{"id":4246,"date":"2024-01-05T16:16:17","date_gmt":"2024-01-05T21:16:17","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=4246"},"modified":"2024-02-07T14:49:46","modified_gmt":"2024-02-07T19:49:46","slug":"source","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/source\/","title":{"rendered":"Source Documents and Source Data"},"content":{"rendered":"

Study documentation 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

One type of study documentation that study teams need to maintain is documentation to support protocol adherence (reference study documentation requirements<\/a> and OHSP Policy 901: Investigator Responsibilities<\/a>).<\/p>\n

This type of study documentation should demonstrate:<\/p>\n

    \n
  1. that you completed the procedures defined in approved protocol, in the manner defined by the approved protocol; and<\/li>\n
  2. the integrity of the data collected.<\/li>\n<\/ol>\n

    This responsibility is typically met through that maintenance of \u2018source documents\u2019 and data collection tools (also referred to as case report forms).<\/p>\n

     <\/p>\n","protected":false},"excerpt":{"rendered":"

    Study documentation 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","protected":false},"author":36,"featured_media":0,"parent":4006,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4246","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nSource Documents and Source Data - Office for Human Subject Protection - University of Rochester<\/title>\n<meta name=\"description\" content=\"Reference definitions of source document and source data, and understand key usages and differences for study documentation. 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