Form 26 Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist

Attach_1z_8214_crossover

OMB#0925-xxxx
Expiration Date: xx/xx/xxxx

Public reporting burden for this collection of information is estimated to vary from 5 to 10 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.

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OMB#0925-xxxx
Expiration Date: xx/xx/xxxx

Attach_1z_8214_crossover

USMCI 8214/Z6091
CROSSOVER REQUEST/CHECKLIST TRANSMITTAL FORM
After completing this form, please FAX (along with all items on the checklist below) to:
Dr. Jesus Esquivel at fax number: 410-951-4007
Note: At the time the transmittal and accompanying documentation are faxed, please alert Dr. Esquivel via email at
[email protected], with copies to [email protected] and [email protected]. If you are experiencing
difficulty faxing, call Ms. Peggie Bieman at (410) 368-2750.
Record only one patient per transmittal sheet
Ensure Patient ID and Protocol ID are recorded on each page of each item included
Remove all patient identifiers or HIPAA protected information
Ensure pages are in proper sequence (2-sided forms must be copied by site before faxing)
Do not fax more than 50 pages in one submission
Re-submit updated reports or additional requested reports that are for the same patient using a new transmittal
Ensure updates to re-submitted documents are initialed and dated

Date: __ __ /__ __ / __ __ __ __

Total # Pages Faxed: _______

(mm/dd/yyyy)

Patient ID#: __ __ __ __ __ __

(including transmittal)

Site Name: ________________________________________________________

NCI Site Code: __ __ __ __ __
(Example TX001)

Site Address: _________________________________________________________________________________
Completed By: ___________________________________________ Phone # ____________________________
Email address: _______________________________________________________________________________
Preferred Method of Communication:

Email

Phone

Contact Information will be used if PI has questions or if additional data is needed, or if needs to be re-submitted with corrective action.

INSTRUCTIONS: Site must complete all information requested on this transmittal form and send via fax within 14
days of determination of limited peritoneal disease progression, along with all items on the checklist below, to
the PI at the number provided at the top of this form. All items must be submitted in one packet. Additional data
or re-submission of data should occur only at the request of the PI. The eligibility review will be performed for
potential crossover from systemic therapy Group 1 to the multi-modality Group 2.
Type of Submission

Initial packet
submission
Additional data or
re-submission
(only if requested
by PI)

Item(s) Attached

Number of
Pages

CT Scan in which progression was determined
Blood work completed within 4 weeks of progression determination (including
CBC with differential, coagulation profile, hepatic function tests, BUN and
Creatinine)
PDR* of Treatment CRFs entered in RDC
PDR* of Adverse Event CRFs entered in RDC
Other :___________________________________

*Instructions for running PDR (Patient Data Report) for data submitted via RDC are available in the study specific RDC
Instructions posted on the CTSU website.

Form Version: 26-Mar-2010