PLANREFERENCE OUTLINE

Source Data Verification Plan

Risk-based verification plan that defines what source is for each data point before the first visit, sets verification depth and sample size per variable by criticality, checks the attributes that make data trustworthy, treats a discrepancy as a question about the process, deliberately looks for data never reported, and records what was not checked as well as what was. Maps to ICH E6(R3).

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
ICH E6(R3)
DOCUMENT TYPE
Plan
LAST UPDATED
August 2026
PURPOSE

Source data verification compares what was reported against the record where the data first appeared. Under a risk-based approach it means checking what matters, on a sample sized by risk, and the hard part is defining what source is for each data point before the first visit. A monitor who settles that question at the site has already lost the visit.

What's Inside

✓Source definition per data point, including which fields are captured directly and are therefore source themselves
✓Risk-based sampling plan setting verification depth and sample size per variable according to criticality
✓The attributes verification actually checks, so two monitors reach the same conclusion on the same record
✓Discrepancy handling routed through process cause rather than through value correction at the record
✓A deliberate search for data that exists at the site and was never reported at all
✓Visit record stating what was checked and, equally importantly, what was deliberately not checked
✓Escalation route when a site’s discrepancy pattern suggests a systematic rather than an isolated problem

How to Use It

1Define source for every data point before the first visit; direct-capture fields are source, not transcriptions waiting to be checked
2Vary verification depth by criticality — uniform depth exhausts the visit before the critical variables are reached
3Size each sample from the assessed risk and record the basis, so the plan can be shown to have been followed
4Treat each discrepancy as a question about the process, because correcting the value alone lets the systematic error repeat everywhere
5Look deliberately for data never reported, since verification that starts from the report cannot find what is missing from it
6Record what was not checked as well as what was, or the sampling plan becomes unverifiable once the visit ends
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Source Definition
2Risk-Based Sampling Plan
3What Verification Checks
4Discrepancy Handling
5Unreported Data and Visit Record
REGULATORY CONTEXT

ICH E6(R3) establishes the risk-based approach to monitoring, the requirement to define source data, and the expectation that monitoring effort follows the risks to subject safety and data reliability. It does not tell you which variables are critical in your trial, what sample size is defensible, or how deep verification goes for a given endpoint — those determinations are the sponsor’s, made in advance and recorded. The plan structure and the unreported-data check are SPEQ practitioner synthesis.

MAPPED STANDARDS
ICH E6(R3)
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