KTA can offer researchers in the Stockholm County Council (SLL) mandate region support and advice in matters concerning the financial and legal aspects of contracts and agreements in the case of industry-sponsored clinical trials.

The Principal Agreement that is drawn up between the hospital and the pharmaceutical company is to describe the type of cooperation and regulate the terms and conditions of financial remuneration. A set of national regulations has been drawn up by SKL (Sweden’s Federation of County Councils) and LIF (the Association of the Swedish Pharmaceutical Industry) governing this type of agreement.

In order to simplify and standardise the process of drawing up agreements and monitoring compliance with them within SLL’s mandate region, KTA has been assigned the task of developing IT support for researchers and business administrators. This includes:
- A costing template for calculating costs prior to entering into an agreement with the company. The cost estimate for KTA’s operations is thus produced in a standardised format and the result can be used in an offer to the company.
- A clinical trials database that can be used for monitoring and evaluating the hospital’s clinical trials operations. The database contains general information about clinical trials, the number of patients, financial data, etc.

Download:
- Clinical Study Agreement
- Agreement (form)
- Specification of resources, additional costs etc. (form)
- National strategy for conducting clinical trials and noninterventional
  studies in Sweden

For more information about the contractual process, please contact

birgitta.strandberg@karolinska.se