{"id":968,"date":"2019-03-21T14:48:41","date_gmt":"2019-03-21T14:48:41","guid":{"rendered":"https:\/\/blog.clinicaltrials.at\/?page_id=968"},"modified":"2021-09-08T08:54:00","modified_gmt":"2021-09-08T08:54:00","slug":"clinical-monitoring-2","status":"publish","type":"page","link":"https:\/\/clinicaltrials.at\/?page_id=968","title":{"rendered":"Site Management"},"content":{"rendered":"<ul style=\"line-height: 200%;\">\n<li>Ensuring effective coordination and support of different phases of a study project<\/li>\n<li><strong>Operative support<\/strong> of clinical studies in accordance with the protocol, corresponding SOPs, current ICH-GCP guidelines and local law<\/li>\n<li>Preparation and creation of <strong>patient information and informed consents<\/strong><\/li>\n<li>Submissions to national and international <strong>ethics committees and regulatory authorities<\/strong><\/li>\n<li>Maintenance of required documentation archives of sites and sponsor<\/li>\n<li>Oversight of maintenance and distribution of <strong>study specific equipment<\/strong><\/li>\n<li>Performing <strong>evaluation, initiation, monitoring and close-out visits<\/strong><\/li>\n<li>Supporting the sponsor during <strong>documentation of adverse reactions <\/strong>and database maintenance<\/li>\n<li>Maintenance of study specific sponsor systems and their access permissions<\/li>\n<li>Planning, Organisation and conduct of <strong>investigator meetings and workshops<\/strong><\/li>\n<li>Support in contractual matters and payments<\/li>\n<li>Support of sites and sponsor during audits and inspections<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Ensuring effective coordination and support of different phases of a study project Operative support of clinical studies in accordance with the protocol, corresponding SOPs, current ICH-GCP guidelines and local law Preparation and creation of patient information and informed consents Submissions to national and international ethics committees and regulatory authorities Maintenance of required documentation archives of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":63,"menu_order":7,"comment_status":"closed","ping_status":"closed","template":"templates\/template-full.php","meta":{"footnotes":""},"class_list":["post-968","page","type-page","status-publish","hentry","post"],"_links":{"self":[{"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/pages\/968","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=968"}],"version-history":[{"count":5,"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/pages\/968\/revisions"}],"predecessor-version":[{"id":2296,"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/pages\/968\/revisions\/2296"}],"up":[{"embeddable":true,"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/pages\/63"}],"wp:attachment":[{"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=968"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}