UT Health Science Center San Antonio
Common Research Application
Step 1 – Intent to Conduct Research
The Common Application consists of Step 1 – Intent to Conduct Research, Step 2 – Institutional Application and Step 2 Continuation –UTHSCSA IRB
Application (when using UTHSCSA IRB).
These forms may be submitted in one of two combinations: A) Step 1 alone (Step 2 to follow later) only for early notification of clinical trials or
external IRB submissions –OR- B) All required forms together.
Items marked with the
icon indicate fields that the institution and the IRB share.
Using this form – To check the checkboxes, click once on the box. To enter text in the text boxes, click once on the gray box and then
type your response. If you are a Mac user and are having trouble using this form, try this alternate version of the form.
Item 1
Title
Item 2
Select the IRB you wish
to use.
Select one
☐ UTHSCSA IRB
☐ NCI IRB**
Note: this option is limited to NCI sponsored studies. If this is the first time the PI will use the NCI IRB,
download / complete the Signatory and/or Component Institution Personnel form and submit with Step
1.
**not an option for STVHCS, BHS, TBRI, SWRI
** if you select an external
IRB, not all study sites are
permitted
☐ Another University of Texas IRB**
Note: you must download and complete the UT Centralized IRB Review Intent to Submit for Centralized
Review Form and include with your Step 1 submission.
**not an option for STVHCS, CSRHCS, BHS, TBRI, SWRI
☐ Western IRB (WIRB) **
Note: this option is limited to Phase III Pharmaceutical Company sponsored protocols; approval by the
IRB Director or Associate Director is required prior to submitting to WIRB (official memo will be
provided)
**not an option for STVHCS, CSRHCS, BHS, TBRI, SWRI
☐ Other External IRB (specify):
**
Note: this option has limited availability - an IRB authorization agreement is required; contact the IRB
Director or Associate Director
**not an option for STVHCS, CSRHCS, BHS, TBRI, SWRI
Item 3
Type of Project
Select one
Item 4
Principal Investigator
First Name*
Organization*
Degree(s)*
Preferred email*
☐ Human Subjects Research (Expedited or Full Board)
☐ Human Subjects Data or Specimen Repository
☐Not Human Subjects Research Determination
☐ Exempt Determination
☐ Treatment Use of a Humanitarian Device (HUD)
☐ Expanded Access (FDA)
☐ Emergency Use of an Unapproved Drug/Device
Last Name*
Department*
Cell Phone or Pager
Office Phone
*Required field
PI’s Point of Contact
First Name*
Office Phone
Last Name*
Cell Phone or Pager
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1
PI’s Point of Contact
Preferred email*
*Required field
Item 5
Origin of the Study Plan
Select one
Item 5a
Will this study be
registered in
ClinicalTrials.gov?
Select one
☐
☐
☐
☐
☐
A local investigator developed the study plan (Investigator Initiated Study)
A collaborating investigator developed the study plan (Investigator Initiated Study)
A company (i.e. Pharmaceutical Company) developed the study plan
A cooperative research group developed the study plan
Other (specify):
☐ Yes, specify:
☐ An applicable clinical trial, specify:
☐ Sponsor (e.g., a pharmaceutical company) is responsible for registering the trial
☐ Local Investigator is responsible for registering the trial
☐ Not an applicable clinical trial, Local Investigator is responsible for registering the trial for
federal funding (e.g. NIH) or ICMJE requirements
☐ Not required, but local Investigator plans to register the trial for the following reason :
☐ No
If this trial has already been registered, provide the NCT number (also called the ClinicalTrials.gov
Identifier):
Note: Per federal requirements, applicable clinical trials must be registered within 21 days of enrollment of the
first participant.
Studies identified with a possible ‘Billing Risk’ (Item 6) may require an NCT number prior to receiving institutional
activation.
Item 6
Billing Risk*
Will any clinical services be used to provide
conventional patient care or research procedures?
This includes items and services typically provided by
professional and technical staff in a clinic, hospital,
laboratory, research center, etc. A bill or claim is typically
generated for these items and services.
Item 7
At this time, has a funding source(s) been identified
for this study or research activity?
Item 8
Will you be obtaining specimens or private
information without needing to interact with the
individuals?
If yes, approximately how many separate records or
specimens do you plan to obtain?
☐ No continue to Item 7
☐ Yes
Note: The VPR Clinical Trial Office (CTO) or the CTRC CTO will approve
the study Coverage Analysis (CA) / Research Activity & Billing Trigger
(RABT) for Step 2. They can assist with conducting the CA and
developing a RABT, as applicable.
Click Here for Guidance on Clinical Trial Billing Requirements
If you have completed the Budget & Billing training, you may start a
draft billing grid prior to meeting with CTO.
☐ No – no funding expected continue to Item 8
☐ No – but future funding is anticipated continue to Item 8
☐ Yes (you will be asked to provide details in Step 2 Institutional)
☐ No continue to Item 9
☐ Yes
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Item 9
Will you be interacting or intervening with living
individuals?
If Yes
What is the age range?
Approximately how many subjects do
you plan to screen for eligibility?
What is your planned target enrollment
number for completers?
Is this a multi-center study and the
sponsor has authorized competitive
enrollment?
☐ No continue to Item 10
☐ Yes
Provide number:
☐N/A this is a HUD or expanded access protocol (not research) Skip to 10
Provide number:
☐ Yes we will enroll as many as we can without exceeding the
maximum number for the study as a whole (total for all sites). Provide
number:
☐ No
Do you plan to pay subjects?
Item 10
Optional Attachments
Indicate if you included any of these documents?
Although not required when only submitting Step 1 – we
strongly recommend including them if they are available
☐ No
☐ Yes - Submit Participant Payment Form
☐
☐
☐
☐
☐
☐
☐
Sponsor Study Protocol
Grant Application
Draft study budget
Draft clinical trial agreement
Schedule of events
Other
No attachments available
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3
Institutional Support
Complete a grid for each organization listed as a study site under the direction of the PI
Item 11
☐
UTHSCSA
Complete the table according to the research activities that will occur at UTHSCSA
N/A – UTHSCSA is not a study site -- continue to Item 12
CTRC
The following research activities will
be performed at UTHSCSA
Recruit or identify subjects, consent
or enroll
FIRST – Outpatient
Research Unit
(FORU)
Dental School
Clinic
☐
☐
Clinic:
(specify clinic)
☐
☐
Oral &
Maxillofacial
Surgery or Implant
Clinic
Core Lab
or
Research Imaging
Institute
Other
☐
☐
☐
☐
Perform other study procedures or
follow-up
☐
☐
☐
☐
☐
☐
Clinic:
☐
☐
(specify clinic or
department)
Clinic:
Clinic:
Review private information held by
the institution
(e.g., health records)
Administer/Provide the study
intervention being tested
For each subject, how many
outpatient research visits will be
done at same time as a regularly
scheduled appointment?
For each subject, how many
outpatient research visits will require
an additional appointment?
Pharmacy support to store and/or
dispense study drug
Laboratory
MARC
☐
Clinic:
☐
☐
☐
☐
Clinic:
☐
Clinic:
☐
☐
☐
☐
☐
☐
Number:
Number:
Number:
Number:
Number:
Clinic:
Clinic:
Clinic:
Number:
Number:
Number:
Clinic:
Clinic:
Clinic:
Clinic:
Clinic:
Number:
Number:
Clinic:
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐Ultrasound
☐
☐
☐
☐
Specify Location:
☐
Specify Location:
Radiology
☐
Specify Location:
☐
Conducting coordinating center
activities
Mobilized support services at
another location
Department:
☐
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Item 12
University Health System (UHS)
Complete the table according to the research activities that will occur at UHS
(affiliated)
☐
N/A – UHS is not a study site -- continue to Item 13
The following research activities will
be performed at UHS.
Determine UHS department and/or
clinic locations.
Recruit or identify subjects, consent
or enroll
University Hospital
(specify the department – e.g., OR,
nursing location, 7th fl, MICU, etc)
Robert B Green-RBG
Texas Diabetes Institute (TDI)
Other
(specify clinic)
(specify clinic)
(specify clinic)
☐
☐
☐
☐
Department:
Clinic:
Clinic:
Clinic:
Review private information held by
the institution
(e.g., health records)
Administer the study intervention
being tested
☐
☐
☐
☐
Department:
Clinic:
Clinic:
Clinic:
☐
☐
☐
☐
Department:
Clinic:
Clinic:
Clinic:
Perform other study procedures or
follow-up
☐
☐
☐
☐
Department:
Clinic:
Clinic:
Clinic:
For each subject, how many
outpatient research visits will be
done at same time as a regularly
scheduled appointment?
For each subject, how many
outpatient research visits will require
an additional appointment?
Research done during a routine
hospitalization
Number:
Number:
Number:
Number:
Department:
Clinic:
Clinic:
Clinic:
Number:
Number:
Number:
Number:
Department:
Clinic:
Clinic:
Clinic:
Research requires hospitalization
☐
☐
Department:
Department:
Pharmacy support to store and/or
dispense study drug
Laboratory
Radiology
☐
☐
☐
☐
☐
☐
☐
☐
vMay16-2016
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☐
☐
Item 13
South Texas Veterans
HealthCare System (STVHCS)
Complete the table according to the research activities that will occur at the VA
(affiliated)
☐
N/A – VA (STVHCS) is not a study site -- continue to Item 14
The following research activities will
be performed at STVHCS
Recruit or identify subjects, consent
or enroll
Audie Murphy Medical Center
(specify the department – e.g., OR,
nursing location, 7th fl, MICU, etc)
Barter Research Unit (BRU) IIMSFIRST
FTOPC
(specify clinic)
☐
☐
☐
☐
Clinic:
Clinic:
☐
☐
Clinic:
Clinic:
☐
☐
Clinic:
Clinic:
☐
☐
Other
(specify clinic)
Department:
Review private information held by
the institution
(e.g., health records)
Administer the study intervention
being tested
☐
Perform other study procedures or
follow-up
☐
Department:
Clinic:
Clinic:
For each subject, how many
outpatient research visits will be
done at same time as a regularly
scheduled appointment?
For each subject, how many
outpatient research visits will require
an additional appointment?
Research done during a routine
hospitalization
Number:
Number:
Number:
Department:
Clinic:
Clinic:
Number:
Number:
Clinic:
Clinic:
Research requires hospitalization
Pharmacy support to store and/or
dispense study drug
Laboratory
Radiology
Dietary (specialized meals or
counseling)
☐
Department:
☐
☐
Department:
Number:
☐
Number:
Department:
☐
☐
Department:
Department:
☐
☐
Department:
Department:
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
vMay16-2016
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☐
☐
☐
Item 14
All Other Study Sites under the
direction of the PI
Include all other study sites
☐
☐
☐
☐
☐
☐
Baptist Health System (BHS) (affiliated)
Christus Santa Rosa Health Care (CSRHC) (affiliated)
UT (Non-UTHSCSA) specify (affiliated)
Texas Biomedical Research Institute (TBRI) (affiliated)
Southwest Research Institute (SwRI) (affiliated)
Other (non-affiliated site) Complete this table and answer item 15
Complete the table according to the research activities that will occur at each study site
☐
N/A – No other study sites
Insert the
following
as
applicable:
List
Organization
Name
List
Department,
division or clinic
- Recruit
- Identify
subjects
- Consent
- Enroll
subjects
Review
private
information
held by the
institution
(e.g., health
records)
Administer
the study
intervention
being tested
Perform
other study
procedures
or followup
Insert
Yes or No
Insert
Yes or No
Insert
Yes or No
For each subject
how many
outpatient
research visits
will be done at
same time as a
regularly
scheduled
appointment?
To add rows use copy & paste
vMay16-2016
7
how many
outpatient
research
visits will
require an
addition
appt?
Research
done
during a
routine
hospitalization?
Research
requires
hospitalization?
Insert
Yes or No
Insert
Yes or
No
Pharmac
y
Laborator
y
Insert
Yes or No
Insert
Yes or No
Radiology
Insert
Yes or No
If you selected the UTHSCSA IRB to review this study (Item 2)
Item 15
Are there other non-affiliated study sites under the
direction of the PI?
Name of the Study Site
To add rows use copy & paste
☐ No All sites are affiliated with UTHSCSA IRB
☐ Yes If yes list each location on a separate row below (also submit Form Y for full board and expedited protocols only)
☐ N/A – using external IRB (locations will be managed by that IRB)
Organization’s
Point of Contact (name) & contact
information
Does this organization want
the HSC IRB to review for
them?
(insert Yes or No)
If yes, contact the IRB Director;
If yes, list the site in the
Institutional Support Table (Item
14)
vMay16-2016
8
If No, indicate the status of
this organization’s IRB (or
equivalent evidence of
institutional support)
approval.
(insert pending or the approval
date)
If Yes, and it is an
international
study site, provide Name and contact
information of an individual (not
affiliated with the study) who can
provide information to the IRB about
the research context at the international
location