What is it? Why is it important?
The feasibility questionnaire asks a set of relevant questions that evaluates whether study implementation and conduct is possible and manageable.
Topics to be addressed are:
- Feedback on the scientific interest of the study
- Feasibility of study design (e.g. blinded, randomised, control group)
- Study management issues (e.g. data handling, site coordination, infrastructure, IMP/MD availability)
- Readiness of participant study site(s) (e.g. resources, infrastructure, know-how)
- Estimation of potential participant recruitment
- Anticipate regulatory requirements, timelines and budget
The feasibility questionnaire ensures that all aspects pertaining to the successful implementation and conduct of a study are addressed.
Some aspects might require that questions become rather detailed.
If study participants are asked to complete questionnaires online:
- Do participants have access to a personal e-mail address?
- Are participants familiar with logins, downloading and forwarding of documents?
- Are e-mail addresses compatible allowing accesses to study documents?
- How are data protection issues handled?
- How is trouble shooting managed?
- How is the data merged with the main database?
- How is data import validated?
What do I need to do?
Based on the planned set-up of your study:
- Define study relevant feasibility questions
- Leave space for the Site-INV to include questions, comments and suggestions
- Add a section that allows for experiences and lessons learned from previous studies
Writing a feasibility questionnaire can be quite challenging as not all eventualities are predictable. Some aspects might only become apparent during study conduct.
Taking time to assess feasibility is an important investment as it avoids problems that potentially could occur.
Problem management during study implementation and conduct will delay the study and most likely require additional resources and funding.
When writing the feasibility questionnaire:
- Use easy language that is well understood by readers
- Allow enough space for answers
- Give a reasonable deadline for answering all questions
- Collect and analyse all answers in order to decide on how to proceed
- The Site-INV completes all feasibility questions
- As applicable, add personal comments, suggestions and questions
- Give feedback within the deadline given by the SP-INV
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 5.0 for Quality management