Managing Safety Monitoring During Clinical Trials

An applied course in clinical trial safety monitoring built around the decisions practitioners actually face.

📍 Abu Dhabi🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points

Course Overview

Clinical staff will work around a process for clinical trial safety monitoring that obstructs care, and they will be right to. In healthcare, a weakness in safety monitoring is eventually paid for by a patient. The programme takes participants through the health and pharmaceutical services discipline end to end, from framing the problem to closing it out. They acquire practical criteria for judging when clinical trial safety monitoring is working and when it is only appearing to. The material serves both public bodies and commercial organisations dealing with this strand of health and pharmaceutical services. The difficulty is not agreeing that safety monitoring matters — it is deciding what to stop doing to make room for it. Practitioner evidence points the same way: clinical trial safety monitoring improves fastest where responsibility for it is named and owned. Participants test their assumptions about safety monitoring against scenarios designed to break weak ones. The programme closes with an action plan for this part of health and pharmaceutical services that each participant writes for their own organisation.

Expected Learning Outcomes

01

Agree the first three actions on clinical trial safety monitoring that will be taken on returning to work.

02

Diagnose whether a problem in safety monitoring is one of design, resourcing or discipline.

03

Protect patient confidentiality and data within clinical trial safety monitoring.

04

Build informed consent and ethics practice into safety monitoring.

05

Design a practical operating method for clinical trial safety monitoring that fits the organisation's size and maturity.

06

Manage the supply chain and cold chain supporting safety monitoring.

07

Apply root cause analysis to adverse events involving clinical trial safety monitoring.

Who Should Attend

01

Infection prevention and control practitioners covering clinical trial safety monitoring.

02

Specialists advising senior management on safety monitoring.

03

Clinical department heads responsible for clinical trial safety monitoring.

04

Health information and records staff supporting safety monitoring.

05

Members of committees that take decisions affecting clinical trial safety monitoring.

06

Accreditation and compliance officers preparing evidence on safety monitoring.

Course Modules

01

Clinical trial safety monitoring: incident reporting, investigation and learning

2 sessions · 8 points

Session 1Reading the current state of clinical trial safety monitoring honestly

  • Confirm patient data handled within clinical trial safety monitoring meets confidentiality obligations.
  • Define acceptance criteria for safety monitoring in advance.
  • Build the internal briefing that explains clinical trial safety monitoring to those affected.
  • Identify infection transmission risks created by safety monitoring and control them.

Session 2Investigating an adverse event involving safety monitoring

  • Build medication safety checks into clinical trial safety monitoring at the point of highest risk.
  • Measure patient experience of safety monitoring and feed it back to the team.
  • Remove steps in clinical trial safety monitoring that add effort without adding assurance.
  • Verify cold chain and storage conditions for materials used in safety monitoring.
02

Safety monitoring: supply, cold chain and availability

2 sessions · 8 points

Session 1Infection risk created by safety monitoring

  • Plan continuity of clinical trial safety monitoring during surge and outbreak conditions.
  • Reduce unwarranted variation in safety monitoring between shifts and sites.
  • Establish what evidence demonstrates clinical trial safety monitoring is under control.
  • Assemble the accreditation evidence pack for safety monitoring.

Session 2Auditing safety monitoring at the bedside, not in the binder

  • Cost clinical trial safety monitoring per episode and identify avoidable waste.
  • Reduce the variation in how safety monitoring is carried out between teams.
  • Decide what will be stopped to create capacity for clinical trial safety monitoring.
  • Compare the cost of safety monitoring with the cost of its absence.
03

Safety monitoring: regulation, licensing and accreditation evidence

2 sessions · 8 points

Session 1What has to be agreed before work on safety monitoring starts

  • Distinguish symptoms from causes when clinical trial safety monitoring underperforms.
  • Match staffing levels on safety monitoring to measured demand across the week.
  • Audit clinical trial safety monitoring by observing practice, not by reading policy.
  • Assign responsibility for keeping documentation of safety monitoring current.

Session 2Choosing indicators for clinical trial safety monitoring that reflect outcome

  • Map the clinical workflow for clinical trial safety monitoring as it is actually performed.
  • Apply structured root cause analysis to the last adverse event involving safety monitoring.
  • Record the rationale for each significant choice made about clinical trial safety monitoring.
  • Prepare the response for the most likely failure in safety monitoring.
04

Safety monitoring: quality indicators and patient outcome

2 sessions · 8 points

Session 1Keeping supply and cold chain reliable for safety monitoring

  • Anticipate the objections clinical trial safety monitoring will raise and prepare the answers.
  • Confirm licensing and regulatory requirements applying to safety monitoring are met.
  • Build the competence framework that supports clinical trial safety monitoring.
  • Define escalation criteria for deterioration detected through safety monitoring.

Session 2The decisions in safety monitoring that cannot be delegated

  • Write down the assumptions underpinning the approach to clinical trial safety monitoring.
  • Define the trigger that would require safety monitoring to be redesigned.
  • Identify single points of dependency in clinical trial safety monitoring and reduce them.
  • Confirm competence and continuing development for staff delivering safety monitoring.

Choose the package that suits you

Silver Package

At least 3 people

USD1,250
  • Workshop or Program Participation
  • Airport Transfers
  • Customized Badge
  • Expert Mentorship (Private Sessions)
  • Supervision & Secretarial Services
  • Accredited Certificate of Participation
  • Complete Training Kit
  • Coffee Break
  • Closing Ceremony

Gold Package

At least 3 people

USD1,850
  • 5-night stay in a 5-star hotel
  • Workshop or Program Participation
  • Airport Transfers
  • Customized Badge
  • Expert Mentorship (Private Sessions)
  • Supervision & Secretarial Services
  • Accredited Certificate of Participation
  • Complete Training Kit
  • Coffee Break
  • Closing Ceremony

Complete your registration

We will contact you within one business day to confirm.