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="<TABLE BORDER="0"CELLPADDING="4" CELLSPACING="0"
WIDTH="100%%" ID="Table1">
<TR>
<TD CLASS="ttl"><B>Subject Record Transfer Affidavit:</B></TD>
</TR>
<TR>
<TD><TABLE CLASS="tbl" BORDER="1" CELLPADDING="4"
CELLSPACING="0" WIDTH="100%%"
BORDERCOLOR="#003366"ID="Table2">
<TR>
<TD><TABLE BORDER="0" CELLPADDING="4" CELLSPACING="0"
WIDTH="100%%" ID="Table3">
<TR>
<TD>
<P>
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:
</P>
<P>
1. The originating site produces or receives a certified copy of the current
CRF data created for all transferred subjects prior to the transfer.
</P>
<P>
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.
</P>
<P>
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.
</P>
<P>
4. The subject(s) being transferred are fully enrolled and a Case Book
has been created for each subject.
</P>
</TD>
</TR>
</TABLE>
</TABLE>
</TABLE>"
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>