SCDM Education Portal

eCRF Design: it’s more than a Piece of Paper!

 

Overview

The most common mistake in creating an eCRF, is to create a paper version of the CRF, and then attempt to copy the design to the Electronic Data Capture (EDC) study build.

 

When we used paper CRFs as data collection methods, they were designed at minimum, for ease of copying information, presentation of a simply designed form, and a logically presented casebook.  We did not have to worry about any of the data validation, as this was always done in the back end.  Yet, one of the most important features of EDC, is the ability to validate data during the data entry process at the site.

 

The validation of the data is going to be dependent on the specific EDC system that is used. There are few commonalities between systems, and knowing which data requires the validation before designing the eCRF layout is an important consideration.  For example, if you want to check the time period between visits, not all systems allow this, and you would then have to have a visit date designated on one form in each visit.

 

Join us in this fast-paced webinar where we review best practice for eCRF design, allowing for a robust eCRF study build leading to cleaner data faster.

 

Learning Objectives

….. understanding how an EDC system affects the design of the eCRF

….  interpreting the features of the EDC system that influence data validation

….. guiding the study team, upfront, to best represent the data for the EDC system in use

 

Who Should Attend:

Beginners and Intermediate; and those preparing to create their first eCRFs.

Participants will benefit from attending this webinar, by learning how to work with EDC systems to create eCRFs that allow for collection of all necessary data, validation during data entry, while creating an intuitive easy to use system for the clinical sites. 

 

Meet the Instructor

Maxine Pestronk, MS,RD,LDN,CCDM

Founder & CEO Passion for Clinical Data Management

Maxine Pestronk has been in the Clinical Trial industry since 1993. Having worked for Contract Research Organizations, EDC Software, Pharmaceutical and Biotechnology companies, Ms. Pestronk has an array of experiences in the field of Clinical Data Management. Many of Maxine's years in the industry were in roles related to training of data managers; reengineering process for conducting studies using EDC systems; and demonstrating the usefulness of quality metric programs. Maxine has been a member of the SCDM Online Courses Committee since 2009, has authored 5 online courses and 2 Webinars. 

Ms. Pestronk has a Master of Science in Computer Information Systems, is a Licensed and Registered Dietitian (RD / LDN) and is proud to be a Certified Clinical Data Manager (CCDM®). 

 

Earn CEUs

Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.

For more information, please contact info@scdm.org