Triticon Training Programs
TriTiCon Provides training in Clinical Development, primarily focused on systems used in clinical trials and Clinical Data Management. Our training program is comprised of a series of individual modules, organized in themes, to provide full flexibility so you can tailor the training to suit your needs.
The training is available as “mix & match” (select any combination of modules) or as pre-defined courses (defined set of modules for different objectives and target audiences). The “mix & match” option is available as self-service (eLearning), whilst the pre-defined courses has both a self-service and instructor lead option. Read more on the About Training page.
OVERVIEW OF TRAINING THEMES AND MODULES
THEME A
CLINICAL DATA MAMAGEMENT
- Clinical development stages, objectives and outcomes
- The basics of clinical trial design and statistics
- Clinical data collection & the role of clinical data
- Clinical development functions
- The role and objectives of clinical data management
- Clinical data management ABC
- Set-up (planning, eCRF Set-up and UAT, handling of external data)
- Conduct (data review and cleaning, status management)
- Close out and delivery (database lock, data management deliveries, archiving)
- Planning, start-up activities and timelines
- Typical data management documents
- eCRF design and set-up
- ePRO / eCOA, handling of external data
- System specifications and UAT
- Data cleaning and query management
- Data review and monitoring
- Handling of external data, reconciliation
- Residual data issues, protocol deviations
- Status management
- “Clean file” checkpoints
- Database lock and release
- Data management deliverables
- Archiving and close out
THEME B
MANAGING DATA MANAGEMENT
- Changes, trends and challenges in clinical data management, including topics like, distributed/virtual clinical trials, dynamic/adaptive trials, new types of data sources, sourcing and oversight, and from data management to data science.
- Sourcing models (services and systems)
- Sourcing options and key considerations for sourcing data management services and systems
- Vendor contracting and oversight basics
- Oversight in data management
- Definitions of clinical data quality
- Data quality risks management
- Data quality planning and responsibilities.
- Data quality monitoring, quality controls
- Bias and fraud
- Overview of industry standards
- Standards management/governance
- Standards in action. Getting standards to work in your favour and as an enabler rather than a constraint
- The changing role of the data manager. Future responsibilities and key skills
- Data management within the organization (from sponsor and CRO perspective)
- Ownerships and responsibilities
- Stakeholder and expectations management
- The role of a department/team business plan. Suggested components and considerations
- Processes monitoring and continuous improvement methods
THEME C
CLINICAL SYSTEMS AND CLINICAL DATA HANDLING
- Overview of clinical systems (role, scope, key functionalities, handled data, users)
- Typical data flow and data/information touch-points (related / redundant data)
- The basics of system validation
- Overview of clinical data sources and data flow
- System data/information “touch-points”
- Data flow models and key considerations
- Specific cases: SAE-data, lab-data, ePRO, IRT vs EDC
- Consolidated data for medical monitoring, oversight and trial management
- Basic and “2nd level” system modules
- System and vendor categories
- Key considerations and differentiators
- Best practice for EDC/eCRF configurations and trial set-up
- Introduction to patient/observer reported data (Validated instruments, regulatory requirements)
- Set-up process and timelines, requirements for CTA/EC/IRB submissions, translations and instrument validity
- Monitoring and compliance management
- Technology and Vendor categories and considerations
- Real life challenges and pit-falls
- Set-up activities, best practice design, UAT
- Data handling, deviation handlings
- Close out / archiving
- System (and vendor) selection, recommended methodology/steps
- System implementation, recommended approach and key considerations
- System validation in practice
THEME D
LEADERSHIP, STRATEGY AND
ORGANISATION
ORGANISATION
- Clinical systems choices and strategies – for your company needs
- System vs. service selection.
- Own versus trial-by-trial sourcing considerations
- Definitions and regulatory requirements
- The oversight process
- Structuring and planning your oversight
- Oversight conduct and documentation
- Do’s and don’ts, practical recommendations
- Definitions, regulatory requirements
- Risk Management in practice: making regulatory requirements and business benefits meet
- Suggested risk assessment areas, methods and processes
- Navigating the cross-functional world
- The benefits and challenge of “responsibility splitting”
- Leading specialists
- Training and learning in the 2020’s
Download overview in pdf-format here
PRE-DEFINED COURSES
Pre-defined courses have self-service or instructor lead options (registration link below). Contact us for courses further tailored to your specific needs. Download course description in pdf format here .
Pre-defined Options
Questions? Just email us or use the contact form.