<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"> <html xmlns="http://www.w3.org/1999/xhtml"> <head> <meta name="ConvertedBy" content="Perceptive" /> <meta http-equiv="Content-Type" content="text/html; charset=UTF-8" /> <meta name="ProgId" content="Word.Document" /> <meta name="Generator" content="" /> <meta name="Author" content="Barr, Alison" /> <meta name="lastModifiedBy" content="Roy Sneddon" /> <meta name="revision" content="3" /> <meta name="lastPrinted" content="2017-07-24T04:53:00Z" /> <meta name="created" content="2017-10-06T04:28:00Z" /> <meta name="modified" content="2019-02-05T04:17:00Z" /> <meta name="Template" content="Normal.dotm" /> <meta name="TotalTime" content="1" /> <meta name="Page-Count" content="2" /> <meta name="Word-Count" content="442" /> <meta name="Character-Count" content="2520" /> <meta name="AppName" content="Microsoft Office Word" /> <meta name="DocSecurity" content="0" /> <meta name="Line-Count" content="21" /> <meta name="Paragraph-Count" content="5" /> <meta name="ScaleCrop" content="false" /> <meta name="Company" content="SA Health" /> <meta name="LinksUpToDate" content="false" /> <meta name="CharactersWithSpaces" content="2957" /> <meta name="SharedDoc" content="false" /> <meta name="HyperlinksChanged" content="false" /> <meta name="AppVersion" content="16.0000" /> <title></title> <style type="text/css"> .cstlDefaultStyle { font-family:Cambria;font-size:11pt;line-height: 1.15; padding-bottom:14pt;} .cstlNormal{ font-family:Times New Roman;font-size:10pt;line-height: 1; padding-bottom:1pt;text-align:left; } .cstlDefaultParagraphFont{ font-family:Calibri;font-size:11pt;text-align:left; } .cstlTableNormal{ font-family:Calibri;text-align:left; } .cstlNoList{ font-family:Calibri;font-size:11pt;text-align:left; } .cstlPlaceholderText{ font-family:Calibri;font-size:11pt;color:#808080;text-align:left; } .cstlStyle1{ font-family:Arial;font-size:11pt;text-align:left; } .cstlBalloonText{ font-family:Tahoma;font-size:8pt;line-height: 1; padding-bottom:1pt;text-align:left; } .cstlBalloonTextChar{ font-family:Tahoma;font-size:8pt;text-align:left; } .cstlHeader{ font-family:Times New Roman;font-size:10pt;line-height: 1; padding-bottom:1pt;text-align:left; } .cstlHeaderChar{ font-family:Times New Roman;font-size:10pt;text-align:left; } .cstlFooter{ font-family:Times New Roman;font-size:10pt;line-height: 1; padding-bottom:1pt;text-align:left; } .cstlFooterChar{ font-family:Times New Roman;font-size:10pt;text-align:left; } .cstlTableGrid{ font-family:Times New Roman;font-size:10pt;line-height: 1; padding-bottom:1pt;text-align:left;border-top-style:solid;border-top-width:1pt;border-top-color:#000000;border-left-style:solid;border-left-width:1pt;border-left-color:#000000;border-bottom-style:solid;border-bottom-width:1pt;border-bottom-color:#000000;border-right-style:solid;border-right-width:1pt;border-right-color:#000000; } .cstlHyperlink{ font-family:Calibri;font-size:11pt;color:#0000ff;text-decoration:underline;text-align:left; } .cstlNoSpacing{ font-family:Calibri;font-size:11pt;line-height: 1; padding-bottom:1pt;text-align:left; } </style> </head> <body> <ol class="cstlDefaultStyle cstlNoSpacing" style="padding-top: 0pt; text-indent: 0pt; list-style-type: none; padding-left: 10pt; font-size: 11pt; padding-bottom: 1pt; font-family: Calibri; line-height: 1; position: relative; text-align: left;"> <li><span style="font-family:Arial;font-size:10pt;">1. Please DO NOT submit a cover letter with this form.</span></li> </ol> <ol class="cstlDefaultStyle cstlNoSpacing" style="padding-top: 0pt; text-indent: 0pt; list-style-type: none; padding-left: 10pt; font-size: 11pt; padding-bottom: 1pt; font-family: Calibri; line-height: 1; position: relative; text-align: left;"> <li><span style="font-family:Arial;font-size:10pt;">2. This form should be filled in electronically and submitted with the original SSA</span></li> </ol> <ol class="cstlDefaultStyle cstlNoSpacing" style="padding-top: 0pt; text-indent: 0pt; list-style-type: none; padding-left: 10pt; font-size: 11pt; padding-bottom: 1pt; font-family: Calibri; line-height: 1; position: relative; text-align: left;"> <li><span style="font-family:Arial;font-size:10pt;">3. Incomplete submissions may be rejected or result in delayed review.</span></li> </ol> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 4pt; text-indent: 0pt; padding-left: -14pt; font-size: 10pt; padding-bottom: 1pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <table cellspacing="0" style="width: 561.50pt; margin-left: 0; writing-mode:lr-tb;border-top:solid 2px #000000;border-left:solid 2px #000000;border-bottom:solid 2px #000000;border-right:solid 2px #000000;"> <tbody> <tr style=" height:17.60pt; "> <td style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#f3f3f3; width: 165.35pt; "> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-weight:bold;">Site:</span> </div> </td> <td colspan="3" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;width: 127.55pt; "> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span class="cstlPlaceholderText" style="color: #808080; font-size: 11pt; font-family: Calibri; text-align: left;">Click here to enter text.</span> </div> </td> <td colspan="2" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#f2f2f2; width: 127.65pt; "> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-weight:bold;">HREC Ref:</span> </div> </td> <td colspan="2" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;width: 140.95pt; "> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span class="cstlPlaceholderText" style="color: #808080; font-size: 11pt; font-family: Calibri; text-align: left;">Click here to enter text.</span> </div> </td> </tr> <tr style=" height:33.45pt; "> <td style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#f3f3f3; width: 165.35pt; "> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-weight:bold;">Study Title:</span> </div> </td> <td colspan="7" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;width: 396.15pt; "> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span class="cstlPlaceholderText" style="color: #808080; font-size: 11pt; font-family: Calibri; text-align: left;">Click here to enter text.</span> </div> </td> </tr> <tr style=" height:19.35pt; "> <td colspan="8" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#a6a6a6; width: 561.50pt; "> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-size:11pt;font-weight:bold;">RESEARCH CO-ORDINATOR PERSONNEL</span> </div> </td> </tr> <tr style=" height:19.35pt; "> <td colspan="8" style=" border-bottom-color:#000000;border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;background-color:#f3f3f3; width: 561.50pt; "> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-weight:bold;">Name of research co-ordinator: </span> <span style="font-family:Arial;font-weight:bold;"> </span> <span style="font-family:Arial;font-weight:bold;"> </span> </div> </td> </tr> <tr style=" height:19.35pt; "> <td colspan="8" style=" border-bottom-color:#000000;border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;background-color:#f3f3f3; width: 561.50pt; "> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-weight:bold;">Research responsibilities at the site (list all tasks as per delegation log):</span> </div> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-weight:bold;">*This section must be completed </span> </div> </td> </tr> <tr style=" height:19.35pt; "> <td colspan="3" style=" border-top-color:#000000;border-right-color:#000000;border-left:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#f3f3f3; width: 281.35pt; "> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-size:9pt;">Obtain informed consent ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-size:9pt;">Subject selection/recruitment ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-size:9pt;">Confirm eligibility (review inclusion/exclusion criteria) ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-size:9pt;">Obtain medical history (source documents) ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-size:9pt;">Perform physical exam ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-size:9pt;">Conduct study visit procedure as outlined in the protocol ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-size:9pt;">Make study related medical decisions ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-size:9pt;">Assess AEs/SAEs ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Dispense study drug ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Perform drug accountability ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Study drug storage and temperature monitoring ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> </td> <td colspan="5" style=" border-top-color:#000000;border-left-color:#000000;border-right:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#f3f3f3; width: 280.15pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Sample collection ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Sample processing and/or shipment ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Evaluate study related test results ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Use IWRS/IVRS ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Make entries/corrections on CRFs ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Sign off CRF ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Maintain essential documents ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Perform study-related assessments as per protocol ☐</span> <span style="font-family:Arial;font-size:9pt;"> </span> <span style="font-family:Arial;font-size:9pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Other (specify): </span> <span style="font-family:Arial;font-size:9pt;font-weight:bold;"> </span> <span style="font-family:Arial;font-size:9pt;font-weight:bold;"> </span> <span style="font-family:Arial;font-size:9pt;font-weight:bold;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Other (specify): </span> <span style="font-family:Arial;font-size:9pt;font-weight:bold;"> </span> <span style="font-family:Arial;font-size:9pt;font-weight:bold;"> </span> <span style="font-family:Arial;font-size:9pt;font-weight:bold;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:9pt;">Other (specify): </span> <span style="font-family:Arial;font-size:9pt;font-weight:bold;"> </span> <span style="font-family:Arial;font-size:9pt;font-weight:bold;"> </span> <span style="font-family:Arial;font-size:9pt;font-weight:bold;"> </span> </div> </td> </tr> <tr style=" height:91.70pt; "> <td colspan="8" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#f3f3f3; width: 561.50pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">Are you currently employed by the site for the purpose of this research project?</span> <span style="font-family:Arial;"> Yes ☐</span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> No ☐</span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> <br /></span> <span style="font-family:Arial;font-weight:bold;font-style:italic;">If no, evidence of Insurance/Indemnity from your employer must be provided</span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">If not employed by the site, list the external organisation and department at organisation: </span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">If not employed by the site, is DCSI clearance required? </span> <span style="font-family:Arial;">Yes ☐</span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> No ☐</span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;font-weight:bold;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <a href="https://screening.dcsi.sa.gov.au/screening-process/types-of-screening" target="_blank"><span class="cstlHyperlink" style="color: #0000ff; font-weight: bold; text-decoration: underline; font-size: 11pt; font-family: Calibri; text-align: left;">https://screening.dcsi.sa.gov.au/screening-process/types-of-screening</span></a> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> </td> </tr> <tr style=" height:19.35pt; "> <td colspan="8" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#a6a6a6; width: 561.50pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:11pt;font-weight:bold;">RESEARCH CO-ORDINATOR DECLARATION</span> </div> </td> </tr> <tr style=" height:19.35pt; "> <td colspan="8" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;width: 561.50pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-style:italic;">I declare that I have read the study protocol & understand my obligations and responsibilities, and that site I will not conduct any study related activities until I have been granted authorisation by the site Research Governance Office.</span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">Signature: </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <a name="bm_Text33"></a> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">Date: </span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> </span> <span style="font-family:Arial;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> </td> </tr> <tr style=" height:19.35pt; "> <td colspan="8" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#a6a6a6; width: 561.50pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:11pt;font-weight:bold;">PRINCIPAL INVESTIGATOR DECLARATION</span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> </td> </tr> <tr style=" height:19.35pt; "> <td colspan="8" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;width: 561.50pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-style:italic;">I confirm that the study co-ordinator named on this form is appropriately qualified and will be trained in the administration of the approved study protocol.</span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <a name="bm_Text34"></a> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">Name: </span> <span style="font-family:Arial;font-weight:bold;"> </span> <span style="font-family:Arial;font-weight:bold;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">Signature: </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">Date: </span> <span style="font-family:Arial;font-weight:bold;"> </span> <span style="font-family:Arial;font-weight:bold;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> </td> </tr> <tr style=" height:29.95pt; "> <td colspan="8" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#a6a6a6; width: 561.50pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-size:14pt;font-weight:bold;">OFFICE USE ONLY</span> </div> </td> </tr> <tr style=" height:29.95pt; "> <td colspan="2" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#f3f3f3; width: 256.90pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:right;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">Received & Authorised </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:right;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">by Research Governance Officer (Name):</span> </div> </td> <td colspan="6" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;width: 304.60pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> </td> </tr> <tr style=" height:31.80pt; "> <td colspan="2" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#f3f3f3; width: 256.90pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:right;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">Signature:</span> </div> </td> <td colspan="3" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;width: 137.65pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> </td> <td colspan="2" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#f3f3f3; width: 72.40pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:right;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">Date:</span> </div> </td> <td style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;width: 94.55pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> </td> </tr> <tr style=" height:47.60pt; "> <td colspan="8" style=" border-left:solid 2px #000000;border-right:solid 2px #000000;border-top:solid 2px #000000;border-bottom:solid 2px #000000;background-color:#f3f3f3; width: 561.50pt; "> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;"> <span style="font-family:Arial;font-weight:bold;">RGO Comments:</span> </div> </td> </tr> </tbody> </table> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <p style="margin-bottom:5px;background-color:#E7EAEF;"> </p> <table cellspacing="0" style="width: 552.85pt; margin-left: -8.80pt; writing-mode:lr-tb;border-top:solid 1px #000000;border-left:solid 1px #000000;border-bottom:solid 1px #000000;border-right:solid 1px #000000;"> <tbody> <tr style=" height:41.75pt; "> <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f3f3f3; width: 273.75pt; "> <div class="cstlDefaultStyle cstlHeader" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Times New Roman;font-size:14pt;font-weight:bold;">SSA Attachment: </span> </div> <div class="cstlDefaultStyle cstlHeader" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Times New Roman;font-size:14pt;font-weight:bold;">Research Co-ordinator Authorisation Form </span> </div> </td> <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f3f3f3; width: 279.10pt; "> <div class="cstlDefaultStyle cstlHeader" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> </div> </td> </tr> </tbody> </table> <div class="cstlDefaultStyle cstlHeader" style="font-size: 10pt; padding-bottom: 1pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <p style="border-bottom:2px solid #E7EAEF;"> </p> <div class="cstlDefaultStyle cstlFooter" style="text-indent: -14pt; padding-left: 0pt; font-size: 10pt; padding-bottom: 1pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Arial;font-size:8pt;">SSA Attachment: Research Co-ordinator Authorisation Form v. 19.01 Jan 2019 Page </span> <span style="font-family:Arial;font-size:8pt;"> </span> <span style="font-family:Arial;font-size:8pt;"> </span> <span style="font-family:Arial;font-size:8pt;">1</span> <span style="font-family:Arial;font-size:8pt;"> of 2</span> </div> <div class="cstlDefaultStyle cstlFooter" style="font-size: 10pt; padding-bottom: 1pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;"> <span style="font-family:Calibri;font-size:22pt;"> </span> </div> <p style="border-bottom:2px solid #E7EAEF;"> </p> </body> </html>