ONLINE COURSE · October 24 - November 20, 2022
Data Quality in Clinical Research
- Orientation Session: October 18, 2022
- Pre-Course Activities: October 21 - 23, 2022
- Session Overview: This course will provide you with insights, tools and new skills development to control quality in clinical data management.
OverviewThis four-week asynchronous course will provide you with insights, tools and new skills development to control quality in clinical data management. Over four weeks, the course will address general principles, best practices and issues in data quality management.
What You'll LearnBy the end of the Course, participants should be able to:
Module 1: Defining Poor Data Quality and Understanding its Impact
- Data vs. Information and Multidimensional definition of information quality
- Impact of poor data quality in study operations and analysis
- Data as an asset and data value quantification
- Clinical data management quality system
- Information Quality CMM
Module 2: Outlier & Discrepancy Identification and Handling
- Data cleaning and discrepancy identification
- Five approaches to identifying discrepancies
- Categories of accuracy and detectability
- Types of discrepancy checks
Module 3: Planning and Conducting Database Audits
- Good auditing practices; Audit Scope, types of audits, and audit Basis; Audit plan, agenda, and opening meeting.
- Database Audits: Scoping a Database audit; Conducting a Database audit.
Module 4: Summarizing and Responding to Database Audits
- Summarizing and communicating database audit observations and findings
- Calculating a database error rate
- Performing Root Cause Analysis andformulating corrective actions
- Responding to audits
Intended AudienceThis course is intended for all clinical data managers responsible for management and control of data quality in clinical trials. There are no course pre-requisites. Participants should be able to dedicate 8 to 10 hours per week to complete the assignments.
Meet the Instructor
PhD. CCRP, President of FB2D Clinical Research Consulting Inc.Over the course of her multi-faceted 23 year career, she has worked in international pharmaceutical companies, CROs as well as academic international oncology group, in Europe and Canada. She has experience in the field of biostatistics, data management and medical writing as well as process improvement (quality assurance), applied in a vast array of therapeutics areas from Phase II to Phase IV, and observational studies. Dr. Dabouz has a strong experience in training investigators, study coordinators, nurses, project managers, CRAs, administrative assistants, QA and data managers, IT, as well as statisticians covering all data aspects, mainly demystifying statistics in clinical trials. Dr Dabouz has a PhD in statistics and certified SOCRA. This certification allows being closer to clinical sites and working with investigators’ teams in improving data quality/integrity at the source.
- $1020 for Members
- $1140 for Non-members
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.
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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