{"id":4046,"date":"2024-01-05T15:03:46","date_gmt":"2024-01-05T20:03:46","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=4046"},"modified":"2024-02-07T14:44:14","modified_gmt":"2024-02-07T19:44:14","slug":"requirements","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/requirements\/","title":{"rendered":"Requirements"},"content":{"rendered":"<h2>Why is study documentation important?<\/h2>\n<p>Study documentation (also referred to as essential documentation, a regulatory file, and\/or site file) serves as evidence to demonstrate the conduct of the research, the quality of the data collected, and the compliance of the Investigator with applicable regulatory and institutional requirements.<\/p>\n<p>In other words, your study documentation should:<\/p>\n<ul>\n<li>Exhibit what took place over the course of the research (i.e., confirm adherence with all study procedures defined in the study protocol approved by the Reviewing Institutional Review Board [IRB]).<\/li>\n<li>Validate the accuracy, completeness and reliability of the data collected; and<\/li>\n<li>Corroborate the compliance of the study team with regulatory and institutional requirements (i.e., confirm adherence with federal regulations, state law and institutional policy).<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Why is study documentation important? Study documentation (also referred to as essential documentation, a regulatory file, and\/or site file) serves as evidence to demonstrate the conduct of the research, the&hellip;<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":4006,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4046","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Study Documentation Requirements - Office for Human Subject Protection - University of Rochester<\/title>\n<meta name=\"description\" content=\"Learn about study document requirements for human subject research, with details for specific types of studies. 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