In clinical research landscape, effective data management is crucial for ensuring data quality, integrity, compliance, and the success of clinical trials. Clinical data management (CDM) bridges science, technology, and regulatory requirements to create reliable, analyzable data that supports critical healthcare decisions.
In this course, critical concepts and practical methods to support planning, collection, storage, and dissemination of data in clinical research will be presented. It’s imperative to note that, understanding and implementing solid data management principles is critical for any scientific domain. Regardless of participants’ current (or anticipated) role in the research enterprise, a strong working knowledge and skill set in data management principles and practice will increase your productivity and improve your science. The goal of this course is to use these modules to help participants learn and practice their skill set. The course will offered through practical lessons, short quizzes, and hands-on exercises while exploring best practices for data management.
Participants who successfully complete the course will receive Certificate of Participation.
Course Objectives
At the end of this course the participants will gain the following skills:
- Survey Design
- Data Collection
- Data Management
- Clinical Data Management
Duration
5 days
Who Should Attend
This course is suitable to the following:
- Clinical Research Coordinators (CRCs)
- Clinical Data Managers
- Clinical Research Associates (CRAs)
- Principal Investigators (PIs)
- Regulatory Affairs Professionals
- Data Analysts and Biostatisticians
- Research Assistants and Study Nurses
- Health care professionals – nurses, psychologists, paramedics, technicians, health assistants, nutritionists, social workers and support personnel
- Anyone involved in clinical trial operations and data management
Course Content
Module 1: Foundations of Clinical Data Management
- Overview of Clinical Research and Trial Phases
- Role and Importance of Data Management in Clinical Trials
- Introduction to Good Clinical Practice (GCP) and Regulatory Requirements
- Data Management Plans (DMP): Purpose and Components
- Setting Up a Clinical Data Management System
Module 2: Data Collection and Case Report Form (CRF) Design
- Principles of CRF Design: Best Practices
- Paper CRFs vs Electronic Data Capture (EDC) Systems
- Building CRFs: Avoiding Common Pitfalls
- Clinical Database Setup and Configuration
- Source Data Verification and Source Document Management
Module 3: Data Validation, Cleaning, and Quality Assurance
- Data Validation Principles
- Query Management: Identifying, Raising, and Resolving Data Queries
- Discrepancy Management Workflows
- Audit Trails and Data Traceability
- Metrics for Monitoring Data Quality and Timeliness
Module 4: Regulatory Compliance, Standards, and Risk Management
- Regulatory Requirements: ICH-GCP, FDA 21 CFR Part 11, GDPR, HIPAA
- Risk-Based Monitoring (RBM) and Risk Management in Data Handling
- Data Standards: CDISC, SDTM, ADaM Overview
- Privacy, Security, and Confidentiality in Clinical Data
- Preparing for Data Audits and Inspections
Module 5: Data Analysis Readiness and Closing the Data Management Lifecycle
- Data Lock and Freeze Procedures
- Preparing Clean Datasets for Statistical Analysis
- Final Data Reconciliation and Reporting
- Lessons Learned: Real-world Case Studies in Clinical Data Management
- Group Exercise: Drafting a Mini Data Management Plan (DMP)
- Course Wrap-Up and Final Q&A Session
GENERAL NOTES
- The instructor led trainings are delivered using a blended learning approach and comprises of presentations, guided sessions of practical exercise, web-based tutorials and group work. Our facilitators are seasoned industry experts with years of experience, working as professional and trainers in these fields.
- The participants should be reasonably proficient in English as all facilitation and course materials will be offered in English.
- Upon successful completion of this training, participants will be issued with a certificate.
- The training will be held at Kincaid Training Centre. The course fee covers the course tuition, training materials, two break refreshments and lunch.
- All participants will additionally cater for their, travel expenses, visa application, insurance, and other personal expenses.
- Accommodation and airport pickup are arranged upon request. For reservations contact the Training coordinator at Email: training@kincaiddevelopmentcenter.org or Tel: +254 724592901
- This training can also be customized to suit the needs of your institution upon request. You can have it delivered in our Kincaid Training Centre or at a convenient location.
For further inquiries, please contact us on Tel: +254 724592901 or send mail to training@kincaiddevelopmentcenter.org
Payments are due upon registration. Payment should be sent to our Bank account before commencement of training and proof of payment sent to training@kincaiddevelopmentcenter.org