Product Monograph (PM) If ‘Investigator Brochure (IB)’: *Please upload Investigator Brochure (IB): Upload Document If ‘Product Monograph (PM)’: *Please upload Product Monograph (PM): Upload Document *Please indicate the status of the Health Canada Clinical Trial Application: Notice of Authorization pending Notice of Authorization enclosed If ‘Notice of Authorization Enclosed’: *Please upload document: Upload Document Medical Devices These questions appear only if ‘Medical Devices’ was selected from list in question 2.18. *Health Canada medical device classification: Class I Class II Class III IV If ‘Yes – an Investigational Testing Application (ITA) the Medical Device Regulations’ selected in question 2.18a, the following questions appear: *Name of all device components, parts and/or accessories as per product label for devices covered under the ITA with Health Canada: Add Another *Please indicate the status of the device(s) with Health Canada (select all that apply): Licensed (e.g., has Medical Device License (MDL)), but being used outside of current Health Canada authorization Investigational If ‘Licensed (e.g. has Medical Device License (MDL)), but being used outside of current Health Canada authorization’: *Describe how the device component, parts and/or accessories is/are being used in the study outside of the parameters of the conditions of use approved by Health Canada: *Does this device contain a drug? Yes No If ‘Yes’: *Drug used: *For each device covered under the ITA, upload the Product Monograph (PM) or equivalent: *Please upload PM or equivalent: Upload Document US Regulatory Requirements
*Please indicate to what extent the study participant is able to withdraw specimens collected for the purposes of the study after the specimens have been shipped offsite, and any limitations to the withdrawal: If ‘For genetic testing (e.g., gene identification, gene mapping, genomic analysis, DNA screening)’ is selected in 2.18.18, questions 2.18.25-2.18.31 appear: *Please indicate whether the sample collection for genetic testing is (select all that apply): Optional Mandatory *Describe the planned genetic testing: *Where will 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): *Please indicate to what extent the study participant is able to withdraw specimens collected for genetic testing after the specimens have been shipped offsite, and any limitations to the withdrawal: *Will participants or their family members or their health care providers be informed of any genetic testing results? Yes No If ‘Yes’: *Describe what information will be shared and with whom? *How will consent be obtained to release this information? *Describe whether participants will be given the option of not receiving information about themselves: If ‘No’: *Please explain/justify: If ‘stored or retained or banked for any future testing’ is selected in 2.18.18, questions 2.18.32-2.18.37 appears: *Please indicate whether the sample collection to be stored or retained or banked for any future testing is (select all that apply): Optional Mandatory *Where will the biobank(s)/repositories be located (e.g., name of bank & address including country)? *Where will the associated data be located (e.g., name & address including country)? *Who will be the custodian of the specimens that will be stored or retained or banked for any future testing? *Who will have access to the banked specimens?
a written decision or documentation of an oral decision in a group setting to approve the proposed research or to decline further participation: Upload Document a written summary of advice received from a culturally informed advisory group or ad hoc committee (e.g., an urban community of interest): Upload Document If ‘No’: *Provide the rationale: SECTION 5.0 - INFORMED CONSENT INFORMATION *Is a waiver of the requirement to obtain informed consent being requested for this study? Yes No If ‘Yes’: *Provide justification: If ‘No’: Question 5.2 and 5.3 will appear: *Upload clean versions of all proposed consent forms (e.g., screening, main, optional): Upload Document Upload versions of any other materials that will be distributed to study participants (e.g., diaries, wallet cards): Upload Document *Does this study include assent form(s)? Yes No If ‘Yes’: *Upload all proposed assent Upload Document If 2.18.25 = ‘optional’, question 5.4 will appear: *Describe the processes used for obtaining and documenting informed consent for genetic testing: *Indicate how the results will be broadly communicated to participants and other stakeholders (e.g., advocacy groups, scientific community): TO PARTICIPANTS Each PI to provide debriefing at end of test session Group debriefing End of study letter Publication(s) Other No Plan If ‘Each PI to provide debriefing at end of test session’: Attach copy of debriefing script, if available: Upload Document If ‘group debriefing’: Attach copy of group debriefing, if available:
Partial initials Full date of birth Partial date of birth Full date of death Partial date of death Age Sex/gender Full postal code 3 digits of postal code Pathology specimen number Medical device identifier Admission date Discharge date Medical record number Ontario health card number Driver’s license number Address Telephone number Fax number E-Mail address Full face photograph Voice/audio recording Other If ‘Other’: *Specify other information: If ‘Other’: *Justify other information: If ‘Full name’: *Justify full name: If ‘Full initials’: *Justify full initials: If ‘Partial initials’: *Justify partial initials: If ‘Full date of birth’: *Justify full date of birth: If ‘Partial date of *Justify partial date of birth: If ‘Full date of death’: *Justify full date of death: If ‘Partial date of *Justify partial date of death: If ‘Age’: *Justify age: If ‘Sex/gender’: *Justify sex/gender: If ‘Full postal code’: *Justify full postal code: If 3 digits of postal code’: *Justify first 3 digits of postal code: If ‘Pathology specimen number’: *Justify pathology specimen number: If ‘Medical device identifier’: *Justify medical device identifier: If ‘Admission date’: *Justify admission date: If ‘Discharge date’: *Justify discharge date: If ‘Medical record number’: *Justify medical record number: If ‘Ontario health card number’: *Justify Ontario health card number: If ‘Driver’s license number’: *Justify driver’s license number: If ‘Address’: *Justify address: If ‘Telephone number’: *Justify telephone number: If ‘Fax number’: *Justify fax number: If ‘E-mail address’: *Justify E-mail address: If ‘Full face photograph’: *Justify full face photograph: If ‘Voice/audio recording’: *Justify voice/audio recording: