Phlexglobal is able to support the training needs of clinical research professionals working within the NHS through a dedicated yet flexible curriculum covering a range of topics:

Good Clinical Practice (for site staff)

• Introduction to GCP and the EU Directives for staff new to the principles of clinical research.
• Two hour update sessions available for those already involved in clinical research.
• Open invites to include mixed groups of investigators, nurses, pharmacists or targeted at specific disciplines or teams.
• Emphasis is on workshop using case studies and real examples of issues to enhance interaction and learning outcomes.

Adverse Event Reporting

• A two hour session to update NHS clinical researchers on the history, and future, of AE reporting.
• Comprehensive definitions and differences for AE, SAE, ADR, and SUSARs, CTIMPs and Non-CTIMPs.
• Understanding the regulations, roles and responsibilities across the clinical research team.
• Uses real examples and discussion of case studies to enhance learning.

Essential Research Nurse

• A one day introduction to the ‘Life of a Research Nurse' for existing Research Nurses who need the confidence that they are doing the right thing, and for those requiring information to move into the role.
• Topics include responsibilities, regulations, consent, trial design, screening strategies, R&D.
• A joint collaboration between Phlexglobal and senior Research Nurses as session leaders.

Inspection Readiness

• General overview, inspection plan/preparation, TMF technical review, interview skills, CAPA. Essential for investigators and research nurses.
• Uses real examples and discussion of case studies.
• Links to AE reporting and monitoring activities.
• Involvement from pharmacy, laboratories, etc, usually encouraged.

Monitoring

• Effective monitoring of non-commercial studies.
• Focuses more on studies that aren't already monitored.
• For NHS Monitors, newly appointed or those about to be monitors, or those doing it as part of their job, e.g. Research Nurses.
• Led by case studies, examples and discussion.
• Focus on eye for detail, SDV, monitoring plans and study conduct.
• Understanding CRF checking and data query loops, reporting standards, documenting and filing.

Transferable Skills

An adjunct portfolio of soft skills training for managers and related, e.g. supervisors, senior nurses, head of pharmacy, radiology, labs, etc.  Core set of ‘business' skills such as project management, dealing with conflict, leading a meeting, coaching/mentoring.  Full day sessions but possible to mix and match attributes within each day, e.g. project management in morning, assertiveness and negotiation in the afternoon, or full days on each. Bespoke design and delivery pertinent to the role(s) of attendees.