<h3>Special Instructions</h3> None. <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> 