Checklist As of January 2014 Clino Appendix 3 Items 1 5

s w i s s e t h i c s Schweizerische Ethikkommissionen für die Forschung am Menschen Commissions d’éthique suisses relative à la recherche sur l'être humain Commissioni etiche svizzere per la ricerca sull'essere umano Swiss Ethics Committees on research involving humans

Checklist as of January 2014 ClinO Appendix 3 Items 1_5

Application documentation for category A clinical trials involving therapeutic products and transplant products

Document templates are available at www.swissethics.ch.

Date/ Reference to other Cantonal ethics version documents, if committee (KEK): No. Document number applicable Comments (leave blank) 0 Covering letter  billing address must be included  to be signed by the applicant (investigator or sponsor)

1a Base form, including synopsis (in layman’s terms) of the study plan for the patients, in the national language(s) spoken at the location where the trial is executed  to be signed by the investigator and, if applicable, by the sponsor

1b Synopsis of the study plan for KEK members  in the national language of the KEK in charge

2 Study plan  to be signed by the investigator and, if applicable, by the sponsor

3 CRF (Case Report Form)

4a Information sheet and declaration of consent  in the national language(s) spoken at the location(s) where the trial is executed, for the responsible persons and contacts on site  if necessary, including specific information for persons incapable of judgement (e.g. urgent care patients, patients suffering from dementia), under-age persons, authorised representatives (e.g. parents) or the pregnant partner of a participant in the trial  separate information on sub-studies (e.g. additional MRI, pharmacokinetic examination)  information for the further use of data and samples for future research purposes 4b Recruitment documentation  namely advertisement, advert text or recruitment letters to the patient or family physician

Checklist ClinO Appendix 3, Items 1_5 19.12.2013 V4.0 page 1/4 s w i s s e t h i c s Schweizerische Ethikkommissionen für die Forschung am Menschen Commissions d’éthique suisses relative à la recherche sur l'être humain Commissioni etiche svizzere per la ricerca sull'essere umano Swiss Ethics Committees on research involving humans

Date/ Reference to other Cantonal ethics version documents, if committee (KEK): No. Document number applicable Comments (leave blank) 5 Additional documentation to be handed to the participant  patient ID, journals, questionnaires in the appropriate national language, or other documentation to be used in the course of the study  e.g. interview guide, questionnaire, scores

6 Details on nature and scope/value of compensation for participants

7 For clinical trials involving medicinal products, the technical information In case of minimal usage deviation: indicate usage deviation according to study information 8 For clinical trials involving medical devices, the conformity labelling, including intended use and user guide 9 If the clinical trial is not using original products: Proof of compliance with Good Manufacturing Practice (GMP) and proper labelling of the therapeutic products (confirm with Swissmedic)

10a Investigator’s CV and proof of GCP training (according to Art. 6 KlinV)  signed and dated

10b List of other persons involved in the clinical trial  including their position and corresponding technical skills

11 Details on infrastructure suitability and availability at the location where the trial is executed  e.g. number of simultaneously conducted studies, number of competing studies, reasonable utilisation of machinery used for the trial, etc.

12 Details on the safe handling of personal data

13 Agreement between sponsor/commissioned institution and investigator  regarding clinical trial financing, the allocation of tasks, the investigator’s compensation and the publication  to be signed by all parties

Date/ Reference to other Cantonal ethics version documents, if committee (KEK): No. Document number applicable Comments (leave blank) 14 Proof of insurance*  or other proof of guarantee for any damage or injury, including the relevant agreements between the sponsor or the institutions/person in Switzerland commissioned by the sponsor, and the investigator * Insurance coverage is not required as long as category A clinical trials do not require research-related measures with more than merely minimal risks (Art. 12, Lit. B KlinV) 15 Foreign ethics committees’ decisions or opinions on the clinical trial  including possible restrictions and their justification

Additional application documentation for category A clinical trials involving therapeutic products capable of emitting ionising radiation or examinations with sources of radiation

Document templates are available at www.swissethics.ch.

Date/ Reference to other Cantonal ethics version documents, if committee (KEK): No. Document number applicable Comments (leave blank) 1 Details on essential aspects of radiological protection, in particular calculations/estimations on the effective radiation dose, organ dose and possible tumour dose

http://www.bag.admin.ch/themen/strahlung/10463/in dex.html?lang=de

2 Required authorisation according to Article 28 of the Radiological Protection Act of 22 March 19911

http://www.admin.ch/opc/en/classified- compilation/19910045/index.html

Ethics committee

Place/date:

1 SR 814.50

Scientific secretariat

Checklist ClinO Appendix 3, Items 1_5 19.12.2013 V4.0 page 4/4