International IDU Study - Site Feasibility Assessment
A phase IV multicentre, international trial of response guided treatment with directly observed pegylated interferon alpha 2b and self-administered ribavirin for patients with HCV genotype 2 or 3 infection and ongoing injection drug use.
1 - Site Principal Investigator - Contact Details
2 - Site Data
In your opinion, does your sites have the interest, time, resources and staff to conduct this trial based upon the current protocol?
Yes
No (end -please click on 'Submit' at the bottom of the page)
How many treatment naive genotype 2/3 patients do you have in your database?
(enter number only)
How many treatment naive genotype 2/3 patients do you follow on a regular basis?
(enter number only)
How many of your treatment naive genotype 2/3 patients are active injection drug users (have injected in the previous 12 weeks)?
(enter number only)
How many of your treatment naive genotype 2/3 active injection drug user patients are injecting less than daily?
(enter number only)
In your opinion, how many of your treatment naive genotype 2/3 active IDU (less than daily injecting) patients would be suitable for treatment?
(enter number only)
In your opinion, how many of your treatment naive genotype 2/3 active IDU (less than daily injecting) patients that are suitable for treatment would be willing to commence treatment?
(enter number only)
How many treatment naive genotype 2/3 active IDUs have you treated over the last 12 months?
(enter number only)
How many hepatitis C clinical trials have you enrolled patients into over the last 3 years?
(enter number only)
How many hepatitis C cohort studies have you enrolled patients into over the last 3 years?
(enter number only)
3 - Additional Information
How will you identify eligible patients for this trial (please tick all that apply)?
Database search
Patient file review
General Practitioner (GP) network
Referral from other Physicians
Cooperation from other hospitals
Other (specify)
Will you be conducting any other trials in the same patient population during the period of this trial?
No
Yes, 1 trial
Yes, 2 trials
Yes, >2 trials
CRF completion via the internet (Electronic Data Capture) will be used for this study. For how many trials have you already used Electronic Data Capture?
None
1-3 trials
>3 trials
[* if one or more trials, which system (specify)]
Can the internet be used freely by the site staff? (Please tick all that apply)
Yes
No, restrictive hospital policy
No, hospital firewall
No, connection fees,
No, equipment limitations
How many MONTHS does it usually take in total from submission of the protocol to your Ethics Committee/IRB until the first patient is screened at your site? (please include contract negotiations, regulatory approval and IRB/IEC approval in your estimation)
(enter number only)
In what language will you need to receive the Informed Consent Document?
4 - Laboratory and Pathology Information
All required tests and evaluations must be performed as standard of care and will not be funded as part of the study budget. Please indicate if this will be a problem at your site?
How many HCV RNA qualitative assessments are funded under standard of care per patient per calendar year?
(enter number only)
How many HCV RNA quantitative assessments are funded under standard of care per patient per calendar year?
(enter number only)
Which assay(s) does your local laboratory use for HCV assessment? (please tick all that apply)
Qualitative
COBAS AMPLICOR HCV 2.0
VERSANT HCV TMA
Other Specify
Quantitative
COBAS AMPLICOR HCV MONITOR 2.0
COBAS Ampliprep/COBAS TaqMan HCV 2.0
Versant HCV RNA bDNA 3.0
ART HCV RealTime HCV
Other Specify
Is the following equipment available in your laboratory? (please tick all that apply)
Handling area for biological samples
Centrifuge
-70 degrees Celsius / -94 degrees Fahrenheit freezer
Is the -70 degrees Celsius / -94 degrees Fahrenheit freezer temperature monitored and alarmed?
Yes
No
5 - Drug Storage and Administration
The protocol requires all peg-interferon injections to be directly observed. Please indicate who would observe these? (Please check all that apply)
Principal Investigator / Co-Investigator
Study Nurse
Pharmacist
Other (specify)
Peg-interferon syringes must be stored in a refrigerator. Do you have a temperate monitored and alarmed refrigerator?
Yes
No
6 - Other Comments
Do you have any other comments you would like to share?