What is it? Why is it important?
When planning the implementation of a given study idea, various factors must be considered in order to evaluate whether the idea can be implemented in a research setting.
Study feasibility is a process with the aim to evaluate the possibility of conducting a study (e.g. at a particular study site).
The SP-INV must be able to guarantee adequate financial resources needed to cover all study costs from start until completion. A financial guarantee must be provided prior to study start and during the concept phase of the study.
The objective is to guarantee the successful implementation and completion of a study, with respect to study safety, data quality, planned timelines, and budget. In this respect, the feasibility questionnaire becomes an important tool in ensuring successful project planning.
In the event of a multi-centre study, the SP-INV is responsible to perform feasibility checks at each participating study site. In addition, the feasibility of added costs and resources due to their participation in the study must be evaluated.
Feasibility checks can be outsourced to a CRO or CTU, but main responsibility and decision whether a site is suitable to participate in a study remains with the SP-INV.
What do I need to do?
Based on the complexity of your study design outline feasibility checks that evaluate:
- Access to an adequate number of study participants needed to answer the study question(s) within an acceptable timeframe
- The ability to perform planned medical examinations (e.g. access to analytical device(s), provision of infrastructure, staff expertise)
- The qualification of site staff
- Provision of additional time needed for study management
- Infrastructure requirements (e.g. offices, patient rooms, storage facilities, labs)
- Access to potential partners needed for study conduct (e.g. internal and external)
- Access to additional study sites qualified for study participation
- Access to funds and resources needed to complete the study
Based on study requirements:
- Draft a realistic financial study budget
- Seek and obtain guarantees from partners able to financially support and cover study costs
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