RWE protocol outline template
Read by RWE Readiness Checker. Write the sentence under each heading; a heading alone is not evidence.

1. Objective and estimand
What to write: The question in one sentence, the estimand, the primary endpoint, time zero and the follow-up window.
Checks: A1, A3

2. Study design and population
What to write: The design and why it is appropriate; eligibility, analysis population and what happens to a patient who meets some rules.
Checks: A4, D6

3. Data sources and fitness
What to write: The source, the years and size, the feasibility work, the limits and the validation of definitions.
Checks: B1, B2, B3

4. Endpoints and ascertainment
What to write: Each endpoint, its operational definition, the code set and the validation result.
Checks: A3, B3, D2

5. Statistical analysis
What to write: The SAP version and lock date, the primary method, missing data, the decision rule.
Checks: A2, B4, C4

6. Robustness
What to write: Sensitivity analyses with the assumption each varies; pre-specified subgroups and the multiplicity position; consistency across methods.
Checks: C1, C2, C3

7. External control
What to write: Eligibility matching, endpoint matching, confounding and diagnostics, contemporaneous care, site comparability, design justification.
Checks: D1 to D6

8. Data use and rights
What to write: The right to use the data in the submission, the agreement and its scope, partner obligations.
Checks: E1, E2, E5

9. Source records and privacy
What to write: Where the records are held, how they are verified, ethics and consent, de-identification, the lawful basis.
Checks: B6, E3, E4

10. Traceability and standards
What to write: The audit trail, the chain through each hand, retention and the CDISC conversion.
Checks: B5, B7, E6

11. Confirmatory study and timeline
What to write: The study, its enrolment start, its milestones and its completion date.
Checks: A6