Driving data capture efficiency

תאריך: יפורסם בהמשך
מיקום הקורס: כפר המכביה, רמת גן
קטגוריה: מומחים מחו"ל
מידע כללי
משך הפעילות: יום לימודים מלא
שעות: 9:00-17:00
עלות: 1,950 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 181006
שפת הקורס: אנגלית
על הקורס

With the stern movement towards faster (more efficient), quality driven data for clinical trials, the industry is looking for unique ways to reduce the time from “patient visit” to “data in the clinical study database”.

Although we have moved at a rapid pace within the management of the data (moving from paper CRF data collection to EDC), we find that many sites are still using paper source. Some have indeed moved over to EMR’s (Electronic medical records), however this does not eliminate the gap in getting the data submitted into the clinical study database. This process is largely manual, transcription from the source (either paper or EMR) into the clinical study database.

Recently, as part of the industry drive, the question has been asked; why not enter the data directly into the study database removing/reducing the need for transcription from traditional source documents? Eliminate transcription by making the clinical study database a source designed database (eSource database) where data is entered during the patient visit (directly into the clinical study database). This effectively takes away the need to transcribe the data, having a significant impact on data collection.

The aim of this course is to discuss the notion of collecting/managing eSource data, what are the challenges the industry faces in making such a significant change, as well as how some of these are being overcome and how others are holding the industry back.

קהל היעד

This course is aimed at anyone in the clinical trials community who is responsible for data oversight and wants to find out more about eSource

  • Clinical site staff
  • Site coordinators
  • Clinical teams (CTAs, CRAs and clinical project managers)
  • Data Managers (management teams, data management project managers and data managers)
התועלת שתופק
  • An over view of eSource data
  • Understanding the reasons for its place in the market and the challenges it brings
  • Working through the adaptions that need to be made to accommodate this data
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • Defining eSource
    • What exactly is eSource data on a clinical trial?
    • Are we already using eSource data?
    • What type of data can/could be eSource?
  • Reasons for using eSource
    • Understanding data capture on a site level
    • When is eSource possible and when not
  • Management of eSource data
    • What makes eSource different?
    • Required adaptations
    • The practical implications
    • Status reporting
    • Challenges
  • Understanding the market
    • eSource vs EDC
    • The challenges in using an eSource approach
    • The limitations
    • The drivers
    • The hesitancies
  • Preparing for eSource data
    • Preparing for eSource data capture
    • Change in our approach
    • Changes in our processes
    • Additional considerations
אודות המרצה

Ms. Tanya du Plessis

M.Med.Sc, the University of the Free State/Universiteit van die Vrystaat (South Africa).
Vice President, Data strategies and solutions at Bioforum the Data Masters
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