This is a ready-to-use source data location list, the per-protocol table that names where the source lives for every data element. It is also called a source documentation agreement or data source matrix. Set it up before the first subject is enrolled and keep it current; inspectors ask for it and monitors live by it. Replace every <<FILL: ...>> placeholder with your specifics. A worked filled specimen follows.
Document control header
| Field | Entry |
|---|---|
| Document title | Source Data Location List |
| Document number | <<FILL: e.g. SDLL-<protocol>-01>> |
| Protocol number / title | <<FILL>> |
| Site number / name | <<FILL: single site, or "sponsor master" for a template>> |
| Version | <<FILL: version>> |
| Effective date | <<FILL: before first subject>> |
| Prepared by | <<FILL: name, role>> |
1. Purpose
This list defines, for each CRF domain and data element in <<FILL: protocol>>, where the source record lives, who or what originated it, and whether a certified copy is required. Its purpose is to remove ambiguity about which record is the source, so that source data verification is unambiguous and no CRF field exists without a defined source. A field in the eCRF with no entry on this list is a gap.
2. How to use this list
- One row per data element or CRF page. Split a domain into rows where different elements have different sources.
- Name the originator: the person or device that first recorded the element.
- Mark certified copy needed where the source is an object that must be copied into the trial file (typically EHR pages), and eSource where a field is entered directly with no upstream record.
- Update it under version control whenever the protocol, EDC, or a vendor changes.
3. Source data location list
| CRF domain / data element | Source location | Originator | Certified copy needed? | eSource? |
|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | Yes / No | Yes / No |
<<FILL>> | <<FILL>> | <<FILL>> | ||
<<FILL>> | <<FILL>> | <<FILL>> |
4. eSource designations
List every field designated as eSource (the eCRF is the source), with the validation and originator basis.
| eSource field | System | Originator captured how? | System validation ref |
|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
5. Acceptance criteria
- Every CRF domain and element appears with a defined source location and originator.
- No eCRF field exists without a row here.
- Certified-copy needs are marked wherever an original object must be copied into the trial file.
- Every eSource field is listed with its validation and originator basis.
- The list is version-controlled and dated before first subject, and kept current.
6. Signatures
| Role | Name | Signature | Date |
|---|---|---|---|
| Prepared by (sponsor/CRA) | <<FILL>> | ||
| Principal Investigator | <<FILL>> | ||
| Sponsor clinical operations | <<FILL>> |
7. References
ICH E6(R2)/E6(R3) Good Clinical Practice (source data, source documents, certified copies, essential records). FDA guidance, Electronic Source Data in Clinical Investigations (originator concept). 21 CFR 312.62 (investigator recordkeeping); 21 CFR Part 11 (electronic records).
Confirm the current version of each reference before issue.
Filled specimen
The following shows the list for an example phase 2 trial. The specifics are illustrative.
| CRF domain / data element | Source location | Originator | Certified copy needed? | eSource? |
|---|---|---|---|---|
| Informed consent date and signatures | Signed paper ICF in subject binder | Subject and investigator | No, original retained at site | No |
| Demographics, medical history | Site EHR / subject chart | Investigator/coordinator | Yes, certified copy of relevant EHR pages | No |
| Vital signs | Paper vitals worksheet | Study nurse | No, original worksheet retained | No |
| Central lab chemistry/hematology | Central lab electronic record / data file into EDC | Central lab analyzer | Lab is source of record | No |
| Local safety labs | Site EHR / printed analyzer report | Local lab | Yes if EHR, certified copy | No |
| ECG | ECG machine printout / vendor portal | ECG device / core lab | Certified copy of tracing | No |
| Investigational product accountability | Drug accountability log (paper or IRT) | Pharmacy | No, original log retained | No |
| Adverse events | Site EHR progress notes + AE worksheet | Investigator | Yes for EHR-sourced AEs | No |
| ePRO diary | ePRO vendor system | Subject | Vendor system is source | Yes |
| Pain score at visit (no prior paper) | Validated eCRF field | Coordinator (entered directly) | n/a | Yes |
| Concomitant medications | EHR medication list + subject report | Coordinator | Yes for EHR portion | No |
eSource designations: the ePRO diary (subject is originator; ePRO vendor system validated under ref VAL-ePRO-2026) and the direct-entry pain score (coordinator originator; EDC validated under ref VAL-EDC-2026).
In this example the two eSource rows are the ones with nothing upstream to source-verify against, so the list flags them explicitly and points to the system validation that replaces transcription SDV. Every other row names an independent source a monitor can compare the eCRF to. A field that appeared in the eCRF but not on this list would be unverifiable data waiting to be cited.
Common findings this matrix prevents
- A CRF field with data but no defined source (“CRF as source by default”), which inspectors call unverifiable data.
- eSource fields never designated, so a monitor tries to source-verify a value with no upstream record.
- Certified-copy needs missed for EHR-sourced data, leaving no defensible source in the trial file.
- An ad hoc, undocumented understanding of what is source, so gaps go unnoticed.
How to adapt this matrix
- Build a sponsor master version from the protocol, then site-specific versions where a site’s EHR or local lab differs.
- Complete and sign it before the first subject and re-issue on any EDC, vendor, or protocol change.
- Give it to every monitor; it is the reference SDV is executed against.
- Cross-check it against the eCRF field list so no field is missing a source.