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

  •  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

Introduction to today’s data management

Objectives: To provide participants with a basic understanding of the role and objectives of data management (DM) in today’s clinical trials and help them establish a comprehensive base knowledge of Clinical Data Management.

Target Audience: Participants with little or no experience in DM, Intermediate Data Managers who want to expand and update their knowledge in this field, Non-Data Managers who are wanting to understand the basics of DM for example sourcing, trial management, line management or QA activities.

Instructor-Led Option:
Duration / Date: 2 days, Spring 2023 
Cost: DKK 9,000, €1,215, US$1,350

Data Management – In depth

Objectives: To strengthen participants capability to independently lead and drive DM activities and interact with external stakeholders. Furthermore, to increase in-depth understanding of DM processes and systems, to work with process and system improvement and to work with company/program level activities.

Target Audience: Data Managers who want to both widen and deepen their understanding of DM plus develop their capability to lead DM teams and manage CROs. Furthermore, those who want to initiate improvement and change initiatives within the company.

Instructor-Led Option:
Duration / Date: 2 days, Spring 2023 
Cost: DKK 9,000, €1,215, US$1,350

Managing Clinical Systems

Objectives: To provide participants with a thorough understanding of the clinical systems landscape, the role of the different systems and overlaps and relations in functionality and system data scope. Further, to understand different options for how to design an overall company or trial solution.  Finally, the typical service and system provider categories and key selection criteria will be discussed.

Target Audience: Clinical System Managers or similar roles. Data Managers, DM team leads, or Line Managers with a clinical systems responsibility or interest.  IT Business partners or IT project Managers working with Clinical Systems.

Instructor-Led Option:
Duration / Date: 2 Days, Spring 2023 
Cost: DKK 9,000, €1,215, US$1,350

Managing Data Management

Objectives: To provide tools for managing and optimizing data management processes. To develop sourcing, processes and system strategies.

Target Audience: Sr Data Managers, DM team leads, Functional Managers and Line Managers with DM as an area of responsibility who are looking to develop their capability to lead and develop a DM unit and/or improve sourcing and oversight capabilities.

Instructor-Led Option:
Duration / Date: 2 days, Spring 2023 
Cost: DKK 12,000, €1,650, US$1,800

Introduction to eCOA / ePRO

Objectives: To provide a basic understanding of the processes, technology and regulatory requirements for eCOA/ePRO. To strengthen the participants ability to evaluate and select and manage ePRO/eCOA provider(s). Further, to give an end-to-end introduction to the typical sponsor/CRO role in eCOA/ePRO, with topics like good design principles, UAT, compliance management, monitoring and data handling.

Target Audience: Data Managers, Trial Managers and Vendor Managers wanting to improve their understanding of ePRO/eCOA process and technology in order to manage services/ providers and/or develop or enhance related internal processes.

Instructor-Led Option:
Duration / Date: 1 day, Spring 2023 
Cost: DKK 5,300, €715, US$825

Data Management for non-Data Managers

Objectives: To provide participants with a basic understanding of the role and objectives of data management (DM) in today’s clinical trials and help them establish a comprehensive base knowledge of Clinical Data Management.

Target Audience: Trial Managers, CRAs, Statisticians, Safety, Medical monitors and other clinical developments roles related to data management.

Instructor-Led Option:
Duration / Date: 1 day, Spring 2023 
Cost: DKK 4,800, €650, US$740

Questions? Just email us or use the contact form.