{"id":2148,"date":"2022-03-31T09:18:45","date_gmt":"2022-03-31T08:18:45","guid":{"rendered":"https:\/\/www.almacgroup.com\/clinical-technologies\/?page_id=2148"},"modified":"2025-11-10T10:12:07","modified_gmt":"2025-11-10T10:12:07","slug":"oversight","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/","title":{"rendered":"OVERSIGHT Trial Data Integrity Monitoring System"},"content":{"rendered":"\n<div class=\"u-bg-white t-theme-component-overwrite\" id=\"halfMediaHalfTextNewBlock\">\n    <div class=\"o-wrapper\">\n        <div class=\"o-grid\">\n            <div class=\"o-grid__item u-width-full\">\n                \n\n                    <!--If media is image, show it left, content right -->\n                    \n                        <div class=\"u-flex u-width-full u-m-y6 u-flex-direction-column@s u-flex-justify-start\">\n\n                            <div class=\"u-width-half u-width-full@m\">\n                                                                    <h2 class=\"u-m-b2 u-m-b2 u-c-text\">OVERSIGHT Fact Sheet<\/h2>\n                                \n                                <div class=\"u-c-text\"><p>It is a critical control point given that in many instances the IXRS<sup>\u00ae<\/sup> acts as an eCRF given it is the first point of entry and as such the source of data that is ultimately pushed to other systems (EDC, eCOA, CTMS) and can be used to investigate any potential discrepancies between systems or ongoing reconciliation activities during the trial.<\/p>\n<\/div>\n\n                                                                                                            <a class=\"c-btn u-m-t2 u-c-text\" href=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2024\/04\/Almac-IXRS-OVERSIGHT-Factsheet_Reduced.pdf\">Download Fact Sheet<\/a>\n                                                                    \n                            <\/div>\n\n                            <div class=\"u-width-half u-width-full@m\">\n                                <div class=\"u-width-half u-block u-center u-width-3\/4@m u-width-full@s u-m-t2@s\">\n                                                                                                                        <img decoding=\"async\" class=\"u-width-full lazyload\" data-src=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2023\/06\/2022_06_Oversight_Fact_Sheet-FINAL.jpg\" alt=\"OVERSIGHT Fact Sheet\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 595px; --smush-placeholder-aspect-ratio: 595\/842;\" \/><noscript><img decoding=\"async\" class=\"u-width-full\" src=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2023\/06\/2022_06_Oversight_Fact_Sheet-FINAL.jpg\" alt=\"OVERSIGHT Fact Sheet\"\/><\/noscript>\n\n                                            <div class=\"u-bg-light-grey u-p3 u-a-center\">\n\n                                                <h3 class=\"u-text-20 u-c-text\">OVERSIGHT Fact Sheet<\/h3>\n\n                                                                                                    <a class=\"c-btn c-btn c-btn2 u-m-t2 u-c-text\" href=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2024\/04\/Almac-IXRS-OVERSIGHT-Factsheet_Reduced.pdf\">Download<\/a>\n                                                \n                                            <\/div>\n                                                                                                            <\/div>\n                            <\/div>\n                        <\/div>\n\n                    \n                            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n\n\n\n<div style=\"height:64px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<!-- Half image, half text -->\n<section class=\"u-bg-white t-theme-component-overwrite\" id=\"halfMediaTextBlock\">\n    <div class=\"c-half-media-text \">\n        <div class=\"o-wrapper\">\n                                                        <article class=\"o-grid u-bg-white\">\n                            <div class=\"u-width-half u-width-7\/12@l u-width-full@m c-half-media__repeat-text black-light u-bg-white\">\n                                                                    <h2 class=\"u-m-b3\">Data Integrity Guidelines &#038; Regulations<\/h2>\n                                                                <p>The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) revised guidance requires documented evidence on how the sponsor performed oversight of the study.<\/p>\n<p>The Data Integrity guidance put out by the MHRA, FDA, and the current (2021) draft guidance by the EMA aimed to not only assure data integrity but to enhance and take a more proactive approach.<\/p>\n                                                            <\/div>\n                            <div class=\"u-width-half u-width-5\/12@l u-width-full@m u-flex c-half-media__repeat-image\">\n                                                                    <img decoding=\"async\" data-src=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/03\/shutterstock_2077260007-e1648660825592.png\" alt=\"Data Integrity Guidelines &#038; Regulations\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" class=\"lazyload\" style=\"--smush-placeholder-width: 1000px; --smush-placeholder-aspect-ratio: 1000\/662;\"><noscript><img decoding=\"async\" class=\"\" src=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/03\/shutterstock_2077260007-e1648660825592.png\" alt=\"Data Integrity Guidelines &#038; Regulations\"><\/noscript>\n                                                            <\/div>\n                        <\/article>\n                                        <\/div>\n    <\/div>\n<\/section>\n\n\n\n\n<div style=\"height:52px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<!-- Accordions -->\n<section class=\"u-bg-white u-p-y4 t-theme-component-overwrite\" id=\"accordionBlock\">\n\t<div class=\"o-wrapper\">\n\t\t<div class=\"o-grid o-grid--center\">\n\t\t\t<div class=\"o-grid__item u-width-full u-align-center u-align-left@m\">\n\t\t\t\t\t\t\t\t\t<h2 class=\"u-line-height-140 u-a-center@s u-c-dark-grey\"><p>Audit Trail Reporting<\/p>\n<\/h2>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"u-c-dark-grey u-a-center@s\"><p>Audit trail reviews conducted by data managers, statisticians, safety staff, and other roles can help identify data inconsistencies, outliers, and protocol deviations; plus any errors in data collection and reporting at a site or across sites; and other data integrity issues.\u00a0 It\u2019s critical to be able to quickly see trends and issues, then drill down into the details to accurately analyze what the trends show and take necessary action.<\/p>\n<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t<div class=\"u-m-t2\">\n\t\t\t\t\t<div class=\"c-accordion js-accordion\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article id=\"item1\" class=\"c-accordion__item u-c-dark-grey accordion-1\">\n\t\t\t\t\t\t        <h4 class=\"c-accordion__title u-bg-white u-c-dark-grey js-accordionTarget-one\">How OVERSIGHT assists sponsors with ICH monitoring guideline compliance<\/h4>\n\t\t\t\t\t\t        <div class=\"c-accordion__content u-bg-white\">\n\t\t\t\t\t\t\t\t\t<div class=\"o-grid\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if image is there then allow content to sit with it -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if not then content goes full width -->\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<p>In late 2016, and subsequently in March 2018, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued revised guidance (E6, R2) concerning sponsors&#8217; responsibilities with respect to trial oversight.<\/p>\n<p>As stated in ICH E6(R2), inspectors expect to see documented evidence on how the sponsor performed oversight of the study. Section 5.18.3 emphasizes the importance of centralized monitoring processes to \u201ccomplement and reduce the extent and\/or frequency of onsite monitoring and help distinguish between reliable data and potentially unreliable data.\u201d Further, the Data Integrity guidance put out by the MHRA, FDA, and the current (2021) draft guidance by the EMA aimed to not only assure data integrity but to enhance and take a more proactive approach.<\/p>\n<p>The audit trail is an integral part of any e-clinical system and should be utilized as a tool to drive data reviews forward. The Audit trail within the IXRS is a critical control point given that in many instances the IXRS acts as an eCRF given it is the first point of entry and as such the source of data that is ultimately pushed to other systems (EDC, eCOA, CTMS) and can be used to investigate any potential discrepancies between systems or ongoing reconciliation activities during the trial.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article id=\"item2\" class=\"c-accordion__item u-c-dark-grey accordion-2\">\n\t\t\t\t\t\t        <h4 class=\"c-accordion__title u-bg-white u-c-dark-grey js-accordionTarget-one\">How can sponsors be successful at providing effective oversight to comply with regulations? <\/h4>\n\t\t\t\t\t\t        <div class=\"c-accordion__content u-bg-white\">\n\t\t\t\t\t\t\t\t\t<div class=\"o-grid\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if image is there then allow content to sit with it -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if not then content goes full width -->\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<ul>\n<li>First, sponsors need on-demand access to the data as the study progresses to be able to identify any risks or needed actions.<\/li>\n<li>Secondly, the data should be presented in a way allowing for ease of review. Both summary and detailed data views are important.<\/li>\n<li>The sponsor can then establish processes and procedures around periodic review and risk identification and remediation.<\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<\/div> <!-- \/c-tabs -->\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div> <!-- \/o-grid -->\n\t<\/div> <!-- \/o-wrapper -->\n<\/section>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<section class=\"u-bg-light-grey  u-p-y8 u-p-y4@m  t-theme-component-overwrite\" id=\"iconGridBlock\">\n\t<div class=\"o-wrapper\">\n\t\t<div class=\"o-grid\">\n\t\t\t\n\t\t\t<div class=\"u-flex u-width-full c-icon-grid js-icon-grid\">\n\t\t\t    \t\t\t\t\t<div class=\"o-grid__item u-width-1\/3 u-width-half@ u-width-full@s u-m-y4\">\n\t\t\t\t\t\t<div class=\"u-a-center u-c-dark-grey\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- <div class=\"js-equal-height\"> -->\n\t\t\t\t\t\t\t\t<div class=\"\">\n\t\t\t\t\t\t\t\t\t \t\t\t\t\t\t\t\t\t<img decoding=\"async\" class=\"u-m-b3 u-center lazyload\" data-src=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/06\/event-view-icon.png\" \n                                                                             alt=\"Event View\"  src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 45px; --smush-placeholder-aspect-ratio: 45\/45;\"><noscript><img decoding=\"async\" class=\"u-m-b3 u-center\" src=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/06\/event-view-icon.png\" \n                                                                             alt=\"Event View\" ><\/noscript>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-bold\">Event View<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p>Provides a count by location for each IXRS<sup>\u00ae<\/sup> event, adjustment type (if applicable), and reason for adjustment\/change.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t    \t\t\t\t\t<div class=\"o-grid__item u-width-1\/3 u-width-half@ u-width-full@s u-m-y4\">\n\t\t\t\t\t\t<div class=\"u-a-center u-c-dark-grey\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- <div class=\"js-equal-height\"> -->\n\t\t\t\t\t\t\t\t<div class=\"\">\n\t\t\t\t\t\t\t\t\t \t\t\t\t\t\t\t\t\t<img decoding=\"async\" class=\"u-m-b3 u-center lazyload\" data-src=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/06\/summary-view-icon.png\" \n                                                                             alt=\"Summary View\"  src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 55px; --smush-placeholder-aspect-ratio: 55\/55;\"><noscript><img decoding=\"async\" class=\"u-m-b3 u-center\" src=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/06\/summary-view-icon.png\" \n                                                                             alt=\"Summary View\" ><\/noscript>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-bold\">Summary View<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p>Provides the same data as the Events view, but breaks out events, adjustments, and reasons separately. This allows the user to identify trends by location, high\/low performers, or any outliers.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t    \t\t\t\t\t<div class=\"o-grid__item u-width-1\/3 u-width-half@ u-width-full@s u-m-y4\">\n\t\t\t\t\t\t<div class=\"u-a-center u-c-dark-grey\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- <div class=\"js-equal-height\"> -->\n\t\t\t\t\t\t\t\t<div class=\"\">\n\t\t\t\t\t\t\t\t\t \t\t\t\t\t\t\t\t\t<img decoding=\"async\" class=\"u-m-b3 u-center lazyload\" data-src=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/06\/traceability-throughout-supply-chain-1.png\" \n                                                                             alt=\"Transaction Details\"  src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 55px; --smush-placeholder-aspect-ratio: 55\/52;\"><noscript><img decoding=\"async\" class=\"u-m-b3 u-center\" src=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/06\/traceability-throughout-supply-chain-1.png\" \n                                                                             alt=\"Transaction Details\" ><\/noscript>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-bold\">Transaction Details<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p>Provides a detailed view of all IXRS<sup>\u00ae<\/sup> events. Providing details such as: who performed the transaction, on what date\/time, before and after values.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t    \t\t    <\/div>\n\t\t<\/div>\n\t<\/div>\n<\/section>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<!-- TX1 title-image.php -->\n\t\t\t<div class=\"c-box-link-title-image inside center black strip-red standard centre\">\n\t\t\t<div class=\"o-wrapper\">\n\t\t\t\t<div class=\"o-grid u-flex-align-stretch\">\n\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t\t<h2 class=\"u-p-b4 u-a-center\"><p class=\"u-text-26\">Other Almac IRT Boosters<\/p><\/h2>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"o-grid u-flex-align-stretch u-m-b6@m u-overflow-hidden u-overflow-initial@l \">\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article class=\"o-grid__item u-width-6\/12 u-width-full@s\" id=\"\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- Show the correct button based off pop up to show or not -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/clinical-technologies\/irt-boosters\/art-accountability-reconciliation-tracking\/\">\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<header class=\"c-link-box__image lazyload\" \n                                                                        role=\"img\" aria-label=\"\" \n                                                                        style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2023\/06\/ART-CTA-Landing-page.jpg&#039;)\">\n   \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/header>\n\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"c-link-box__content strip-none\">\n\t\t\t\t\t\t\t\t\t\t<div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-m-b2\">ART\u2122 <br> Reconciliation Tracking<\/h3>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"u-m-b2\">\n\t\t\t\t\t\t\t\t\t\t\t\tDrug Accountability and Reconciliation Tracking\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\n\n    <div class=\"  u-m-t-auto \">\n                            <div class=\"c-btn c-btn-secondary c-btn--red\">Find out more<\/div>\n                    <\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<!-- Only show pop up if acf is checked to show it -->\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/article>\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article class=\"o-grid__item u-width-6\/12 u-width-full@s\" id=\"\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- Show the correct button based off pop up to show or not -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/clinical-technologies\/irt-boosters\/archival\/\">\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<header class=\"c-link-box__image lazyload\" \n                                                                        role=\"img\" aria-label=\"\" \n                                                                        style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2024\/03\/2024_02_Website-Thumbnail-Archival-Site-Data.jpg&#039;)\">\n   \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/header>\n\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"c-link-box__content strip-none\">\n\t\t\t\t\t\t\t\t\t\t<div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-m-b2\">Archival Site Data \u2013 Investigator Access<\/h3>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"u-m-b2\">\n\t\t\t\t\t\t\t\t\t\t\t\tProvide designated personnel with the unblinded subject and kit audit trail data at the study closeout.\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\n\n    <div class=\"  u-m-t-auto \">\n                            <div class=\"c-btn c-btn-secondary c-btn--red\">Find out more<\/div>\n                    <\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<!-- Only show pop up if acf is checked to show it -->\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/article>\n\n\t\t\t\t\t\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<article class=\"o-grid o-grid--full\">\n\n\t\t<div class=\"o-grid__item u-width-full u-m-t6 u-m-t4@m u-m-b4\">\n\t\t\t<h2 class=\"u-normal u-a-center\">Latest Resources<\/h2>\n\t\t<\/div>\n\n\t\t<div class=\"u-flex u-flex-justify-center u-flex-wrap u-width-full c-news-panels__slider js-news-panels\">\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/clinical-technologies\/clinical-trials-need-preventive-maintenance-just-like-cars-do\/?utm_campaign=CT_Social_WhitePaper_MattLowrie_Jul22&#038;utm_source=CT_OVERSIGHT&#038;utm_medium=CT_OVERSIGHT\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/07\/Resrouce-banner-Matt-Lowrie.jpg&#039;)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">Clinical Trials Need Preventive Maintenance Just Like Cars Do<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\n\n<!-- <article id=\"related\">\n\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full u-a-center\">\n\t\t\t\t\t\t\t<h3 class=\"u-normal u-m-b4\">Latest Resources<\/h3>\n\t\t\t\t\t<\/div>\n\t\n\t\t<div class=\"u-flex u-flex-justify-center u-flex-wrap u-width-full c-resources__slider js-resources-panels\">\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t<article class=\"c-resources__grid u-width-half u-width-full@m\">\n\t\t\t\t\n\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/clinical-technologies\/clinical-trials-need-preventive-maintenance-just-like-cars-do\/?utm_campaign=CT_Social_WhitePaper_MattLowrie_Jul22&utm_source=CT_OVERSIGHT&utm_medium=CT_OVERSIGHT\" target=\"\">\n\t\t\t\t\t\t<div class=\"c-resources c-overlay__ u-a-center lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/07\/Resrouce-banner-Matt-Lowrie.jpg&#039;)\">\n\t\t\t\t\t\t\t<div class=\"c-resources__gradient-inner\">\n\t\t\t\t\t\t\t\t<p class=\"c-resources__type u-text-small u-bold u-m-b1\"><\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-normal\">Clinical Trials Need Preventive Maintenance Just Like Cars Do<\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/article> -->\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<section class=\"c-cta-panel__gradient c-overlay__black lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/06\/contact-banner.jpeg)\">\n\t\t<div class=\"o-wrapper c-cta-panel__gradient-inner\">\n\t\t\t<div class=\"o-grid o-grid--center\">\n\t\t\t\t<div class=\"o-grid__item u-width-half u-width-full@m\">\n\t\t\t\t\t<div class=\"u-bg-white u-p-x4 u-p-x3@m u-p-y5 u-p-y4@m u-a-center\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<h2>Contact us today<\/h2>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t\t\t<p>See how our technology will surpass your expectations, and experience how our seamless delivery will match your study-specifics regardless of size, phase, or complexity.<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"u-m-t2 c-btn c-btn--red\" href=\"\/clinical-technologies\/contact-us\/\">Contact Us<\/a>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n<\/section>\n\n\n\n\n\n\n\n<style>\n.c-btn2, .c-btn-secondary.c-btn--red, .c-btn-secondary {background-color: #fff; !important}\n.c-event-panels--coloured {background-color: #f3f3f3 !important; !important}\n.c-icon-grid .slick-dots {padding-right: 23px};\n<\/style>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":2230,"parent":2311,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-2148","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>OVERSIGHT Trial Data Integrity Monitoring System - Clinical Technologies<\/title>\n<meta name=\"description\" content=\"Almac&#039;s IRT add-on OVERSIGHT is a Trial Data Integrity Monitoring System that identifies data inconsistencies, protocol deviations, and data integrity issues through audit trail reviews.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"OVERSIGHT Trial Data Integrity Monitoring System\" \/>\n<meta property=\"og:description\" content=\"Almac&#039;s IRT add-on OVERSIGHT is a Trial Data Integrity Monitoring System that identifies data inconsistencies, protocol deviations, and data integrity issues through audit trail reviews.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/\" \/>\n<meta property=\"og:site_name\" content=\"Clinical Technologies\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-10T10:12:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/03\/oversight-web-banner-1-e1648657956155.png\" \/>\n\t<meta property=\"og:image:width\" content=\"694\" \/>\n\t<meta property=\"og:image:height\" content=\"399\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/\",\"url\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/\",\"name\":\"OVERSIGHT Trial Data Integrity Monitoring System - Clinical Technologies\",\"isPartOf\":{\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/03\/oversight-web-banner-1-e1648657956155.png\",\"datePublished\":\"2022-03-31T08:18:45+00:00\",\"dateModified\":\"2025-11-10T10:12:07+00:00\",\"description\":\"Almac's IRT add-on OVERSIGHT is a Trial Data Integrity Monitoring System that identifies data inconsistencies, protocol deviations, and data integrity issues through audit trail reviews.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/#breadcrumb\"},\"inLanguage\":\"en-GB\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-GB\",\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/#primaryimage\",\"url\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/03\/oversight-web-banner-1-e1648657956155.png\",\"contentUrl\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/03\/oversight-web-banner-1-e1648657956155.png\",\"width\":694,\"height\":399,\"caption\":\"Almac IRT Solutions Suite IXRS\u00ae3 IRT Interactive Response Technology platform system add-ons booster OVERSIGHT Trial Data Integrity Monitoring System audit trail reporting\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Clinical Technologies\",\"item\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Interactive Response Technology (IRT) Boosters\",\"item\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"OVERSIGHT Trial Data Integrity Monitoring System\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/#website\",\"url\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/\",\"name\":\"Clinical Technologies\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-GB\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/#organization\",\"name\":\"Almac Group Ltd\",\"url\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-GB\",\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2020\/04\/almac-logo-with-strapline.jpg\",\"contentUrl\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2020\/04\/almac-logo-with-strapline.jpg\",\"width\":643,\"height\":296,\"caption\":\"Almac Group Ltd\"},\"image\":{\"@id\":\"https:\/\/www.almacgroup.com\/clinical-technologies\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"OVERSIGHT Trial Data Integrity Monitoring System - Clinical Technologies","description":"Almac's IRT add-on OVERSIGHT is a Trial Data Integrity Monitoring System that identifies data inconsistencies, protocol deviations, and data integrity issues through audit trail reviews.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/","og_locale":"en_GB","og_type":"article","og_title":"OVERSIGHT Trial Data Integrity Monitoring System","og_description":"Almac's IRT add-on OVERSIGHT is a Trial Data Integrity Monitoring System that identifies data inconsistencies, protocol deviations, and data integrity issues through audit trail reviews.","og_url":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/","og_site_name":"Clinical Technologies","article_modified_time":"2025-11-10T10:12:07+00:00","og_image":[{"width":694,"height":399,"url":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/03\/oversight-web-banner-1-e1648657956155.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Estimated reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/","url":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/","name":"OVERSIGHT Trial Data Integrity Monitoring System - Clinical Technologies","isPartOf":{"@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/#primaryimage"},"image":{"@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/#primaryimage"},"thumbnailUrl":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/03\/oversight-web-banner-1-e1648657956155.png","datePublished":"2022-03-31T08:18:45+00:00","dateModified":"2025-11-10T10:12:07+00:00","description":"Almac's IRT add-on OVERSIGHT is a Trial Data Integrity Monitoring System that identifies data inconsistencies, protocol deviations, and data integrity issues through audit trail reviews.","breadcrumb":{"@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/#breadcrumb"},"inLanguage":"en-GB","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/"]}]},{"@type":"ImageObject","inLanguage":"en-GB","@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/#primaryimage","url":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/03\/oversight-web-banner-1-e1648657956155.png","contentUrl":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2022\/03\/oversight-web-banner-1-e1648657956155.png","width":694,"height":399,"caption":"Almac IRT Solutions Suite IXRS\u00ae3 IRT Interactive Response Technology platform system add-ons booster OVERSIGHT Trial Data Integrity Monitoring System audit trail reporting"},{"@type":"BreadcrumbList","@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/oversight\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Clinical Technologies","item":"https:\/\/www.almacgroup.com\/clinical-technologies\/"},{"@type":"ListItem","position":2,"name":"Interactive Response Technology (IRT) Boosters","item":"https:\/\/www.almacgroup.com\/clinical-technologies\/irt-boosters\/"},{"@type":"ListItem","position":3,"name":"OVERSIGHT Trial Data Integrity Monitoring System"}]},{"@type":"WebSite","@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/#website","url":"https:\/\/www.almacgroup.com\/clinical-technologies\/","name":"Clinical Technologies","description":"","publisher":{"@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.almacgroup.com\/clinical-technologies\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-GB"},{"@type":"Organization","@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/#organization","name":"Almac Group Ltd","url":"https:\/\/www.almacgroup.com\/clinical-technologies\/","logo":{"@type":"ImageObject","inLanguage":"en-GB","@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/#\/schema\/logo\/image\/","url":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2020\/04\/almac-logo-with-strapline.jpg","contentUrl":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-content\/uploads\/sites\/8\/2020\/04\/almac-logo-with-strapline.jpg","width":643,"height":296,"caption":"Almac Group Ltd"},"image":{"@id":"https:\/\/www.almacgroup.com\/clinical-technologies\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-json\/wp\/v2\/pages\/2148","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-json\/wp\/v2\/comments?post=2148"}],"version-history":[{"count":144,"href":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-json\/wp\/v2\/pages\/2148\/revisions"}],"predecessor-version":[{"id":5237,"href":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-json\/wp\/v2\/pages\/2148\/revisions\/5237"}],"up":[{"embeddable":true,"href":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-json\/wp\/v2\/pages\/2311"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-json\/wp\/v2\/media\/2230"}],"wp:attachment":[{"href":"https:\/\/www.almacgroup.com\/clinical-technologies\/wp-json\/wp\/v2\/media?parent=2148"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}