Development↦Management↦Study Management↦Infratructure and Maintenance
Was betrifft es? Warum ist das wichtig?
Infrastructures include both physical structures and logistics. Both are 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/IMD including temperature and access control
- Laboratory: handling and analysis of biological material (e.g. sample workflow)
- Logistic tools: transportation systems, freezers, measuring instruments, computers, printers, defibrillator
- Communication network: methods used to facilitate communication within a team, and with partners
Inventory management:
- Refers to the ongoing maintenance of study infrastructure during study conduct. It is an integral part of study Quality Assurance aimed at securing data quality
- Includes ongoing risk assessment with the implementation of applicable risk- control measures
Was muss ich befolgen?
As a SP-INV and Site-INV, define for your study:
- The study 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/IMD 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/IMD, study material)
Stored study material (e.g. IMP/IMD, biological material, archived study 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/IMD 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 (e.g. logs) during storage?
Wo kann ich Hilfe anfordern?
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
External Links
Swissethics – in particular see
- Suitability and availability of infrastructure