SickKids study staff and will not be available to the (Sponsor/Funding agency/Coordinating centre). SickKids guidelines include the following: All information that identifies you, both paper copy and electronic information, will be kept confidential and stored and locked in a secure place that only the study staff will be able to access. Electronic files will be stored securely on hospital or institutional networks or securely on any portable electronic devices. No information identifying you will be allowed off site in any form without your consent. Examples include your hospital or clinic charts, copies of any part of your charts, or notes made from your charts. If identifiable information will also be collected as part of this study: The study will also collect personal information that could identify you, such as: Include what potentially identifiable information will be collected name, address, full date of birth, new or existing medical records, that includes types, dates and results of medical tests or procedures sensitive information about HIV and genetic testing, or treatment for drug or alcohol abuse or mental health problems. Indicate how this identifiable information will be protected, used, and disclosed. The study staff and the others listed above will keep the information they see or receive about you confidential, to the extent permitted by applicable laws. Even though the risk of identifying you from the study data is very small, it can never be completely eliminated. Access to your personal health information will take place under the supervision of the Study Doctor. You have the right to access, review and request changes to your personal health information. The following people may come to the hospital to look at your personal health information to check that the information collected for the study is correct and to make sure the study followed the required laws and guidelines: Sponsor Name, the company that makes the DRUG (including trade name) / INTERVENTION}, and its representatives and partner companies; Representatives of the SickKids Research Ethics Board and/or Research Quality and Risk Management team; Representatives of Health Canada, group of people who oversee the use of drugs in research in Canada, and (if applicable) other regulatory bodies such as the United States Food and Drug Administration (FDA). The study staff will keep any personal health information about you in a secure and confidential location for (# of years) years and then destroy it according to SickKids policy. Drug, device or natural health product studies that are regulated by Health Canada require 25-year study-related record retention. There
SickKids study staff and will not be available to the (Sponsor/Funding agency/Coordinating centre). SickKids guidelines include the following: All information that identifies you, both paper copy and electronic information, will be kept confidential and stored and locked in a secure place that only the study staff will be able to access. Electronic files will be stored securely on hospital or institutional networks or securely on any portable electronic devices. No information identifying you will be allowed off site in any form without your consent. Examples include your hospital or clinic charts, copies of any part of your charts, or notes made from your charts. If identifiable information will also be collected as part of this study: The study will also collect personal information that could identify you, such as: Include what potentially identifiable information will be collected name, address, full date of birth, new or existing medical records, that includes types, dates and results of medical tests or procedures sensitive information about HIV and genetic testing, or treatment for drug or alcohol abuse or mental health problems. Indicate how this identifiable information will be protected, used, and disclosed. The study staff and the others listed above will keep the information they see or receive about you confidential, to the extent permitted by applicable laws. Even though the risk of identifying you from the study data is very small, it can never be completely eliminated. Access to your personal health information will take place under the supervision of the Study Doctor. You have the right to access, review and request changes to your personal health information. The following people may come to the hospital to look at your personal health information to check that the information collected for the study is correct and to make sure the study followed the required laws and guidelines: Sponsor Name, the company that makes the DRUG (including trade name) / INTERVENTION}, and its representatives and partner companies; Representatives of the SickKids Research Ethics Board and/or Research Quality and Risk Management team; Representatives of Health Canada, group of people who oversee the use of drugs in research in Canada, and (if applicable) other regulatory bodies such as the United States Food and Drug Administration (FDA). The study staff will keep any personal health information about you in a secure and confidential location for (# of years) years and then destroy it according to SickKids policy. Drug, device or natural health product studies that are regulated by Health Canada require 25-year study-related record retention. There