This is a ready-to-use transfer-of-obligations matrix, the document inspectors ask for by name and the one sponsors most often cannot produce cleanly. Under 21 CFR 312.52, every sponsor obligation a CRO assumes must be described in writing, and any obligation not covered by the written transfer is deemed not transferred, so it stays with the sponsor. This matrix lists each obligation and marks who holds it, with no blanks. Replace every <<FILL: ...>> placeholder with your own specifics and keep it under version control, reconciled to the contract and work orders. A filled specimen follows. This content is general educational reference, not legal or regulatory advice.
Document control header
| Field | Entry |
|---|---|
| Matrix title | Transfer of Regulated Obligations, <<FILL: study / program>> |
| Document number | <<FILL: e.g. TRO-XYZ-201>> |
| Version | <<FILL: e.g. 1.0>> |
| Effective date | <<FILL: date>> |
| Study / protocol | <<FILL: protocol number>> |
| Sponsor | <<FILL>> |
| Prime CRO | <<FILL>> |
| Named vendors | <<FILL: EDC, IRT, central lab, PV, eTMF, ...>> |
| Reconciled to | <<FILL: master agreement + work order numbers>> |
How to use this matrix
- List every sponsor obligation for the study (from 21 CFR 312.50 and ICH E6, plus study-specific duties).
- For each, mark the holder: Owns (accountable and performs), Performs (does the work under another’s accountability), Oversees (accountable, work done by another), Supports (contributes), or a dash where genuinely not involved.
- There are no rows nobody can claim. A row that is genuinely not transferred is fine; the sponsor owns it. A row with no owner is the finding, because the regulation assigns it to the sponsor anyway.
- Reconcile the matrix against the executed contract and work orders. If the contract and the matrix disagree, one of them is wrong; fix it before an inspector finds the gap.
The matrix
| Sponsor obligation (per 21 CFR 312 / ICH E6) | Sponsor | Prime CRO | Vendor (named) | Notes / where written |
|---|---|---|---|---|
| Protocol design and amendments | <<FILL: Owns>> | <<FILL: Supports>> | <<FILL: ->> | <<FILL: WO ref>> |
| IND maintenance, safety reporting to FDA | <<FILL: Owns>> | <<FILL: ->> | <<FILL: ->> | <<FILL: not transferred>> |
| Investigator selection and qualification | <<FILL: Approves>> | <<FILL: Performs>> | <<FILL: ->> | <<FILL>> |
| Site monitoring | <<FILL: Oversees>> | <<FILL: Owns>> | <<FILL: ->> | <<FILL: per monitoring plan>> |
| EDC provision and validation | <<FILL: Reviews>> | <<FILL: ->> | <<FILL: EDC vendor Owns>> | <<FILL>> |
| Randomization / IRT and drug supply | <<FILL: Approves URS>> | <<FILL: Oversees>> | <<FILL: IRT vendor Performs>> | <<FILL>> |
| SAE collection, assessment, expedited reporting | <<FILL: Owns reporting>> | <<FILL: Collects, reconciles>> | <<FILL: PV vendor Performs>> | <<FILL>> |
| Central laboratory analysis | <<FILL: Oversees>> | <<FILL: Oversees>> | <<FILL: Central lab Performs>> | <<FILL: lab subcontracts storage, flow-down>> |
| TMF / eTMF maintenance | <<FILL: Oversees, owns content>> | <<FILL: Maintains>> | <<FILL: eTMF vendor Hosts>> | <<FILL: sponsor has live access>> |
| Clinical study report | <<FILL: Owns, approves>> | <<FILL: Drafts>> | <<FILL: ->> | <<FILL>> |
| Records retention / archival | <<FILL: Owns>> | <<FILL: Archives during study>> | <<FILL: ->> | <<FILL: return to sponsor at close>> |
<<FILL: add study-specific obligations>> |
Acceptance criteria
- Every obligation has an explicit holder; there are no blank or ambiguous rows.
- Every transferred obligation points to where it is written (contract clause or work order).
- The matrix reconciles with the executed agreement and work orders.
- Subcontracted duties (for example sample storage under a central lab) carry a flow-down note.
- The matrix is version-controlled and re-approved when the contract or scope changes.
References
21 CFR 312.52, Transfer of obligations to a contract research organization. 21 CFR 312.50, General responsibilities of sponsors. ICH E6(R3) Good Clinical Practice, sponsor responsibilities and use of service providers.
Confirm the in-force version for every region the study touches before issue.
Revision history and approvals
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
| Role | Name | Signature | Date |
|---|---|---|---|
| Author | <<FILL>> | ||
| Reviewer (QA / regulatory) | <<FILL>> | ||
| Approver | <<FILL>> |
Filled specimen
Illustrative excerpt for study XYZ-201.
| Sponsor obligation | Sponsor | Prime CRO | Vendor (named) | Notes / where written |
|---|---|---|---|---|
| Protocol design and amendments | Owns | Supports | - | Sponsor signs; CRO drafts operational sections (MSA 3.1) |
| IND maintenance, safety reporting to FDA | Owns | - | - | Not transferred; sponsor regulatory affairs |
| Site monitoring | Oversees | Owns | - | Per monitoring plan (WO-02) |
| EDC provision and validation | Reviews | - | EDC vendor Owns | Sponsor reviews validation summary (WO-05) |
| SAE collection and reporting | Owns FDA reporting | Collects, reconciles | PV vendor Performs | Reporting to FDA stays with sponsor (QA-Agr 6) |
| Central laboratory analysis | Oversees | Oversees | Central lab Performs | Lab subcontracts cryo storage; flow-down required (WO-07) |
| Records retention / archival | Owns | Archives during study | - | Return to sponsor at close (MSA 9) |
Every obligation has an owner and a written home. The central-lab row carries the flow-down note so the subcontracted storage does not fall into a gap. The IND/safety-reporting row is explicitly “not transferred,” which is a valid answer; the invalid answer would be a blank.
Common inspection findings this matrix prevents
- The sponsor cannot produce a written description of which obligations were transferred, so the inspector holds the sponsor responsible for everything and then finds gaps.
- A duty split informally between sponsor and CRO with nobody clearly accountable, so it is done by neither.
- The matrix and the contract disagree, revealing that the written transfer does not match practice.
- A subcontracted obligation (sample storage, translation, a data transfer) that appears nowhere and is overseen by no one.
How to adapt this matrix
- Start from 21 CFR 312.50 and ICH E6 sponsor responsibilities, then add every study-specific obligation.
- Fill every cell; resolve any blank before issue, because the regulation will assign it to the sponsor.
- Point each transferred duty to its contract clause or work order, and reconcile the two.
- Re-approve the matrix whenever scope, vendors, or the contract change. Pair it with the sponsor oversight plan and the article sponsor oversight of CROs and vendors.