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.