*Has this study been submitted to the US Food and Drug Administration (FDA) under an Investigational New Drug (IND), Investigational Device Exemption (IDE), or Pre-Market Approval (PMA) Application? Yes No *Is this research supported by the United States federal government? Yes No Biological Specimen Collection This section appears only if Specimen Collection” was selected from list in question 2.18. “Biological *What type of specimen(s) will be collected from the study participants? *Will stem cells be collected or used in this study? Yes No If *Describe the stem cell component of the study: ‘Yes’: *How will the specimens be collected (select all that apply)? Previously acquired clinical specimens (i.e., leftover or archived specimens) Prospectively collected for this study (i.e., not yet collected) Other If *Specify Details: *Does the sponsor plan to put a material transfer agreement (MTA) or similar contract in with each participating centre to ensure secure transfer and storage of specimens? Yes No N/A (specimens will not be transferred out of the centres) If *Explain and justify: ‘No’: (select *Select the purpose(s) for which the specimens will be collected all that apply): For the purposes of this study (excluding specimens taken as part of normal care or for safety) For genetic testing (e.g., gene identification, gene mapping, genomic analysis, DNA screening) Stored or retained or banked for any future testing If the purposes of this study (excluding specimens taken as part of normal care or for safety)’ is selected ‘For in 2.18.18, questions 2.18.19-2.18.24 appear: *Please indicate whether the specimen collection for the purposes of this is (select all that apply): Optional Mandatory *Describe how the specimens will be used in this study: *Where will the specimens be sent (e.g., name & address including country)? *Indicate how long the specimens will be retained: *Describe what will happen to the specimens at the end of that period (e.g., destroyed, returned):
*Has this study been submitted to the US Food and Drug Administration (FDA) under an Investigational New Drug (IND), Investigational Device Exemption (IDE), or Pre-Market Approval (PMA) Application? Yes No *Is this research supported by the United States federal government? Yes No Biological Specimen Collection This section appears only if “Biological Specimen Collection” was selected from list in question 2.18. *What type of specimen(s) will be collected from the study participants? *Will stem cells be collected or used in this study? Yes No If ‘Yes’: *Describe the stem cell component of the study: *How will the specimens be collected (select all that apply)? Previously acquired clinical specimens (i.e., leftover or archived specimens) Prospectively collected for this study (i.e., not yet collected) Other If *Specify Details: *Does the sponsor plan to put a material transfer agreement (MTA) or similar contract in with each participating centre to ensure secure transfer and storage of specimens? Yes No N/A (specimens will not be transferred out of the centres) If ‘No’: *Explain and justify: *Select the purpose(s) for which the specimens will be collected (select all that apply): For the purposes of this study (excluding specimens taken as part of normal care or for safety) For genetic testing (e.g., gene identification, gene mapping, genomic analysis, DNA screening) Stored or retained or banked for any future testing If ‘For the purposes of this study (excluding specimens taken as part of normal care or for safety)’ is selected in 2.18.18, questions 2.18.19-2.18.24 appear: *Please indicate whether the specimen collection for the purposes of this is (select all that apply): Optional Mandatory *Describe how the specimens will be used in this study: *Where will the specimens be sent (e.g., name & address including country)? *Indicate how long the specimens will be retained: *Describe what will happen to the specimens at the end of that period (e.g., destroyed, returned):