What is it? Why is it important?
Infrastructure includes both physical structures and logistics. Depending on the study, infrastructures are important aspects that must be carefully evaluated and planned.
Aspects to consider might include:
- Facilities: patient examination rooms, office space, Phase I Unit, public transport, parking, etc.
- Storage space: study documents and materials, biological samples, IMP/IMD
- Laboratory: handling and analysis of biological samples
- Logistic tools: freezers, measuring instruments, computers, printers, defibrillator, etc.
What do I need to do?
As a SP-INV or Site-INV, based on the planned study, define study infrastructure and storage requirements and compare against current local inventory.
Clarify and ensure access to:
- Local infrastructure at planned study site
- Additional premises including blocking of required time slots
- Availability of local storage space
Whether it is an IMP/MD, study documents, or biological material, access control including protection against damage must be guaranteed.
Include required infrastructure in the cost estimate of your study.
The cost estimate should cover required infrastructure from concept until completion. Do not forget the archiving period that will require many years of available storage space.
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 – see in particular
- Suitability and availability of infrastructure
Swiss Exp.Com.Biosafety – see in particular
- Transport of biological material
ICH GCP E6(R2) – see in particular guidelines
- 4.0 Site-INV qualification
- 4.2 Adequate Resources
- 5. SP-INV Responsibilities
ISO 14155:2020 Medical devices – see in particular sections (access liable to costs)
- 9 Responsibilities of the sponsor (SP-INV)
- 10 Responsibilities of the principal investigator (Site-INV)
- 10.3 Qualification of investigation site
ClinO – see in particular articles
- Art. 18 Storage of health related data and biological material
- Art. 45 Data retention
HRO – see in particular article
- Art. 5 Storage of health related data and biological material