<h3>Special Instructions</h3>     <p>CRD Form Fillers and Form Managers which support the CDASH option run this test.</p>  <h3>Description</h3> <p>This test asks Form Fillers to create pre-population data for two subjects/patients and then       verifies that this data is sent back correctly by the Form Manager in the form returned to the       Form Filler.</p>     <p>Data to be used in this test follows. This table contains all of the "R" and "R2" elements.       Refer to the CRD Trial Implementation Supplement Sec 5.8.4 for a definition of each Clinical       Database Variable Name. </p>     <table width="668" border="3" cellspacing="0" cellpadding="0">       <tr>         <td width="146" bgcolor="#CCCCCC">           <strong>CDASH Domain </strong>         </td>         <td width="96" bgcolor="#CCCCCC">           <strong>Clinical DB variable name </strong>         </td>         <td width="110" bgcolor="#99FFCC">           <div align="center">             <strong>Subject 1 </strong>           </div>         </td>         <td width="49" bgcolor="#99FFCC">           <div align="center">             <p>               <strong>Eval:<br/>               </strong>               <strong>Y/N</strong>             </p>           </div>         </td>         <td width="105" bgcolor="#FFFFCC">           <div align="center">             <strong>Subject 2 </strong>           </div>         </td>         <td width="49" bgcolor="#FFFFCC">           <div align="center">             <strong>Eval:<br/> Y/N</strong>           </div>         </td>         <td width="93" bgcolor="#CCCCCC">           <div align="center">             <strong>Evaluator's Comments </strong>           </div>         </td>       </tr>       <tr>         <td>           <strong>Common Identifiers </strong>         </td>         <td>STUDYID</td>         <td>111</td>         <td>'</td>         <td>112</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>SITEID</td>         <td>Chicago09</td>         <td>'</td>         <td>Vienna09</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>SUBJID</td>         <td>SUBJ-1</td>         <td>'</td>         <td>SUBJ-2</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Demography</strong>         </td>         <td>BRTHRY</td>         <td>1944</td>         <td>'</td>         <td>1966</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>BRTHMO</td>         <td>04</td>         <td>'</td>         <td>06</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>BRTHDY</td>         <td>04</td>         <td>'</td>         <td>06</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>SEX</td>         <td>M</td>         <td>'</td>         <td>F</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>DMDTC</td>         <td>today's date </td>         <td>'</td>         <td>today's date </td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>RACE</td>         <td>2106-3 (White) </td>         <td>'</td>         <td>2029-7 (Asian Indian) </td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Subject Characteristics </strong>         </td>         <td>SCDTC</td>         <td>today's date </td>         <td>'</td>         <td>today's date </td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Medical History </strong>         </td>         <td>MHTERM</td>         <td>Patient is recovering from a salomnella infection from eating raw eggs. </td>         <td>'</td>         <td>           <p>Patient suffers from asthma </p>           <p>Patient experiences arthritis in her left foot that was broken in the past.</p>         </td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>MHONG</td>         <td>'</td>         <td>'</td>         <td>Arthritis is ongoing </td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Concomitant Medication </strong>         </td>         <td>CMTRT</td>         <td rowspan="8">           <p>Augmentin 125 Mg Chew</p>           <p>Freq: twice/day. Start: 11-Feb-09. Status: active </p>         </td>         <td>'</td>         <td rowspan="8">           <p>Albuterol Sulfate 108 MCG/ACT AERS</p>           <p>Freq: 2 puffs q6hrs pm. Start: 21-Feb-09. Status: active </p>           <p>=================</p>           <p>Naproxen Sodium 550 MG TABS</p>           <p>Take one tablet by mouth every six hours as needed.</p>         </td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>CMINDC</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>CMDOSTOT</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>CMROUTE</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>CMSTDTC</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>CMSTTM</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>CMENDTC</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>CMENTM</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Substance Use </strong>         </td>         <td>SUTRT</td>         <td>None</td>         <td>'</td>         <td rowspan="2">Patient was a pack-a-day tobacco smoker for 10 years. She quit smoking in           1990.</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>SUNCF</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Vital Signs </strong>         </td>         <td>VSDTC</td>         <td>today's date </td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>VSTEST</td>         <td rowspan="6">           <p>code/code=8380-6</p>           <p>code/displayName=<br/> INTRAVASCULAR SYSTOLIC</p>           <p>code/codeSystem=<br/> 2.16.840.1.113883.6.1</p>           <p>value/value=68</p>           <p>value/unit=mm[Hg]</p>           <p>==========</p>           <p>code/code=8462-4</p>           <p>code/displayName=<br/> INTRAVASCULAR DIASTOLIC</p>           <p>code/codeSystem=<br/> 2.16.840.1.113883.6.1</p>           <p>value/value=108</p>           <p>value/unit=mm[Hg]</p>           <p>=========</p>           <p>Pulse: 82 / minute</p>           <p>Respiration: 29 / minute </p>         </td>         <td>'</td>         <td rowspan="6">           <p>code/code=8380-6</p>           <p>code/displayName=<br/> INTRAVASCULAR SYSTOLIC</p>           <p>code/codeSystem=<br/> 2.16.840.1.113883.6.1</p>           <p>value/value=102</p>           <p>value/unit=mm[Hg]</p>           <p>========</p>           <p>code/code=8462-4</p>           <p>code/displayName=<br/> INTRAVASCULAR DIASTOLIC</p>           <p>code/codeSystem=<br/> 2.16.840.1.113883.6.1</p>           <p>value/value=140</p>           <p>value/unit=mm[Hg]</p>           <p>======</p>           <p>Pulse: 86 / minute</p>           <p>Respiration: 30 / minute </p>         </td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>VSSTAT</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>VSORRES</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>VSORRESU</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>VSLOC</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>VSPOS</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Physical Exam - Traditional Approach </strong>         </td>         <td>PEDTC</td>         <td>April 1, 2008</td>         <td>'</td>         <td>December 1, 2008 </td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Adverse Events </strong>         </td>         <td>AETERM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>AESER</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>AEENDTC</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>AESTTM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>AEENDTC</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>AEENTM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td height="22">'</td>         <td>AESEV and/or AETOXGR </td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>AEREL</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>AERELTP</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>AEACN</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>AEOUT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Lab Test Results - Scenario 1: Local processing </strong>         </td>         <td>LBDTC</td>         <td>'</td>         <td>'</td>         <td rowspan="7">           <p>             <strong>Test: CBC w/ Differential ; Platelet</strong>           </p>           <p>White Blood Cell (WBC) Count:</p>           <p>Result=4.50<br/> Units=MILL/MCL<br/> Ref Range=3.8-10.8 </p>           <p>------------------</p>           <p>Hemoglobin:</p>           <p>Result=13.7<br/> Units=G/DL<br/> Ref Range=11.7-15.5 </p>         </td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBTM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBSTAT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBCAT LBSCAT </td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBTPT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBFAST</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBREFID</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Lab Test Results - Scenario 1: Local processing</strong>         </td>         <td>LBDTC</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBTM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBSTAT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBCAT LBSCAT </td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBTPT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBFAST</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBPCCND</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBTESTCD and/or LBTEST </td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBORRES</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBORRESU</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBORNRLO LBORNRHI LBSTNRC </td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBNRIND</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBCLSG</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBNAM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBREFID</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>Lab Test Results - Scenario 3: Central processing but CRF... </strong>         </td>         <td>LBDTC</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBTM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBSTAT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBCAT LBSCAT </td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBTPT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBFAST</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBTEST</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBORRES</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBCLSG</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBNAM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBREFID</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>ECG Test Results - Scenario 1: Central reading... </strong>         </td>         <td>LBDTC</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>SBSTAT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBCAT LBSCAT </td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>LBTPT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>ECG Test Results - Scenario 2: Local reading: ECGs... </strong>         </td>         <td>EGSTAT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGDTC</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGTM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGTPT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGTESTCD and/or EGTEST </td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGORRES</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGORRESU</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>           <strong>ECG Test Results - Scenario 3: Central reading (as in Scen 1): But...</strong>         </td>         <td>EGSTAT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGDTC</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGTM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGTPT</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGTEST</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGORRESU</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGCLSG</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGORRESU</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGCLSG</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGORRES</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>EGNAM</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td colspan="7" bgcolor="#CCCCCC">           <em>             <strong>List below optional attributes that are supported, but which were not included               above. Include the CDASH domain in Column 1 and Variable Name in Column 2 </strong>           </em>         </td>       </tr>       <tr>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>       <tr>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>         <td>'</td>       </tr>     </table> <h3>Evaluation</h3>     <p>The Connectathon Monitor will check for correct exchange of the pre-population data contained       in the test description. </p>     <p>The table in the test description contains all "R" and "R2" elements in the CDASH option. The       connectathon monitor will use this table to record (Y/N) which elements were successfully       exchanged.</p>     <p>The Connectathon Monitor may ask the Form Filler to request the forms for the test       subjects/patients again in his/her presence, or to send data for an additional subject/patient       and observe the transfer real-time.</p>     <p>On the <strong>Form Filler</strong>, the Connectathon monitor will observe that a form is       returned with the data in the Test Description pre-populated on the form. The Form Filler       should be able to add additional data, or change existing fields, and then submit the       completed form back to the Form Manager.</p> 