Training activity: 6

Details

Explore current clinical trials involving aseptic products and reflect on the impact this will have on practice

Type

Observational training activity (OTA)

Evidence requirements

Evidence the observation or experience has been undertaken by the trainee.

Reflections on the observation or experience at two timepoints including contextualisation to the trainees own practice. E.g., for planned observations, a reflection before the observation and after, or for unplanned events a reflection one day after and another reflection a week later.

Considerations

Considerations are suggestions about what may be useful for the trainee to think about while undertaking a training activity. They should not be considered as a mandatory checklist. Trainees should not be expected to demonstrate or provide evidence for each of the considerations listed.

• Consider elements of the trial including:
  • IMP licensing
  • Role of the Qualified Person
  • Legislation of clinical trials
  • Range of ongoing trials
  • Processes for setting up clinical trial, ongoing management and close out

Relevant learning outcomes

#	Outcome
# 1	Outcome Explore the contribution of the Pharmacy Aseptic Unit to patient care.
# 3	Outcome Describe the working practices of the Pharmacy Aseptic Unit.
# 4	Outcome Examine the impact of innovation in the Pharmacy Aseptic Unit.
# 6	Outcome Compare and contrast the practices of the Pharmacy Aseptic Unit with other areas of the Pharmaceutical Sciences.