This is a ready-to-use study TMF Index, the actual tailored expected-document list a reference-model-based reconciliation process needs, not just the plan for how to build one. The TMF Management Plan describes the tailoring steps; this matrix is the artifact those steps produce, and it is the denominator every completeness metric in the article and its companion metrics report is measured against. Replace every <<FILL: ...>> placeholder with your own specifics, and add or remove rows to match your actual reference-model artifact list. This is general guidance to adapt, not legal or regulatory advice.
Document control header
| Field | Entry |
|---|---|
| Document ID | <<FILL: e.g. TMF-INDEX-001>> |
| Study / protocol | <<FILL>> |
| Reference model and version | <<FILL: e.g. CDISC/DIA TMF Reference Model v3.x>> |
| Owner | <<FILL: TMF Lead>> |
| Effective date | <<FILL>> |
1. How to read this matrix
Each row is one artifact from the reference model, tailored to this study. Expected level states whether one instance is expected at trial, country, or site level, which is what turns “expected documents” into an actual denominator per site or per country rather than a single trial-wide guess. Timeliness target states the number of business days from the trigger event to the file date; leave the column blank only where the TMF Plan defers to a routine, undated tier. Included is No only where the artifact genuinely does not apply to this study design, with the rationale stated, never a silent removal.
2. Tailoring decisions applied to this study
| Step | Decision | Rationale |
|---|---|---|
| Zones excluded | <<FILL: e.g. none, or Central and Local Testing (no central lab)>> | <<FILL>> |
| Artifacts added beyond the base model | <<FILL: e.g. eConsent validation summary, wearable data transfer agreement>> | <<FILL: study design driving the addition>> |
| Artifacts excluded from the base model | <<FILL: e.g. none>> | <<FILL>> |
3. Study TMF Index
| Zone | Section | Artifact | Core / Recommended | Expected level | Owner | Timeliness target (business days from trigger) | Included |
|---|---|---|---|---|---|---|---|
| Central Trial Documents | Protocol | Protocol and amendments (signed) | Core | Trial | <<FILL>> | <<FILL: e.g. 3>> | Yes |
| Central Trial Documents | Investigator’s Brochure | IB and updates | Core | Trial | <<FILL>> | <<FILL>> | Yes |
| IRB/IEC and Approvals | Informed Consent | Blank ICF, each version/language | Core | Site / country | <<FILL>> | <<FILL>> | Yes |
| IRB/IEC and Approvals | IRB/IEC Approval | IRB/IEC approval and composition | Core | Site | <<FILL>> | <<FILL>> | Yes |
| Regulatory | Regulatory Authority | Regulatory approval / IND safety acknowledgements | Core | Country | <<FILL>> | <<FILL>> | Yes |
| Site Management | Site Selection | Statement of Investigator (Form FDA 1572, or regional equivalent) | Core | Site | <<FILL>> | <<FILL>> | <<FILL: Yes/No, region-dependent>> |
| Site Management | Site Selection | Financial disclosure | Core | Site | <<FILL>> | <<FILL>> | Yes |
| Site Management | Site Set-Up | Signed clinical trial agreement / budget | Core | Site | <<FILL>> | <<FILL>> | Yes |
| Site Management | Site Management | Delegation of Authority Log | Core | Site | <<FILL>> | <<FILL>> | Yes |
| Site Management | Site Set-Up | CVs and licenses, investigators/sub-Is | Core | Site | <<FILL>> | <<FILL>> | Yes |
| Central and Local Testing | Lab Administration | Lab certifications, normal ranges, accreditation | Core | Site / central | <<FILL>> | <<FILL>> | <<FILL>> |
| Trial Management | Monitoring | Monitoring plan | Core | Trial | <<FILL>> | <<FILL>> | Yes |
| Site Management | Site Management | Monitoring visit reports | Core | Site | <<FILL>> | <<FILL>> | Yes |
| IP and Trial Supplies | Product Accountability | IP shipment, accountability, temperature records | Core | Site | <<FILL>> | <<FILL>> | Yes |
| Safety Reporting | Safety Reporting | SAE / SUSAR reports | Core | Trial / site | <<FILL>> | <<FILL>> | Yes |
| Safety Reporting | Safety Reporting | DSUR | Core | Trial | <<FILL>> | <<FILL>> | Yes |
| Data Management | Data Management Plan | Sample CRF / data management plan | Core | Trial | <<FILL>> | <<FILL>> | Yes |
| Statistics | Randomization | Randomization and unblinding records | Core | Trial / site | <<FILL>> | <<FILL>> | Yes |
| Trial Management | Trial Closure | Trial close-out report and final reconciliation | Core | Site / trial | <<FILL>> | <<FILL>> | Yes |
| Statistics | Statistical Analysis | Statistical analysis plan and final CSR | Core | Trial | <<FILL>> | <<FILL>> | Yes |
<<FILL: study-specific addition, e.g. Data Management>> | <<FILL: e.g. Computerized Systems>> | <<FILL: e.g. eConsent system validation summary and Part 11 assessment>> | <<FILL: Core/Recommended>> | <<FILL: Trial>> | <<FILL>> | <<FILL>> | Yes |
<<FILL: study-specific addition>> | <<FILL>> | <<FILL: e.g. wearable device data transfer agreement>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | Yes |
<<FILL: add remaining artifacts from your reference-model version>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
4. Excluded artifacts and rationale
Every artifact removed from the base reference model is listed here with its rationale, so an inspector or a new CRO reading this matrix sees a documented decision, not a silent gap.
| Zone / artifact excluded | Rationale |
|---|---|
<<FILL: e.g. Central and Local Testing / Central Lab Certification>> | <<FILL: e.g. study uses only local labs; see Central and Local Testing / Local Lab Certification row instead>> |
5. Acceptance criteria for this matrix
A reviewer who has never seen the study can, for any document type, tell whether it applies, at what level it is expected, who owns it, and how quickly it should be filed after the trigger event. Every exclusion carries a stated rationale. The matrix, not an out-of-box reference-model export, is what the eTMF’s expected-document configuration is loaded against, and it is the denominator the completeness metrics in the TMF metrics document are calculated from.
6. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
7. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (TMF Lead) | <<FILL>> | ||
| Reviewer (Clinical QA) | <<FILL>> |
Filled specimen
The following shows three rows completed for an illustrative Phase 2 decentralized trial with eConsent and a wearable device, tailored from the base reference model per the worked example in the companion article. Numbers and owners are illustrative.
| Zone | Section | Artifact | Expected level | Owner | Timeliness target | Included |
|---|---|---|---|---|---|---|
| IRB/IEC and Approvals | Informed Consent | Blank ICF, each version/language | Site / country | TMF Coordinator | 3 business days from IRB approval | Yes |
| Data Management | Computerized Systems | eConsent system validation summary and Part 11 assessment | Trial | Clinical Systems Lead | 10 business days from validation sign-off | Yes |
| Third Parties | Vendor Oversight | Home-nursing vendor qualification, contract, and training records | Per vendor | TMF Coordinator | 10 business days from qualification completion | Yes |
Excluded artifact (specimen): Central and Local Testing / Central Lab Certification, rationale: study uses only local site labs, see the Site Management / Lab certifications row instead.
Common inspection findings this matrix prevents
- No documented expected-document list, so completeness has no defensible denominator.
- Artifacts silently dropped from the reference model with no rationale, discovered only when an inspector asks why one is missing.
- Study-specific artifacts, such as eConsent validation or vendor oversight for a decentralized design, never added to the index, so they are never tracked or QC’d.
- Timeliness targets that exist only informally, never tied to a specific artifact row, making late filing hard to prove or disprove.
- An eTMF left on an out-of-box expected list that does not match what was actually tailored for the study.
How to adapt this matrix
- Replace the illustrative rows in section 3 with the full artifact list from your actual reference-model version; this specimen shows the pattern, not a complete list.
- Set the expected level and timeliness target for every row from your TMF Management Plan, not from this template’s placeholders.
- Add every study-specific artifact your design requires (decentralized elements, novel modalities, combination-product components) with the same level of detail as the base rows.
- Load this matrix into the eTMF as the expected-document configuration so completeness metrics are calculated against it directly, and re-version it whenever the reference-model version or the study design changes.