The healthcare regions in Denmark have formed a legal network within Trial Nation to ensure that the regions act as a united negotiation party for contract templates in relation to the industry.

The network provides efficient negotiation of contract templates (for CDAs, CTAs and Clinical Investigations) relating to clinical trials and investigations in Denmark. Contract templates can be used as they are or be tailored to your company. Consider using the standard templates below for the fastest possible processing time as they are pre-approved in all regions and no negotiation time is needed. Please note that the Trial Nation network only negotiate contract templates, individual contracts are handled in each region. Please also note that the Trial Nation network does not provide general legal advice.

Confidentiality Undertaking for a Clinical trial

Standard Clinical Trial Agreement

Standard Clinical Investigation Agreement – Medical Devices

Study Start-Up Agreement

CRO- Standard Clinical Trial Agreement

Standard Letter of Indemnification

How to Guide – Contract Negotiation Process

You can contact us regarding a company specific contract template (CDA/CTA/Clinical Investigation) negotiation request at legal@trialnation.dk

Companies with contract templates for industry initiated clinical trials.

Please note that there is not a specific template requirement, however there are minimum requirements that must be included.

Minimum requirements to contractual amendments:

• Contract identifier for the amended contract
• Parties (same as in the original contract)
• Amended information (depending on the extent of changes this can be described as ”changed from… to” or described as what section is substituted).
• Signatories (same as in the original contract)

Furthermore, it may be helpful having a sequence number on the amendments if the clinical trial has a long duration and therefore may be more prone to a need for amendments.

Trial Nation have, together with The Danish health regions, Aalborg University and seven life science companies, delivered the Innovation Fund project PACT (Decentralised Patient-Centred Clinical Trials). As part of this work, we have developed the templates and guidelines below to support project staff at Danish hospitals. They are also a practical resource for collaboration with life science companies, helping to strengthen partnerships and enable smoother trial execution.

The templates and guidelines have been developed by representatives from all five regions, drawing on broad expertise across GCP, clinical research units and research support. Together, they form a solid, quality-assured foundation, and implementation across Danish hospital departments is recommended.

QC statement – Compliance with IVDR (EU 2017/746) in Danish Clinical Trials conducted
according to CTR (EU 536/2014).

Guidelines on using the statement –  QC Statement – Compliance with IVDR (EU 2017/746) in Danish Clinical Trials conducted according to CTR (EU 536/2014).

SOP Monitoring of clinical trials

The templates are intended as dynamic documents and should be adjusted by each department before local implementation.

Curriculum Vitae (CV) and GCP certificate (in English)

Job description – project bioanalyst (in Danish)

Job description – project nurse (in Danish)

Job description – project nurse (in English)

Guide to starting up clinical trials (in Danish)

Local collaboration agreement (in Danish)

Decentralised Clinical Trials in Denmark – one-pager, which covers our capabilities in digitalisation and decentralisation, and the national strategic focus on DCTs. The folder is developed under the PACT project.

Report; Experiences with decentralised recruitment methods – with a focus on the perspective from trial participants

Patient Recruitment – Effective recruitment is key to successful clinical trials. Denmark offers a strong foundation: high public trust and a positive attitude towards participation. Download our English overview of proven recruitment methods here. For the full guide, visit our Danish website.