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 to start. A study is ready for study-initiation once a study site(s) fulfils all requirements needed for participant recruitment.
Participant recruitment can start when, based on a Site Initiation Visit, the following criteria are met:
- The study is Ethics Committee (EC) and if applicable also RA (e.g. Swissmedic, international) approved
- The study is registered
- Contracts with partners are finalised and signed (e.g. insurance for liability coverage, contract with CRO)
- The study`s investigational product (IMP / IMD) is labelled, delivered, and correctly stored at the study site
- The study database is validated and ready for data entry
- Essential documents are completed and filed in the TMF/ISF
- Documents needed for participant recruitment are ready for use (e.g. PIS, ICF, ICF-process, participant screening- and identification-log)
- The Site-INV and additional study staff are trained and the delegation of study tasks is defined (e.g. study staff delegation-log)
What do I need to do?
As a Site-INV, check that all aspects needed for study start are fulfilled:
- The site is initiated and prepared for participant recruitment (e.g. based on a study Site-Initiation-Visit (SIV) organised and coordinated by the SP-INV of the study)
- Upon SIV, the SP-INV can decide whether the site is ready for study conduct. In the event important outstanding issues remain, participant recruitment should be postponed
- Participant recruitment can only start when participant safety and the quality of study data can be guaranteed
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External Links
Swissethics – see in particular
- Information on professional qualifications
- List of persons conducting a study
References
ICH-GCP E6(R3) – in particular see guidelines
- 2.3 Investigator responsibilities
- 3. Sponsor responsibilities
- Appendix C. Essential documents for the conduct of a clinical trial
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
ClinO-MD – see in particular
- Art. 5 Professional qualifications
HRO – see in particular article
- Art. 4 Professional qualifications