Protocol registration & deviations (lite) — v1.0.0
Released: 2026-02-02 · Hash: sha256:829b7baea436e9f55fd1ed44350b7abad50341c0de92d0f9bf85ffef295557cf
Registration
| Criterion | Text |
|---|---|
| must PRG-01 | Provide a registry/preregistration identifier and a stable URL, including the registration date and whether it was prospective. |
| should PRG-02 | Clarify what was registered (protocol, analysis plan, outcomes) and which version of the registration record is considered primary if multiple exist. |
| must PRG-03 | State prespecified primary outcome(s) and timepoints, and indicate where they appear in the registration/protocol. |
| should PRG-04 | State the prespecified target sample size (or dataset size) and the rationale (power/precision/feasibility), and flag any later changes. |
Protocol basics
| Criterion | Text |
|---|---|
| must PRG-10 | Provide access to the full protocol and/or analysis plan (appendix, repository, or DOI), including version/date. |
| must PRG-11 | Describe eligibility criteria, setting, and (as applicable) interventions/exposures, comparators, and follow-up. |
| must PRG-12 | Define outcomes and measurements (instruments/operational definitions) and the schedule/timepoints for assessment. |
Outcomes & analysis plan
| Criterion | Text |
|---|---|
| must PRG-20 | Describe the prespecified primary analysis (estimand, model/test, covariates, and population), including planned subgroup/interaction analyses if any. |
| should PRG-21 | Describe the missing data plan and any prespecified sensitivity/robustness analyses (and their triggers). |
| may PRG-22 | If applicable, report interim analyses, stopping rules, allocation/randomization/blinding procedures, and protocol-specified decision rules. |
Amendments & deviations
| Criterion | Text |
|---|---|
| must PRG-30 | Report protocol amendments with dates, rationale, and approvals (ethics/sponsor), and link to the amended protocol version. |
| must PRG-31 | Explicitly flag and justify deviations from the registered plan (e.g., outcome changes, analysis changes, sample size changes) and separate prespecified vs exploratory results. |
| should PRG-32 | Label post hoc / exploratory analyses as exploratory and avoid presenting them as confirmatory. |
Transparency
| Criterion | Text |
|---|---|
| must PRG-40 | Include a concise protocol/registration availability statement summarizing what is available and where (links/IDs + versions). |
| must PRG-41 | Disclose funding, sponsor role, and competing interests relevant to the protocol and its amendments. |