3. Principal investigator:
* must provide value
2.1a Principal Investigator Email Address:
* must provide value
2.1b Principal Investigator Phone Number:
* must provide value
4. What type of project is this?
* must provide value
Non-Human Research - Research involving only anonymous data/specimens provided by an honest broker and/or data/specimens of deceased individuals.
Non-Regulated Research - Projects such as Quality Improvement, Health Surveillance, Case reports of 3 or fewer cases, etc. Typically, these projects are designed to describe a condition/treatment/etc. or used to make an immediate change in procedures/processes at the local institution. These projects are not considered to be generalizable beyond the institution.
Non-Research, Treatment Protocols (Compassionate Use/Expanded Access) These protocols are intended for treatment with unapproved drugs or devices. These protocols are not considered clinical investigations but are regulated by the FDA and require IRB review and approval.
4.1 Select the type of Treatment Protocol:
* must provide value
Emergency Use Treatment using an unapproved drug/device/biologic
Single Patient Treatment using an unapproved drug/device/biologic
This application should not stand in the way of providing urgent medical treatment. Although reporting to the IRB is required, should you need to proceed with treatment before IRB review, you may do so and then report use within 5 days of use.
5. Is your study evaluating the effects of an intervention on health-related biomedical or behavioral outcomes?
* must provide value
Yes
No
6. Will the study take place at UTSW, Parkland, or Children's?
* must provide value
Yes
No
7. Are any members of the research team employed by (paid by or in not paid, they are primarily affiliated with e.g., students) UTSW, Parkland, or Children's?
Yes
No
7a. Will the study take place at THR?
* must provide value
Yes
No
7b. If this study will take place at THR, upload the signed THR Entity Review Form.
8. Will there be any Epic-scheduled and/or billable study-related events at UTSW or Parkland (e.g., visits, professional services, procedures, etc.)?
Yes
No
2.2 Credentials and Licensing:
* must provide value
2.4 - Home Affiliated Institution:
* must provide value
UT Southwestern
Children's Health
Parkland Health and Hospital System
Texas Health Resources
Scottish Rite for Children
UT Dallas (UTD)
UT Arlington (UTA)
Retina Foundation
VA North Texas
Other (this response typically applies to non-UTSW contract workers (CWRs) and Persons of Interest (POls) that were provided a UT Southwestern username and email address)
If Other selected, provide the institution name:
* must provide value
2.5 What treatment activities will this individual be responsible for in this protocol?
* must provide value
2.5.1
2.6 - Where will this individual be conducting treatment activities? (Select all that apply)
* must provide value
2.6a. Specify UTSW Location:
* must provide value
Specify UTSW Other Location:
2.7 Does the individual, or their family member(s), have a financial interest in the company funding this study, OR in any entity that manufactures a drug, device, or piece of software being used or studied in this project? This can include drugs or devices being used or studied as part of standard clinical care. Please note: All research personnel must complete a financial disclosure. Final approval will be withheld until all Statements of Financial Interests have been received by the Conflict of Interest office.
* must provide value
Yes
No
2.7a Has a management plan been issued by UTSW COI or non-UTSW COI Committee?
Yes - UTSW COI Committee
Yes - non-UTSW COI Committee
N/A - no management plan issued
2.7b Upload a copy of your COI management plan here:
Do you have a second person to add?
Yes
No
Study Personnel Email Address
* must provide value
2.2 Credentials and Licensing:
* must provide value
If other, specify:
* must provide value
2.3 - Which role best describes this individual?
* must provide value
Co-Principal Investigator (Co-PI) (this is not typical, justification is required)
Sub-Investigator
Study Coordinator
Faculty Sponsor
Local site PI
Regulatory Contact
Research Nurse
Research Assistant
Data Coordinator
Honest Broker
Statistician
Relying site PI
Relying Site Contact
Other
2.3.a. Is this individual the Primary Study Coordinator?
* must provide value
Yes
No
Provide a justification for appointing a Co-PI to share the PI responsibilities here:
* must provide value
If other, specify:
* must provide value
2.4 - Home Affiliated Institution:
* must provide value
UT Southwestern
Children's Health
Parkland Health and Hospital System
Texas Health Resources
Scottish Rite for Children
UT Dallas (UTD)
UT Arlington (UTA)
Retina Foundation
VA North Texas
Other (this response typically applies to non-UTSW contract workers (CWRs) and Persons of Interest (POls) that were provided a UT Southwestern username and email address)
If Other selected, provide the institution name:
* must provide value
2.5 What treatment activities will this individual be responsible for in this protocol?
* must provide value
2.5.1
2.6 - Where will this individual be conducting treatment activities? (Select all that apply)
* must provide value
2.6a. Specify UTSW Location:
* must provide value
Specify UTSW Other Location:
2.7 Does the individual, or their family member(s), have a financial interest in the company funding this study, OR in any entity that manufactures a drug, device, or piece of software being used or studied in this project? This can include drugs or devices being used or studied as part of standard clinical care. Please note: All research personnel must complete a financial disclosure. Final approval will be withheld until all Statements of Financial Interests have been received by the Conflict of Interest office.
* must provide value
Yes
No
2.7a Has a management plan been issued by UTSW COI or non-UTSW COI Committee?
Yes - UTSW COI Committee
Yes - non-UTSW COI Committee
N/A - no management plan issued
2.7b Upload a copy of your COI management plan here:
2.8 Should this individual receive notifications related to this study?
Yes
No
Do you have a third person to add?
Yes
No
Study Personnel Email Address:
* must provide value
2.2 Credentials and Licensing:
* must provide value
If other, specify:
* must provide value
2.3 - Which role best describes this individual?
* must provide value
Co-Principal Investigator (Co-PI) (this is not typical, justification is required)
Sub-Investigator
Study Coordinator
Faculty Sponsor
Local site PI
Regulatory Contact
Research Nurse
Research Assistant
Data Coordinator
Honest Broker
Statistician
Relying site PI
Relying Site Contact
Other
2.3.a. Is this individual the Primary Study Coordinator?
* must provide value
Yes
No
Provide a justification for appointing a Co-PI to share the PI responsibilities here:
* must provide value
If other, specify:
* must provide value
2.4 - Home Affiliated Institution:
* must provide value
UT Southwestern
Children's Health
Parkland Health and Hospital System
Texas Health Resources
Scottish Rite for Children
UT Dallas (UTD)
UT Arlington (UTA)
Retina Foundation
VA North Texas
Other (this response typically applies to non-UTSW contract workers (CWRs) and Persons of Interest (POls) that were provided a UT Southwestern username and email address)
If Other selected, provide the institution name:
* must provide value
2.5 What treatment activities will this individual be responsible for in this protocol?
* must provide value
2.5.1
2.6 - Where will this individual be conducting treatment activities? (Select all that apply)
* must provide value
2.6a. Specify UTSW Location:
* must provide value
Specify UTSW Other Location:
2.7 Does the individual, or their family member(s), have a financial interest in the company funding this study, OR in any entity that manufactures a drug, device, or piece of software being used or studied in this project? This can include drugs or devices being used or studied as part of standard clinical care. Please note: All research personnel must complete a financial disclosure. Final approval will be withheld until all Statements of Financial Interests have been received by the Conflict of Interest office.
* must provide value
Yes
No
2.7a Has a management plan been issued by UTSW COI or non-UTSW COI Committee?
Yes - UTSW COI Committee
Yes - non-UTSW COI Committee
N/A - no management plan issued
2.7b Upload a copy of your COI management plan here:
2.8 Should this individual receive notifications related to this study?
Yes
No
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. The information is private because it includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). The information is individually identifiable because the identity of the participant is or may be ascertained by the investigator or associated with the information The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations have different definitions of the term Human Research. Use the following series of questions to determine whether the activity you propose is Human Research for either agency.If you answer "Yes" any of the following questions, IRB review is required, and you will need to submit the study in UTSW ETHOS.
a. Will the UTSW or an affiliated institution receive a direct federal (DHHS) award to conduct human subjects' research, even where all activities involving human subjects are carried out by a non-UTSW entity (e.g., subcontractor or collaborator)?
Research Funding from the Department of Health and Human Services (DHHS) (e.g., Agency for Healthcare Research and Quality (AHRQ); Centers for Disease Control and Prevention (CDC); National Institutes of Health (NIH); etc.)
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
b. Does the project involve a drug or device used outside of usual medical practice, including non-FDA-approved agents, or off-label uses of FDA-approved drugs or devices being administered to one or more humans?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
c. Will the safety and/ or effectiveness of a drug (FDA approved or non-FDA approved) or regulated device being administered to one or more humans be evaluated or be compared to that of another?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
d. Will data from the activity of an active group or a control group be submitted to, or held for inspection by the FDA in support of a marketing or research application for an FDA-regulated product (drug or device)?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
e. Will data obtained from use of a device on human tissue specimens be submitted to, or held for inspection by, the FDA in support of a marketing application or research application for an FDA regulated product?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
f. Will you obtain data through intervention or interaction with living individuals?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
g. Will information be obtained about living individuals that is both private and identifiable?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
h. Are you obtaining newborn screening blood spots for research purposes (regardless of funding or identifiability)?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
i. Will you collaborate with/involve sites outside of UTSW and Partner Hospitals for this project?
* must provide value
Yes
No
f. Is the intent of the project either to test a novel hypothesis or to replicate another researcher's original study?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
g. Will patients or personnel be exposed to additional discernable risks or burdens beyond those of usual care at this institution?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
h. Does the project involve withholding of any aspect of conventional care shown to be beneficial in prior well-conducted clinical trials?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
i. Does the project seek to test interventions, practices or treatments that are not standard of care (neither consensus-based nor evidence-based)?
* must provide value
Yes
No
STOP - IRB review is required because you answered "Yes" to this question. You will need to submit this study in UTSW ETHOS.
j. Will you collaborate with/involve sites outside of UTSW and Partner Hospitals for this project?
* must provide value
Yes
No
4.a.2. Do the Research Activities involve collecting data about living individuals?
* must provide value
Yes
No
All individuals in this research are deceased
4.a.2a Upload Form H1
* must provide value
4.a.2b. Which of the following apply to your research? (Select all that apply)
* must provide value
4.a.2b1 Provide the reason the investigator will never obtain the identity of the subjects. (Select all that apply)
* must provide value
4.a.2. Classify your activity:
* must provide value
Academic Projects: academic projects or student assignments involving collection of data from human subjects when the data is used solely for the purpose of learning research methods and not intended to be used to develop or contribute to generalizable knowledge.
Case Reports: use medical information collected from a clinical activity rather than a research activity and presented on no more than three (3) patients. Case reports are generally done by retrospective review of the medical record and highlights a unique treatment, case or outcome. The examination of the case is usually not systematic and there is usually no data analysis or testing of a hypothesis. Investigators must ensure that the HIPAA privacy rules are followed with respect to using or accessing PHI (a HIPAA authorization or waiver may be required)
Community Outreach: The primary intent of research is to generate or contribute to generalizable knowledge. The primary intent of non-research community outreach activity is to prevent or control disease or injury and improve health, or to improve an ongoing community outreach program or service. Knowledge may be gained in any community outreach endeavor designed to prevent disease or injury or improve a program or service. In some cases, that knowledge may be generalizable, but the primary intention of the endeavor is to benefit patients participating in an outreach health program or a population by controlling a health problem in the population from which the information is gathered.
Criminal Justice and Intelligence Activities: The scope of these activities is collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. The activities are necessary for the operation and implementation of the criminal justice system. In addition, authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions does not constitute research.
Customer satisfaction surveys. This refers to surveys of program users to obtain feedback for use by program managers. This is similar to program evaluation.
Health surveillance. Health surveillance is an ongoing part of the medical care and public health care functions closely integrated with timely dissemination of these data to those responsible for preventing and controlling disease or injury (may include emergent or urgently identified or suspected imminent health threats to the population to document the existence and magnitude).
Medical quality assurance. This refers to activities particular to an institution's QA program, such as those activities protected from disclosure as part of its confidential medical quality-assurance program or other equivalent programs. (e.g., see applicable university or institutional policy)
Program evaluation. This refers to assessments of the success of established programs in achieving objectives when the assessments are for the use of program managers, for example, a survey to determine if program beneficiaries are aware of the availability of program services or benefits. [Note: Non-research evaluation is generally designed to assess or improve the program or service rather than to generate knowledge about a disease or condition.]
Routine Quality Improvement (QI) means systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of health care in particular settings. QI involves deliberate actions to improve care, guided by data reflecting the effects (e.g., types of practical problem solving; an evidence-based management style; the application of science of how to bring about system change; review of aggregate data at the patient/provider/unit/ organizational level to identify a clinical or management change that can be expected to improve care). For QI - answers to the following questions should be YES: a. Are patients who receive the project intervention expected to benefit? b. Will all groups in the project receive, at the minimum, usual care at this institution? c. Is the purpose to measure the performance of or to determine the effect of a process change intended to improve health care delivery? d. Will the results be used to inform and implement improvements in patient care at the institution the process is being implemented?
Scholarly and Journalistic Activities: Research where the focus is directly on the specific individuals about whom the information is collected and used without extending that information to draw generalizations about other individuals or groups is not generalizable knowledge. (e.g. Biography, oral history of a single subject, journalism, literary criticism, legal research, and historical scholarship) (see precautions in case reports)
Other
6.2 Concise Summary of Project: Provide a brief description of the treatment plan.
* must provide value
6.5 Upload the study protocol documentation:
6.8 Will you obtain written, signed informed consent from each patient/patient's representative?
* must provide value
Yes
No
6.11 Upload informed consent document(s), information sheets, verbal script(s), and stand-alone HIPAA Authorization forms (Form E-E.S2, F, F2, etc.):
* must provide value
24.1 Drugs, Devices (Select all that apply)
* must provide value
* A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. This includes articles (other than food or supplements) intended to affect the structure or any function of the body. If you are unsure if your product is a drug, visit the FDA page Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) page or Orange Book for more information. Note: some supplements may be considered drugs if they meet the definition above.
25.1 Name of Drug:
* must provide value
25.2. Manufacturer/Company:
* must provide value
25.3.1 Name of IND Holder:
* must provide value
25.3.2 Who is the IND holder?
* must provide value
Funder/Manufacturer
Principal Investigator of this study
Other UTSW Investigator
Other
25.3.2a If other, please describe:
* must provide value
25.3.3 Have you received a Cross-Reference letter from the original IND holder to assume Sponsor Responsibilities for this protocol under this IND?
* must provide value
Yes
No
25.3.3.a Submit Cross Reference Letter from the Sponsor/Manufacturer:
* must provide value
25.3.4 IND Number: (25 character limit, please enter only the IND number)
* must provide value
25.3.4a Please upload a copy of the IND confirmatory documentation (FDA IND Letter, Sponsor email, Sponsor protocol with IND Number, etc.):
* must provide value
25.3.4.b Upload second IND confirmatory documentation, if applicable:
25.3.4.c Upload third IND confirmatory documentation, if applicable:
25.3.5a Attach any additional supporting documentation for the use of this drug: (i.e. FDA Forms 1571 or 1572)
25.3.5b Attach second supporting documentation for the use of this drug: (i.e. FDA Forms 1571 or 1572)
Do you have a second drug to add?
Yes
No
25.1 Name of Drug:
* must provide value
25.2. Manufacturer/Company:
* must provide value
25.3.1 Name of IND Holder:
* must provide value
25.3.2 Who is the IND holder?
* must provide value
Funder/Manufacturer
Principal Investigator of this study
Other UTSW Investigator
Other
25.3.2a If other, please describe:
* must provide value
25.3.3 Have you received a Cross-Reference letter from the original IND holder to assume Sponsor Responsibilities for this protocol under this IND?
* must provide value
Yes
No
25.3.3.a Submit Cross Reference Letter from the Sponsor/Manufacturer:
* must provide value
25.3.4 IND Number: (25 character limit, please enter only the IND number)
* must provide value
25.3.4a Please upload a copy of the IND confirmatory documentation (FDA IND Letter, Sponsor email, Sponsor protocol with IND Number, etc.):
* must provide value
25.3.4.b Upload second IND confirmatory documentation, if applicable:
25.3.4.c Upload third IND confirmatory documentation, if applicable:
25.3.5a Attach any additional supporting documentation for the use of this drug: (i.e. FDA Forms 1571 or 1572)
25.3.5b Attach second supporting documentation for the use of this drug: (i.e. FDA Forms 1571 or 1572)
Do you have a third drug to add?
Yes
No
25.1 Name of Drug:
* must provide value
25.2. Manufacturer/Company:
* must provide value
25.3.1 Name of IND Holder:
* must provide value
25.3.2 Who is the IND holder?
* must provide value
Funder/Manufacturer
Principal Investigator of this study
Other UTSW Investigator
Other
25.3.2a If other, please describe:
* must provide value
25.3.3 Have you received a Cross-Reference letter from the original IND holder to assume Sponsor Responsibilities for this protocol under this IND?
* must provide value
Yes
No
25.3.3.a Submit Cross Reference Letter from the Sponsor/Manufacturer:
* must provide value
25.3.4 IND Number: (25 character limit, please enter only the IND number)
* must provide value
25.3.4a Please upload a copy of the IND confirmatory documentation (FDA IND Letter, Sponsor email, Sponsor protocol with IND Number, etc.):
* must provide value
25.3.4.b Upload second IND confirmatory documentation, if applicable:
25.3.4.c Upload third IND confirmatory documentation, if applicable:
25.3.5a Attach any additional supporting documentation for the use of this drug: (i.e. FDA Forms 1571 or 1572)
25.3.5b Attach second supporting documentation for the use of this drug: (i.e. FDA Forms 1571 or 1572)
An instrument, apparatus, machine, contrivance, implant, in vitro reagent, (including a component part or accessory) that is: 1) intended to treat, cure, prevent, mitigate, diagnose disease in man; and 2) it does not achieve any of its primary intended purposes through chemical action on or within the body and is not required to be metabolized to achieve its primary intended purposes. If so, it would be regulated as a drug.
26.1 Name of Device
* must provide value
26.2 Manufacturer/Company:
* must provide value
26.3 Is the Device a Humanitarian Use Device (HUD)?If you are unsure, you may use the FDA HDE/HUD Database FDA HDE/HUD Database
* must provide value
Yes
No
26.3.1 Upload FDA Approved Label/Patient Information for HUD
* must provide value
26.3.2 Is the use in accordance with HDE Labeling?
* must provide value
Yes
No
26.3.2a HDE Number
* must provide value
26.4.1 IDE Number
* must provide value
26.4.2 Who holds the IDE?
* must provide value
Funder/Manufacturer
Principal Investigator of this study
Other UTSW Investigator
Other
26.4.2a If other, please describe.
26.4.3 Name of IDE Holder (Specify the individual or company name)
* must provide value
26.4.4 Upload the IDE letter from the FDA.
Do you have a second device to add?
Yes
No
26.1 Name of Device
* must provide value
26.2 Manufacturer/Company:
* must provide value
26.3 Is the Device a Humanitarian Use Device (HUD)?If you are unsure, you may use the FDA HDE/HUD Database FDA HDE/HUD Database
* must provide value
Yes
No
26.3.1 Upload FDA Approved Label/Patient Information for HUD
* must provide value
26.3.2 Is the use in accordance with HDE Labeling?
* must provide value
Yes
No
26.3.2a HDE Number
* must provide value
26.4.1 IDE Number
* must provide value
26.4.2 Who holds the IDE?
* must provide value
Funder/Manufacturer
Principal Investigator of this study
Other UTSW Investigator
Other
26.4.2a If other, please describe.
26.4.3 Name of IDE Holder (Specify the individual or company name)
* must provide value
26.4.4 Upload the IDE letter from the FDA.
Do you have a third device to add?
Yes
No
26.1 Name of Device
* must provide value
26.2 Manufacturer/Company:
* must provide value
26.3 Is the Device a Humanitarian Use Device (HUD)?If you are unsure, you may use the FDA HDE/HUD Database FDA HDE/HUD Database
* must provide value
Yes
No
26.3.1 Upload FDA Approved Label/Patient Information for HUD
* must provide value
26.3.2 Is the use in accordance with HDE Labeling?
* must provide value
Yes
No
26.3.2a HDE Number
* must provide value
26.4.1 IDE Number
* must provide value
26.4.2 Who holds the IDE?
* must provide value
Funder/Manufacturer
Principal Investigator of this study
Other UTSW Investigator
Other
26.4.2a If other, please describe.
26.4.3 Name of IDE Holder (Specify the individual or company name)
* must provide value
26.4.4 Upload the IDE letter from the FDA.
Sometimes called "compassionate use," expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
29.1 Qualify Criteria Questions 1-5 (for drugs) or 1-6 (for devices) must be yes to qualify for Emergency Use. If patient doesn't not have an immediately life-threatening condition, you may still qualify for review by an IRB Chair with an approved sIND and completed FDA FORM 3926
1. The patient has a condition that is life-threatening or severely debilitating
Yes
No
2. No standard treatment is available
Yes
No
3. There is not sufficient time to obtain IRB review and approval for the use of the test article
Yes
No
4. This is the first use of this test article at UTSW or the manufacturer does not have plans to pursue marketing or change of marketing and there is no current planned subsequent use.
Yes
No
5. There is no known available IRB approved protocol using the same article, or the patient does not qualify for an existing protocol
Yes
No
6. Due to the immediate need to use the device, there is no time to use existing procedures to obtain FDA approval for the use
Yes
No
Yes
No
7.1 Upload the FDA Form 3926
7.2 Provide the following information to assist the IRB Chairperson in making a determination. This information may also be used to complete the FDA FORM 3926 (if required)
7.2a Brief Clinical History of the patient including the diagnosis, the disease status, prior therapy, response to prior therapy and the rationale for requesting the proposed treatment.
7.2b Proposed Treatment Plan including the dose, route, planned duration, monitoring procedures and modifications (e.g. dose reduction or treatment delay) for toxicity. Reference a published protocol or journal article if appropriate.
8. Manufacturer Information:For Devices: • Prior FDA approval is not required for shipment or emergency use • NOTE: FDA does not need to be contacted prior to the emergency use of the unapproved device. NOTE: If the manufacturer requires a letter from the IRB prior to shipping, contact the HRPP main line (214) 648-3060. If no answer or after business hours, you may contact the IRB Director at 361-548-7904 or IRB Manager at 713-291-1195.
8.1 Does the manufacturer require a signed Agreement?
Yes
No
8.1.a If you have a copy of the agreement from the sponsor, upload it here: You must contact Sponsored Programs to have the agreement signed by an authorized official.
8.2 Do you have an authorization from the IDE sponsor, if an IDE exists?
Yes
No
8.3 Did you receive an independent assessment from an uninvolved physician?
Yes
No
8.4 Did the manufacturer authorize this use under an existing IND?
Yes
No
8.5 Did you obtain FDA authorization of shipment in advance of an IND submission?
Yes
No
9.0 Informed Consent Waiver. Upload the certification from an uninvolved physician (Form U3) confirming that informed consent should be waived.
10.0 You must submit the following to the IRB within 5 working days of the treatment:
Notification of Emergency Use (Create a Reportable Event submission, Select "Reportable Event," then select "Emergency Use Follow Up") Copy of the FDA EIND or SIND Letter should be provided (if not already submitted in UTSW ETHOS) Copy of signed informed consent form (patient name redacted ) or a signed Form U3 (consent waiver from uninvolved physician) 11.0 Additional Information
If an IDE is held by the Manufacturer, you must provide the IDE holder (sponsor) with a report. The sponsor is required to report to the FDA within 5 working days.
Automatic Upload of Survey