# RWE protocol and SAP deviation log

> **Editorial governance worksheet, not an official regulatory form.** Start
> this log when the protocol or statistical analysis plan is approved. Record
> the rationale, timing, impact, and approval of every change; a log does not
> make a post-results change pre-specified.

**Study / protocol ID:** [enter]  
**Protocol version / date:** [enter]  
**SAP version / date:** [enter]  
**Log owner:** [enter]

## Change log

| ID | Date identified | Affected document / section | Original pre-specified text or rule | Proposed change | Trigger and whether results were viewed | Scientific and operational rationale | Effect on estimand, population, exposure, outcome, follow-up, covariates, or analysis | Classification | Approval and effective date | Reporting/disclosure action |
|---|---|---|---|---|---|---|---|---|---|---|
| DEV-001 | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] | [clarification / administrative / amendment / deviation] | [enter] | [enter] |
| DEV-002 | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] |
| DEV-003 | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] |

## Required evidence for each record

- Link the signed protocol/SAP versions, analysis code commit, code-list version,
  and any data-quality evidence that prompted the change.
- State whether treatment/outcome results, unblinded comparative results, or
  interim estimates were available to the people proposing or approving it.
- For a methodological amendment, state the affected estimand and pre-specify
  the primary and sensitivity analysis consequences.
- Use the final report to disclose material departures from the registered or
  approved plan and explain them plainly.

## Periodic reconciliation

| Review date | Versions compared | Open changes | Changes that need protocol/SAP revision | Reviewer / decision |
|---|---|---|---|---|
| [enter] | [enter] | [enter] | [enter] | [enter] |
| [enter] | [enter] | [enter] | [enter] | [enter] |

## Source basis

- Wang SV, Pottegård A, Crown W, et al. HARmonized Protocol Template to Enhance
  Reproducibility of hypothesis evaluating real-world evidence studies on
  treatment effects. *Pharmacoepidemiology and Drug Safety*. 2023;32:44-55.
  https://doi.org/10.1002/pds.5507
- Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for
  planning and reporting on the implementation of real world evidence studies.
  *BMJ*. 2021;372:m4856. https://doi.org/10.1136/bmj.m4856
- Langan SM, Schmidt SAJ, Wing K, et al. The reporting of studies conducted
  using observational routinely collected health data statement for
  pharmacoepidemiology (RECORD-PE). *BMJ*. 2018;363:k3532.
  https://doi.org/10.1136/bmj.k3532