Standardised Contracting Process in Clinical Studies
Guidance through the contracting process
Clinical Studies Sweden has developed a standardised step-by-step guide to the contracting process in clinical studies. The guide outlines the different stages of the process and indicates which of our contract templates are appropriate to use at each stage.
1. Discussion on the study conditions
Discussions between the parties usually take place by telephone or in meetings (so-called pre-study visit/ site selection visit). It is important to document agreed terms, for example in a document or e-mail, as these will form the basis for subsequent contract negotiations.
The company (Sponsor) conducting the study often wants the principal investigator (PI) to sign a Confidentiality Disclosure Agreement (CDA) before important information can be disclosed. Please contact your legal department or equivalent to clarify whether you are delegated to sign the confidentiality agreement.
*Party may be, for example, the Sponsor as defined by ICH-GCP (often a pharmaceutical company), contract research organisation (so-called CRO), hospital and/or university.
2. Joint decision on the conduct of the study
The sponsor chooses which sites/clinics will be offered to participate in the study. The site/clinic decides whether it wants to and can participate based on the conditions discussed in step one as well as the information available.
3. Specification of agreements
The Contact information and timelines contract - Clinical Study Agreement
Word, 146 kB. is sent by either party and completed by both parties.
National details to consider Word, 123 kB. is sent to company/CRO from the clinic.
The internal agreement template Word, 122 kB. can be used for agreements with internal cooperation partners.
4. The final protocol, agreement and budget will be obtained
Relevant staff read through and assess the time consumption for various parts of the study, as well as that the conditions agreed at the start 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/Excel.
The costing template and the study agreement checklist can be used as a basis for negotiating the study agreement.
At the start of the agreement process, the persons who will sign the agreement and a target date for when this will happen is documented in Contact information and timelines - Clinical Study Agreement. This is done to facilitate the signing process once the agreement is finalised.
Contact information and timelines – Clinical Study Agreement Word, 146 kB.
To get a good follow-up of the agreement during the study, with transparent invoicing records and checks of all reimbursements, the visit tracker for invoicing can be used.
About the Documents in the Contracting Process
Our templates and support documents are designed to assist with contract drafting and cost calculations in clinical studies. They primarily serve as practical guidance on matters related to compensation but do not claim to provide a comprehensive overview of these issues or the contracting process as a whole. Legal aspects are addressed only in general and overarching terms within these documents.
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