Att_31 IRB Approval 2013 Continuing Review

CLINICAL RESEARCH PROTOCOL
CONTINUING REVIEW APPLICATION
PROTOCOL TITLE:

PROTOCOL NO.

PRINCIPAL INVESTIGATOR (NIH Employee Name, Inst/Br, Address, Telephone and email):

11-E-N076

Dale P Sandler, Ph.D., NIEHS/EB, 919-541-4668, [email protected]

GuLF Study: Gulf Long-Term Follow-Up Study

PROTOCOL STATUS:
… Renew
-Recruitment of participants has not yet begun.
… Renew
-Participants are currently being recruited or enrolled.
… Renew
-No longer recruiting or enrolling participants, subject follow-up only.
X
… Renew
-Participants have completed study; study and data analyses ongoing.
… Renew
-Clinical Hold/Recruitment or enrollment of participants suspended.
… Terminate -Study closed. Participants have completed study. Recruitment and
data analysis complete.

IONIZING RADIATION USE (X-rays, e.g., CT; radioisotopes, e.g. PET, etc.) check all
that apply:
X

None

Medically indicated

Research indicated. Since the last review,
… Research usage HAS NOT changed.
… Research usage HAS changed. (Explain in summary report)
INVESTIGATIONAL NEW DRUG/DEVICE: X
… None … IND
*If reporting more than one IND/IDE, list on attached sheet.

SUMMARY OF PROTOCOL ENROLLMENT (Aggregate): Only when the NIH is the
coordinating site, provide totals and enrollment table for other site.

NIH Site

Other Sites

FDA No.

Total

0

55000

55000

0

6084

6084

0

32812

32812

… IDE

Accrual ceiling by IRB

Name:

New subjects accrued since last CR

Sponsor:

Aggregate total accrued

Who is the manufacturer of the above entity?

Are you currently recruiting healthy volunteers?
… No
X
Will the protocol involve adults unable to give informed consent? …
X No

… Yes
… Yes

Does the protocol involve a Tech Transfer Agreement?

… No
X

… Yes

Does the protocol involve a drug/device/product that may lead to you or the NIH
receiving payment and/or royalties?
X

No

Yes (Append a statement of disclosure)

Have analyses by sex, racial/ethnic subgroups been conducted for Phase 3 Clinical
… No
… Yes (answer a and b) X
… N/A
Trials as required?
a. Have analyses been reported? … No (explain in narrative) … Yes
b. Have significant differences been found? … No … Yes

Have there been any amendments since the last review?

No
X

Yes (Describe briefly in the attached narrative.)

Have any non-NIH Investigators or sites been added since the last review?
X No

… Yes (Identify the persons or sites and describe the collaboration in the
summary report)

Have there been any changes in the informed consent process or documentation since
the last review?

No

Yes (Describe in Summary report)
X

WITH THIS REVIEW, I AM REQUESTING A CHANGE TO THE FOLLOWING:
*Include Name, Inst/Branch, Telephone, Address, e-mail. Check box if an NIH Employee and initial
line. Attach sheet if necessary.

PRINCIPAL INVESTIGATOR:

Have there been any changes in the subject population, recruitment or selection criteria
since the last review?

No

Yes (Explain changes in the attached narrative.)
X

Delete:
Add*:
EXTRAMURAL ADJUNCT PRINCIPAL INVESTIGATOR:

Have any unexpected complications or side effects been noted since the last review?
X

No

Yes (Identify and explain in the attached narrative.)

Delete:
Add:
MEDICAL ADVISORY INVESTIGATOR:

Have any subjects withdrawn from this study since the last IRB approval?

No
X

Yes (Discuss in the attached narrative.)

Delete:
Add*:

Has any information appeared in the literature, or evolved from this or similar research,
that might affect the IRB’s evaluation of the risk/benefit analysis of human subjects
involved in this protocol?

No
X

Yes (Discuss in the attached narrative.)

LEAD ASSOCIATE INVESTIGATOR:
Delete:
Add*:
RESEARCH CONTACT:

Has the NIH IRP COI Guide been distributed to new NIH investigators?
… No
… Yes
… N/A
X

Delete:
Add*:

Has the NIH IRP COI Guide been distributed to new Non-NIH investigators?
… No
… Yes
… N/A
X

ASSOCIATE INVESTIGATOR(S):
Delete:

CONFLICTS OF INTEREST REVIEW?

Add*:

Date submitted to IC DEC:____________ Date cleared by IC DEC:_____________

SIGNATURE
RECOMMENDATION

Dale P Sandler
____________________________________
Principal Investigator
Dale P Sandler

Dale P Sandler, Ph.D.
Dale P Sandler, Ph.D.

Accountable Investigator

Dale P Sandler

Stavros Garantziotis

Dale P Sandler, Ph.D.
Stavros Garantziotis, M.D.

N. Almodovar

Date

e-Signed on 8/7/13 6:31 PM

Send to Branch Chief, or CC
Dept. Head of Accountable Investigator

e-Signed on 8/7/13 6:31 PM

Date

Send to Clinical Director

Date

e-Signed on 8/14/13 4:38 PM

Send to Chair, Institutional
Review Board

Print/Type Name

David B Resnik, J.D., Ph.D.

Chair, For Institutional Review Board
COMPLETION

Send to Accountable Investigator

Print/Type Name

Clinical Director

David B Resnik

e-Signed on 8/7/13 6:30 PM

Print/Type Name

Br Chief/CC Dept. Head of Acct. Invest
APPROVALS

Date

Print/Type Name

Print/Type Name
Date

9/17/13

Date

e-Signed on 9/16/13 2:02 PM

Protocol & Consent
Approved Effective

Send to Office of Protocol Services,
through IRB Protocol Coordinator

Protocol Specialist

Clinical Research Protocol Continuing Review Application
NIH-1195-1 (9-06) Page 1 of 1