T & M Paediatric Vaccine UK
Research type
Research Study
Full title
Time and Motion Study of Vaccine Administration in Paediatrics in United Kingdom
IRAS ID
171097
Contact name
Nicholas Jones
Contact email
Sponsor organisation
GlaxoSmithKline (GSK) Biologicals S.A.
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
This is a multi-site, prospective, single-arm, non-interventional time and motion (T&M) study to be conducted in 6 sites performing paediatric vaccinations in the UK. HCPs who are directly involved in vaccine administration at each site are the subject of these observations. Trained “observers” (i.e. qualified site personnel ideally not involved in the day-to-day vaccine administration process) will record time for pre-specified tasks using a stopwatch as well as the time of day [military time; (HH:MM, in 24-hour notation] when guardian/subject enter/leave the GP practice and record the time on paper Case Report Forms (CRFs).
The study will not require that subjects undergo any additional medical intervention, test, or procedures. No investigational product or other medication will be evaluated through this study. The study primarily focuses on measuring time required to perform pre-specified tasks, rather than directly observing subjects.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
15/ES/0013
Date of REC Opinion
14 Jan 2015
REC opinion
Favourable Opinion