X Any limits to the confidentiality of the research records That records identifying the subject will be kept 4.8.10 confidential and, to the extent permitted by the o applicable laws and/or regulations, will not be made publicly available. The measures to be undertaken for dissemination of research results, and whether 3.2 f participants will be identified directly or indirectly. 4.8.10 If the results of the trial are published, the X o subject’s identity will remain confidential. S/ WILL INFORMATION ABOUT THIS STUDY BE AVAILABLE ONLINE? # REB TCPS2 GCP US-CFR CGSB Element Yes No N/A 21 CFR For clinical trials subject to FDA’s Part 50 jurisdiction, include the following exact statement description of this clinical trial will “A be available on , as required by U. S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.” T/ WHAT IS THE COST TO PARTICIPANTS? # REB TCPS2 GCP US-CFR CGSB Element Yes No N/A 4.8.10 X X The anticipated expenses, if any, associated l with participation in the clinical trial. U/ ARE STUDY PARTICIPANTS PAID TO PARTICIPATE IN THIS STUDY? # REB TCPS2 GCP US-CFR CGSB Element Yes No N/A Note: The TBRHSC REB recommends that all study participants receive reimbursement for parking for visits that are above standard of care. Information any payments, including 3.2 j incentives for participants, reimbursement for participation-related expenses. 4.8.10 The anticipated prorated payment, if any, to the k subject for participating in the trial. V/ WHAT HAPPENS IF I HAVE A RESEARCH RELATED INJURY? # REB TCPS2 GCP US-CFR CGSB Element Yes No N/A A description of the compensation, if any, that 4.8.10 3.2 j X X will be provided to the participant in the event j that he or she is injured during the research X X X X A description of the type of response that will be undertaken if injury occurs to a participant during the research (e.g. that treatment will be made available and covered by (x), or that no such response is planned
X Any limits to the confidentiality of the research records 4.8.10 o That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. 3.2 f The measures to be undertaken for dissemination of research results, and whether participants will be identified directly or indirectly. X 4.8.10 o If the results of the trial are published, the subject’s identity will remain confidential. S/ WILL INFORMATION ABOUT THIS STUDY BE AVAILABLE ONLINE? # REB TCPS2 GCP US-CFR CGSB Element Yes No N/A 21 CFR Part 50 For clinical trials subject to FDA’s jurisdiction, include the following exact statement “A description of this clinical trial will be available on , as required by U. S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.” T/ WHAT IS THE COST TO PARTICIPANTS? # REB TCPS2 GCP US-CFR CGSB Element Yes No N/A 4.8.10 l X X The anticipated expenses, if any, associated with participation in the clinical trial. U/ ARE STUDY PARTICIPANTS PAID TO PARTICIPATE IN THIS STUDY? # REB TCPS2 GCP US-CFR CGSB Element Yes No N/A Note: The TBRHSC REB recommends that all study participants receive reimbursement for parking for visits that are above standard of care. 3.2 j Information any payments, including incentives for participants, reimbursement for participation-related expenses. 4.8.10 k The anticipated prorated payment, if any, to the subject for participating in the trial. V/ WHAT HAPPENS IF I HAVE A RESEARCH RELATED INJURY? # REB TCPS2 GCP US-CFR CGSB Element Yes No N/A 3.2 j 4.8.10 j X X A description of the compensation, if any, that will be provided to the participant in the event that he or she is injured during the research X X X X A description of the type of response that will be undertaken if injury occurs to a participant during the research (e.g. that treatment will be made available and covered by (x), or that no such response is planned