{"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":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-4246","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"text","anchor":"","css_class":"","title":"

    Definitions: Source documents and source data<\/h2>","content":"Source documents are \u2018original<\/em> documents, data and records\u2019 and include documents such as hospital records, laboratory reports, academic records, memoranda, subject diaries, assessment measures, and pharmacy dispensing records. Source data is the information recorded in a source document, such as clinical findings and observations.[1]<\/sup><\/a>\r\n

    examples of source documents and corresponding source data<\/h4>\r\n[ninja_tables id=\"4236\"]","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"

    What's the difference between a source document and a data collection tool?<\/h2>","content":"Data collection tools (also referred to as Case Report Forms [CRF]) are paper or electronic forms\/instruments that are used to facilitate the collection of data. Depending on the nature of the research, you might use a data collection tool to:\r\n\r\nA.<\/strong> Record original<\/em> data, e.g., an investigator measures a subject\u2019s grip strength using a hand dynamometer and records the measurement;\r\n\r\nB.<\/strong> Record data that was originally collected for another purpose (outside the context of the research), e.g., a study coordinator records a blood pressure measurement from the medical record; or\r\n\r\nC.<\/strong> Record data that was collected for study purposes from another study-specific source, e.g., a research assistant records the total carbohydrate, fat and protein grams consumed by a subject based on what the subject recorded in their the food diary.\r\n\r\nDepending on how a data collection tool is used, it may or may not be considered a source document.\r\n\r\nIn Item A above, where the investigator records the subject\u2019s grip strength, the data collection tool is the original (first) source of documentation of the data. Therefore the data collection tool would also be considered the source document.\r\n\r\nWhereas in Items B and C, the data collection tool would not<\/em> be consider the source because it is not where the data was originally documented (respectively, the medical record and food diary are the source documents).","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"text","anchor":"why","css_class":"","title":"

    Why does it matter?<\/h2>","content":"A key attributes of \u2018good\u2019 study documentation<\/a>, as identified in the ALCOAC standard, is maintaining original<\/em> documentation (i.e., source documentation).\u00a0This is because original documentation provides accurate<\/em> information (accuracy being another key attribute of study documentation), which ultimately effects the precision with which a study team is able to test hypotheses and meet the aims of the research.\r\n\r\nTherefore, during the planning phase of the research, study teams need to carefully consider:\r\n
      \r\n \t
    1. How study procedures will be documented; and<\/li>\r\n \t
    2. How the data flows from the subject to the study database.<\/li>\r\n<\/ol>\r\nGenerally, it is best practice to consider each<\/em> data point(s) from each study procedure independently and determine what each corresponding source document is.\r\n\r\nSome procedures, by virtue of their conduct, will result in corresponding source documentation\u2013e.g., a blood sample that gets sent to a certified laboratory for analysis will result in a lab report or a survey\/assessment form gets completed. The same is true when pre-existing data is collected from routine procedures performed outside the context of the research\u2013e.g., collecting current medications maintained in the medical record or a standardized test score maintained in an academic record.\r\n\r\nSome procedures, on the other hand, will require the creation of study-specific records in order to document the conduct of the procedures and resulting data. It is best practice to make maximum use of original source documentation (i.e., documentation that exists by virtue of the conduct of the procedure) and create study-specific documentation only for:\r\n
        \r\n \t
      1. procedures lacking an original source (e.g., verbal assessments of eligibility criteria, interviews, or other study-specific procedures); or<\/li>\r\n \t
      2. to support compliance (e.g., study checklists).<\/li>\r\n<\/ol>\r\nStudy teams should also try to avoid unnecessary duplication of documentation (e.g., recording the results from a lab report into additional CRFs and then into an electronic database) when possible in order to avoid transcription and data entry errors. [3]<\/sup><\/a>","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"references","classes":"","title":"

        Additional details<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"FDA-regulated research","icon":"","row_content":"The \u2018good\u2019 documentation attributes identified above<\/a> (original and accurate) are specifically identified as investigator responsibilities related to the maintenance of study records in guidance applicable to research regulated by the Food & Drug Administration (FDA). FDA<\/a> (2018) and International Council for Harmonization (ICH) Good Clinical Practice<\/a> (2016) guidance specifically states:\r\n