UT Health Science Center San Antonio
Common Research Application
Step 2 – Institutional
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 three forms may be submitted in one of two combinations: A) Step 1 alone (Step 2 and Step 2 Continuation to follow later) –OR- B) All three
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.
UTHSCSA Tracking Number
Item 16
Does the research fall under the purview of any other departments, committees or
agencies?
Principal Investigator’s Department Chair or equivalent
Radiation Safety Committee (submit Form Q as part of RSC application)
(radiation exposure, radioactive materials, radiation generating equipment)
Radioactive Drug Research Committee (submit Form Q as part of RDSC application)
(radioactive material not covered by IND)
Institutional Biosafety Committee (submit Form Q-1 as part of IBC application)
(biologic hazards, microbiologic or viral agents, pathogens, cell lines, vaccine trials,
recombinant DNA, human gene therapy)
CTRC Protocol Review Committee (PRC)
(all cancer related research regardless of funding)
Texas Dept. of Family and Protective Services Request for Approval
(research involving Child Protective Services)
VA Safety Committee
(required of all studies being conducted at the VA)
Other:
Item 17
Would you like this study to be posted on the
UTHSCSA Find a Study website with contact
information for prospective subjects’ use?
Yes
No
Attach signed Form A
☐ Pending
☐ Approval notice
attached
☐ Pending
☐ Approval notice
attached
☐ Pending
☐ Approval notice
attached
☐
☐
☐
☐ Pending
☐ Approval notice
attached
☐ Pending
☐ Approval notice
attached
Submit Safety Survey to VA
R&D Office
☐
☐ Pending
☐ Approval notice
attached
☐
☐
☐
☐ N/A because this is a CTRC study, L-1 information provided by IDEAS
☐ No continue to Item18
☐ Yes download and complete Form L-1
Item 18
☐ No - Only using publically available information continue to Item 24
Will you be using private information during this
☐ Yes If yes, describe below & complete the Use of Identifiers Table (Item 19)
study?
☐protected health information (PHI) held by a covered entity
Describe:
☐other types of private information
vSep17-2015
1
If Yes,
select all
applicable
☐research information (non-PHI) that is
not publically available (i.e., student
Describe:
records)
Complete if using private information Yes to Item 18
Item 19
Use of identifiers with private
information
For each column (representing ways that identifiers are encountered or used in research), select either:

None of the identifiers will be used in the activity described by checking “None”, or

One or more of those listed will be used in the activity described by checking all applicable
identifiers
Column A
Column B
Column C
Column D
Column E
Column F
Looked at by
research team
Recorded on an
enrollment log,
subject list, or
key list
Recorded on data
collection tools
(CRFs, surveys,
spreadsheets,
etc.)
Recorded
on
specimen
containers
Shared with
others
(outside
research
team)
Stored
after study
completed
List of identifiers
Important Note:
Complete this table by starting with
Column A and moving to the right
Identifiers
None of the identifiers listed below
↓
Names
a study code that is linked to the
individual’s identity using a key that
is only accessible by the researcher
Address
Dates (except year)
Ages over 89
Phone or Fax numbers
E-mail addresses
- Social security numbers,
- Scrambled SSNs (SCRSSNs), or
- the last four digits of a SSN
Numbers (including)
- Medical record numbers
- Account numbers
- Certificate/license numbers
- Health plan beneficiary numbers
- Vehicle identifiers and serial
numbers, or license plate numbers
- Device identifiers and serial
numbers
Web Universal Resource Locators
(URLs) or Internet Protocol (IP)
address numbers
- Biometric Identifiers, including
finger and voice prints
- Full face photographic images and
any comparable images
Any other pre-existing unique
identifying number, characteristic, or
code
vSep17-2015
☐
☐
☐
If selected – stop
Go to Item 24
If selected – stop
Go to Item 23
If selected – stop
Go to Item 23
☐
☐
☐
☐
☐
☐
☐
☐
☐
N/A
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
Specify:
Specify:
Specify:
Specify:
☐
Specify:
Specify:
☐
Specify:
Specify:
☐
Specify:
☐
☐
☐
☐
☐
☐
Specify:
☐
Specify:
☐
Specify:
☐
☐
☐
☐
☐
Specify:
Specify:
Specify:
☐
☐
☐
☐
☐
☐
Specify:
Specify:
Specify:
☐
☐
☐
2
Note: the code, algorithm, or pseudonym should not be derived from other related information about
the individual, and the means of re-identification should only be known by authorized parties and not
disclosed to anyone without the authority to re-identify records.
Item 20
Coding Plan
Not applicable, no identifiable information will be collected
☐
(None is checked in Columns B or C - Identifier Table (Item 19) --continue to Item
23
Describe the method that will be
used to create and assign a
unique study code to the data
Describe the method that will be
used to create and assign a
unique study code to the
specimens
What is the format of the key?
Who will have access to the key?
Where will the key be stored and
how will it be protected?
If a key will be located at more than
one location list all applicable. If
confidentiality measures differ at the
locations describe differences.
☐Describe:
-OR☐N/A, not collecting specimens
☐Paper
☐Electronic
Location(s):
Describe confidentiality measures:
Item 21
Data / Specimen Storage Plan
Not applicable, coded or identifiable information will not be collected
☐
(None is checked in Column C - Identifier Table (Item 19) -- continue to Item 23
Check all that apply and complete the table as applicable
If data/specimens will be stored at more than one location list all
applicable. If storage differs at the locations describe differences.
Paper data
(including completed consent forms)
☐
How will coded or identifiable data/specimens be stored?
Electronic data
☐
☐
☐
☐
(consider the computing environment e.g., platform,
number of computers, type of computers, network or
standalone computers, access to and security of physical
environment, audit capabilities to track access activity)
Note: If stored on VA server provide the path (e.g., 11vhastxmu15\VA
Research\___)
Social Security Numbers (SSNs, Scrambled
SSNs, or last four digits of an SSN)
Specimens
Long-term storage (following completion of the
study and inactivation of IRB approval)
Item 22
Calculating HIPAA Disclosures
(use this table to figure out whether your information collection and storage plan will result in disclosure of PHI
☐
Not applicable, not collecting protected health information (PHI) held by a covered entity
(PHI is not checked in Item 18) -- continue to Item 23
Covered Entity where the source PHI is held
(Source Location)
vSep17-2015
Research Storage Location(s)
3
NOTE: list all study sites from Step 1
You may list more than one site on a row if the file
type and storage locations are exactly the same.
Paper files
Electronic
files
☐
☐
☐
☐
☐
☐
☐
☐
Where do you plan to store the PHI from this
organization? (list all storage locations – i.e., UTHSCSA,
UHS, VA, etc.)
NOTE: If the Storage location is different than the Source location it is considered a disclosure.
All disclosures must be justifiable and must be listed in the IRB approved HIPAA authorization form or waiver form.
Item 23
Maintaining Confidentially
Not applicable, no identifiable information will be viewed (looked at)
☐
(None is checked in Column A - Identifier Table (Item 19) -- continue to Item 22
Describe measures that the research team will take to protect the confidentiality of subjects while looking at private information
(i.e., while viewing medical records)
☐The researchers will follow all institutional rules and regulations (to include HIPAA or FERPA if applicable)
during the time which the data is being accessed. All policies and procedures of the institution (i.e., covered
entity) regarding confidentiality of patient data will be followed.
-OR☐Describe different approach:
Item 24
Sharing of Research Data/Specimens to Entities Outside the Affiliated Study Sites
Not applicable, not sharing data/specimens with groups outside of the Affiliated study sites -- continue to Item 25
☐
Mark all entities that may have access to subject information linked to research data and/or specimens either viewed on site or transferred:
Transferred
Viewed
Transferred
Viewed
Transferred
dates, city,
state, zip)
Viewed
Entity
(select all
applicable)
For each entity, select all applicable
Limited
Data Set
Non(i.e. may
Identifiable
identifiable
include
materials
elements of
materials
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
If information will leave the covered entity:
Describe how the materials will be transferred from one
location to another.
If using eCRF, provide website.
Note – those entities receiving identifiable information
or a limited data set must also be listed on the HIPAA
authorization or waiver.
Describe:
☐
Sponsor
and/or CRO
or
☐ N/A research data will not leave the covered entity
Describe:
☐
Monitor
vSep17-2015
or
☐ N/A research data will not leave the covered entity
4
Describe:
☐
☐
☐
☐
Coordinating
Center
Other sites,
investigators
or
collaborators
participating in
this study.
Specify:
Others not
participating in
this study.
Specify:
☐
☐
☐
☐
☐
or
☐ N/A research data will not leave the covered entity
Describe:
☐
☐
☐
☐
☐
☐
or
☐ N/A research data will not leave the covered entity
Describe:
☐
☐
☐
☐
☐
☐
or
☐ N/A research data will not leave the covered entity
Item 25
If Yes to any – continue to Item 26 or item 27. If No to all – skip to Item 28.
Yes
No
Does the study plan dictate the use of any of the following?
A drug
A biologic
☐ (list in Item 26)
☐ (list in Item 26)
☐
☐
☐ (list in Item 26)
☐ (list in Item 26)
☐
☐
☐ (list in Item 27)
☐
(e.g., blood product, vaccine, virus, toxin, etc.)
A compound intended to affect structure or any function of the body
A dietary supplement or substance generally recognized as safe (GRAS) that will be used to
diagnose, cure mitigate, treat or prevent disease
A Device
Item 26
List all protocol directed
items below
a)
List the Drugs directed by
this protocol
Insert the following for each
drug:
 Name (trade and
generic),
 Dosage,
 Route of
administration
Select one status choices below
b)
FDA
Approved?
Insert either:
 Yes
 No
c)
Used in
accordanc
e with FDA
approved
labeling?
Insert
either:
 Yes
 No Submit
a drug
record form
(Inst F)
To add rows use copy &
paste
Insert response here
Submit FDA
approved
package
insert/ IB
Insert
response
here
vSep17-2015
 N/A (no
d)
Will study data be
submitted to or held
for inspection by the
FDA for approval or
a change in labeling,
marketing or
advertising?
(any time now or in the
future)
Insert either:
 Yes
 No
FDAapproved
labeling)
Insert
response
here
Additional IND Information
e)
Status of IND
f)
Name of the IND
Holder (Sponsor)
Insert one of the
following:
 Submitted on
(insert date)
 Approved (insert
IND number and
include FDA IND
letter)
 Exempt from IND
If the IND is held by a
local investigator,
submit an Inst-H Local
Investigator FDASponsor form with Step
2.
– Submit Form O)
 N/A
Submit a drug record
form (Inst F) If IND
submitted or approved
Insert response
here
Insert response
here
Insert response
here
5
Item 27
List all protocol directed
items below
a)
List the Devices directed
by this protocol
Insert the following for each
device:
Name (trade and
generic)
Select one status choices below
b)
FDA
Approved?
Insert either:
 Yes
 No
 HUD (used
in clinical
investigati
on)
To add rows use copy &
paste
Insert response here
c)
Used in
accordanc
e with FDA
approved
labeling?
d)
Is the device
being tested
for safety
and/or
effectiveness?
Insert
either:
Insert either:
 Yes
 No
 N/A (no
FDAapproved
labeling)
Submit FDA
approved
package
insert/ Device
Manual
Insert
response
here
 Yes
 No
Additional IDE Information
e)
Will study
data be
submitted to
or held for
inspection by
the FDA for
approval or a
change in
labeling,
marketing or
advertising?
(any time now
or in the future)
Insert either:
 Yes
 No
Insert
response
here
Insert
response
here
Insert
response
here
f)
Status of IDE
g)
Name of the IDE
Holder (Sponsor)
Insert either:
 Submitted to
FDA on (insert
date)
 Approved
(insert IDE
number and
submit FDA
IDE letter)
 Exempt from
IDE
submission to
FDA – Submit
If the IDE is held by
a local
investigator,
submit an Inst-H
Local Investigator
FDA-Sponsor form
with Step 2.
FORM P)
 N/A
Insert response
here
Insert response
here
Protocol directed procedures, items, services or tests
Complete items 28 - 34 below by including all procedures directed by the research plan - including items or services provided as part of routine or
conventional care and those needed to diagnosis or treat research related complications.
Item 28
Study Intervention(s) being tested or evaluated
Applicable only to interventional studies – this can include prevention, diagnostic or therapeutic interventions (e.g., drug or device) or
educational, health services or basic science interventions (e.g., educational program, health care delivery model, or examining basic physiology)
☐ N/A - this study does not test or evaluate an intervention - skip to Item 29
(i.e., the investigator does not assign specific interventions to the subjects of the study)
Who will administer the intervention? (select all applicable)
Study Intervention(s)
Select either:
To add a row – select a row, copy & paste
To remove – select the row & delete
Routine1 or
Research Only2
#
encounters
per subject
Researc
h Team
Study Site
Employees
(not-research staff)
list applicable study
sites from Step 1
☐
☐
Commercial
Source
Other
☐
☐
1 – intervention is routinely or typically provided absent a research study; 2 – research only = required solely for the study
Item 29
Other drugs or devices – that are not the intervention being tested or evaluated
List all other drugs or devices that are not considered the intervention being tested or evaluated under this protocol but are being directed by the
protocol
☐
N/A – no other drug, biologic used as a drug, or devices - skip to Item 32
Who will administer the drug/device? (select all applicable)
vSep17-2015
6
Drug or Device
Select either:
To add a row – select a row, copy & paste
To remove – select the row & delete
Routine care1
or Research
Only2
#
encounters
per subject
Researc
h Team
Study Site
Employees
(not-research staff)
list applicable study
sites from Step 1
Commercial
Source
☐
☐
Other
☐
☐
1 – routine care = typically provided absent a research study; 2 – Research Only = required solely for the study
Item 30
Where will the drugs, biologics, or devices (listed in item 28 and 29) be stored and managed?
(check all that apply)
☐ Hospital Pharmacy
☐ Investigational Drug Section of CTRC
☐ Other location(s) approved by
the Office of Clinical Research (OCR)
☐ Other location(s) NOT approved by
the Office of Clinical Research (OCR)
Are you transferring the drug(s)/device(s) between
institutions?
If checked, list hospital(s):
If yes, provide OCR site approval number(s):
If yes, attach approval request OCR Policy for Drug/Device Storage
☐ No
☐ Yes, attach letter or memorandum of understanding for originating
institution and each receiving institution Pharmacy LOU
Item 31
Who will be supplying the drug(s) or device(s) (listed in item 28 and 29) ?
Drug/Device Name
Provided by
Paid by
To add a row – select a row, copy & paste
To remove – select the row & delete
☐ Hospital Stock; List hospital(s):
☐ Sponsor
☐ Prescription will be provided to fill at a commercial
pharmacy
☐ Hospital
☐ Sponsor
☐ Insurance/3rd Party
☐ Hospital Stock; List hospital(s):
☐ Sponsor
☐ Prescription will be provided to fill at a commercial
pharmacy
☐ Hospital
☐ Sponsor
☐ Insurance/3rd Party
Item 32
Laboratory/Specimen collection
List of laboratory tests that are dictated by the research protocol (e.g., CBC, CMP, PK, pregnancy test, etc.)
☐
N/A - this study does not involve lab tests - continue to Item 33
Who is performing the lab procedure? (select all applicable)
Laboratory procedures
Study Site
# Routine
# Research
Note: You may group tests that
Employees/Services
are always performed together
Care
Only
(not-research staff)
3
4
Procedures
Procedures
list applicable study sites from Outside
Research
(per
(per
Other
Step 1
To add a row – select a row, copy & paste
Team
Source
subject)
subject)
To remove – select the row & delete
Obtain
specimen
Perform the
analysis
☐
☐
3 – routine care procedures = typically provided absent a research protocol; 4 – research only = lab services provided solely for the research
vSep17-2015
7
Item 33
Imaging
List of imaging procedures that are dictated by the research protocol (e.g., x-ray, CT, MRI, US, etc.)
☐
N/A - this study does not involve imaging procedures - continue to Item 34
Who is performing the imaging procedure? (select all applicable)
Imaging procedures
Study Site
# Routine
# Research
Employees/Services
Care
Only
(not-research staff)
Procedures3 Procedures4
Outside
Research
list applicable study sites from
To add a row – select a row, copy &
(per
(per
Other
Step 1
paste
Team
Source
subject)
subject)
To remove – select the row & delete
Obtain image
Perform the
analysis
☐
☐
3 – routine care procedures = typically provided absent a research protocol; 4 – research only = lab services provided solely for the research
Item 34
ALL Other Research Activities
List of research procedures, items or services provided or tests that are directed by the study plan (i.e., chart review, questionnaire, etc.). Submit
data collection instruments (Form M, i.e. surveys, questionnaires, etc.) as applicable.
☐
N/A – no other activities are directed by the study plan - continue to Item 35
Who is performing the activity / service? (select all applicable)
Activities, Procedures,
Study Site
#
Routine
#
Research
Services, Surveys, Chart
Employees/Services
Care
Only
Reviews, Tests, etc.
(not-research staff)
Activities3
Activities4
Research
list applicable study sites from Outside
To add a row – select a row, copy & paste
(per
(per
Other
To remove – select the row & delete
Team
Source
Step 1
subject)
subject)
Collect
Perform the
analysis
☐
☐
3 – routine care = typically provided absent a research protocol; 4 – research only = lab services provided solely for the research
Item 35
Describe the plan for training
personnel who are not part of
the research team and will be
administering the
intervention(s) listed in Item
28.
OR
Describe the plan for
training/informing clinical
personnel about the study.
vSep17-2015
☐Not applicable – no training of non-study personnel required - continue to Item 36
Who will you train?
☐ Nurses who will administer the study drugs
☐ Pharmacy staff on receipt, storage, and dispensing primary study intervention
☐ Radiology staff who will administer primary study intervention (radiation treatment)
☐ Other:
Example: UHS clinical areas impacted by the enrollment of subjects and collection of research blood
samples. Clinical personnel will be inserviced about the study. Nurses will be asked to assist with blood
collection.
When will you provide the training?
☐ Prior to the first subject being enrolled
☐ Each time a new subject is enrolled
☐ Other:
How will you provide the training?
☐ In person
☐ Using paper or electronic documents read by the trainees
☐ Other:
8
Item 36
Category of Funding
If the research is being submitted to, supported by, or conducted in cooperation with an external or internal funding program, indicate the
categories that apply. Check ALL applicable If the research is supported by a subcontract mark the funding source as the originator of the
funds.
☐
☐
Not applicable - no funding - continue to Item 37
Federal Funding (specify Department or Agency below)
*You must submit a copy of the entire grant application for a required congruency check.
☐
☐
☐
Agency for International
Development
Consumer Product Safety
Commission
Dept of Agriculture
☐
Department of Health and Human Services
(i.e., CDC, NIH, FDA, SAMHSA, HRSA )
Dept of Housing and Urban Development
☐
Dept of Commerce
☐
Dept. of Justice (DOJ)
☐
☐
☐
☐
☐
☐
Dept of Defense (DoD)
Dept of Education (DOE)
Environmental Protection Agency
National Science Foundation
☐
☐
☐
☐
☐
Dept of Energy
Dept of Veterans Affairs (VA)
Dept of Transportation (DOT)
National Aeronautics and Space Administration
Central Intelligence Agency
Other Federal Department or
Agency. Specify:
☐ Foreign
☐ Private
☐ Foundation
☐ State
☐ HSC Institutional Award
☐ State University
☐ Local Government
☐ University
☐ Pharmaceutical – Industry, Device or Biotech, if selected mark one
☐ Other:
appropriate response below:
☐ Intellectual Property (IP) owned solely by Pharmaceutical Company
☐ Intellectual Property (IP) shared by Investigator and Pharmaceutical Company
☐ Intellectual Property (IP) owned solely by Investigator
Item 37
Funding Details
Not applicable – no funding (Item 36) - continue to Item 38
☐
Name of agency or Grant or Contract Title:
Granting/
funding entity
Funding
organization’s
tracking
number:
To add a row – select a
row, copy & paste
To remove – select the row
& delete
[Warning: Do not delete the section break immediately below this text]
PI listed on the
grant award or
contract
Funding administered by:
Insert:
-UTHSCSA OSP
-UHS
-STVHCS (VA)
-Biomedical Research
Foundation of South Texas (BRFST)
-insert other
vSep17-2015
10
Item 38
Research Team - Roles and Activities
Note: Submit Inst-M Personnel Form (list of all research team members by name) with Step 2.
☐
Not applicable – this is an exempt protocol or chart review study
Column A
Build your research
team below by
identifying key position
titles
At a minimum, all
studies must have a
Principal Investigator.
Other suggested
positions have been
inserted below. Delete
positions as appropriate
to your study.
Position Title (DO NOT
MODIFY POSITION
TITLES)
Column B
For each key position, list the roles & responsibilities that could be assigned to research team members in this position.
Use the following codes to identify the responsibilities that are applicable for the role you created in Column A.
Not all roles are applicable to every study
General research responsibilities
Oversight responsibilities
1. recruitment a
18. directing the research team members and assessing
compliance with study protocol
2. assess inclusion and exclusion criteria a
a
19.
Lead PI - direct the study site PI(s) at other locations
3. obtain informed consent
a
20.
determine significance of subject safety indicators
4. assist with the consent process
(e.g., AE/SAEs, UADEs, SUSAR, UPs, etc.)
a
5. source documentation or case report form completion
21.
determine the significance of protocol deviations or
6. perform physical examination a, b
violations
7. perform physical assessment a, b
22. ensure the integrity of the data
8. obtain medical history or evaluate concomitant
23. Sponsor-Investigator monitoring and reporting d
medications a, b
24. Other:
9. prescribe intervention being tested a, b
25. Other:
10. administer intervention being tested a, b
26. Other:
11. perform study procedures a, b
27. Other:
12. adverse event inquiry and reporting a
28. Other:
13. laboratory or other specimen handling
14. other specimen shipping c
15. investigational product dispensing & accountability a
16. regulatory & essential documents, other record keeping
or admin function
17. review private identifiable information
Principal Investigator
(required)
List applicable numbers from above:
Co-PI (delete as appropriate
List applicable numbers from above:
Sub-Investigator (delete
List applicable numbers from above:
for study)
as appropriate for study)
vSep17-2015
Column C
For each position, list the minimum
credentials and training required for
any person assigned to this role.
Use the following codes to identify the
credentials & training for the role you
created in Column A.
A. Medical license (US)
B. Dental license (US)
C. RN license (US)
D. RPH license
E.
license (US)
F. Good Clinical Practice (GCP)
training
G. Research related certification
(e.g., CCRC)
H. Advanced academic degree
I.
certification
J.
certification
K. Specialized training for the use of
a device
L. Other:
M. Other:
List applicable codes from above:
List applicable codes from above:
List applicable codes from above:
11
Study Coordinator
(delete as appropriate for
study)
Study Nurse (delete as
appropriate for study)
Research Assistant
(delete as appropriate for
study)
Data Coordinator
(delete as appropriate for
study)
Honest Broker (delete as
appropriate for study)
Statistician (delete as
appropriate for study)
List applicable codes from above:
List applicable numbers from above:
List applicable codes from above:
List applicable numbers from above:
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a
Research Scope of Practice (RScOP) Form is required for Students, Residents, Fellows, Non-licensed MDs, and Other Non-Licensed professions/personnel if interacting or intervening with human
subjects - Excluding Exempt Research
b
Credentialing and clinical privileges will be verified by institutional research office
c
Requires IATA Training / Safety-Shipping Infectious Substances, Clinical Specimens, and Dry Ice
d Requires GCP for investigator initiated studies of drugs, biologics or devices
vSep17-2015
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