Early Feedback Form

What is the Early Feedback Form?

The Early Feedback Form is the questionnaire completed by experts in a Country Feasibility request. The questions form the basis for the overall assessment of whether a clinical study can be conducted in Sweden.

The questions cover areas such as patient population, recruitment opportunities, Swedish standard of care and the types of clinics that may be relevant if the study is allocated to Sweden.

How the questionnaire works

Most questions have predefined response options, with the possibility to add comments. You may also add individual questions if needed.

For experts to provide relevant feedback, the Country Feasibility request needs to include clear information about the study. If available, please attach a protocol synopsis or equivalent study information.

Additional questions and questionnaires

Company-specific questionnaires should not be attached to the Country Feasibility request. The standardised questions are designed to make the process faster, easier to handle and more comparable.

More detailed or company-specific questions can instead be handled at a later stage with investigators or clinics that have expressed interest in the study.

Questions in the Early Feedback Form

Below are the questions and response options included in the form.

1. Is the patient population present in Sweden?

• Yes
• No
• Unknown

Comments

2. What are the chances of recruiting the desired number of patients?

• Very Good
• Good
• Small

3. What factors limit the chances of recruiting patients to the study (if any)?

• Competing studies
• Exclusion criteria¨
• No factors
• Other reasons (comment)

4. Are there any factors that may discourage patients from participating?

• Yes
• No
• Unknown

Comments

5. Is the study compatible with standard of care in Sweden?

• Yes
• No
• Unknown

6. Describe the normal care setting for the patients in this study

Free text

7. Do you have any recommendations or comments on challenges such as study design, feasibility or ethics?

Free text

8. What type of sites/clinics would be able to participate?

Multiple choice question

• Sites that are new to commercial research
• Well established research centres
• Sites with a specific patient population
• Sites with specific expertise
• Sites specialised in early phase studies
• Primary care centres
• Other (comment)

9. Do you anticipate large interest by investigators if the study is allocated to Sweden?

• Yes
• No
• Unknown