Legal Agreement Templates

Contractual Framework for Multi-Center Projects

Research projects sharing sensitive personal health data between institutions require a legal agreement. SPHN offers a nationally harmonized contractual framework with a series of templates for legal agreements adaptable to various collaboration setups. These agreements define key principles of the collaboration (data use, ownership, publications, intellectual property and liability) and outline the rights, obligations and responsibilities of all parties involved (e.g. Investigator, Data Provider, Data Recipient, Processor, etc.). The relevant terms used are explained in the SPHN Glossary.

Legal Agreement Templates - a strong foundation for collaborations

The SPHN legal agreement templates, refined through eight years of experience with complex, multi-institutional projects, provide a strong foundation for collaborations. Incorporating insights from the SPHN National Data Streams projects (NDS) and the Data Governance Working Group (DGWG), these templates address key legal considerations, providing a national harmonization of several key issues related to nation-wide data sharing. While tailored for Switzerland, they can also serve as a basis to set up legal frameworks in international collaborations.  

Download Legal Agreement Templates

Multi-center research projects typically require a Consortium Agreement integrating a Data Transfer and Use Agreement (DTUA) and Data Transfer and Processing Agreement (DTPA). Further templates listed below offer options for specific configurations.

Consortium Agreement + DTUA + DTPA - new version

Specifies the parties’ collaboration, their rights and obligations according to project plan and funding decision
Describes governance structure between project leader, sponsor, investigators and defines executive and scientific board
Regulates financial conditions, confidentiality, intellectual property, publications, exit and further warranties
Reflects the agreement between the parties regarding the terms governing the processing, security and sharing of data under the Consortium Agreement
Describes terms and conditions for providing data by the provider, who is the controller of the data, to recipient, who wishes to conduct the research project. It specifies:
- - Multi-node: Data provision defined in the DTPA with more than one BioMedIT node
  - Single-node: Data provision defined in the DTPA with one BioMedIT node
  - Data processing
  - Liability and third party rights
  - Miscellaneous items, such as force majeure
  - Security requirements for recipient and external processor ensuring appropriate confidentiality, integrity, availability and resilience of the systems with regard to processing of the data.

Consortium Agreement (CA)

DTUA + DTPA

Describes terms and conditions for providing data by the provider, who is the controller of the data, to recipient, who wishes to conduct the research project. It specifies:

Multi-node: Data provision defined in the DTPA with more than one BioMedIT node
Single-node: Data provision defined in the DTPA with one BioMedIT node
Data processing
Liability and third party rights
Miscellaneous items, such as force majeure
Security requirements for recipient and external processor ensuring appropriate confidentiality, integrity, availability and resilience of the systems with regard to processing of the data.

Download Template:

Multi-Node Single-Node

DTPA

DTUA without an external processor

Describes terms and conditions for providing data by the provider, who is the controller of the data, to recipient, who wishes to conduct the research project. It specifies:

Transfer and access rules for data
Liability and third party rights
Miscellaneous items, such as force majeure
Security requirements for recipient ensuring appropriate confidentiality, integrity, availability and resilience of the systems with regard to processing of the data.

Download Template

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Legal Agreement Templates

Contractual Framework for Multi-Center Projects

Legal Agreement Templates - a strong foundation for collaborations

Download Legal Agreement Templates

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