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OMB#0925-0624
OMB#0925-0624
Expiration Date:
Expiration
Date:12/31/2013
12/31/2013
Public
to average
10 minutes
response,
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reporting burden
burdenfor
forthis
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informationisisestimated
estimated
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5 to 10per
minutes
per response,
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time
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searching
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the data
including the time for reviewing instructions, searching existing data sources, gathering and maintaining
the data
needed,
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aa person
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person is not required to respond to, a collection of information unless it displays a currently valid OMB
control
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controlnumber.
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Send
comments
regarding
burden
estimate
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collection
information,
including
suggestions
for
reducing
this
burden,
to:
NIH,
Project
Clearance
Branch,
6705
Rockledge
Drive,
MSC7974,
including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC
7974,
Bethesda,
MD 20892-7974,
PRA (0925-0624).
notthe
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Bethesda,
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Request for Patient Transfer (For studies in OPEN and on the CTSU menu; SWOG sites must use the SWOG
online system for SWOG studies; all sites must use the GOG system for GOG studies.)
Date of Request:
Requested Effective Date of Transfer:
MM/DD/YY
MM/DD/YY
Group/Protocol Number:
Patient ID#:
Case Status:
Active Trt
Is the transfer occurring between registration steps? Yes/No
F/up
Transferring Site/Investigator* Information: (Please submit the form to receiving site (if applicable) after
completion of this section.)
Site Name:
CTEP Code:
Treating Investigator Name:
CTEP IID#:
Treating Investigator Signature:
Receiving Site/Investigator* Information:
Site Name:
CTEP Code:
Credited Cooperative Group (For follow*up credit):
Treating Investigator Name:
CTEP IID#:
Treating Investigator Signature:
*By signing this form the receiving site takes responsibility for all outstanding data from the
originating site. Please review the Transfer checklist.
*Completion of this form is required for transfers between investigators located at the same site.
Level of responsibility being transferred to receiving site or investigator:
□ Full: (All responsibility for the patient is transferred to receiving institution)
□ Partial: (Temporary transfer of subject to another site; please indicate the level of responsibility at the receiving site)
____________________________
□ Data Share: (For transfers for studies in Rave, if supported by the LPO; sites may elect to share data. Indicate length of
time required for data sharing.) _________________
Contact Person: ___________________________________________________________
Phone #:
Email Address:
Complete this form and submit to the CTSU Operations Center by e*mail at ctsucontact@westat.com or by
fax to 1*888*691*8039. For more information, contact the CTSU Help Desk at 1*888*823*5923 or
CTSUContact@westat.com.
Requests will be reviewed within 3 business days of receipt.
Office Use Only:
Receiving site approved for registration:
Receiving Investigator eligible:
Date:
Int.
Date:
Int.
LPO Authorization: _______________
Request for Patient Transfer
PMB Copied: dt_
Int._
Page 1 of 1
Patient Transfer and Investigator Update
Checklist
Transferring sites that are having difficulty locating a receiving site are encouraged to
contact the CTSU or the Lead Protocol Organization for assistance in locating a
participating site. If processing of the transfer request is urgent please note this on the
fax cover sheet and notify the CTSU Help Desk at 1-888-823-5923.
The following information must be provided to CTSU for patient transfers and physician
updates:
ü
ü
ü
ü
ü
ü
ü
ü
ü
ü
ü
ü
ü
ü
ü
Patient ID
Protocol/Study ID
Date of Request
Transfer Effective Date
Level(s) of responsibility being transferred to the receiving site.
o Full (all responsibility for the patient is transferred to the receiving site)
o Partial, (temporary responsibility for the patient is transferred to the
receiving site; dependent on the agreement between the sites data
management responsibilities may be retained by the originating site.)
Name of transferring institution and its CTEP Code
Name of transferring investigator and his/her CTEP IID
Name of the receiving institution and its CTEP Code
Name of the receiving treating investigator and his/her CTEP IID
Signature of transferring institution treating investigator (if available)
Signature of receiving institution treating investigator
Name, phone number and email address of individual completing the request
Status of the patient case
If the transfer is occurring between patient registration steps (needed to update
OPEN)
If a large subset of subjects is being transferred or the investigator is being
updated, a single transfer form with an attached list can be submitted to CTSU.
Please ensure the list includes all applicable patient records.
The following regulatory requirements must be verified by the CTSU Patient Transfer
Coordinator:
ü The receiving site has an active Institutional Review Board (IRB) approval status
for the study
ü The receiving treating investigator (physician of record) has an active CTSU
membership
Patient Transfer and Investigator Update Checklist
Page 1 of 2
Transferring Site Responsibilities
ü All outstanding CRFs should be submitted prior to the transfer.
ü Copies of all CRFs and subject records, as appropriate, must be submitted to the
receiving site prior to the transfer.
ü A listing of any outstanding queries or forms that cannot be resolved prior to
transfer should be submitted to the receiving site.
ü Transferring sites will be subject to audit for visits up to the point of transfer.
Receiving Site Responsibilities
ü Receiving sites are responsible for all queries upon acceptance of the transfer.
ü Receiving sites are responsible for all delinquent forms upon acceptance of the
transfer.
ü Patients should be reconsented per local institutional and IRB policies.
ü Receiving sites may be subject to audit of cases after the time of subject transfer.
ü For transfers received from a lead Group site and that were not processed in
OPEN, the site must submit the CTSU Patient Enrollment Form and copies of the
enrollment confirmation with the transfer form to CTSU to establish a subject
record.
ü Sites must select a credited Group for follow-up payments and audit.
Patient Transfer and Investigator Update Checklist
Page 2 of 2
File Type | application/pdf |
Author | myers_r |
File Modified | 2013-08-15 |
File Created | 2012-12-21 |