Template
The outline template the checks read
The checker reads headings and the sentences under them. This template gives you the section skeleton that lets each check find what it needs, plus a CSV of the 29 checks to work through. Fill it in, paste it back, and the check reads your words rather than a blank page.
How to use it
- Copy the template into the document your team already uses.
- Write the sentence under each heading. A heading alone does not satisfy a check.
- Paste the outline into the free check.
- Work the contradictions first, then the absences, then the partly evidenced checks.
A template is not a protocol. The headings tell you where the reviewer will look. The sentences have to be true for your study, your data and your agreements.
The sections
| Section | What it has to carry | Checks it feeds |
|---|---|---|
| Objective and estimand | The question, the estimand, the primary endpoint, time zero and follow-up | A1, A3 |
| Study design and population | Design, eligibility, analysis population and why the design is appropriate | A4, D6 |
| Data sources and fitness | The source, the feasibility work, the limits and the validation of definitions | B1, B2, B3 |
| Statistical analysis | The SAP, its version and lock date, the methods, missing data and the decision rule | A2, B4, C4 |
| Robustness | Sensitivity analyses, subgroups, multiplicity and consistency across methods | C1, C2, C3 |
| External control | Eligibility, endpoints, confounding, contemporaneous care and site comparability | D1 to D6 |
| Data use and verification | The right to use the data in the submission, the agreement, source records and privacy | E1 to E6 |
| Traceability and standards | The audit trail, the retention, the CDISC conversion and the chain through each hand | B5, B7, E5, E6 |
| Confirmatory study and timeline | The study, its enrolment, its milestones and its completion date | A6 |