Managing a Hybrid (Paper-EDC) Study - Challenges and Learning

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The paper case report form (CRF) is a preferred way of data capture for small size or fast track studies. However, there are occasions where a hybrid study needs to be designed or a transition from paper to electronic data capture (EDC) is sought. Increase in number of patients and sites to real time monitoring of data, the reasons for this may vary.

To design a database which will accommodate both paper and EDC CRF is challenging as a hybrid database needs to address specific technical requirements of each mode of data capture and at the same time be user friendly for the sites.

Key Learnings from the Session

  • Challenges and mitigation strategies for hybrid studies
  • Managing the basic differences between paper and EDC using a case study

Who Should Attend?

  • Data management professionals
  • Clinical operations professionals
  • Industries, sponsors or site personnels

Speaker Profile

Dr. Swati Tare

Manager – Clinical Data Management

A biochemist by education (Ph.D), Swati has about 18 years of industry experience in pharmaceutical and clinical research area. She has worked with pharma companies like Hoechst Marion Roussel, Nicholas Piramal and Glenmark, and has successfully handled projects on data migration, hybrid studies (paper – RDC), fast track studies in data management and screening assays for new chemical entities for diabetes.