What is it? Why is it important?
Infrastructure includes both physical structures and logistics. Depending on the study, infrastructures are important contributing factors to the successful implementation of a study and must be carefully evaluated and planned.
Aspects to consider might include:
- Facilities: patient examination rooms, office space, storage and archiving facilities, a phase I unit, pharmacy, access to public transport, parking space, suitable facilities for disabled study participants etc.
- Storage means: access protected storage means for study documents, biological material (e.g. freezers), IMP/IMD, additional study material
- Laboratory: handling and analysis of biological material (e.g. centrifuge, analytical tools)
- Logistic tools: computers, printers, IT support, safety equipment such as defibrillator, transport logistics (e.g. communication, study material, biological material)
What do I need to do?
Clarify and ensure access to:
- Logistics equipment and support needed for study conduct
- Additional premises including blocking of required time slots (e.g. patient examination facilities)
- Adequate local storage facilities that are access protected and if needed temperature controlled
- Local infrastructure at planned participating study site (e.g. multi-centre study)
Irrespective of whether it concerns study IMP/MD, study documents/materials, or biological material, ensure ongoing access control, and protection against loss or destruction.
Include required infrastructure in the cost estimate of your study. The budget 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