) Data quality and validation

Structured checks improve consistency and comparability across records.

• Consistency checks: dates, recruitment status, and sample size must not conflict.

• Terminology: use standard condition and intervention terms when possible.

• No promotional language: describe the protocol, not marketing claims.

• Completeness: required fields must be populated before publication.

5) Updates, amendments, and versioning

Records must be kept current. Material changes are tracked as new versions to preserve provenance.

• Recruitment status: update when recruitment changes (planned, recruiting, active, completed, terminated).

• Protocol changes: eligibility, interventions, outcomes, or sample size changes require an amendment reason.

• Investigator or site changes: keep contacts and locations accurate.

• Results links: add protocol, analysis plan, preprint, or publication links when available.

6) Ethics, consent, and privacy

Registration does not replace local governance. Submitters must comply with applicable laws and institutional policies.

• Ethics status: indicate approval, pending review, exemption, or not required (with brief justification).

• Consent approach: describe written, verbal, waived, or deferred consent where applicable.

• No personal identifiers: do not include individual participant data or direct identifiers.

• Data protection: describe high-level safeguards where relevant (storage, access, retention).

7) Withdrawals, corrections, and removals

We prioritize correction and versioning over deletion to protect citation integrity and transparency.

• Corrections: handled through updated versions with a reason for change.

• Withdrawal: shown as a status change; prior versions remain in the audit trail.

• Exceptional removal: may occur for unlawful content or serious safety concerns and may leave a minimal “tombstone” record.

• Cross-registration: external identifiers are encouraged when the study is registered elsewhere.

8) Governance and contact

If you need help aligning a record to these standards or reporting an integrity concern, contact the governance team.