Laboratory Tests
Pregnancy test type: FORMCHECKBOX Blood FORMCHECKBOX UrinePregnancy test result: FORMCHECKBOX Positive FORMCHECKBOX NegativePregnancy Test (β-HCG): bloodPregnancy Test (β-HCG): urineIndicate the appropriate result for each testTable 1 Toxicology screen resultsDrugPresent?Anticonvulsants FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownAnalgesics FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownSedatives FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownBarbiturates FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownSympathomimetics FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownStimulants FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownPsychotropics FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownOther FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownTable 2 Electrolyte Laboratory TestsTestResultUnit for ResultSodium (Na+)TBDTBDPotassium (K+)TBDTBDChloride (Cl-)TBDTBDCarbon Dioxide (CO2)TBDTBDAnion GapTBDTBDBlood Urea Nitrogen (BUN)TBDTBDCreatinineTBDTBDGlucoseTBDTBDMagnesium (Mg2+)TBDTBDPhosphate (PO4)TBDTBDCalcium (Ca2+)TBDTBDIonized Calcium (Ca2+)TBDTBDBicarbonate (HCO3)TBDTBDFasting GlucoseFasting InsulinUreaGamma-glutamyl transpeptidase (GGT)Lactate Dehydrogenase (LDH)Table 3 Lipid Laboratory TestsTestResultUnit for ResultTotal cholesterol (TCHOL)TBDTBDLow density lipoprotein (LDL)TBDTBDHigh density lipoprotein (HDL)TBDTBDTriglycerides (TGs)TBDTBDVery low density lipoprotein (VLDL)TBDTBDLipoprotein (a) [Lp(a)]TBDTBDTable 4 Complete Blood Count (CBC) Laboratory TestsTestResultUnit for ResultWhite blood cell count (WBC)TBDTBDLymphocyte count TBDTBDNeutrophil countTBDTBDMonocyte countTBDTBDEosinophil countTBDTBDHematocrit count (HCT)TBDTBDHemoglobin (HB)TBDTBDPlatelet count TBDTBDTable 5 Arterial Blood Gas Laboratory TestsTestResultUnit for ResultPartial pressure of arterial oxygen (PaO2)TBDTBDPartial pressure of arterial carbon dioxide (PaCO2)TBDTBDArterial base excess value (Be)TBDTBDAcidity/pHTBDTBDTable 6 Liver Function Laboratory TestsTestResultUnit for ResultAlbuminTBDTBDTotal proteinTBDTBDAspartate aminotransferase (AST/ASAT/SGOT)TBDTBDAlanine aminotransferase (ALT/ALAT/SGPT)TBDTBDTotal BilirubinTBDTBDDirect BilirubinTBDTBDAlkaline PhosphataseTBDTBDTable 7 Clotting Laboratory TestsTestResultUnit for ResultProthrombin Time (PT)TBDTBDActivated Partial Thromboplastin Time (aPTT)TBDTBDInternational Normalized Ratio (INR)TBDTBDFibrinogenTBDTBDThrombin TimeTBDTBDTable 8 Inflammatory Laboratory TestsTestResultUnit for ResultHigh Sensitivity C Reactive Protein (hsCRP)TBDTBDErythrocyte Sedimentation Rate (ESR)TBDTBDTable 9 Miscellaneous Laboratory TestsTestResultUnit for ResultLactateTBDGlycosylated Hemoglobin (HgbA1C)TBDTBDCreatinine ClearanceTBDTBDGlomerular Filtration Rate (GFR)TBDTBDStool GuaiacTBDTBDAmmonia (NH3)TBDTBDAmylaseTBDTBDTable 10 Cardiac Laboratory TestsTestResultUnit for ResultTroponin ITBDTBDTroponin TTBDTBDCreatine KinaseTBDTBDCreatine Kinase - Myocardial Bands (CK-MB) TBDTBDTable 11 Cerebral Spinal Fluid (CSF) Laboratory TestsTestResultUnit for ResultCSF ProteinTBDTBDCSF GlucoseTBDTBDCSF White Blood Cell CountTBDTBDCSF Red Blood Cell CountTBDTBDGeneral InstructionsLaboratory tests are routinely administered in clinical trials of pharmacological interventions to assess subject safety. Laboratory tests may also be used to determine an individual’s eligibility for a study.Laboratory results may be received via electronic files directly from central study laboratories or recorded manually on case report forms if the study is using a local lab. In either scenario, it is recommended that the Laboratory Test form be used to record when samples were collected (date and time) so that the laboratory tests results can be matched with the samples collected for each subject.The elements on this CRF are classified as Supplemental and should only be collected if the research team considers them appropriate for their study.Specific InstructionsPlease see the Data Dictionary for definitions for each of the data elements included in this CRF Module.Test – Indicate the name of each laboratory test that is run on the specimen. See the data dictionary for additional information on coding the test name using Logical Observation Identifiers Names and Codes (LOINC).Result – Record the numeric or alpha-numeric results for each laboratory test.Unit for Result – Record the units of the numeric results for each laboratory test are measured in. See the data dictionary for additional information on coding the unit of measure using Unified Code for Units of Measure (UCUM). ................
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