CRF Design for Data Managers

 

 

Online Course Starts March 28

This asynchronous online course has been designed for anyone directly involved in EDC or paper case report form design, review, development, distribution and archiving for clinical trials. It assumes that learners will have some basic clinical research knowledge and that the course will provide a more expert level of detail in designing case report forms - as well as practice in applying what they learn.

Over four weeks, the course will address general principals, best practices and issues to consider for EDC vs. paper, international trials and standards, and relationship to database structures in all phases of clinical trials.

At the conclusion of the course, learners will be able to:

  1. Describe the importance of a well designed CRF including considerations related to database structure, content, layout and clinical site locations
  2. Explain the impact of CDASH and SDTM on CRF design.
  3. Design, revise and finalize CRFs according to the study protocol and client specifications while adhering to best practices for CRF design
  4. Author essential supporting documentation for CRFs, including Completion Guidelines and Data Entry Guidelines.
  5. List and implement data governance procedures for a Case Report Form standard library.

Course Tuition

$850 members/$950 non-members

SCDM is authorized by IACET to offer 1.6 CEUs for this program.

Register for this Course Registration is now closed.