Agreement and budget
Agreement and budget in clinical studies
When conducting of clinical studies, the contracting process is a key issue and important to clarify the conditions, rights and obligations of all parties involved. The contracting process can be complicated, especially when several parties are involved and if the parties are from different countries. Regulatory requirements are high, as are demands for a fast contracting process and awareness of cost efficiency and cost recovery.
Clinical Studies Sweden has developed templates and supporting documents to facilitate and shorten the contracting process for researchers, clinics and the industry. In the long term, it is hoped that the support will facilitate and promote the possibility of conducting studies and thus increase the number of clinical studies conducted in Sweden.
Calculation of study budget
Clinical Studies Sweden provides support for cost calculations and has developed templates and tools that can be used to facilitate calculations prior to study start.
Contract review
Clinical Studies Sweden has developed useful tools and processes to facilitate the contracting process in clinical studies and can also assist with the review.
Standardised contracting process for clinical studies
The contracting process is important when conducting clinical studies. It clarifies the conditions, rights and obligations of all involved parties. A standardised contracting process allows for:
- Facilitating the cost calculations
- Cutting down the negotiation time
- Collecting the relevant information
Templates and tools from Clinical Studies Sweden are developed from the perspective of the clinic/site. However, clarity and transparency in the contracting process benefits both parties signing contracts. The tools are adapted for contracts in industry-sponsored studies with medicinal products. However, they can be applied in full or in part to other types of study contracts.
1. Discussion between the parties 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 is sent by either party and completed by both parties.
National details to consider is sent to company/CRO from the clinic.
The internal agreement template 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.
- Costing template
- Study agreement checklist (with in-depth information)
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.
- Costing template
- Study agreement checklist (with in-depth information)
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
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.
Visit tracker for invoicing
The documents are designed to support contracting and costing in clinical studies. They mainly provide practical guidance on compensation issues, but do not claim to provide a complete picture of either of these issues or the contracting process in general. The legal issues are only touched upon in a general way in these documents.
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