calls. More specifically, the following information may be collected, used, and shared with others: When you are a subject, we will collect health information about you that also includes your name, address, telephone number, or other data that could identify the health information as yours. Under HIPAA, this health information is protected and can't be used without your permission, unless otherwise permitted by law. If you sign this authorization, you are giving permission for AbbVie to use and disclose your personal health information as described below Your personal health information could include results of tests and procedures such as physical examinations and results of blood and tissue testing your biological samples information about your medical conditions and history The collected information may contain your name, address, telephone number, social security number, health plan number, date of birth, medical record numbers, dates relating to various medical procedures, and/or other identifying information. This information will be stored in locked filing cabinets or in computers with security passwords. Some of the information collected could be included in a "limited data set" to be used for other research purposes. If so, the limited data set will include only information that does not directly identify you. For example, the limited data set cannot include your name, address, telephone number, social security number, or any other photographs, numbers, codes, or so forth that link you to the information in the limited data set. If limited data sets are created and used, agreements between the parties creating and receiving the limited data set are required in order to protect your identity, confidentiality, and privacy. Your PHI may be collected, used, and shared with others to make sure you can participate in the research, throughout your participation in the research, and to evaluate the results of the research study. More specifically, your PHI may be collected, used, and shared with others for the following study-related purpose(s): To evaluate whether or not atrasentan is effective in delaying the time to serum creatinine doubling or the onset of end stage renal disease in subjects with type 2 diabetes and kidney disease and to test the safety of atrasentan. Once this information is collected, it becomes part of the research record for this study.
Appendix A – Study Activities Visit Duration in Weeks Until Randomization Screening (2 Weeks) Run-In Period (Up to 12 Weeks)a Enrichment Period (6 Weeks) Dosing Period F/U Period Wk –14 Wk –13 Wk –12 Wk –10, –8, –6, –4 Wk –2 Day 1 Wk 1 Wk 2 Wk 4 Wk 6 Wk 7 Activities S1 S2 R1 R2, R3, R4, R5 R6 E1 E2 E3 E4 E5 Wk 1 Call Wk 2 Call T 1 Every 3 Mths Yearly Visits Final Treatment Visit (PD)b F1c Medical History – including questions regarding tobacco and alcohol use X Xl Xl Xl Xl Xl Complete Physical Exam X X Vital Signs (blood pressure, heart rate, weight and temperature)d X X X X X X X X X X X X X X X X Assess Limb Swellinge X X X X X X X X X X X X X X X X Blood Drawsf X X X X X X X X X X X X X X First Morning Void Urine Collectionsg X X X X X X X X (if discontinued during dosing period only) X Optional Genetic Sample X Urine Testsh X X X X X (T3 only) X X X Blood Pressure Medication Dose Adjustments X X X X