If you decide to open a trial through industry, you most likely will need to complete a Confidentiality Disclosure Agreement (CDA) before the sponsor will release the protocol document to you and your staff.
The CDA should always pass through the Office of Grants & Contracts (GCO) to ensure the language is appropriate for the investigator to sign; often, the language requires some level of editing before signature.
The Medical College of Wisconsin maintains a corporate policy Contract Requirements for Sponsored Human Research (RS.GC.040)which is available on the College’s intranet site. If you have access to InfoScope, review this policy by searching for keywords “contract requirements” and select the link to this policy.
A Material Transfer Agreement (MTA) is a written contract between two or more organizations that covers the transfer of tangible research materials. It defines the terms and conditions under which one entity – the provider – is making the material available to the other – the recipient – for the recipient’s research purposes. The purpose of the MTA is to identify and protect any intellectual and other property rights of the provider, while permitting use of the material for a limited and specified research purpose by the recipient. These agreements generally identify the specifics of the material to be transferred, describe the terms and purpose of the exchange, publication rights, liability issues, confidentiality and any intellectual property rights to the material itself as well as any derivatives.
Outbound MTAs: An MTA should be put in place when you will be providing any biological materials (e.g. reagents, cell lines, plasmids, vectors, animals), chemical compounds, equipment or other tangible material to another organization for their research purposes. The MCW Office of Grants & Contracts (GCO) prepares these MTAs upon request of the MCW provider investigator and negotiates terms with the recipient organization. Once the terms are agreed upon, the MCW provider investigator signs the agreement and it is forwarded to GCO to obtain MCW institutional signature. View the MCW MTA Template (DOCX).
Inbound MTAs: An MTA should be put in place when you will be receiving biological or other research materials from another organization. The GCO reviews all inbound MTAs to ensure there are no conflicts with basic academic rights and that there are no unnecessary restrictions to investigators. Potential issues are often found in the areas of confidentiality, publication, use of materials in sponsored research projects, and conflicts with existing agreements. Inbound MTAs are reviewed and processed for MCW institutional signature by the GCO. Investigators and research staff should not sign and return MTAs to material providers themselves.
Material Transfer in Academia – an informative booklet from the Council On Governmental Relations (COGR) about entering into Material Transfer Agreements. (PDF)
NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources – NIH portal for policy and guidance on resource sharing, including Biological Materials Policy.
Review the MCW/VA Joint Appointment Memorandum of Understanding Guidance (PDF) for information on reporting effort for faculty with research effort that hold joint MCW/VA appointments.
Attachment A (PDF)
Attachment B (PDF)
Attachment C (PDF)
Fillable Template (XLSX)
A DUA is a contractual agreement that covers the transfer of non-public, restricted, data. MCW requires a DUA when we provide data that:
- Is HIPAA-protected or constitutes a Limited Data Set (LDS);
- Contains Protected Health Information (PHI);
- Was collected under a sponsored research agreement that limits disclosure of data.
When MCW is the recipient of such data, we defer to the providing organization regarding whether a DUA is required.
When MCW is providing the data, the Office of Grants & Contracts (GCO) prepares the DUA upon request of the MCW provider investigator and negotiates terms with the recipient organization. Once the terms are agreed upon, the MCW provider investigator signs the agreement and it is forwarded to GCO to obtain MCW institutional signature. View the MCW DUA Template (DOCX).