Monitoring

Monitoring

A guidance document and a template for writing a monitoring plan is available on the website of the Swiss Clinical Trial Organisation (SCTO) (Link)

Recruitment of study participants

Checklist for the recruitment of study participants by means of advertising
Deutsch
8
updated: 24.11.2013
Français
8
updated: 24.11.2013
Italiano
n/a
updated: 24.11.2013
English
8
updated: 24.11.2013
Specimen text for advertisement
Deutsch
n/a
updated: 31.12.2013
Français
n/a
updated: 31.12.2013
English
n/a
updated: 31.12.2013

Other templates and documents

Staff list

Note: The ‘Staff list’ should be used in accordance with the Ordinance on Clinical Trials (ClinO) Annex 3 (1.10, 2.11, 3.9, 4.4) and with the Ordinance on Human Research with the Exception of Clinical Trials (HRO) Annex 2 (1.8, 5.11, 7.9). The ‘staff list’ does not fulfill the requirements set by ICH-GCP E6R2 Art. 4.1.5 and thus it can’t be use as ‘delegation log’.

English
2.1
updated: 29.10.2018
Suitability and availability of infrastructure at the research site

Clinical trials, art. 25 lit. h ClinO
Clinical trials of medical devices, art. 11 ClinO-MD, resp. 1.13 chapter II annex XV MDR
Research projects with persons (non-clinical trials), art. 15 lit. i HRO

Deutsch
15.12.2021
updated: 15.12.2021
Français
15.12.2021
updated: 15.12.2021
Italiano
15.12.2021
updated: 15.12.2021
English
15.12.2021
updated: 15.12.2021