Coded Information. The link between the code and your personal information will be kept confidential by the study staff. Your Coded Information will be used by the following: • Pfizer and its representatives (including its affiliated companies) • People and/or organizations providing services to or collaborating with Pfizer • Any organization that obtains all or part of Pfizer's business or the rights to the product under study • Other researchers • Advarra IRB • Government or regulatory authorities The above parties may use your coded information for the following purposes: • Conducting the study, including: o Examining your response to the study drug o Understanding the study and the study results and learning more about weight management o Assessing the safety of the study drug • Complying with legal and regulatory duties such as: o Ensuring the study is conducted according to good clinical practice o Making required disclosures to IRB(s), or government or regulatory authorities o Seeking approval from government or regulatory authorities to market the study drug ▪ It is possible that these government or regulatory authorities may disclose your Coded Information to other researchers for the conduct of future scientific research o Sharing study data with other researchers not affiliated with the study staff or Pfizer. This includes through publication on the internet or other ways. However, information that could directly identify you will not be made available to other researchers • Publishing summaries of the study results: o In medical journals o On the internet o At educational meetings of other researchers You will not be directly identified in any publication or report of the study. But some journal representatives may need access to your Coded Information to verify the study results and ensure the research meets the journal's quality standards. Also, journals may require that genetic and other information from the study that does not directly identify you be made available to other researchers for further research projects. • Improving the quality, design, and safety of this study and other research studies How are my biological samples handled? If biological samples are taken during the study, those samples will be handled in the same way as your Coded Information. All samples will be treated as required by law. Can my coded information and biological samples be used for other research? Yes. Pfizer may use your Coded Information, biological samples, images, and/or ...
