Agreements with internal and external parties

  • WMO
  • Non-WMO

Agreements with external parties

If an external party is involved in a research project, agreements must be documented in a written contract. Depending on the type of research, this could be a Clinical Trial Agreement, Site Agreement, Research Collaboration Agreement, Consortium Agreement, Material Transfer Agreement or Data Transfer/Sharing Agreement.

Templates are available for some agreements, but in certain cases, you may need advice from - or be required to involve - our Legal Research Department (LRS).

Legal Research Support (LRS) provides support on legal issues regarding (medical) research, including clinical trials, pre-clinical lab research, intellectual property, privacy, and EU projects.

They offer various legal services for your research, such as: 

  • Reviewing and drafting of (medical) research-related agreements;
  • Providing general legal advice on (medical) research matters.

LRS provides legal advice only for the following agreements: Clinical Trial Agreements, Consortium Agreements, Data Registry Agreements & Data Sharing Agreements, IP Assignment Agreements, Joint Ownership Agreements, License Agreements, Material Transfer Agreements with commercial parties, Research Collaboration Agreements and Study Support Agreements.

For other types of agreements, templates are available, and parties can finalize them without consulting LRS.

The most common agreement is the Clinical Trial Agreement (CTA). If you need to draft a CTA, you can use the national CCMO models. Different templates are available for research subject to the WMO, CTR, MDR and IVDR, as well as investigator initiated studies, industry-sponsored studies and for the use with or without the VGO. LRS will assist you with the drafting, review and negotiation of those CTA's.

For more information about LRS including whom to contact, the LRS intake form, the signature process of agreements, and relevant templates, visit the LRS website or contact lrs@amsterdamumc.nl.

FDA Form 1572

Some U.S. sponsors request the local investigator to sign form FDA Form 1572. However, signing this implies adherence to Title 21 of the Code of Federal Regulations (CFRs), which is in conflict with European Union (EU) and national legislation. Since the U.S. has no jurisdiction in the Netherlands or the EU, FDA Form 1572 should not be signed. Instead, alternative forms must be used.
For more information, visit the website of the Inspection of Healthcare and Youth (IGJ).

Standard Data Processing Agreement

If specific aspects of a research project will be outsourced and the supplier (for example a participating center in a multicenter study) is given access to (personal) data, a contractual agreement must be established with the supplier.

Both Amsterdam UMC and the researcher are responsible for safeguarding the privacy of individuals involved in research and ensuring that their (personal) data is processed in compliance with the General Data Protection Regulation (GDPR/AVG) and other applicable privacy and healthcare regulations.

For questions or to request the latest versions of model contracts, please contact the department of Privacy Protection and Information Security (in Dutch: Privacybescherming en Informatiebeveiliging, PB&IB) via the Service Portal: navigate to the ‘Contact & Meldingen – Iets melden’ tab and click the button ‘Privacy Vragen’.
More information is also available on their intranet page.

Agreements with internal parties

Agreements with internal parties must also be documented in writing. If these agreements are not covered by a written quotation, you can use the Template for Agreements with Facilitating Department.

Industry collaborations

Here we bridge the gap between industrial R&D and clinical development. The IXA team supports this process by initiating, facilitating and structuring scientific discussions, leading to clearly defined project plans and research contracts.
For more information, visit the website of IXA.

Inducements and side activities

Inducements (in Dutch: gunstbetoon) refer to offering money, services or goods with the apparent aim of promoting the sale of a medical device or the prescription of a medicinal product. This practice is prohibited by law.
The selection of a particular medical device or medicinal product for patient treatment should be based solely on the patient's health interests. However, there are exceptions to the ban on inducements. For more information, visit the HR website.

In some cases, side activities (in Dutch: nevenwerkzaamheden) may also be closely linked to inducements. Therefore, we recommend to check this page to determine whether specific conditions apply to your situation.