What is it? Why is it important?
Depending on their roles and responsibilities study team members can give important feedback regarding the feasibility of a study.
- Study design: such as resources, definition of work flow and processes, time investment, know-how, availability of study participants
- Infrastructure: such as equipment, labs, access, storage space both for samples and Documents, patient room availability
- Experience: such as lessons learned from previous studies
SP-INV makes final decision regarding study feasibility and whether to implement a study as planned.
Any QMS measures required for study set-up and implementation only start after the study is deemed feasible (e.g. study required SOPs / WIs / processes, extent of study monitoring / data management).
What do I need to do?
As a study team member and based on delegated tasks:
- Carefully read the protocol and if applicable the IB
- Provide comments or address open issues with a problem solving approach
- Provide suggestions with potential improvements to processes related to their tasks
- Assess and provide comments on the feasibility questionnaire(s), and inform the Site-INV or SP-INV of any potential risks or issues identified during the feasibility assessment
- As a Site-INV forward the feasibility assessment to the SP-INV within deadline
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 Quality management
ISO 31000 – see in particular section
- Risk management: Principles and guidelines (access liable to costs)