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 principles, 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.
What You'll Learn
At the conclusion of this program, attendees will be able to:
- Describe the importance of a well designed CRF including considerations related to database structure, content, layout and clinical site locations
- Explain the impact of CDASH and SDTM on CRF design
- Design, revise and finalize CRFs according to the study protocol and client specifications while adhering to best practices for CRF design
- Author essential supporting documentation for CRFs, including Completion Guidelines and Data Entry Guidelines
- List and implement data governance procedures for a Case Report Form standard library
Meet the Instructor
Denise Redkar-Brown is the Principal at Sunburst Clinical Solutions dedicated to consultation in the area of Clinical Data Management training and auditing capabilities. Her last assignment in the corporate area was as Director of Scientific Affairs, Data Management at Cetero Research in Fargo, North Dakota. She is also a frequent contributor to the GCDMP and former chair of the SCDM Online Course Committee. Denise began her career as a Medical Technologist working in a hospital laboratory environment. She made the transition to the pharmaceutical industry, and after more than 20 years, she has held positions in basic and clinical research. She is published in the European Journal of Pharmacology for her work in Pharmacology while at AstraZeneca and contributed to the successful submission for Accolate®, the first leukotriene antagonist for asthma therapy as well as other drugs and vaccines. Her latest publication was in the Good Clinical Practices journal (GCPj) in 2008 describing the evolving role of Clinical Data Managers.
$1020 members/$1140 non-members
Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the course start date. If cancellation occurs by the end of week one of the course, students will be allowed to apply 50% of the course fee to the next offering of the same course. No refunds will be offered after that time.
SCDM is authorized by IACET to offer 1.6 CEUs for this program.