NOTE: All Changes from Previous Versions of This

NOTE: All changes from previous versions of this form are highlighted in grey for your convenience. CONTINUING REVIEW SUBMISSION FORM

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 fourth Friday 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: CONTINUING REVIEW WITH CHANGE Yes No If YES, please see Section V

SECTION III: PROTOCOL STATUS Date of initial IRB approval: 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 IV: ACCRUAL INFORMATION A. UNMC/The Nebraska Medical Center (NMC) and 1Associated Locations Accrual Information:

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

Continuing Review Submission Form – Non CTEP or DCP Reviewed (Version 01/01/2014) Page 1 of 5 1NOTE: A UNMC/NMC associated location includes but is not limited to the Bellevue Medical Center, Village Pointe Medical Center, NE Orthopedic Hospital, and UNMC/NMC Clinics. This does not include Children’s Hospital and Medical Center. 1. What was the ORIGINAL target accrual goal per year at UNMC/NMC and their associated locations? (Example: 25 subjects per year.) 2. What was the ORIGINAL duration of the study at UNMC/NMC and their associated locations? (Example: 5 years.) 3. What is the CURRENT target accrual goal per year at UNMC/NMC and their associated locations? (Example: 25 subjects per year.) 4. What is the CURRENT duration of the study at UNMC/NMC and their associated locations? (Example: 5 years.) 5. How many total subjects have been accrued and over what period of time at UNMC/NMC and their associated locations? (Example: 15 subjects since 01/01/00.) 6. How many subjects have been accrued at UNMC/NMC and associated locations since the last SRC review? B. 2 Participating Site Accrual Information––ONLY COMPLETE for trials sponsored by UNMC and being implemented at one or more participating site(s): NOTE: If more than one participating site is part of this study, please break the targeted accrual down by site. 2NOTE: The previous definitions of “Affiliate” and “Participating” sites are no longer valid. All sites other than UNMC/NMC and their associated locations are now considered “Participating” sites. This includes Children’s Hospital and Medical Center. 1. What was the ORIGINAL target accrual goal per year at UNMC's Participating site(s)? (Example: 25 subjects.) 2. What was the ORIGINAL duration of the study at UNMC's Participating site(s)? (Example: 5 years.) 3. What is the CURRENT target accrual goal per year at UNMC's Participating site(s)? (Example: 25 subjects.) 4. What is the CURRENT duration of the study at UNMC's Participating site(s)? (Example: 5 years.) 5. How many total subjects have been accrued and over what period of time at Participating site(s)? (Example: 15 subjects since 01/01/00.) 6. How many subjects have been accrued at UNMC's Participating site(s) since the last SRC review? C. Overall Accrual Information for UNMC/NMC and UNMC Associated Locations (plus for all 2Participating sites for studies sponsored by UNMC, if applicable): 1. What date was the first subject consented (please complete either 1.a or 1.b below)?

Continuing Review Submission Form (Version 06/01/2014) Page 2 of 5 a. For trials being conducted only at UNMC and/or a UNMC Associated Location:

b. For trials that are sponsored by UNMC and being implemented at multiple participating sites: 2. Did subject recruitment begin as soon as the study received approval by UNMC’s IRB? Yes No

3. If NO, please explain the reason for the recruitment delay. 4. What percentage of the CURRENT total accrual goal has been reached to date? a. For trials being conducted only at UNMC and/or a UNMC Associated Location:

b. For trials that are sponsored by UNMC and being implemented at multiple participating sites: 5. If the accrual to date at UNMC/NMC and its associated locations (plus for all participating sites for trials sponsored by UNMC, if applicable) is less than 30%, what plans do you have to improve it? (Please be specific.) 2NOTE: The previous definitions of “Affiliate” and “Participating” sites are no longer valid. All sites other than UNMC/NMC and their associated locations are now considered “Participating” sites. This includes Children’s Hospital and Medical Center. D. Accrual to a Study That Is Partially Cancer Related: A study that includes subjects with cancer but also includes subjects who do not have cancer as their current disease diagnosis. 1. Does this study include subjects who do not have cancer in addition to subjects with cancer as their current disease diagnosis? Yes No

If YES, please answer question 2 - 5 2 below. 2. What percentage of this trial is cancer related? NOTE: The percentage of the trial that is cancer related is determined by dividing the number of subjects with cancer as their current diagnosis enrolled to date by the total number of subjects enrolled to date for the entire study 3. What is the CURRENT target accrual goal per year and per duration of the study for subjects with cancer as their current diagnosis at UNMC/NMC and its associated locations (plus for all participating sites for trials sponsored by UNMC, if applicable)? (Example: 25 subjects with cancer per year for 5 years.) 4. How many total subjects with cancer as their current diagnoses have been accrued and over what period of time at UNMC/NMC and its associated locations (plus for all participating sites for trials sponsored by UNMC if applicable)? (Example: 15 subjects with cancer as their current disease diagnosis since 01/01/00.) 5. What percentage of the CURRENT total accrual goal for subjects with cancer as their current diagnosis at UNMC/NMC and its associated locations (plus for all

Continuing Review Submission Form (Version 06/01/2014) Page 3 of 5 participating sites for trials sponsored by UNMC, if applicable) has been reached to date?

SECTION V: REQUEST FOR CHANGES TO THE PROTOCOL A. Does this Continuing Review include a Request for Change? Yes No

If changes in personnel (other than change of Principal Investigator) are the only changes to this protocol, complete section “B” below and Do Not submit an SRC Change form with this Continuing Review. For all other changes (Example: All Major Changes or the Addition or Deletion of Participating Site(s), Changes to the Reporting Requirements, Title Changes and Other Minor Changes), please complete an SRC Request for Change form and submit along with this Continuing Review.

B. Personnel Change/s: (NOTE: Change of PI must be accompanied by a Request for Change form) 1. Not Applicable:

2. Personnel to be added: 3. Personnel to be deleted:

SECTION VI: PREVIOUSLY SUBMITTED or APPROVED CHANGES TO THE PROTOCOL A. Since the last SRC Continuing Review, have any major developments occurred in the scientific area that affects the specific objectives of this study? Yes No

B. Since the last SRC Continuing Review, have any major changes been made to the protocol? (Example: drug dosage changes, modifications to the treatment plan, amendments from the sponsor, changes resulting from adverse event, etc.) Yes No If YES to either A or B above: 1. Has the protocol been revised accordingly? Yes No

Has the protocol amendment(s) been registered with NCI’s Clinical Trials Reporting Program (CTRP)? Yes No

2. Please list protocol revisions and provide SRC approval dates. C. Since the last SRC Continuing Review, have any changes been made to the Investigator Brochure? Yes No

If YES to C above:

Continuing Review Submission Form (Version 06/01/2014) Page 4 of 5 1. Has the protocol been revised as a result of these changes? Yes No

2. Has the revised Investigator Brochure been submitted to the SRC? Yes No

SECTION VII: Does this protocol compete with other ongoing studies at UNMC/NMC and 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 studies is available from the Fred & Pamela Buffett Cancer Center PRMS office or on their searchable web site at http://crweb.unmc.edu/CTO/CTO_Main_Page.jsp. ALSO NOTE: It is only necessary to list studies that treat the same disease population and have similar eligibility criteria when determining priority below. R IRB # Protocol Title an Classification k

SECTION VIII: Continuing Review Submission Checklist (please mark all that apply and submit in order listed)

Original Signed and Dated SRC Continuing Review Submission Form - required Cover letter and/or copy of relevant correspondence (if applicable)

Copy of the IRB Application for Continuing Review form - required The REVISED protocol with version and date clearly marked on the face page (if applicable)

______Signature of Principal Investigator Date

Continuing Review Submission Form (Version 06/01/2014) Page 5 of 5