Concept↦Quality and Risk↦Study Feasibility↦Feasibility Questionnaire
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. It 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.
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/IMD availability)
- Readiness of participant study site(s) (e.g. resources, infrastructure, staff expertise and training, adequate time available to conduct the study)
- Access to target participants at particpating study sites
- Anticipate regulatory requirements (e.g. EC, Swissmedic, FOPH), timelines and budget
Questions to address in a study where 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?
As a SP-INV, 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 later. 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 a clear and 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
As a Site-INV:
- Ensure to completes all feasibility questions
- As applicable, add personal comments, suggestions and questions
- Return the feedback questionnaire 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, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 5.0 for Quality management