CLINICAL AND TRANSLATIONAL RESEARCH COMMITTEE
SUBMISSION APPLICATION
FORM 2
FOR INTERVENTIONAL STUDIES AND STUDIES MANAGED BY THE WINSHIP CLINICAL TRIALS
OFFICE
INSTRUCTIONS:
This form serves as application to the Clinical Translational Research Committee (CTRC) for protocol review.
It is designed to be a tool for the investigator(s), to ensure that before the approval process begins, the many
facets surrounding the initiation of clinical trials are carefully thought through, understood and agreed upon by
all of those involved in the trial. The form is designed in such a way that a completed form will provide the
Winship regulatory department with all of the information needed for IRB submission, and application can be
made to the IRB immediately following CTRC approval. Please complete this application electronically,
print it, and obtain the necessary signatures. The form is available on the Winship Cancer Institute
website under Clinical Trials - http://www.cancer.emory.edu.
WHAT TYPE OF REVIEW ARE YOU SEEKING?
EXPEDITED – For NCI cooperative group trials, or expanded access trials only. Protocols of this type
are routed directly to the CTRC chairman or designee. Approval can be given without presenting the
protocol formally at CTRC meeting. There are no submission deadlines; however, the chair (or designee)
may send the protocol to the Committee for review at his discretion.
Submission requirements: Signed CTRC submission application, protocol, investigational new drug
brochure (if applicable), consent form template. Electronic copies of all documents sent via email to
winshipctrc@emory.edu with signature page of CTRC form delivered (see page 11).
____________________________________________________________________________
LIMITED – For non-invasive trials including non-interventional studies that are part of peer-reviewed
grants. Protocols that qualify for limited review would likely fall under the IRB review category of
“expedited” or “exempt” [chart review, laboratory (tissue/blood draw), behavioral, quality of life, etc.]
These submissions will be sent to the CTRC chairman (or designee), one additional CTRC reviewer, and
statistician. The reviewers may present
their recommendations to the next CTRC meeting, or may determine that protocol needs to be reviewed
by the full committee. The reviewer may request that you be present at the CTRC meeting at which
your protocol is being discussed, in which case you will notified of the time and date.
Submission requirements: Signed CTRC submission application and protocol, consent form template
(if applicable), any other study related documents (questionnaires, assessment tools, etc. Electronic
copies of all documents sent via email to winshipctrc@emory.edu or with signature page of CTRC form
delivered (see page 11).
FULL COMMITTEE – Required for all studies that do not fall under one of the above categories. The
principal investigator is invited to the CTRC meeting at which their protocol is being discussed.
The meeting dates/times and submission deadlines are posted on the Winship website.
Submission requirements: Signed CTRC submission application, protocol, investigational new drug (if
applicable), consent form template. Electronic copies of all documents sent via email to
winshipctrc@emory.edu with signature page of CTRC form delivered (see page 11).
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
Version: 07April 2015
Page 1 of 11
Office for Clinical Research (OCR) Study Submission Form
The OCR must receive this Study Submission Form with all fields completed and all required documents to
begin the Prospective Reimbursement Analysis (PRA) and budget development. All Externally
Funded/Industry studies need to have documents routed to the OCR via EPEX.
If EPEX Submission is not required for your study, email all documents as a package to: ocr@emory.edu
Principal Investigator and Department Information
Name:
Office Phone #:
Cell Phone #:
School:
Dept:
Division:
PIC #:
Email:
PI Emory Faculty?:
Y
N
Sub-PI and Department Information (Only if effort attached to study - If more than two, submit separately or note at the bottom of page 2)
Sub-PI #1 - Name:
Office Phone #:
Cell Phone #:
School:
Dept:
Division:
PIC #:
Email:
Sub-PI Emory Faculty?:
Y
N
Sub-PI #2 Name:
Office Phone #:
Cell Phone #:
School:
Dept:
Division:
PIC #:
Email:
Sub-PI Emory Faculty?:
Y
N
Is PI or Sub-PI an Emory Specialty Associate (ESA) Physician?:
Y
N
NA
If yes, where conducting research?:
Saint Joseph’s
John’s Creek
List if Other Facility:
Clinical Research Coordinator Information
Name:
Office Phone #:
Cell Phone #:
Email:
Department/Research Administrator (DA/RA) or RAS Information
Name:
Office Phone #:
Email:
Additional Contacts (Specify the names and email addresses of others not listed above who need to be copied on emails or sent the PRA and/or budget)
Name:
Name:
Email:
Email:
Study Information
Length of Study:
Months or
Years
Protocol Title:
Short Title/Acronym:
Protocol Version and Date:
IRB#:
EPEX #:
Competitive Enrollment?:
Y
N
Target Enrollment #:
Is this an Amendment?:
Y
N
Are you expecting any amendments in the next 30 days?
Y
N
CRN/ACTSI?
Y
N
Overnight Stay CRN?
Y
N
CRN/ACTSI Application Approved?
Y
N
Pending or NA
PI Initiated?:
Y
N
Other (Specify):
Registered with ClinicalTrials.gov?:
Y
N
Unknown
ClinicalTrials.gov (NCT) #:
Drug or Device Information (Check all that apply)
Drug Study?:
Y
N
NA IND#:
IND Exempt?:
Y
N
NA
IND Holder:
Device Study?:
Y
N
NA IDE#:
IDE Exempt: (FDA approved, 510K, PMA, HDE, or Abbrev IDE):
IDE Holder:
Emory Purchasing Notified?
Y
N
NA (see form
Contacted EHC Office Of Compliance for submission to Local Medicare Director?
on http://www.ocr.emory.edu/forms/index.html.
Y
N
NA (contact judith.campbell@emoryhealthcare.org for info)
If not provided free, is price approved by Emory Healthcare?:
Y
N
NA
If Drug Trial – Phase:
I
II
I/II
III
IV
If Device Study - Category:
A
B
NA
Provided Free by
FDA Approved?
Approved for
Name of Drug/Device (If more than 5, list on bottom of next page)
Sponsor?
this Indication?
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Funding Sources (Check all the apply)
Federal
Federal Flow Through
Umbrella Grant
Foundation (Specify):
Sub-Contract
Industry
Internal, Department
Other (Specify):
Has the budget been pre-negotiated?:
Y
N
NA
Received the Notice of Award?:
Y
N
NA
Sponsor Information
Sponsor Name:
Budget Contact:
Contract Contact:
Email:
Email:
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
Version: 07April 2015
Page 2 of 11
Phone #:
Contract Research Organization (CRO)
Y
Budget Contact:
Email:
Phone #:
Check all Facilities where Subjects will be seen
Children’s Egleston:
Hughes Spalding or
Emory Children’s Center (ECC)
Emory Clinic (TEC)
Emory University Hospital (EUH)
Emory University Hospital Midtown (EUHM)
Emory Orthopedic & Spine Hospital
Other (Specify):
N
NA
Phone #:
CRO Name:
Contract Contact:
Email:
Phone #:
Scottish Rite
Emory Vaccine Center (Hope Clinic)
Grady Memorial Hospital
Grady-Ponce Center
John’s Creek Hospital
Saint Joseph’s Hospital
Wesley Woods Hospital/Health Center
Will you Use any of these Facilities?(If checked note fee or room charge)
Fee or Room Charge:
ACTSI/CRN
Ambulatory Surgical Center (ASC)
Hospital OR
CSI/WW
BITC
Pediatric Research Center
Infusion Center
Required Documents
Completed Study Submission Form
Emory Draft Consent Form
Sponsor Budget
Dedicated Research Space
Sibley Heart Center
Final Protocol (No drafts will be accepted)
Clinical Trial Agreement or Award Letter
PI Effort Sheet(s) (Only needed if negotiable budget)
Other Documents (If available/applicable)
Y
N Draft Budget Prepared by Department
Y
N ACTSI/CRN Budget/Application
Y
N Additional Fees for Radiology Services
Y
Y
Y
N IND/IDE Approval Letter
N IND/IDE Exemption Letter
N Emory/PI Standard Practice Protocols/Guidelines
Study Items/Services – Regardless if SOC/Routine Care
Physical Exam/Office Visit
Research Room - no EHC
billable
Y
N
Y
N
If Yes, check all that apply and provide information
CPT code used
No CPT code used (Effort only)
Electrocardiogram (ECG)
Y
N
Pregnancy Test
Y
N
Radiology/Imaging
Y
N
Lab Samples
Y
N
Anesthesia/Sedation
Y
N
Patient Compensation/Stipends?
Y
N
ECG machine provided by sponsor
Tracing to Central Lab
Study Staff will perform
Cardiology will perform
Study staff will read
Cardiology will read
Test sent to Emory Lab
Kits provided by sponsor
Test sent to Central Lab
Kits bought by department
POC (Point of Care Testing)
BITC
CSI/WW
Emory Radiology
Sibley Heart Center
Grady
CHOA
Other (Specify):
Emory Medical Lab (EML)
Other (Specify):
Emory Pathology Lab
POC (Specify):
Central Lab
Additional lab preparatory
Internal Emory Research Lab
fees, provide cost:
General Anesthesia
Time required:
Conscious/MAC Sedation
Local
Amount(s):
Comments and/or Items/Services Not Addressed Above
This form is an important step as we continue to improve our processes. For any questions about this form, email ocr@emory.edu. Thank you for your support.
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
Version: 07April 2015
Page 3 of 11
DATA/STUDY LOGISTICS
(Please note that this information will be utilized to develop and negotiate the budget by SOM CTO. For assistance in
calculating effort, please contact Janet Davis at 404 778-4770.)
1) Will this study be managed by the Winship CTO?
2) Is a nurse/coordinator needed for this study? If so, what
% of his/her time is needed for this study?
3) Please list all procedures required for this study that are
not standard of care.
4) Does the funding cover the costs of the study? Please
discuss the financial soundness of the study.
GENERAL PROTOCOL INFORMATION
Study Design:
Primary Objective:
Secondary Objectives:
1) PHASE
2) STUDY TYPE
3) CLINICAL RESEARCH
CATEGORY
4) NCI PROTOCOL TYPE
Phase I
Feasibility/pilot
Phase II
Extended Access
Phase III
Prevention
Phase IV
Other – Explain
Treatment (involves an intervention)
Cancer Prevention (involves the use of medications in persons who do not have an
active cancer)
Ancillary/Companion (QOL or tissue study that is appended to a therapeutic trial)
Laboratory only (uses previously banked human blood or tissue – no patient
interaction)
Correlative (non-interventional studies that assess QOL, symptom control, behavior...
Ancillary or Correlative
Interventional
N/A
Observational
Treatment (Protocol designed to evaluate one or more interventions for treating a
disease, syndrome, or condition).
Prevention (Protocol designed to assess one or more interventions for preventing,
or decreasing the chance of getting, a specific disease or condition).
Screening (Protocol designed to assess or examine methods of identifying a
condition or risk factor for a condition in people that are not yet known to have the
condition or risk factor).
Supportive Care (Protocol designed to evaluate one or more interventions where
the primary intent is to maximize comfort, minimize side effects or mitigate against
a decline in subject’s health or function. In general, supportive care interventions are
not intended to cure a disease).
Basic Science (Protocol designed to examine the basic mechanism of action of an
intervention).
Diagnostic (Protocol designed to evaluate one or more interventions aimed at
identifying a disease or health condition).
Health Services Research (Protocol designed to examine the delivery, processes,
management, organization or financing of health care).
Other (Protocol that is not in other categories, and is defined in free text).
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
Version: 07April 2015
Page 4 of 11
3) TUMOR SITE (Disease Site from NCI guidelines):
4) Date of working group approval:
Approved by:
Note: Disease site Working Group approval is required prior to CTRC submission. Questions? Contact Lydia Cox at (404) 778-5569.
In cases where the study plan involves patient accrual across multiple tumor types, it is recommended to obtain approval from a single
working group that oversees the disease site where the major bulk of participants will be recruited from.
Working Group Priority Score:
1
2
3
4
5
– Highest (The highest priority study this year for this working group)
- High (One of the top 5 studies for the year for this working group)
– Medium (Majority support for the study but moderate enthusiasm)
– Low (Mixed opinion from the group about opening this study)
– Lowest (The majority in the working group did not want to open this study)
Comments (optional):
5) Are there any protocol priority conflicts?
No If no, explain how this study does not compete with any existing protocol that enrolls a similar patient
population:
Yes If yes, please list all conflicting protocols in order of priority and their current patient accrual:
6) SCHEMA - Please attach a copy of the study schema to this application.
Attached
Not attached – Reason:
7) FOLLOW-UP
Does this study involve long term follow-up of subjects?
Yes
No
8) What is the expected termination date?
Investigational Drugs (for all drugs used in the protocol)
Drug Name (Generic/Trade)
Is this drug
approved for
this
application?
IND Number or IND
Exemption Waiver
(if utilizing waiver,
please include
attached waiver
certification)
Who holds
the IND?
(Sponsor,
Investigator)
Manufacturer/s
No
Yes
Investigator's
Brochure or
package insert
present?
Yes
No
(explain
Yes
No
(explain
Yes
No
(explain
Yes
No
(explain
Yes
No
(explain
No
Yes
No
Yes
No
Yes
No
Yes
)
)
)
)
)
Investigational Devices
1) Are investigational devices used in this protocol?
2) If yes, is there an IDE?
No
No
Yes
Yes (IDE #:
)
Radiation
1) Is radiation used in this project?
2) If yes, what forms of radiation?
If yes, complete Radiation Safety
application (see link)
No
Yes
Diagnostic x-rays
Radiation therapy
Radioisotopes
http://www.ehso.emory.edu
Biosafety
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
Version: 07April 2015
Page 5 of 11
Does this study involve:
(If you answered yes to any of these questions,
this study requires approval by the Emory
University Health and Biosafety Committee.
See link.)
Recombinant DNA?
No
Biological Toxins?
No
Infectious Agents?
No
http://www.ehso.emory.edu
Yes
Yes
Yes
Study Origin
3) INITIATION
Is this an investigator-initiated study? (If the PI is the sponsor or if the PI and or Coinvestigators design, or participate in designing the study)
Yes
No
(If NO, please skip this section)
Winship Investigator-Initiated Research
Yes
No
If Yes: Winship Biostatistics Core consult recommended prior to submission
Study statistician Name:
Email:
Date of Consult:
Did you use a non-Winship Core Biostatistics support?
Name and contact information:
High Throughput Genomic-based research?
Yes
Yes
No
If yes, Cancer First Studio consult with Genomics and or Bioinformatics Core
recommended.
Core Collaborator Name:
Email:
Date of consult:
4) NCI TRIAL TYPE
(Please choose all that
apply)
National Group (e.g. ECOG, PrECOG, etc) – Please specify which group below:
Name of National Cooperative group:
- (qualifies for expedited CTRC review)
Consortium – Name:
Other Externally Peer-Reviewed Trial (R01, P01, other funded by NIH, ACS,
Komen Foundation, etc) Name:
Institutional Trial (in-house, internally reviewed trials, including those collaborative
studies conducted with industry sponsorship or participation in a multi-site trial
initiated by an investigator at another center.
Initiation by:
Funded by:
Industry Trial (design and implementation of the study by the pharmaceutical
company) Sponsor Name:
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
Version: 07April 2015
Page 6 of 11
Winship Program
PRIMARY SCIENTIFIC
PROGRAM
TEAM
(Working Group)
CCB - Cancer Cell Biology
CGE - Cancer Genetics & Epigenetics
CPC - Cancer Prevention and Control
DDT - Discovery and Developmental Therapeutics
Breast
Heme/BMT
GI
Heme/Leuk
Aero-digestive
Heme/Lymph
Melanoma
Heme/MM
Neuro
GU
Phase I
Other
CO-INVESTIGATORS/STUDY PERSONNEL
List all co-investigators and support staff (clinic nurses, advanced midlevel practitioners, research nurse,
coordinator, regulatory specialist) who will be participating in research activities, data collection or regulatory
filing and administrative support on the study. Please note that all study personnel must have IRB certification.
http://www.emory.edu/IRB/hsep.php
(add rows by hitting the TAB key from the bottom right cell)
Name, Degree
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
Role
Dept/Div
Version: 07April 2015
Page 7 of 11
STUDY PARTICIPANTS
GENDER
AGE GROUP(S)
(Check all that apply.)
Both
Male Only
Female Only
N/A (blood or tissue samples only)
Infants or Children under age 6
Children aged 6-10
Children aged 11-16
Children aged 17
Adults 18 - 64
Adults 65 +
Indicate which of the following populations will be included in the research {mark all that apply}:
Intellectually or emotionally impaired
Patients
Pregnant subjects or fetuses
Prisoners, parolees, incarcerated subjects
Students or trainees
Employees of study sites
Subjects whose 1st language is not English
Normal Volunteers
Employees/subordinates of investigators
No subjects – e.g. chart or database review
ACCRUAL
NOTE: The CTRC reviews accrual to open trials quarterly. If after one year of being open to accrual, the rate of
accrual is ≤ 25% of what is proposed below, the study will be subject to closure.
1) How many subjects to do you expect to enroll annually?
2) What is the planned total enrollment on this protocol
3) When is the estimated study activation date?
4) What is the expected duration of accrual?
5) If this is a multi-center study, what is the total number of
subjects to be enrolled at all sites:
6) Please explain how you will recruit participants.
N/A
7) How many patients with this disease were seen at
Winship in the past year?
DATA SAFETY/HIPAA
1) If this is a phase III study, will a Data Safety Monitoring
Board (DSMB) review the data?
Yes
No
N/A
External –
Specify responsible entity
Internal –
List members
2) State data safety monitoring plan. If no DSMB is
required, please describe the plan to minimize the risks
and ensure the safety of the subjects.
3) Please indicate how the safety and data integrity will be
monitored. (Note: Winship DSMC review is required for all
Winship investigator-initiated-trials)
4) External Data Monitoring. If noted above, please
indicate the entity conducting the monitoring and the
expected frequency:
5) State stopping rules (reference page and paragraph
from the protocol.)
6) Please explain how the study is HIPAA compliant:
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
A - Winship DSMC and Monitors
B - External DSMC and CRO Monitors
C - External DSMC/Winship Monitors
D – CTEP or Cooperative Group/Winship DSMC and
Monitors
Not applicable; please explain
Frequency:
1) You will obtain authorization from the participant for
the use and disclosure of PHI (Personal Health
Information) through obtaining informed consent.
2) The data will be completely de-identified and
therefore the need of authorization from the individual is
waived. (See attached list of 18 identifiers.)
3) This is a Limited Data Set and you are seeking a
Data Use Agreement. (See attached list of allowed
Version: 07April 2015
Page 8 of 11
identifiers.)
4) This study involves only the use of decedent data.
BLOOD AND/OR OTHER TISSUE STORAGE/BANKING
1) Does this research involve blood/tissue storage or banking?
2) Describe the nature and number of samples to be collected.
3) For what period of time will these samples remain stored?
4) Identify the primary custodian of the samples.
5) Are the use of the samples for both current and/or future
research activities clearly described in the informed consent form
and process?
6a) Describe any identifiers that will be linked to the samples.
6b) If linked, are subjects able to request destruction of samples at
a later date? (If so, this should be described in consent form).
7) If the samples have direct or indirect links to the subject,
describe the measures in place to maintain the confidentiality of
information relating to the samples.
8a) Are there current plans to make the samples available to
researchers outside of the institution?
8b) If yes, provide a list of recipients and a description of how
decisions are made to release samples to researchers outside
of Emory.
9) Are there plans to re-contact the subjects to request additional
samples?
10) Will cells be immortalized?
11) Do the subjects and/or their families receive information
regarding the interpretation of research or other incidental
findings?
12) Are there any genetic findings recorded in the subject’s medical
record?
13a) Are any genetic findings made known to third parties (e.g.,
subject’s physician, family members, other researchers,
insurance company)?
13b) If yes, describe the conditions under which such disclosures
are made.
14. Will genetic counseling be offered to subjects and/or their
families?
No
Yes (If No, indicate so and move to
next section)
No
Yes
No
Yes
No
Yes
No
Yes
No
No
Yes
Yes
No
Yes
No
Yes
No
Yes
If no, please justify:
CONFLICT OF INTEREST
Does any participating research team member (or his/her spouse or depedent children) have
any financial interest such as royalty, equity or any other payments (e.g. consulting, salary, etc)
No
Yes
in the sponsor or other entities having a financial interest in the intellectual property, product, or
service which is the subject of the proposed research?
Please review the following information concerning Emory University’s Conflict of Interest and Disclosure guidelines:
http://www.or.emory.edu/share/policies/conflict.html
Any potential conflict of interest must be disclosed to the Dean’s Office.
SIGNATURES
As Principal Investigator, I acknowledge responsibility for this project and assure that the faculty and staff who
participate in it are qualified (or will be adequately trained) to conduct it.
Principal Investigator
Date:
signature:
Typed name of PI
Working Group Chair
signature
Typed name of working
group chair
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
Date:
Version: 07April 2015
Page 9 of 11
Submit form and all supporting documentation to:
Lydia Cox
CTRC Coordinator
Clinical & Translational Research Committee
Winship Cancer Institute
1365C Clifton Road, Suite 3012
Atlanta, GA 30322
(404) 778-5569 (phone)
(404) 778-4389 (fax)
Winshipctrc@EMORY.EDU
HIPAA IDENTIFIERS
DE-IDENTIFIED personal health information (PHI) does not fall under the HIPAA rule. Therefore you can waive
authorization for its use and disclosure.
To de-identify PHI these 18 identifiers must be removed:
1. Names
2. Geographic subdivisions smaller than a state, including street address, city, county, precinct, zip cope and their
equivalent geocodes, except for the initial 3 digits of the zip code if, according to the current policy available from
the Bureau of the Census
 The geographic unit formed by combining all zip codes with the same 3 initial digits contains more than
20,000 people; AND
 The initial 3 digits of the zip code for all geographic units containing 20,000 or fewer people is changed to
000.
3. Dates (except year) directly related to an individual (e.g., DOB, discharge date, date of death) and all ages over
89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be
aggregated into a single category of age 90 or older
4. Telephone numbers
5. Fax numbers
6. Electronic mail addresses
7. Social Security Number
8. Medical Record numbers
9. Health plan beneficiary numbers
10. Account numbers
11. Certificate/license numbers
12. Vehicle identifiers and serial numbers, including license plate numbers
13. Device identifiers and serial numbers
14. Web Universal Resource Locators (URLs)
15. Internet Protocol (IP) address numbers
16. Biometric identifiers, including finger and voice prints
17. Full face photographic images and any comparable images; and
18. Any other unique identifying number, characteristic or code
LIMITED DATA SETS
A “Limited Data Set” is a set of data that is not fully de-identified. You do not need authorization from the patient, nor
do you need to seek a waiver, however you must have a “data use agreement” with Winship that describes the
permitted uses and disclosures of the information received, and prohibits re-identifying or using this information to
contact individuals. This plan must be reviewed by the IRB.
Of the 18 identifiers listed above, the following MAY be used in a Limited Data Set
1. Dates
2. Geographic information (not street address)
3. Other unique identifying numbers characteristics, or codes that are not expressly excluded
(The other 15 identifiers must be removed.)
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
Version: 07April 2015
Page 10 of 11
Applicable for single site investigator initiated trials only.
IND Exemption Waiver
The clinical investigation of a marketed drug or biologic does not require submission of an IND if ALL
six of the following conditions are met:
(i) it is not intended to be reported to FDA in support of a new indication for use or to support any
other significant change in the labeling for the drug;
(ii) it is not intended to support a significant change in the advertising for the product;
(iii) it does not involve a route of administration or dosage level, use in a subject population, or other
factor that significantly increases the risks (or decreases the acceptability of the risks) associated
with the use of the drug product;
(iv) it is conducted in compliance with the requirements for IRB review and informed consent [21 CFR
parts 56 and 50, respectively];
(v) it is conducted in compliance with the requirements concerning the promotion and sale of drugs
[21 CFR 312.7]; and
(vi) it does not intend to invoke 21 CFR 50.24 (this has to do with waiver of informed consent in an
emergency room setting).
I confirm that the use of ____________________________ in the protocol titled
(drug)
________________________________________________________________________________
meets all six of the above criteria and does not require the submission of an IND.
______________________________________________________
PI NAME (printed)
______________________________________
PI Signature
Winship Cancer Institute Protocol Submission Application
(Includes OCR Submission Form v2.0 dated 3/4/14)
___________
Date
Version: 07April 2015
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