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Simplified agreement process

The aim is to facilitate and shorten the agreement process for researchers, clinics and industry by creating a standardised agreement process (prerequisites, rights and obligations of all parties involved) and in this way shorten the start-up period for studies.

Background

The prerequisites, rights and obligations of all parties involves are central issues in clinical studies. There is a need to facilitate and simplify matters for researchers, clinics and industry by creating a standardised contracting process and in this way shorten the start-up period for studies.

Goals

The goal is to create a simplified agreement process that can be used by the parties involved in contracting processes for clinical studies. The long-term goal is to make it easier to carry out clinical studies, and in this way increase the number of studies carried out in Sweden.

The project shall develop:

  • a template for a process document with time plans and contact persons
  • a checklist with items to be included in contracts
  • general recommendations and useful contract texts for negotiating and drawing up contracts
  • proposals for internal contracts to be used when clinics collaborate
  • a national tool for calculating costs based on time

Time plan

The project started in Q1 2016 and is expected to conclude by Q2 2017.

Revision of the simplified agreement process

In the spring of 2021, a complementary initiative was underway. The initiative aimed to inventory, quality assure and update templates and documents from previous development initiative "Standardized process for agreements between sponsors and principals".