This is a ready-to-use log for recording CRF-to-source discrepancies found during source data verification and the queries raised to resolve them. It gives the monitor a controlled record of what was found, what was asked, and how it closed, and it surfaces the clusters that signal a site-level process problem. Replace every <<FILL: ...>> placeholder with your specifics. A filled sample row follows.
Document control header
| Field | Entry |
|---|---|
| Log title | SDV Discrepancy and Data Query Log |
| Log / record number | <<FILL: e.g. QLOG-<protocol>-<site>>> |
| Protocol / site | <<FILL>> |
| Maintained by | <<FILL: CRA name>> |
| Retention | <<FILL: per essential-records rule>> |
1. Purpose
This log tracks each SDV discrepancy and data query for <<FILL: protocol / site>> from discovery to resolution, so that no discrepancy is lost, corrections preserve the original entry, and repeated patterns are visible and escalated. It supports the monitoring visit report and is itself a monitoring record.
2. Field definitions
| Field | Format | Required | Who enters | When |
|---|---|---|---|---|
| Query ID | Q-<subject>-<seq> | Yes | CRA | At discovery |
| Date raised | Date | Yes | CRA | At discovery |
| Subject ID | Text | Yes | CRA | At discovery |
| CRF domain / field | Text | Yes | CRA | At discovery |
| Discrepancy type | Transcription / missing source / non-contemporaneous / correction obscures original / SDR finding | Yes | CRA | At discovery |
| CRF value vs source value | Text | Yes | CRA | At discovery |
| Severity | Critical / important / minor | Yes | CRA | At discovery |
| Query text | Text | Yes | CRA | At discovery |
| Site response | Text | Yes | Site | On resolution |
| Correction made (original preserved?) | Yes / No / N/A | Yes | CRA verifies | On resolution |
| Status | Open / answered / closed | Yes | CRA | Ongoing |
| Date closed | Date | Yes | CRA | On closure |
| Escalated? | Yes / No, with reference | Yes | CRA | If a pattern emerges |
3. Log table
| Query ID | Date raised | Subject | CRF field | Type | CRF vs source | Severity | Query text | Site response | Corrected (original preserved?) | Status | Date closed | Escalated? |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
4. Instructions
- Raise a query for every CRF-to-source mismatch and every SDR finding; the monitor never corrects site data.
- Confirm on resolution that the correction preserved the original entry through the audit trail or a proper paper correction (one line through, correct value, initials, date, reason).
- Watch for clustering: three or more discrepancies of the same type for one subject or site is a process signal; escalate to the clinical lead and reference the escalation here.
- Do not close a query on a verbal assurance; close it on the confirmed, documented correction.
5. Acceptance criteria
- Every discrepancy found during SDV/SDR has a log entry.
- Each entry names the source-vs-CRF values, the type, and the severity.
- Each closed entry confirms the correction preserved the original.
- Clusters are escalated with a reference recorded.
- The log reconciles with the EDC query system and the monitoring visit report.
6. References
ICH E6(R2) sections 4.9 and 5.18.4; ICH E6(R3) (data corrections and monitoring). 21 CFR Part 11 (audit trail, corrections); good documentation practices for paper corrections.
Confirm the current version of each reference before issue.
Filled specimen
The following shows one completed row. The specifics are illustrative.
| Field | Entry |
|---|---|
| Query ID | Q-0123-014 |
| Date raised | 09 July 2026 |
| Subject | 0123 |
| CRF field | Vital signs, Week 4 systolic BP |
| Type | Transcription |
| CRF vs source | eCRF 138 mmHg vs worksheet 158 mmHg |
| Severity | Important |
| Query text | Week 4 systolic BP eCRF value 138 does not match source worksheet value 158. Please verify and correct. |
| Site response | Worksheet confirmed correct; eCRF corrected to 158 with reason for change. |
| Corrected (original preserved?) | Yes, original 138 preserved in audit trail |
| Status | Closed |
| Date closed | 16 July 2026 |
| Escalated? | Yes, third transcription error for subject 0123; site data-entry quality concern raised (ESC-2026-031) |
In this example the log captures not just the fix but the pattern: a third transcription error for the same subject triggered an escalation, which is how a monitor turns individual queries into a site-level quality signal rather than a pile of isolated corrections.
Common findings this log prevents
- Discrepancies found but never tracked to resolution, so open queries linger unseen.
- Corrections that overwrote the original, with no evidence the original was preserved.
- Repeated errors treated as one-offs because nothing aggregated them into a pattern.
- A visit report that cannot be reconciled against what was actually queried and closed.
How to adapt this log
- Set your log number and align the field set with your EDC query system so the two reconcile.
- Keep the severity and clustering columns; they are what turn the log into a quality signal.
- Retain it with the monitoring records under the study’s essential-records retention.
- Confirm the references in section 6 before issue.