Pre-Qualification Questionnaire
Clinical Investigators Consortium
P.O. Box 9218
Lombard, Illinois 60148, USA
www.CICdomain.com
Contact: A.K. Hazari
Phone: 630.916.1886
Email: Trials@CICdomain.com
Bronchoscopy Sedation Trial
(6659)
Upon Submission The Sponsor/CRO Will Contact Your Site Directly
DO NOT CONVERT TO PDF. EMAIL IN WORD FORMAT ONLY.
Site Name
Email Address
Phone Number
Fax Number
Street Address
City
State
Zip Code
Country
Investigator Name
License Number
State License Issued
PI Specialty
Board Certification
PI Sub-Specialty
Board Certification
Trials Experience
# of Trials Completed
Yes
No
Yes
No
Years
PLEASE SEE QUESTIONNAIRE BELOW
Section 1: Site Contact Information:
Principle Investigator
Title:
First Name(s):
Surname:
Address
Clinic / Practice Name:
Department:
Address:
Contact Details
Phone Number:
Fax
Number:
Email:
Site Contracts Negotiator
Title:
First Name(s):
Surname:
Address
Clinic / Practice Name:
Department:
Address:
Contact Details
Phone Number:
Fax
Number:
Email:
Site Budgets Negotiator
Title:
First Name(s):
Surname:
Address
Clinic / Practice Name:
Department:
Address:
Contact Details
Phone Number:
Email:
Fax
Number:
Section 1: Site Contact Information:
Regulatory Contact for Essential Document Completion
Title:
First Name(s):
Surname:
Address
Clinic / Practice Name:
Department:
Address:
Contact Details
Phone Number:
Fax
Number:
Email:
Person Completing Questionnaire
Title:
First Name(s):
Surname:
Address
Clinic / Practice Name:
Department:
Address:
Contact Details
Phone Number:
Fax
Number:
Email:
Section 2: Site Experience and Resource:
Principal Investigator Specialty
Board Certified
Primary Speciality:
Q1 Please tell us about
the PI’s training
Q2 How many years has
the proposed Principal
Investigator conducted
trials as a PI in
pharmaceutical research?
Q3 At your site, how
many patients undergo a
bronchoscopy each
month?
Yes
No
Eligible
Yes
No
Eligible
Sub Speciality:
Number of Years
Number of Years
# Number of Years:
Number of Patients
Number of Patients
# Per month:
Q4 In your opinion,
where will the
prospective patients
come from?
Q5 Based on the
information provided
above, how many
patients do you
anticipate you can
randomise into this study
in 4 / 8 month(s) if the
start is in November
2014?
Q6 Based on the study
information provided
above; do you anticipate
any problems/ issues in
conducting the proposed
study?
%
% of total patients identified (overall 100%)
Study Centre database:
%
Referrals: Primary care
consultants:
%
Referrals: Secondary care
consultants:
%
Referrals: Referral networks:
%
Patient outreach:
(inc advertising)
%
Number of Patients
Number of Patients
# in 4 month:
# in 8 months:
Issue(s)
Comment(s)
Problem(s) / issue(s)
Study design:
Inclusion / exclusion criteria:
Study assessment(s):
Concomitant medications:
Ethical issues:
Length of study:
Frequency of visits:
Other:
Other:
Other:
Other:
Q7 Has your center
conducted any studies in
sedation or bronchial
device within the last 3
years?
Study 1
Study Information
Study Start Date:
Indication:
Drug / Drug class:
Phase of study:
Study status:
(Ongoing / completed)
# of subjects enrolled:
(i.e. dosed / randomised)
# of subjects completed:
# of months to enrol subjects:
Study 2
Study 3
Q8 Are you planning to
conduct any other studies
involving sedation or
bronchoscopy patients
during the study period,
which may compete with
this study for subjects?
Q9 Please indicate which
of the following research
staff would be available
at your site for this study
and whether they are
ICH/GCP trained*
No
Competition
for Resources
Study 2:
Study 3:
Name
Yes
Staff availability from November 2014 through June 2015
Primary Study Coordinator
Back-up Coordinator
Back-up Coordinator
Yes
No
Yes
No
Equipment
EKG:
Blood/Urine Collection and
Prep Area
Questionnaires and Scales
Modified Observers Assessment
of Alertness / Sedation
(MOAA/S):
Aldrete Scale:
Hopkins Verbal Learn Test –
Revised (HVLT-R):
Q12 Will the
bronchoscopies be
performed on site? If no,
please comment where
the bronchoscopies take
place.
Q13 The study drug
comes in a lyophilized,
10ml vial. Does the site
maintain or have access
to a working laminar
airflow hood? If no,
where would the site
reconstitute drug
ensuring sterility is
maintained.
Q14 As part of the
standard of care, does the
site administer any kind
of analgesic (i.e fentanyl)
pre- or intra-operatively
to subjects undergoing
bronchoscopy? If yes,
Anticipated
End Date
Study 1:
Pulse Oximeter:
Q11 Does the site have
familiarity with the
following scales
Start
Date
Study Period planned November 2014 through June 2015
* (with 2 yrs training
documentation
available).
Q10 Does your site have
access to the following
equipment?
Competition
for Patients
Yes
Yes
No
Comment
Yes
No
Comment
Yes
No
Comment
ICH / GCP trained*
No
Unknown
please indicate analgesic
and the typical number
of doses administered
(i.e. one bolus dose or
average number of topup doses
Q15 Who at the site
typically administers
anesthesia medications to
subjects undergoing
bronchoscopy?
Physician
Anesthesiologist
Nurse
Anesthetist
Physician
Assistant
Registered
Nurse
Other
Section 3: Ethics Committees and Contracts:
Q16 Has your research
facility ever been audited
by a regulatory agency?
No
Audited
Yes
Outcome(s)
Regulatory Agency
If so, please provide the
outcome (i.e., no findings,
major observations, etc)
FDA:
483 Issued
NA
No
Yes (Please provide copy)
Sponsor
Q17 Please indicate what
kind of IRB/EC you can
use.
IRB/Ethics Committee
Central:
Local:
Other:
Q18 Please estimate the
average length of time
needed (in weeks) in
order to obtain all local
IRB approvals.
Q19 What is your
standard turnaround time
for contract / budget
review?
Q20 Are separate
contracts required for
pharmacy, involved
departments (e.g.
radiology) and/or
hospital administrators?
Weeks
NA
EC / IRB Approval Timelines
Time till approvals:
Weeks
Contract / Budget Review
Time till approvals:
Yes
Additional Contracts
Pharmacy:
Laboratory:
Hospital Administrators:
Other:
No
Comment(s)