{"id":6,"date":"2023-06-14T01:10:26","date_gmt":"2023-06-14T01:10:26","guid":{"rendered":"https:\/\/atri.usc.edu\/medicalsafety\/?page_id=6"},"modified":"2023-09-21T16:45:01","modified_gmt":"2023-09-21T16:45:01","slug":"medical-safety","status":"publish","type":"page","link":"https:\/\/atri.usc.edu\/medicalsafety\/","title":{"rendered":"Medical Safety"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;11316aca-0147-466a-9e63-9fc59cc51e44&#8243; background_color=&#8221;#990000&#8243; background_image=&#8221;https:\/\/atri.usc.edu\/medicalsafety\/wp-content\/uploads\/sites\/9\/2023\/06\/medsafety.jpg&#8221; background_position=&#8221;center_right&#8221; custom_padding=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row admin_label=&#8221;row&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;58c73493-0737-4bc2-81b1-d4e1b2038a7f&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; header_font=&#8221;|||on|||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1>Section of Medical Safety<\/h1>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.20.0&#8243; _module_preset=&#8221;11316aca-0147-466a-9e63-9fc59cc51e44&#8243; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;90deg&#8221; background_color_gradient_stops=&#8221;rgba(255,255,255,0) 63%|#990000 63%&#8221; background_color_gradient_start=&#8221;#eae3dc&#8221; background_color_gradient_start_position=&#8221;34%&#8221; background_color_gradient_end=&#8221;rgba(255,255,255,0)&#8221; background_color_gradient_end_position=&#8221;0%&#8221; custom_margin=&#8221;||-1px||false|false&#8221; custom_padding=&#8221;||80px|||&#8221; background_last_edited=&#8221;on|tablet&#8221; use_background_color_gradient_tablet=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;58c73493-0737-4bc2-81b1-d4e1b2038a7f&#8221; width_tablet=&#8221;80%&#8221; width_phone=&#8221;90%&#8221; width_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;||0px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_css_main_element=&#8221;margin: auto;&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; header_2_font=&#8221;|||on|||||&#8221; max_width=&#8221;80%&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Welcome to ATRI medical safety<\/h2>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;80%&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>The Alzheimer\u2019s Therapeutic Research Institute (ATRI) brings together the innovative, experienced and dedicated talent required to design and oversee every aspect of rigorous clinical trials.<\/p>\n<p>Our Medical Safety team is responsible for clinical monitoring of sites to ensure proper study conduct as well as medical monitoring to ensure medical oversight of participant safety. The unit also interacts closely with Study Sponsors and the Data and Safety Monitoring Board (DSMB).<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_css_main_element=&#8221;margin: auto;&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/atri.usc.edu\/medicalsafety\/wp-content\/uploads\/sites\/9\/2023\/09\/group.jpg&#8221; _builder_version=&#8221;4.22.1&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; alt=&#8221;Group photo of the medical safety team&#8221; sticky_enabled=&#8221;0&#8243;][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;section&#8221; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;11316aca-0147-466a-9e63-9fc59cc51e44&#8243; custom_padding=&#8221;||0px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row admin_label=&#8221;row&#8221; _builder_version=&#8221;4.20.0&#8243; _module_preset=&#8221;58c73493-0737-4bc2-81b1-d4e1b2038a7f&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; header_font=&#8221;|||on|||||&#8221; header_2_font=&#8221;|||on|||||&#8221; custom_margin=&#8221;||0px||false|false&#8221; border_width_bottom=&#8221;1px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Our Activities<\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;90%&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>The Medical Safety Unit at ATRI is dedicated to ensuring participant safety, protocol adherence, and maintaining the highest level of data integrity. With clinical site monitoring and medical monitoring as key functions, we provide crucial oversight throughout the entire clinical trial process. From protocol development to study closeout and data lock, our team collaborates with sites, vendors, and research partners to ensure the safety and well-being of participants. We work closely with site Principal Investigators, who hold ultimate responsibility, to safeguard participants and ensure strict adherence to the study protocol.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; admin_label=&#8221;row&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;58c73493-0737-4bc2-81b1-d4e1b2038a7f&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.22.1&#8243; _module_preset=&#8221;6caee23e-a284-414f-8bc8-45f67fbb84b6&#8243; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h6>Medical Monitoring<\/h6>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;313b3815-5b9e-4ca2-bf53-66b85d3d9818&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<ul>\n<li>SAE reviews<\/li>\n<li>AE MedDRA coding<\/li>\n<li>Eligibility questions<\/li>\n<li>Medical management questions<\/li>\n<li>Abnormal lab\/ECG\/MRI reviews<\/li>\n<li>Protocol deviation reviews<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.22.1&#8243; _module_preset=&#8221;6caee23e-a284-414f-8bc8-45f67fbb84b6&#8243; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h6>Clinical Monitoring<\/h6>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;313b3815-5b9e-4ca2-bf53-66b85d3d9818&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<ul>\n<li>In-person and remote site visits<\/li>\n<li>Site communication and documentation<\/li>\n<li>Study timelines and deliverables<\/li>\n<li>Source Document Verification<\/li>\n<li>Drug Accountability Review<\/li>\n<li>Query resolution<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Section of Medical SafetyWelcome to ATRI medical safetyThe Alzheimer\u2019s Therapeutic Research Institute (ATRI) brings together the innovative, experienced and dedicated talent required to design and oversee every aspect of rigorous clinical trials. Our Medical Safety team is responsible for clinical monitoring of sites to ensure proper study conduct as well as medical monitoring to ensure [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"difl_page_category":[],"class_list":["post-6","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/atri.usc.edu\/medicalsafety\/wp-json\/wp\/v2\/pages\/6","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/atri.usc.edu\/medicalsafety\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/atri.usc.edu\/medicalsafety\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/atri.usc.edu\/medicalsafety\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/atri.usc.edu\/medicalsafety\/wp-json\/wp\/v2\/comments?post=6"}],"version-history":[{"count":11,"href":"https:\/\/atri.usc.edu\/medicalsafety\/wp-json\/wp\/v2\/pages\/6\/revisions"}],"predecessor-version":[{"id":236961,"href":"https:\/\/atri.usc.edu\/medicalsafety\/wp-json\/wp\/v2\/pages\/6\/revisions\/236961"}],"wp:attachment":[{"href":"https:\/\/atri.usc.edu\/medicalsafety\/wp-json\/wp\/v2\/media?parent=6"}],"wp:term":[{"taxonomy":"difl_page_category","embeddable":true,"href":"https:\/\/atri.usc.edu\/medicalsafety\/wp-json\/wp\/v2\/difl_page_category?post=6"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}