Set-Up↦Management↦Study Ready for Conduct↦Requirements
What is it? Why is it important?
Clear requirements exist when evaluating whether a study is ready for initiation. Study conduct is initiated once the study can actively start to recruit participants.
Participant recruitment can start when the following criteria are met:
- Study is EC and if applicable also RA approved
- Study is registered
- Contracts with partners/vendors are finalised and signed (e.g. insurance for liability coverage, contract with CRO)
- IMP/MD is labelled and delivered to the study site
- Essential documents are completed and filed
- Additional documents are ready for use (e.g. PIS, ICF, screening log, patient identification log)
What do I need to do?
Check that all aspects needed for study start are fulfilled:
- The site is initiated and prepared for participant recruitment at the SIV
- Upon SIV the SP-INV is able to decide whether the site is ready for study conduct
- In the event outstanding issues remain, participant recruitment should be postponed
- Recruitment can only start when participant safety and the quality of study data can be guaranteed during study conduct
For more information refer to Monitoring and Documents in this Study Guide.
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
External Links
Swissethics – see in particular
- Information on professional qualifications
- List of persons conducting a study
References
ICH-GCP E6(R2) – in particular see guidelines
- 5 Sponsor responsibilities
- 4 Investigator
ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections
- 9 Responsibilities of the sponsor
- 10 Responsibilities of the PI
Swiss Law
HRA – see in particular article
- Art. 10 Scientific requirements
ClinO – see in particular article
- Art. 6 Professional qualifications
HRO – see in particular article
- Art. 4 Professional qualifications