LBH IRB Form #23: HUD Renewal Applicationpage 1Of 4

IRB #

DEPARTMENTOFRESEARCH

LBH IRB Form #23: HUD Renewal ApplicationPage 1of 4

Version 1, 10-09-14

Institutional Review Board

Humanitarian Use Device Renewal Form

HUD Title:
Primary Physician: / Degree: Select OneBACRNAM.D.PharmDPhD.RND.O.CRNP / Faculty: Select OneYesNoPrivate
Email:
Phone:
Dept:
Associate Physician: / Degree: Select OneBACRNAM.D.PharmDPhD.RND.O.CRNP / Faculty: Select OneYesNoPrivate
Email:
Phone:
Dept:
Associate Physician: / Degree: Select OneBACRNAM.D.PharmDPhD.RND.O.CRNP / Faculty: Select OneYesNoPrivate
Email:
Phone:
Dept:
Associate Physician: / Degree: Select OneBACRNAM.D.PharmDPhD.RND.O.CRNP / Faculty: Select OneYesNoPrivate
Email:
Phone:
Dept:
Associate Physician: / Degree: Select OneBACRNAM.D.PharmDPhD.RND.O.CRNP / Faculty: Select OneYesNoPrivate
Email:
Phone:
Dept:
Associate Physician: / Degree: Select OneBACRNAM.D.PharmDPhD.RND.O.CRNP / Faculty: Select OneYesNoPrivate
Email:
Phone:
Dept:
Contact Person:
*Email: / Beeper:
Phone: / Fax:
Dept:

*Email address may be published on the Department of Research’s webpage Yes No

Date patient contact began:

If this Humanitarian Use Device has an IDE, please complete the following:

HUD IDE# HCFA Device Class:

Certification of Principal Investigator/Faculty Sponsor: Signature certifies that all Investigators have reviewed the proposed protocol and grant, if HHS sponsored, that the documents are in agreement (or if not, an explanation is attached), and that the research will be conducted in full compliance with federal/state regulations and LBH procedures/guidelines. It is understood that: 1) continuing IRB review is required in order to maintain the approval status and that the investigator must submit a progress report for this review; 2) all changes in the study must be approved by the IRB prior to implementation; and 3) serious, unexpected study related adverse events must be promptly reported to the IRB.

Signature of Primary PhysicianPrint NameDate

Signature of Associate PhysicianPrint NameDate

If there are additional associate physicians, please have them sign on one of the associate physician lines.

Submission Instructions:

Humanitarian Use Device Renewals may be reviewed in an expedited manner per federal regulation. Therefore, only the following documents need to be submitted on paper: the completed and signed Renewal Application (this form), theunstamped assent/consent form(s), the complete protocol (if not previously submitted), and the investigator brochure (if not previously submitted). All of the above should be submittedelectronically (in either WORD or PDF formats) even if previously submitted.

Patient Population - check and complete all that apply:

AdultsPatientsStudentsPregnant Women

MinorsEmployeesSubjects incapable of giving consent

Attached to the HUD Renewal Form (check all that are included):

Assent/Consent form(s)

Protocol Version #, dated

Investigator Brochure Version #, dated

Additional information Primary Physician considers important for review by IRB

Annual Review Summary

Answer the following questions regarding your ongoing study:

a)Have any devices been used to date? Yes No

If yes, how many were used since the last review?

If yes, provide the total number of devices used to date?

b)Have any devices expired? Yes No

If yes, how many were destroyed or returned to the company since the last review?

If yes, how many were destroyed or returned to the company to date?

c)Have there been any device related adverse events or unanticipated problems involving risks to patients since the last IRB review? Yes No

If yes, please describe whether these events have changed your current risk/benefit assessment.

d)Have there been any early terminations, withdraws or complaints about the device since the last IRB review? Yes No

If yes, please describe.

e)Have there been any substantive changes in the protocol since the last IRB review?

Yes No

If yes, please summarize the changes.

f)Has there been any new literature, findings, reports on multi-center trials, or other relevant information, particularly with respect to possible risks to patients, associated with this device? Yes No

If yes, please describe.

g)Are there any preliminary results of the device? Yes No

If yes, please describe.

Patient Status Report:During the Past Year Cumulative Accrual

Number of patients enrolled

Number of patients terminated early

Number of patients in active treatment

Number of patients in follow-up

Number of patients who completed the study

Has enrollment ended? Yes No

If No, state who is consenting patients:

Are any patients receiving protocol required follow-up procedures not otherwise done as standard care and which involve more than minimal risk (such as involving radiation exposure or injection of radiographic contrast material)? Yes No

Cumulative Accrual by Race/Ethnic Group

African Am. / Caucasian / Am. Indian / Hispanic / Asian / Others / Totals
Males
Females
Totals

LBH IRB Form #23: HUD Renewal ApplicationPage 1of 4

Version 1, 10-09-14