SAMP-101 A sample study to determine the usefulness of the CDISC ODM 1.3 Snapshot MetaData Standard SAMPLESTRA (SAMP-101) cm kg bpm °C mmHG All Concomitant Medications are collected in this event. All Adverse Reactions are collected in this event. The Visit Info form. Concomitant Medications Form Subject Demography Form Pregnancy Test Form Vital Signs Form Adverse Events Form Visit Information Demography Pregnancy Test Blood-related vital signs Vital Signs: Height & Weight Vital Signs: Body temperature Concomitant Medication Question Concomitant Medications detail Adverse Events detail Any Adverse Events Question Center Number CENTER Center number must be four digits. Subject Number Subject Number Date of visit Visit Date :localtime) ]]> Visit date cannot be a future date! Subject Reported Feeling Subject Reported Feeling Continue to next visit? Will the subject continue to the next visit? Date of Birth Date of Birth :localtime) ]]> Date of Birth cannot be a future date! Age at visit date Age 18 Subject should be at least 18 years of age at this visit 120 Subject should be less than 120 years of age at this visit Sex Sex Female of childbearing potential If Female, of childbearing potential Race Race Race Other Specify If Race Other, Specify: Test result Test result Pregnancy Test Performed Was a pregnancy test performed? Height Weight BMI Pulse Sys Dia Body Temperature Any Concomitant Medications Is the Subject taking any Concomitant Medications? Drug repeat number # Drug name Drug Name Drug dose Dose Dose units Units Dosing Frequency Frequency Date medication started Start Date :localtime) ]]> Medication Start Date cannot be a future date! Date medication ended End Date :localtime) ]]> Medication End Date cannot be a future date! "ID.STARTDAT")) ]]> Medication End Date cannot be prior to Start Date Drug continuing Continuing? "ID.ENDDAT")) ]]> Cannot be continuing if End Date is set. Diagnosis Diagnosis Any Adverse Events Have any Adverse Events been reported? AE repeat number # Adverse Event Description AE Description Date AE started Start Date :localtime) ]]> Adverse Event Start Date cannot be a future date! Date AE ended End Date :localtime) ]]> Adverse Event End Date cannot be a future date! "ID.AESTARTDAT")) ]]> Adverse Event Date cannot be prior to Start Date Adverse Event continuing Continuing? "ID.AEENDDAT")) ]]> Cannot be continuing if End Date is set. Adverse Event Severity Severity Is Adverse Event classified Serious? Serious Adverse Event Relationship to Study Drug Relationship Action taken on Adverse Event Action Taken Yes No Male Female Much Worse than usual Worse than usual Average Better than usual Much Better than usual Caucasian African Asian Other Positive Negative QID BID TID Mild Moderate Severe Unrelated Unlikely Related Likely Related Related Continued Dose Changed Temporary Withdrawal Permanent Withdrawal Returns True if the subject is not male (i.e. they are female) "SE.INIT", form->"FD.DEMOG", item->"ID.SEX") != "Male" ]]> Returns True if the subject is not of "Other" Race "SE.INIT", form->"FD.DEMOG", item->"ID.RACE") != "Other" ]]> Returns True if pregnancy test was not performed "SE.INIT", form->"FD.PREG", item->"ID.TESTPERFORMED") == "No" ]]> Returns True if the subject is not a female of childbearing potential. "SE.INIT", form->"FD.DEMOG", item->"ID.SEX") == "Male" ) OR ( Decode(event->"SE.INIT", form->"FD.DEMOG", item->"ID.FERTILE") == "No" ) ]]> Returns True if the subject did not elect to continue in the previous visit. :previous,form->"FD.VISITINFO",item->"ID.CONT") == "No" ]]> Assign an AE repeat number unique within the repeats of the ItemGroup. "SE.AE", form->"FD.AE", item->"ID.AENUM") aenum = 1 while true { if not In(daenum,itemnums) { break } aenum += 1 } //return the new number aenum ]]> Assign a drug reference number, unique within the repeats of the ItemGroup. "SE.CM", form->"FD.CM", item->"ID.DRUGNUM") drugnum = 1 while true { if not In(drugnum,itemnums) { break } drugnum += 1 } //return the new number drugnum ]]> Body Mass Index Calculation: Weight (kg) / Height(m)^2 "ID.HEIGHT") weight = itemgroup.fields(name->"ID.WEIGHT") weight / square(height / 100) ]]> Age at visit date "ID.DOB") //VDAT comes from Visit Info form vdat = Select(event->"SE.INIT", form->"FD.VISITINFO", item->"ID.VDAT") TimeSpan(vdat,dob).years ]]>