Form 16 Transfer

Attachment_A16_transfer

OMB# 0925-0753
Expiration Date: 07/31/2021

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 (0925-0753). Do not return the completed form to this address.

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Final_July 2018
Authorized by CTSU for local reproduction

OMB# 0925-0753
Expiration Date 07/31/2021

Attachment_A16_transfer

CANCER TRIALS SUPPORT UNIT
PATIENT TRANSFER FORM
Complete this form and upload to the Regulatory Submission Portal. Select the
Enrollment/Transfer document type. For more information contact the CTSU Help Desk at 1-888823-5923 or CTSUContact@westat.com.
Requests will be reviewed within 5 business days of receipt.
Notifications will be sent to the Receiving Site, Lead Protocol Organization, and the
Pharmaceutical Management Branch.

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

MM/DD/YY

Patient ID#:

Group/ProtocolNumber:

Case Status: ☐ Active Treatment

☐ Follow up

Transferring Site/Investigator* Information: (Please submit the form to receiving site (if applicable) after completion of this
section.)

SiteName:

CTEP Code:

TreatingInvestigatorName:

CTEP ID#:

Treating Investigator Signature:
Receiving Site/Investigator* Information:
SiteName:

CTEP Code:

CreditedOrganization (For follow-up credit):
TreatingInvestigatorName:

CTEPID#:

Treating Investigator Signature:
*By signing this form the receiving site takes responsibility for all outstanding data from the originating site.
Please review the Transferchecklist.
*Completion of this form is required for transfers between investigators located at the same site.
Contact Person:
Phone #:

Final_July 2018
Authorized by CTSU for local reproduction

Email Address: ____

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OMB# 0925-0753
Expiration Date 07/31/2021

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 in the Regulatory Submission
Portal (select urgent) 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
Name of transferring institution and itsCTEPCode
Name of transferring investigator and his/herCTEP 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

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
 The Study PI for the protocol must have an active status

Final_December 2017
Authorized by CTSU for local reproduction

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OMB# 0925-0753
Expiration Date 07/31/2021

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.

Final_December 2017
Authorized by CTSU for local reproduction

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