FAQ

What is the difference between a Country Feasibility and a Site Feasibility?

The Country Feasibility answers questions about feasibility, such as whether the study protocol is compatible with Swedish therapy guidelines and whether the patient population is available in Sweden. The questions answered in the Country Feasibility are available here.

Site Feasibility mediates contact between sponsors and clinics/investigators. Clinical Studies Sweden identifies and facilitates contacts to clinicians and investigators with an interest and ability to participate in studies with medicinal products, medical devices or other types of interventions.

What questions do I get answered with a Country Feasibility?

The Country Feasibility, that is sent to leading experts within the therapy area, answers, among other things, whether the study protocol is compatible with Swedish therapy guidelines and whether the patient population is available in Sweden. The experts contacted can also register if they have an interest to participate in the study if it will be conducted in Sweden. All questions answered are available here. There is also a possibility to pose single questions that are not addressed by the standardized questions.

How do I know that the Site Feasibility has been distributed throughout Sweden?

A Site Feasibility can be distributed to investigators/clinics all over Sweden, or in selected healthcare regions. Site Feasibilities are sent to all clinics and investigators that are available within the relevant therapeutic area. The service mediates contact to investigators/clinicians interested in the study and shows which hospitals have declined to participate. However, it is not possible to see who has received the request.

Does it cost anything to use the feasibility service?

The feasibility service is free of charge.

What are the benefits of creating a user account/profile to submit a feasibility request?

Creating a user account gives you access to forms that simplifies the process of feasibility requests. The forms clarify what information you need to contribute in order for the investigator/clinic to be able to respond to the request. All incoming feasibility requests are reviewed by Clinical Studies Sweden before they are sent out and, if necessary, you can provide additional information in the request. The answers are collected to the system, where you get an overview of the answers.

What does the feasibility service entail?

The feasibility service guides what information is needed for investigators/clinics within Swedish healthcare to be able to make a decision about the study.Enquirers can see the contact details of the investigators/clinics that are interested in the study. Enquirers then contact the investigators/clinicians directly, without involving Clinical Studies Sweden.Contact details of investigators/ clinicians who decline to participate in a study are not provided to enquirers. However, the enquirer can see which hospitals/clinics have declined to participate, and the reason for this

How quickly can answers be provided?

Clinical Studies Sweden will check the feasibility request as soon as it has been received. If necessary, Clinical Studies Sweden will contact the enquirer for further information. Clinical Studies Sweden submits requests directly when complete documentation is available and works to ensure that all requests are responded to within the agreed time. In many cases, responses are received within a few days. However, depending on the therapeutic area, it may take longer.

The service is available all year round, but it may be more difficult to get a quick response during long weekends and holiday periods due to limited resources within the healthcare.

Country Feasibilities: if I have my own questionnaire/feed-back form that I want to have completed by investigators, how do I do?

The standardised questions for Country Feasibility are designed to speed up the process. If the standardised questions do not meet the needs of the enquirer, Clinical Studies Sweden will help to make the process run as smoothly as possible. Contact Clinical Studies Sweden to discuss solutions and individual adaptations.

Does Clinical Studies Sweden provide lists with contact details of investigators/clinics?

Contact with clinics/investigators interested in participating in clinical studies within specific therapeutic areas is provided through the Site Feasibility service. Clinical Studies Sweden does not provide contacts to clinics/investigators without their consent.

Can my request be sent to a specific hospital/region?

It is possible to choose which healthcare regions a clinic request should be sent to. Country requests are sent to experts working throughout Sweden.

Published:

Table of Content