template documents for the above procedures in the Manual of Procedures and provide training to the investigators and clinical staff on regulatory and ethical considerations. All study personnel will be responsible for completing and remaining current with all applicable human subjects’ protection, good clinical practice and data security and privacy training requirements 3.2.2 Existing Populations in the Clinical Site Practices Methods for identifying potentially eligible participants within the clinical practice of the research settings may include: a targeted review of medical records or databases for those meeting the trial's inclusion criteria, referrals from providers/employees within the practice and/or from practice participants themselves. Additional approaches may also include written materials such as direct mailing and/or advertisement on such items as appointment reminders. 3.3. Screening Visits/ Baseline Visits Screening Activity Considerations Each SPRINT clinical center should consult their local IRB regarding approval requirements to access internal medical record searches for potential SPRINT patients. Depending upon the institution, prior approvals for data transfer agreements may be needed to obtain de-identified patient information. Pursuant to such agreements investigators may be required to sign a privacy agreement to protect the patient’s protected health information (PHI) as well as comply with other policies and procedures as defined by the institution’s designated privacy, security and compliance services. SPRINT clinical centers will work with the respective CCNs to complete Health Insurance Portability and Accountability Act (HIPAA) Privacy rule documents, preparatory to research waivers and training prior to patient medical record searches. Version 4.0 22 November 1, 2012 Once local regulatory requirements have been approved, investigator plans to identify potential study patients may be implemented. Large scale data base searches, stratified by key specified inclusion criteria may also yield a global assessment of the potentially eligible study population. Other study parameters (e.g. age, race, gender CKD status, etc.) can be added to further specify the eligible population. Prior to conducting prescreening and screening activities, it may also be necessary to request additional approvals beyond the IRB (e.g. physician approval or consultation for a screening referral to the SPRINT clinic). Participant informed consent must also be obtained prior to performing any procedures related to the trial. Screening Visits/Baseline Visit The following are key elements of the screening and baseline visits and are outlined in the study assessments and procedures below: Screening Visit(s) 1. Verify participant's interest in study. 2. Obtain in person study consent and HIPAA authorization for main trial, and if applicable, SPRINT MIND, genetic testing and any ancillary studies 3. Continue collection of screening information, including such items as contact information, additional eligibility information including BP measurement, concomitant medications, and medical history. Baseline visit (Randomization Visit) 1. Confirmation that all inclusion/exclusion criteria satisfied 2. Verification of participant consent and HIPAA authorization. 3. Verification of participant contact information 4. Obtain a Release of Information, as permitted by local policy, to collect event and serious adverse event (SAE) documentation 5. Completion of the study randomization procedure and baseline data collection, including obtaining BP, ECG, and blood and urine samples for analysis and storage at the central lab Data obtained from the screening, and randomization visits must be supported in the patient’s source documentation. Visit data will be entered into the SPRINT database within a specified time frame determined by the SPRINT Coordinating Center. Version 4.0 23 November 1, 2012 Chapter 4 – Intervention Blood Pressure Goals Participants eligible for the trial will be randomized to one of two goals: SBP 160 mm Hg.” Additional visits will be scheduled as needed for management of adverse effects or for monitoring significant medication changes or other clinical issues. Intensive BP Goal Group (Figure 4.1) The SBP goal for the Intensive Group,