Training activity: 7

Details

Explore a current clinical trial involving manufacture of 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

• Reflect on the impact this will have on practice 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
  • Blinding arrangements

Relevant learning outcomes

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