<p>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</p><p>Checklist as of January 2014 ClinO Appendix 3 Items 1_5</p><p>Application documentation for category A clinical trials involving therapeutic products and transplant products</p><p>Document templates are available at www.swissethics.ch.</p><p>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)</p><p>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</p><p>1b Synopsis of the study plan for KEK members  in the national language of the KEK in charge</p><p>2 Study plan  to be signed by the investigator and, if applicable, by the sponsor</p><p>3 CRF (Case Report Form) </p><p>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</p><p>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</p><p>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</p><p>6 Details on nature and scope/value of compensation for participants</p><p>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) </p><p>10a Investigator’s CV and proof of GCP training (according to Art. 6 KlinV)  signed and dated</p><p>10b List of other persons involved in the clinical trial  including their position and corresponding technical skills </p><p>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.</p><p>12 Details on the safe handling of personal data</p><p>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</p><p>Checklist ClinO Appendix 3, Items 1_5 19.12.2013 V4.0 page 2/4 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</p><p>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</p><p>Additional application documentation for category A clinical trials involving therapeutic products capable of emitting ionising radiation or examinations with sources of radiation</p><p>Document templates are available at www.swissethics.ch.</p><p>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 </p><p> http://www.bag.admin.ch/themen/strahlung/10463/in dex.html?lang=de </p><p>2 Required authorisation according to Article 28 of the Radiological Protection Act of 22 March 19911</p><p> http://www.admin.ch/opc/en/classified- compilation/19910045/index.html</p><p>Ethics committee </p><p>Place/date:</p><p>1 SR 814.50</p><p>Checklist ClinO Appendix 3, Items 1_5 19.12.2013 V4.0 page 3/4 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</p><p>Scientific secretariat</p><p>Checklist ClinO Appendix 3, Items 1_5 19.12.2013 V4.0 page 4/4</p>