Data Quality in Clinical Research
September 9 – October 6, 2019
This 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 LEARN
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
- General Audits
Good auditing practices
Audit Scope, types of audits, and audit Basis
Auditor and auditee responsibilities
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 and formulating corrective actions
- Responding to audits
WHO SHOULD ATTEND
This 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 INSTRUCTORS
Denise Redkar-Brown, MT is the Principal at Sunburst Clinical Solutions dedicated to consultation in the area of Clinical Data Management training and auditing capabilities. She is also Senior Director, Data Management at Inflamax Research in Mississauga, Canada. Denise is a frequent contributor to the GCDMP and chairs SCDM’s Committee on Electronic Learning.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.
Farida Dabouz, PhD. CCRP, is the president of FB2D Clinical Research Consulting Inc., a consulting company.
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.
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.
Participants are eligible to receive CEUs upon successful completion of the course.
SCDM is authorized by IACET to offer 4.0 CEUs for this program.