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Subject transfer affidavit XML

The <FORM> tag for the Subject Record Transfer page follows with the default affidavit text highlighted.

Caution: Do not change anything in the form definition other than the highlighted text.


<FORM REFNAME="PSC_FORM" UUID="3389a7c6-cba5-46f2-b48f-8e034a28a349"

NOTE="&lt;TABLE BORDER=&quot;0&quot;CELLPADDING=&quot;4&quot; CELLSPACING=&quot;0&quot;
WIDTH=&quot;100%%&quot; ID=&quot;Table1&quot;&gt;

&lt;TR&gt;

&lt;TD CLASS=&quot;ttl&quot;&gt;&lt;B&gt;Subject Record Transfer Affidavit:&lt;/B&gt;&lt;/TD&gt;

&lt;/TR&gt;

&lt;TR&gt;

&lt;TD&gt;&lt;TABLE CLASS=&quot;tbl&quot; BORDER=&quot;1&quot; CELLPADDING=&quot;4&quot;
CELLSPACING=&quot;0&quot; WIDTH=&quot;100%%&quot;
BORDERCOLOR=&quot;#003366&quot;ID=&quot;Table2&quot;&gt;

&lt;TR&gt;

&lt;TD&gt;&lt;TABLE BORDER=&quot;0&quot; CELLPADDING=&quot;4&quot; CELLSPACING=&quot;0&quot;
WIDTH=&quot;100%%&quot; ID=&quot;Table3&quot;&gt;

&lt;TR&gt;

&lt;TD&gt;

&lt;P&gt;

The sponsor takes responsibility for and has clear processes/procedures

in place around the handling of subject transfers and coordinating across

sites to ensure that:

&lt;/P&gt;

&lt;P&gt;

1. The originating site produces or receives a certified copy of the current
CRF data created for all transferred subjects prior to the transfer.
&lt;/P&gt;

&lt;P&gt;

2. The target site accepts responsibility for the management of any
outstanding queries and data cleaning following the subject record transfer,
since the originating site will no longer have modification access.
&lt;/P&gt;

&lt;P&gt;

3. Trial version differences due to protocol amendments or country
specific data requirements are acknowledged and the sponsor has
appropriate regulatory approvals in place to support subject record transfer.
&lt;/P&gt;

&lt;P&gt;

4. The subject(s) being transferred are fully enrolled and a Case Book
has been created for each subject.
&lt;/P&gt;

&lt;/TD&gt;

&lt;/TR&gt;

&lt;/TABLE&gt;

&lt;/TABLE&gt;

&lt;/TABLE&gt;"

TITLE="Subject Record Transfer Form" MNEMONIC="PSC_FORM"

QUESTIONWIDTH="30" CONTROLWIDTH="70" TYPE="CUSTOMTRIAL" LANGUAGE="English">
. . .

<SECTIONREF REFNAME="PSC_SECT2" />
. . .

<SECTIONREF REFNAME="PSC_SECT" />

</FORM>

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