Request for Change Submission Form

REQUEST FOR CHANGE SUBMISSION FORM

For All Protocols EXCEPT National Cooperative Group (NCG) and Other Externally Peer Reviewed

(OEPR) trials that have been previously reviewed by CTEP (Cancer Therapy Evaluation Program) or DCP

(Division of Cancer Prevention)––changes to NCG and OEPR protocols do not require SRC review or approval.

Instructions: Please complete and submit this form to the Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office (Campus Zip 6805) by the 4thFriday of each month. Submissions received after this deadline will be reviewed at the subsequent SRC meeting. Note: Due to the holidays, the submission deadline for November and December is the 3rd Friday of the month.

SECTION I: Basic Protocol Data

Current IRB#:

Title:

Principal Investigator (PI): Phone: Email:

PI Dept.: PI Zip:

Study Coordinator/Contact: Phone: Email:

Data Coordinator/Contact: Phone: Email:

Statistician (if applicable):Phone: Email:

SECTION II: Protocol Status

Actively Accruing Patients

Study on Hold Date study placed on hold

Reason study was placed on hold

NOTE: If study was previously on hold and is no longer on hold, please give date study was taken off hold

Closed to Accrual Date study was closed to accrual

Reason study was closed to accrual

SECTION III: Changes That Are Being Requested

Major Change(s)
Addition or reduction of subject accrual goals
Change(s) to design, method, or procedures
Change(s) to drug dosage or delivery
Change(s) to eligibility criteria
Change(s) to data collection forms
Change(s) to the Investigator Brochure that affect the protocol1(see note on next page)
Change of Principal Investigator (PI)
Previous/Current PI:
Change PI to:
Other: Please explain:
1NOTE: While the SRC is required to have the most current copy of the Investigator Brochure (IB) on file, if changes to the IB do not cause a change to the protocol, no "Request for Change" needs to be submitted. / Minor Change(s)
Personnel change(s) (Other than Change in PI)
Personnel to be added:
Personnel to be deleted:
Addition or deletion of 2(see note on next page)participatingstudy Site(s)
Study Site(s) to be added:
Study Site(s) to be deleted:
Reporting requirements
Title change – Please list new title:
Other – Please explain:
2NOTE:The previous definitions of “Affiliate” and “Participating” sites are no longer valid. All sites other than UNMC/NM and their associated locations (i.e. Bellevue Medical Center, Village Pointe Medical Center, NE Orthopedic Hospital, and UNMC/NM Clinics) are now considered “Participating” sites. This includes Children’s Hospital and Medical Center.

ALSO NOTE: The SRC does not review changes to the Informed Consent form.

B. Are the proposed changes the result of an adverse event? Yes No

If YES, please attach a copy of the adverse event report.

C. Are the proposed changes the result of a request for funding/grant application? Yes No

If the proposed change (including title change) is the result of a new request for financial support, please attach a copy of the schema and abstract from the grant.

D. Are the proposed changes the result of a protocol change oramendment? Yes No

If YES:

Provide version or amendment number and date
Has the protocol amendment(s) been registered with NCI’s Clinical Trials Reporting Program (CTRP)? Yes No

SECTION IV: Justification for Requested Changes

For all changes to the protocol, all changes to the data collection forms and/or changes in the investigator brochure that affect the protocol, please describe the justification for each of the requested changes.

Change requested: Summarize the change or include the proposed language. / Change from: Summarize what is being replaced. / Rationale for Change: Give the scientific rationale for the change or preliminary findings that indicate the need for change.

SECTION V: Impact of the Requested Changes

If this is an Investigator-Initiated Institutional protocol and accrual has been changed, has a biostatistician been consulted to ensure that the statistical considerations are appropriate? Yes No N/A

B. If the requested changes involve eligibility or accrual, do changes cause the study to compete with other ongoing studies at UNMC/NMand their 1Associated Locations? Yes No

If YES, please list any competing studies (i.e. those with similar eligibility criteria) and rank them in the order of priority that they would be offered to the patient (e.g. #1, #2). Please remember to include this protocol submission in the list of studies.

NOTE: Per NCI Guidelines, protocols must be ranked in the following order of priority: 1)Institutional trials; 2)National Cooperative Group trials; 3) Industry trials; and 4)Other Externally Peer Reviewed––Non-Institutional trials. A list of active studiesis available from the Fred & Pamela Buffett Cancer Center PRMS office or on their searchable web site at .

ALSO NOTE: It is only necessary to list studiesthat treat the same disease population and have similar eligibility criteria when determining priority below.

Rank / IRB # / Protocol Classification / Title

SECTION VI: Request for Change Checklist (please mark all that apply and submit in order listed)

Original Signed and Dated SRC Request for Change Submission Form - required

If adding a participating site to any trial with UNMC as the Study Source (i.e. Sponsor): Documentation of participating site's agreement to abide by UNMC Audit Committee and DSMC reporting requirements. - required for all sites currently participating

Cover letter and/or copies of any correspondence related to this change (if applicable)

Copy of the IRB Request for Change - required, if submitted to the IRB

The REVISED Data collection form(s) (if applicable)

The REVISED Investigator Brochure (if applicable)

Copy of the schema and abstract from the grant (If the proposed change, including title change, is the result of a new request for financial support)

The REVISED protocol with version and date clearly marked on the face page (if applicable)

NOTE: A protocol in SRC format is required for all Investigator Initiated Institutional Treatment Intervention, Prevention Intervention, Other Intervention, and Ancillary trials sponsored by UNMC. Instructions on preparing a protocol in SRC format are available from the Fred & Pamela Buffett Cancer Center PRMS office or on their web site at .

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Signature of Principal Investigator Date

Fred Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office Eppley Institute (ECI) Room 3009

986805 Nebraska Medical Center Phone: (402) 559-4969

Omaha NE 68198-6805 Fax: (402) 559-4970

Request for Change Submission Form (Version 06/01/2014)Page 1 of 4