What is it? Why is it important?
Infrastructures include both physical structures and logistics required for the successful implementation of a study.
This might include:
- Facilities: patient examination room / office space / Phase I Unit / parking
- Storage: study material / biological material / IMP/MD including temperature and access control
- Laboratory: handling and analysis of biological material
- Logistic tools: freezers, measuring instruments, computers, printers, defibrillator
What do I need to do?
For your study, define:
- Required infrastructure
- Maintenance requirements in order to guarantee faultless functioning of study equipment (e.g. freezers, analytical equipment, computers)
Provide or write relevant:
- SOPs or WIs for handling of study equipment (e.g. IMP/MD storage, utilisation of analytical or other study material, processing of biological material)
- Documents for inventory / traceability checks from arrival, retrieval until destruction (e.g. IMP/MD, study material)
Stored study material (e.g. IMP/MD, biological material, archived documents) must be monitored on an ongoing basis to ensure proper storage conditions. Processes and emergency procedures should be in place.
Example Freezer break-down
- Is there a reserve freezer in place?
- What redistribution procedures must be followed?
- How is the beak-down event and any material redistribution documented?
- How is study staff informed?
Example IMP/MD handling
- Are there inventory / traceability logs in place?
- How is access control monitored?
- How is temperature monitored during transport, stock transfer, and shipment?
- How is temperature monitored during storage?
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
Swissethics – in particular see
- Suitability and availability of infrastructure