Standardised Contract Process in Clinical Studies
This page outlines the contract process and the support available at each stage.
Guidance through the contract process
The contract process in clinical trials involves several steps, from early dialogue to signed agreements and follow-up throughout the study. This page outlines the process and the support available at each stage.
Templates and supporting documents on this page are designed as practical tools for the contract process, including cost calculations and compensation-related matters. They provide guidance but do not replace legal assessment or local procedures.
1. Initial discussion of the study
Discussion of study feasibility and conditions
Parties involved in a clinical trial may include:
- the sponsor, as defined by applicable regulations (for example, a life science company)
- a contract research organisation (CRO)
- a region
- a hospital
- a university
Initial discussions between the parties regarding the conditions for the study are typically held via telephone, email or meetings, such as pre-study visits or site selection visits.
It is important to document agreements made at this stage, as they form the basis for subsequent contract negotiations. Documentation can, for example, be recorded in a document or via email.
Confidentiality agreements (CDA)
When a company acts as sponsor, the principal investigator is sometimes asked to sign a Confidential Disclosure Agreement (CDA) before more detailed information about the study is shared.
However, healthcare organisations are subject to public access and confidentiality legislation, which provides a corresponding level of protection. A signed CDA is therefore generally not required.
If the sponsor nevertheless requires a CDA, the relevant legal function or equivalent should be consulted to review the agreement and clarify who is authorised to sign.
2. Joint decision on the conduct of the study
The sponsor selects which trial sites or clinics will be invited to participate in the study.
Each trial site or clinic then decides whether to participate, based on the conditions discussed.
3. Specification of agreements
At this stage, it is clarified which agreements need to be established and between which parties.
The document Contact information and timelines contract - Clinical Study Agreement docx, 146 kB. is sent by either party and completed by both parties.
The document National details to consider docx, 123 kB. is provided to the company or CRO from the clinic.
The internal agreement template docx, 122 kB. can be used for agreements with internal cooperation partners.
4. The final protocol, agreement and budget will be obtained
Relevant staff review the documents and assess the time required for different parts of the study, as well as whether the conditions agreed at the outset still apply.
5. Costing and contract review
A costing template can be used to assist in the costing process.
For the contract review, there is a checklist with an in-depth section containing more information and useful contract wording in English.
Please note that the templates may look incorrect before editing is activated in Word and Excel.
The costing template and the study agreement checklist can be used as a basis for negotiating the study agreement.
Early in the agreement process, the following should be clarified:
- who will sign the agreement
- when the agreement is to be signed
This is documented in Contact information and timelines – Clinical Study Agreement docx, 146 kB., which helps ensure a smooth and efficient signing process.
To ensure effective follow-up of the agreement during the study, including transparent invoicing records and verification of all reimbursements, a Visit tracker for invoicing xlsx, 97 kB. can be used.
Published: