ONLINE COURSE - POSTPONED - 2024 dates to be announced soon
- Session Overview: This asynchronous online course has been designed for anyone directly involved in EDC or paper case report from design, review, development, distribution and archiving for clinical trials.
OverviewThis asynchronous online course has been designed for anyone directly involved in EDC or paper case report from 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 LearnBy the end of the course, participants should 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.
- $1020 for Members
- $1140 for Non-members
Participants will receive a full refund if notice is provided in writing via 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.
Meet the Instructor
Maria del Pilar Rodriguez
Operations Lead/GDMS-GDO, MSDMaria del Pilar Rodriguez has 14 years of experience in Data Management. She holds a MSc in Clinical Trials from the University of London, and a B.Sc. degree in Chemistry from Universidad Pedagógica Nacional, in Bogotá, Colombia. She joined MSD in 2009 as a Lead Clinical Data Manager and afterwards, she has held different positions with increased level of responsibility including Data Management Subject Matter Expert and Trainer of new CDMs. Additionally, Pilar supported the organization in the role of Study Designer within the Oncology area where she was responsible to support trial design - including new components and existing library components- as per protocol/trial design and Industry Standards as well as monitoring and support of ongoing change control as needed. More recently she started to support the organization in strategic projects focused in Quality aspects and Customer Satisfaction.
Earn CEUsParticipants are eligible to receive CEUs upon successful completion of the course. SCDM is authorized by IACET to offer 4.0 CEUs for this program.
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