Kaiser Foundation Hospitals

CONNECT TASK ORDER 8

"UNDER THE LEADERSHIP OF CO-PI DR. CHU, THE UNIVERSITY OF WASHINGTON (UW) STUDY TEAM WILL EXECUTE THIS STUDY IN COLLABORATION WITH PRIME RECIPIENT AND CO-PI DR. NALEWAY€„¢S TEAM AT THE KAISER PERMANENTE CENTER FOR HEALTH RESEARCH (KPCHR). ESTABLISH A COMMON PROTOCOL IN COLLABORATION WITH KPCHR, CDC AND OTHER SITES (IF RELEVANT), ESTABLISH A COMMON PROTOCOL FOR THIS PROSPECTIVE COHORT STUDY. THE COMMON PROTOCOL WILL DESCRIBE REQUIRED ELEMENTS FOR STUDY ENROLLMENT, DATA/SPECIMEN COLLECTION, INCLUDING DATA COLLECTION TOOLS, AND LABORATORY TESTING. OBTAIN INSTITUTIONAL REVIEW BOARD APPROVAL OBTAIN INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL FOR ALL STUDY ACTIVITIES BEFORE INITIATING CONTACT WITH POTENTIAL PARTICIPANTS. THE KPNW IRB WILL SERVE AS THE SINGLE IRB OF RECORD FOR THE STUDY. THE IRB REVIEW WILL INCLUDE REVIEW OF ALL PARTICIPANT-FACING STUDY MATERIALS INCLUDING ENROLLMENT MATERIALS AND INFORMED CONSENT AND HIPAA AUTHORIZATION. IRB APPROVAL WILL BE RENEWED ANNUALLY AND WILL BE MODIFIED AS NECESSARY FOR CHANGING STUDY CONDITIONS. THE UW STUDY TEAM WILL FOLLOW AGREED-UPON PROCEDURES FOR SUBSEQUENT STUDY MODIFICATION TO THE IRB. THE UW STUDY TEAM WILL TRACK ALL STUDY DEVIATIONS AND ADVERSE EVENTS FOR THEIR SITE. DEVIATIONS AND ADVERSE EVENTS WILL BE REPORTED TO KPCHR ANNUALLY PRIOR TO CONTINUING REVIEW OR IMMEDIATELY IF THE UW PI DETERMINES THEY MEET PROMPT REPORTING REQUIREMENTS. THE UW TEAM WILL DOCUMENT PI DETERMINATION OF WHETHER DEVIATIONS OR EVENTS ARE SUBJECT TO PROMPT REPORTING REQUIREMENTS ACCORDING TO KP IRB POLICIES"