Please provide evidence of SCOTT review OR provide evidence that SCOTT review is not required for this study. (Ethical Guidelines for Intervention Studies Appendix 1) The Committee had concerns about the consent process. Please amend the protocol to allow for a face to face consent meeting on the day of participant’s surgery. (Ethical Guidelines for Intervention Studies paras 5.41 & 6.11) The Committee requested that Researchers obtain verbal consent for being approached for research participation when they enter the outpatient clinic. (Ethical Guidelines for Intervention Studies paras 5.41 & 6.11) The Committee requested the following changes to the Participant Information Sheet and Consent Form: Add that the study is not externally funded. Please include a statement about who will have access to data produced by the study after collection and in what form. For example, will study data be sent overseas and if so whether it will it be permanently de-identified. Decision This application was by consensus, subject to the following information provisionally approved being received. Please amend the information sheet and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). Please amend the study protocol taking into account the suggestions made by the Committee. (Ethical Guidelines for Intervention Studies para 5.41) Please provide evidence of SCOTT review OR provide evidence that SCOTT review is not required for this study. (Ethical Guidelines for Intervention Studies Appendix 1) This following information will be reviewed, and a final decision made on the application, by Dr Patries Herst & Ms Helen Walker 2 Ethics ref: 17/CEN/204 Title: APD334-010: Proof of Concept Study of Etrasimod in Patients with Primary Biliary Cholangitis Principal Investigator: Dr Dominic Ray-Chaudhuri Sponsor: Arena Pharmaceuticals Inc. Clock Start Date: 12 October 2017 Dr Dominic Ray-Chaudhuri was present by teleconference for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study The is an Open-label, Pilot, Proof of Concept Study to Evaluate the
Please provide evidence of SCOTT review OR provide evidence that SCOTT review is not required for this study. (Ethical Guidelines for Intervention Studies Appendix 1) The Committee had concerns about the consent process. Please amend the protocol to allow for a face to face consent meeting on the day of participant’s surgery. (Ethical Guidelines for Intervention Studies paras 5.41 & 6.11) The Committee requested that Researchers obtain verbal consent for being approached for research participation when they enter the outpatient clinic. (Ethical Guidelines for Intervention Studies paras 5.41 & 6.11) The Committee requested the following changes to the Participant Information Sheet and Consent Form: Add that the study is not externally funded. Please include a statement about who will have access to data produced by the study after collection and in what form. For example, will study data be sent overseas and if so whether it will it be permanently de-identified. Decision This application was provisionally approved by consensus, subject to the following information being received. Please amend the information sheet and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). Please amend the study protocol taking into account the suggestions made by the Committee. (Ethical Guidelines for Intervention Studies para 5.41) Please provide evidence of SCOTT review OR provide evidence that SCOTT review is not required for this study. (Ethical Guidelines for Intervention Studies Appendix 1) This following information will be reviewed, and a final decision made on the application, by Dr Patries Herst & Ms Helen Walker 2 Ethics ref: 17/CEN/204 Title: APD334-010: Proof of Concept Study of Etrasimod in Patients with Primary Biliary Cholangitis Principal Investigator: Dr Dominic Ray-Chaudhuri Sponsor: Arena Pharmaceuticals Inc. Clock Start Date: 12 October 2017 Dr Dominic Ray-Chaudhuri was present by teleconference for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study The is an Open-label, Pilot, Proof of Concept Study to Evaluate the
cen-24-oct-2017-meeting-minutes.docx