A Feasibility study for real time reporting of adverse events
Research type
Research Study
Full title
A Feasibility study for the real time reporting of adverse events in an oncology clinical trial setting
IRAS ID
224078
Contact name
Michelle Harry
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
The research is looking at whether real time reporting of adverse events would be feasible and effective in the data collection and reporting of adverse events experienced by participants who are on an oncology clinical trial. The research is important as it will identify any discrepancies in real time reporting of Adverse events and the method of collection used at present, this would potentially provide sponsors with more accurate data on toxicities experienced by patients, and provide a robust reporting procedure ensuring accurate validated data.
The participants will be recruited from those already on an oncology clinical trial. They will need to have at least 2 cycles of chemotherapy remaining in their treatment pathway.
The study will be conducted at the Queen Elizabeth Hospital, Birmingham.
The study will last 12 weeks from the date the last participant is recruited.
Once the data has been analysed the findings will be submitted as part of the CI's dissertation. Documents collected will be held securely for 10 years as per the University of Birmingham code of practice.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0051
Date of REC Opinion
8 Feb 2018
REC opinion
Favourable Opinion