A clinical trial data sharing agreement (DUA) governs personal, identifiable, or re-identifiable participant data and must address re-identification bans, data security safeguards, publication rights, and data disposal — none of which a Material Transfer Agreement (MTA), which governs tangible materials like biospecimens or reagents, is built to cover. Vivli’s own Data Use Agreement (DUA) and Data Contributor Agreement (DCA) templates show exactly where that line falls.
A data sharing agreement clinical trial teams sign is not a relabelled MTA. A Data Use Agreement is a contract that defines the permitted purpose, security controls, and disposition of a dataset — particularly one derived from human research participants — whereas an MTA is a contract for the transfer of a physical or digital research material, such as a cell line, reagent, or software tool. Confusing the two during contract negotiation is one of the most common causes of delay in secondary-use clinical research.
- What is a clinical trial data sharing agreement?
- How does a DUA differ from a Material Transfer Agreement?
- What must Vivli’s Data Use Agreement cover beyond an MTA?
- How does Vivli’s Data Contributor Agreement differ from the DUA?
- Common questions on clinical trial data sharing agreements
- Implications for research administrators
What is a clinical trial data sharing agreement?
A clinical trial data sharing agreement, usually called a Data Use Agreement (DUA) or Data Sharing Agreement (DSA), is the written contract that governs how a named recipient may access, analyse, and eventually dispose of a clinical dataset. The UK Health Research Authority defines a DSA as “a written agreement put in place to govern the sharing of personal data between two or more independent data controllers,” used to demonstrate accountability under UK GDPR.
Since 1 January 2019, the International Committee of Medical Journal Editors (ICMJE) has required manuscripts reporting clinical trial results to include a data sharing statement describing whether individual participant data will be shared and on what terms — a policy that pushed data sharing agreements from a niche pharma practice into a routine requirement across academic clinical research.
How does a DUA differ from a Material Transfer Agreement?
An MTA transfers a physical or digital research asset and protects the provider’s intellectual property in that asset. A DUA transfers a dataset — frequently one derived from human participants — and protects the privacy interests of the people the data describes. The two documents solve different legal problems and are not interchangeable.
The table below sets out where the two document types diverge, plus where Vivli’s Data Contributor Agreement (DCA) sits as a third, related-but-distinct instrument.
| Document | Who signs | What it governs | Clauses an MTA typically lacks |
|---|---|---|---|
| Material Transfer Agreement (MTA) | Provider institution and recipient institution | Transfer of a tangible/digital research material (biospecimen, reagent, software) | — |
| Data Use Agreement (DUA) / DSA | Data requestor (and their institution) and data controller/repository | Access to and analysis of a dataset, often participant-level | Re-identification prohibition, security safeguards, IRB/ethics consistency, disposal terms, publication review |
| Data Contributor Agreement (DCA) | Data-contributing institution’s Principal Investigator and the repository | Deposit of a dataset into a repository for future re-use | Contributor warranties on consent scope, anonymisation obligations pre-deposit, ongoing stewardship terms |
What must Vivli’s Data Use Agreement cover beyond an MTA?
Vivli, an independent non-profit clinical data-sharing platform, requires every data requestor to complete data access training and execute a DUA before receiving a data package. Vivli states plainly that its DUA “is the product of extensive negotiation with the organizations that contribute data to Vivli, and as such, the agreement is non-negotiable” — a governance stance an MTA rarely takes, since MTAs are typically negotiated bilaterally per transfer.
Vivli’s DUA process illustrates the additional clauses a data-sharing contract must carry:
- Purpose limitation — the approved Final Research Plan is appended as Exhibit A to the executed DUA, binding use of the data to that specific, reviewed proposal.
- Independent review — requests pass through an administrator check, a data-contributor feasibility check, and an Independent Review Panel or Scientific Committee before the DUA is issued.
- Controlled environment access — rather than transferring a copy of the dataset outright, Vivli grants access inside a secure cloud research environment; under Vivli’s 2025 pricing, a Standard Research Environment carries no charge for 365 days (then $12/day), while a Premium Research Environment carries no charge for 90 days (then $25/day).
- Execution mechanics — the DUA is issued and signed via DocuSign, with Vivli reviewing the completed form before routing it to the institutional signatory, a workflow built specifically around dataset access rather than physical shipment.
None of these mechanisms — purpose-bound exhibits, independent scientific review, environment-based access instead of physical custody, or a non-negotiable master template — are standard features of an MTA, which typically just fixes shipment terms, permitted derivatives, and IP ownership over any resulting invention.
How does Vivli’s Data Contributor Agreement differ from the DUA?
The Data Contributor Agreement (DCA) is the mirror-image document to the DUA: where the DUA governs the requestor receiving data, the DCA governs the institution depositing it. Vivli requires the DCA to be “read, understood and signed by the Principal Investigator” of the contributing study before any dataset is uploaded to the platform.
The distinction matters operationally. The University of California, San Francisco Library reports holding “a signed master Data Contributor Agreement with Vivli,” under which its researchers’ deposits are covered up to a set data volume before additional terms apply — evidence that a DCA is negotiated once, institution-wide, while a DUA is executed per data request. A research administration office that treats the DCA and DUA as the same document risks routing a contributor’s deposit through requestor-side review, or vice versa, causing avoidable delay.
Common questions on clinical trial data sharing agreements
What is the difference between a data use agreement and a material transfer agreement?
A Data Use Agreement governs access to a dataset, typically one derived from human participants, and must address re-identification, security, and disposal. A Material Transfer Agreement governs the transfer of a physical or digital material and focuses on intellectual property and permitted derivatives. The two are not interchangeable substitutes.
Is a Vivli Data Use Agreement negotiable?
No. Vivli states its DUA is non-negotiable, describing it as “the product of extensive negotiation” already conducted with contributing organisations. Individual data requestors sign the standard template as issued, with only the Exhibit A research plan varying per approved request, rather than negotiating bespoke clauses institution by institution.
Who signs a Vivli Data Contributor Agreement?
The Principal Investigator of the contributing study signs the Data Contributor Agreement, alongside their institution where a master agreement is not already in place. This differs from the DUA, which is signed by the data requestor seeking access, making the DCA the deposit-side counterpart to the DUA’s access-side terms.
Does a clinical trial always need a data sharing statement?
Under the ICMJE policy effective from 1 January 2019, trials must register a data sharing statement describing whether individual participant data will be shared as a condition of publication in ICMJE-member journals. The statement does not replace the underlying DUA — it discloses intent; the DUA is the enforceable contract that follows.
Implications for research administrators
Research offices that template their clinical trial contracts around a single generic MTA risk drafting a document that omits mandatory data-protection clauses, then discovering the gap only when a sponsor or repository rejects the paperwork. Building separate templates — one for material transfer, one for data access as requestor, one for data contribution as depositor — mirrors how Vivli, the HRA, and the ICO already structure their own agreements.
As data sharing statements become a routine publication requirement under ICMJE policy, institutions that pre-negotiate master DUA and DCA terms with major repositories, in the way UCSF has done with Vivli, will clear individual data requests faster than those renegotiating contract language on every trial. The practical lesson from Vivli’s model is that a data sharing agreement is not a variant of an MTA — it is a distinct instrument with its own review pathway, execution mechanics, and disposal obligations, and treating it as one is what causes avoidable delay for research administration offices managing multi-site data requests.