Research Roadmap

Agreements with external parties

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

For some agreements templates are available, but you might need advise from, or sometimes must involve, our Legal Reasearch Department (LRS):

Legal Research Support

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 provide various types of legal services for your research, such as: 

• the review and drafting of (medical) research related agreements;
• general advise concerning legal issues related to (medical) research;

LRS will advise you only on the following agreements:

Clinical Trial Agreements, Consortium Agreements, Data Registry Agreements & Data Sharing Agreements, IP Assignment, Joint Ownership Agreements, License Agreements, Material Transfer Agreements with commercial parties, Research Collaboration Agreements and Study Support Agreements.

Other agreements may be arranged between parties with the provided templates without consulting LRS.

The most common agreement is what is known as the Clinical Trial Agreement (CTA). If you need to set up a CTA, you can make use of the national CCMO models. Different templates are available for investigator intiated trials, industry-sposored trials and for the use with or wthout the VGO. These templates can be filled in by researchers and shared with LRS. Your legal counsel will further assist you.

Please visit the page of Legal Research Support (LRS) whom to contact at lrs@amsterdamumc.nl, the LRS intake form, the signature process of agreements and much more information about LRS support and relevant templates.

Form FDA 1572

Some US sponsors request the local investigator to sign form FDA 1572. Signing form FDA 1572 implicates adherence to the Code of Federal Regulations 21 (CFRs), which is in conflict with EU and national legislation.
The US has no jurisdiction in the Netherlands/European Union, so no form FDA 1572 should be signed. Instead alternative forms must be signed. For more information see the website of the Inspection of Healthcare and Youth (IGJ).

Standard Data Processor Agreement

If specific aspects of the project will be outsourced and the supplier (for example a participating center in a multicenter study) will be given access to data/personal data, then contractual arrangements must be made with the supplier. Amsterdam UMC and the researcher are responsible for maintaining the privacy of the data of the persons involved in research trials, and for ensuring that their details are processed in accordance with GDPR and other government privacy and healthcare regulations.

For questions or to request the latest versions of model contracts, you can contact the department of Privacy & Informatiebeveiliging at privacy@amsterdamumc.nl  or visit the intranet page.

Agreements with internal parties

Agreements with internal parties must also be set out 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 cross the gap between industrial R&D and the clinical development. The IXA team facilitates this by initiating, facilitating and structuring the scientific discussions leading to clearly defined project plans and research contracts. For more information see the website of IXA.

Inducements and side activities

Inducements (in Dutch: gunstbetoon) are about offering money, services or goods for the apparent objective of promoting the sale of a medical device or the prescription of a medicinal product. This is prohibited by law.
The choice of a particular device or medicinal product for the treatment of a patient should not be based on anything other than the patient's health interests. There are exceptions to the ban of inducements. For more information, see the HR website.

Sometimes side activities (in Dutch: nevenwerkzaamheden) is also closely linked to inducements. Therefore, also check this page to see whether the conditions apply to your situation.