Hospital or Emory Johns Creek Hospital a site location? Yes No If yes: does involve drug under a REMS for reproductive risk? Yes No CoC Provisions Certificate of Confidentiality Is this Study There is a Certificate of Confidentiality from the National Institutes of NIH-Funded Health for this Study. The Certificate of Confidentiality helps us to keep (whether directly others from learning that you participated in this study. Emory will rely on or via the Certificate of Confidentiality to refuse to give out study information subaward), or that identifies you. For example, if Emory received a subpoena for study Applying for a records, it would not give out information that identifies you. CoC? The Certificate of Confidentiality does not stop you or someone else, like Yes a member of your family, from giving out information about your participation in this study. For example, if you let your insurance No company know that you are in this study, and you agree to give the insurance company research information, then the investigator cannot use the Certificate to withhold this information. This means you and your family also need to protect your own privacy. The Certificate does not stop Emory from making the following disclosures about you: Giving state public health officials information about certain infectious diseases, Giving law officials information about abuse of a child, elderly person or disabled person. Giving out information to prevent harm to you or others. Giving the study sponsor or funders information about the study, including information for an audit or evaluation. Medical Record Medical Record If you have been an Emory Healthcare patient before, then you already Will this study have an Emory Healthcare medical record. If you have never been an access add Emory Healthcare patient, you do not have one. An Emory Healthcare or data to the medical record will be made for you if an Emory provider or facility gives Emory or you any services or procedures for this study. affiliated Medical Record system?
Hospital or Emory Johns Creek Hospital a site location? Yes No If yes: does involve drug under a REMS for reproductive risk? Yes No CoC Provisions Is this Study NIH-Funded (whether directly or via subaward), or Applying for a CoC? Yes No Certificate of Confidentiality There is a Certificate of Confidentiality from the National Institutes of Health for this Study. The Certificate of Confidentiality helps us to keep others from learning that you participated in this study. Emory will rely on the Certificate of Confidentiality to refuse to give out study information that identifies you. For example, if Emory received a subpoena for study records, it would not give out information that identifies you. The Certificate of Confidentiality does not stop you or someone else, like a member of your family, from giving out information about your participation in this study. For example, if you let your insurance company know that you are in this study, and you agree to give the insurance company research information, then the investigator cannot use the Certificate to withhold this information. This means you and your family also need to protect your own privacy. The Certificate does not stop Emory from making the following disclosures about you: Giving state public health officials information about certain infectious diseases, Giving law officials information about abuse of a child, elderly person or disabled person. Giving out information to prevent harm to you or others. Giving the study sponsor or funders information about the study, including information for an audit or evaluation. Medical Record Will this study access or add data to the Emory or affiliated Medical Record system? Medical Record If you have been an Emory Healthcare patient before, then you already have an Emory Healthcare medical record. If you have never been an Emory Healthcare patient, you do not have one. An Emory Healthcare medical record will be made for you if an Emory provider or facility gives you any services or procedures for this study.