Warwick Clinical Trials Unit
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
Tel: 02476 151377
Fax: 02476 151586
Protocol Feasibility Questionnaire
Tackling Early Morbidity and Mortality in Myeloma: Assessing the benefit of antibiotic
prophylaxis and its effect on healthcare associated infections (TEAMM)
Dear Colleague,
Thank you for taking the time to read the enclosed trial summary.
We would be grateful if you could please complete the attached questionnaire and return it to Jill Waddingham
using any of the contact methods below:
Warwick Clinical Trials Unit
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
Fax: 02476 151586
Email: J.S.Waddingham@warwick.ac.uk
Many thanks.
Yours sincerely,
Mark Drayson
Professor Clinical Immunodiagnostics, Director Clinical Immunology Service
Enc. TEAMM Trial Summary
Protocol Schedule
Consultant
Name:
Specialty:
Address:
Telephone No:
Fax No:
E-mail Address:
Centre Type:
University/Academic Hospital
Community Based Hospital
Specialist Centre
Research Centre
Private Clinic
Other, please specify
Section 1: Patient Population & Recruitment
1.
How many eligible patients would usually
be seen at your site per year?
2.
How many patients from the eligible
population would your site realistically be
able to recruit per month? (please be
realistic as this will help us to determine
logistics of drug supply)
3.
Please list any potential issues which may
impact on the recruitment of this study?
4.
Are you currently taking part in any other
myeloma trials? If yes, please list which
trial(s) and how many patients have been
randomised at your site
5.
How will study subjects be identified at
your site?
6.
Please provide names of any other
physicians that may be interested in
participating in this study?
Multidisciplinary Team meetings
By Research Nurses checking notes pre-clinic
By Senior & Junior oncological staff in new patient clinics
Section 2: Standard of care
7.
8.
Do you routinely treat patients who have
early symptomatic myeloma with
prophylactic antibiotics as standard?
Yes
No
Do you routinely use the same diagnostic
procedures as listed in the protocol
schedule attached? If no, please specify which
Yes
No
procedures you do not undertake as standard and
list any alternative diagnostic procedures
Section 3: Study Logistics
9.
Do you have the necessary facilities and
qualified staff to conduct the TEAMM trial
at your site? If yes, please provide brief
details
10. Can your site comply with the protocol
schedule attached?
11. Does your site have the necessary
resources to take additional samples as
detailed in the protocol schedule?
12. Does your site have experience of working
with central laboratories?
Yes
No
Yes
No
Yes
No
Yes
No
If no, do you foresee any problems with
sending samples to central labs?
13. What is the usual period of time between
receiving the protocol for review and R&D
approval, allowing for internal review
committees?
Would you be interested in taking part in this study?
YES, definitely interested in participation in this study
MAYBE, unsure if I would like to participate in this study
NO, definitely NOT interested in participation in this study
Thank you for taking the time to complete this questionnaire