Form 35 CIRB SAE Reviewer Worksheet

Attachment 6K: CIRB SAE Reviewer Worksheet

OMB#: 0925 – xxxx

Expiry Date: xx/xx/xxxx

STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. While your participation is completely voluntary, to participate in the NCI CIRB, completion of this
form is required. Data collected as part of the NCI CIRB review is private and protected by law. Under the provisions of Section 301d of the Public Health Service Act,
no information that could permit identification of a participating individual may be released. All such information will be kept private under the Privacy Act and will be
presented only in statistical or summary form.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding
this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705
Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this address.

CIRB SAE Reviewer Worksheet
1 No Changes to informed consent document and/or protocol
2 Informed consent document requires clarification of existing risk
5 CTEP Action Letter-awaiting Group's amendment
12 New Risk identified not currently in informed consent document: request more information
13 New Risk identified not currently in protocol: request more information
14 New Risk identified not currently in protocol and informed consent document: request more information
15 Need more information-AE Report contains preliminary information and a determination cannot be made
AENumber

Study

1034535 FU1 CALGB 40502

Study
Status

IND Holder

Agent

Report
Date

PrimaryEvent

Previous
Rcmnd And
Comments

OHRP
Expiration
Date

DateRecei DateSentTo
Subcommitte
Recommen
vedFromG Subcommitt
e Reviewer
dation
roup
ee

Newly
received
from CTEP

CTEP

bevacizumab

05/15/2009

Dehydration

Initial report in
review

02/22/2010

05/18/2009

1277486

CALGB 40502

Newly
received
from CTEP

CTEP

Gr. 3
Bevacizumab
pneumonitis/pulm
and
04/07/2009
onary infiltrates,
Lenalidomide
atrial fibrillation

Initial report

02/22/2010

05/18/2009

1314985

CALGB 40502

Newly
received
from CTEP

CTEP

Bevacizumab 04/17/2009

Initial report

02/22/2010

05/18/2009

1433885 FU1 CALGB 40502

Newly
received
from CTEP

CTEP

bevacizumab

Pneumonitis/piul
monary infiltrates, 1-fever and
02/22/2010
pericardial
infections noted
effusion

04/22/2009

04/15/2009

Sudden death

Rationale

DateOfSub
committee
Review