24.90 per module

Design your clinical research training course

24.90 per module

Design the training you want

Combine our training modules to build your personalized training plan!

Select from a range of our most popular training course modules and create a training plan that truly meets your personal requirements. Each module comes with E-learnings, Practice assignment, a Test and a Certificate.

All modules are self paced, 100% online and you can start immediately and got 12 months access to your training content.

From our Clinical Research Associate Training Course

  • Background of medicines development
  • Research and discovery stage & product development
  • Clinical development
  • Regulatory submission, Health Technology Assessment, lifecycle management
  • ICH GCP and other applicable regulations
  • Applicable international and national regulations
  • ICH GCP E6 (R2)
  • FDA Regulation
  • Quality Assurance: Audits and Inspections
  • The Study Protocol
    • Elements of a Study Protocol according to ICH GCP
    • Trial Design
    • Methodologies
  • Roles and Responsibilities
    • Ethics Committees
    • Sponsor / Monitor
    • Investigator
    • Competent Authority
  • Selecting an Investigational Site
    • Assessing Investigational Sites
    • Training and Upgrading Investigational Sites
  • Initiating Investigational Sites
    • Organizing the Initiation Visit
    • Setting up the required documentation – Essential Documents
  • Effective Monitoring
    • Planning, Conducting, Documenting, and Reporting Monitoring Visits
    • Managing Issues
  • Closing Investigational Sites
    • Organizing the Close-Out Visit
    • Documentation
    • Reporting
  • Patient Protection
    • Patient Information
    • Collecting Patient Consent
    • Special Patient Populations
  • Adverse Event Reporting
    • Types of Adverse Events
    • Identifying and Reporting Serious Adverse Events
  • Definition of investigational medicinal product (IMP) / study drug
  • Provision of the IMP
  • Drug Accountability
  • Randomization, blinding and un-blinding processes
  • Managing Expiry Dates
  • Collecting IMP after Site Close-out
  • Data Collection
    • Clinical Research Form (CRFs)
    • Process of Data Collection
    • Data Collection Systems
  • Data Validation
    • Data validation process
    • Query Process
    • Data Quality Assurance

From our Study Start Up Specialist Training Course

  • SSU structure, responsibilities and involvement in project life-cycle
  • Main groups of core study submission documents
  • Core documents required for submissions
  • Documents development responsibilities
  • Core submission package
  • Critical path for efficient start up
  • Main regulatory bodies and their responsibilities
  • Submission strategies and dependencies (main groups on diagrams)
  • Submissions and approval timelines
  • Comments, conditional approvals, rejections

From our Clinical Project Management Training Course

  • Get familiar with project management terminology.
  • Define project success criteria.
  • Set up project phases correctly.
  • Choose fitting tools to manage a project.
  • Communicate efficiently while managing a project.
  • Understand typical differences between the PM’s role depending on the company type.
  • Understand the stakeholder landscape.
  • Analyse stakeholders.
    Identify key stakeholders.
  • Communicate successfully with different stakeholders choosing adequate style, frequency, and the level of detail.
  • Understand the project external and internal environment.
  • Assess how the environmental factors affect the project.
  • Define requirements to make the project a success story.
  • Define the project scope.
  • Build a strong project definition.
  • Obtain the approval for your project definition.

From our Monitoring Oncology Studies Training Course

  • Be able to discuss Oncology trial schematics and understand the design features.
  • Be able to describe the four phases of Oncology studies.
  • Understand Endpoint requirements in Oncology.
  • Be able to discuss recruitment challenges in Oncology studies.
  • Describe the screening and enrollment process.
  • Understand the role of the medical monitor and various key members during screening process.
  • Distinguish between RECIST 1.0 and RECIST 1.1.
  • Utilize appropriate oncology disease progression algorithms.
  • Understand disease progression.

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"The VIARES Academy training has been exceptional - VIARES' investment in their students goes above and beyond."
Khilna S VIARES Clinical Research Associate Training Course Graduate
Khilna S
VIARES Graduate