Form 16 Transfer

Attachment_A16_transfer

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

Public reporting burden for this collection of information is estimated to average 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 (0925-0624). Do not return the completed form to this address.

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Final_April_2016
Authorized by CTSU for local reproduction

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

Attachment_A16_transfer

Request for Patient Transfer (For transfers that cannot be completed in OPEN.)
Date of Request:

Requested Effective Date of Transfer: ____________________
MM/DD/YY

MM/DD/YY

Patient ID#:_________________________Group/Protocol Number: _______________________________
Case Status:

Active Trt

F/up

Is the transfer occurring between registration steps? Yes / No

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 Organization (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 Help Desk by e-mail at [email protected] or by fax to 1888-691-8039. For more information, contact the CTSU Help Desk at 1-888-823-5923 or
[email protected].

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:
PMB Copied:
Date: ________________ Int.____________
Date: ________________ Int.____________

Final_April_2016
Authorized by CTSU for local reproduction

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:
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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:
 The receiving site has an active Institutional Review Board (IRB) approval
status for the study
 The receiving treating investigator (physician of record) has an active
CTSU membership
Patient Transfer and Investigator Update Checklist
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Transferring Site Responsibilities
 All outstanding CRFs should be submitted prior to the transfer.
 Copies of all CRFs and subject records, as appropriate, must be submitted to the
receiving site prior to the transfer.
 A listing of any outstanding queries or forms that cannot be resolved prior to
transfer should be submitted to the receiving site.
 Transferring sites will be subject to audit for visits up to the point of transfer.
Receiving Site Responsibilities
 Receiving sites are responsible for all queries upon acceptance of the transfer.
 Receiving sites are responsible for all delinquent forms upon acceptance of
the transfer.
 Patients should be reconsented per local institutional and IRB policies.
 Receiving sites may be subject to audit of cases after the time of subject transfer.
 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.
 Sites must select a credited Organization for follow-up payments and audit.

Patient Transfer and Investigator Update Checklist
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