{"product_id":"source-documentation-what-is-adequate-and-accurate-2027-01-21","title":"Source Documentation: What is Adequate and Accurate?","description":"\u003cp\u003e \u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e \u003cp\u003eLack of adequate and\/or accurate source documentation has been noted as a common deficiency in inspection findings of Clinical Investigators, andregulators report that quality source documents reinforce quality site data. Regulatory requirements (FDA, ICH) will be reviewed in this web seminar. Further, the following topics will be covered: Variability of stakeholder requirements (sponsor-to-sponsor, per study, sponsor to site), case report forms (CRFs) as source data, electronic medical records, shadow charts, source document worksheets, protocol deviations, telephone and email contacts, good documentation practices, making corrections to source documents, late entries, back-dating (oh no!), and details of FDA inspection methods and findings regarding source documents. Leading practices will be discussed to assist sites with implementing the regulatory requirements for source documents.\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eVideo Preview\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eDefine source data and source documents\u003c\/li\u003e \u003cli\u003eIdentify regulatory required characteristics of source data and source documents\u003c\/li\u003e \u003cli\u003eIdentify three attributes of source document worksheets\u003c\/li\u003e \u003cli\u003eDescribe three attributes of ALCOAC (attributable, legible, contemporaneous, original, accurate, complete) for source documents\u003c\/li\u003e \u003cli\u003eDiscuss CRFs as source data\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eSite Research Directors\/Managers\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003ePrincipal Investigators\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associate Managers\u003c\/li\u003e \u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eInstructor\u003cspan\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003eMarla Hoelle, R.N., B.S.N., C.C.R.A.-PM., P.M.P.\u003c\/p\u003e \u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"\/pages\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003e \u003c\/p\u003e \u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003e\u003cspan\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/span\u003e\u003cb\u003e\u003cspan\u003e\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375364366701,"sku":"BI17635","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/source-documentation-what-is-adequate-and-accurate-2027-01-21","provider":"Barnett International ","version":"1.0","type":"link"}