Requirements Definition Document (RDD)

Transcription

1 Requirements Definition Document (RDD) Revision History Date Version Created By/Revised By: Reason for Revision: 20 Jan Tauhid Siddiqui 27 Jan Tauhid Siddiqui Incorporating changes suggested by Oracle Version <1.0> Page 1 of 24

2 Prepared By CDS: Signature: Name: Tauhid Siddiqui Title: PL Date: 27 Jan 2012 Accepted And Agreed By DMS: Signature: Name: Title: Date: CDS PM Approval: Signature: Name: Title: Date: Version <1.0> Page 2 of 24

3 Table of Contents 1 Document Overview Abbreviations and Acronyms Introduction RID 1 Specified Configuration Settings RID 2 List of Visits RID 3 List of Lab Forms RID 4 List of Lab Tests RID 5 IIE-LNMT Configuration Version <1.0> Page 3 of 24

4 1 Document Overview This Requirements Definition Document (RDD) details the requirements, defined by DMS, to allow the LNMT 4.0 Solution to be properly implemented and configured for the study. Once this document has been finalized and approved, it will be utilized to implement the solution. 2 Abbreviations and Acronyms This is a list of definitions of specific technical and functional terms and concepts that may be used in this and other documents relating to this system. Item Definition LNMT Lab Normal Management Tool LNR Lab Normal Range ecrf Electronic Case Record Form InForm Oracle s Web-based Electronic Data Capture solution N/A Not Applicable Pdf Portable Document File RDD Requirements Definition Document RID Requirements Identifier SOW Statement of Work 3 Introduction The following sections of this document capture the necessary specific requirements to properly implement and configure the LNMT 4.0 solution. Each requirement is identified via a Requirements Identifier (RID) for traceability purposes. Version <1.0> Page 4 of 24

5 RID 1 Specified Configuration Settings LNMT CONFIGURATION SETTINGS ITEM STANDARD /DEFAULT DMS SPECIFIED Security Rights Group for Lab Vendor Data entry access <AllowedGroups></AllowedGroups> (Allows Add/Edit/Delete on Lab Vendor page) Security Rights Group for LNR Data entry access <LNRDataEntryGroups></LNRDataEntryGroups> (Allows Add/Edit/Delete on LNR page) Security Rights Group for LNMT Read Only Access <ReadOnlyGroups></ReadOnlyGroups> (Allows Read only access on Lab Vendor and Lab Normal page) Security Rights Group for LNMT Admin Access <AdminGroups></AdminGroups> (Allows mapping InForm Lab Form controls and InForm Demographic controls with LNMT) Security Rights Group for viewing Audit Reports Access <ViewAuditReportGroups></ViewAuditReportGroups> (Allows access to view complete Audit of Lab Vendor and LNR entries in LNMT) LNMT Refresh Interval 15 minutes Sponsor Data Entry,PI,CRC, System Creator Group Sponsor Data Entry,PI,CRC, System Creator Group GDMS,Project Manager,Developer,Medical Monitor,Safety Specialist,CRA,PIsig,Support,Vendor View Only Developer,Support, System Creator Group GDMS,Project Manager,Developer,Medical Monitor,Safety Specialist,CRA,Support,Vendor View Only Version <1.0> Page 5 of 24

6 RID 2 List of Visits VISIT MNEMONIC Example: UNSCHED Visit 1 Visit 2 Visit 4 Visit 5 Visit 6 Unscheduled REPEATING VISIT S REF NAME (CASE SENSITIVE) TO BE COMPLETED DURING IMPLEMENTATION VISIT1 VISIT2 VISIT4 VISIT5 VISIT6 UNSCHED Version <1.0> Page 6 of 24

7 RID 3 List of Lab Forms LAB Form (FORM MNEMONICS) Example: CLB01 CLB01 CLB01A HLB01 HLB01A OLB01 ULB01 ULB01A REPEATING FORM REF NAME (CASE SENSITIVE) TO BE COMPLETED DURING IMPLEMENTATION CLB01FM CLB01AFM HLB01FM HLB01AFM OLB01FM ULB01FM ULB01AFM Version <1.0> Page 7 of 24

8 RID 4 List of Lab Tests LAB TEST UNITS LNMT ITEMS REF PATH (FROM SECTION ONWARDS) TO BE COMPLETED DURING IMPLEMENTATION Example: RBC 10^12/L, DisplayString scthema2.0.itmlymphlnmt.gclymphlnmt.tclymphlnmtrng cells/l, cells/mm^3 scthema2.0.itmlymphlnmt.gclymphlnmt.tclymphlnmtflag LAB TEST UNITS REF PATH <!--CLB01AFM--> Total Bilirubin Total Protein Uric Acid Urea Carbon Dioxide Creatine Kinase Indirect Bilirubin Triglycerides <!--CLB01FM--> mg/dl,mmol/l,g/dl,mg%,u mol/l,mg/l gm/dl,g/l,g%,mg/dl mg/dl,mmol/l,umol/l,nmo l/l,mg/l,mg% gm/l,mg/dl,mmol/l,mg% meq/l,mmol/l IU/L,mIU/mL,microkat/L gm/dl,mg/dl,mmol/l,micr omol/l,mg/l,mg% mg/dl,mmol/l,mg% DisplayString CLB01ARSLTSN.0.CL1ALBORNRTBUIT.CL1ALBORNRTBUGC.CL1ALBORNRTBUTB CLB01ARSLTSN.0.CL1ALBORNRTBUIT.CL1ALBORNRTBUGC.CL1ALBINRANGETBTB DisplayString CLB01ARSLTSN.0.CL1ALBORNRTPUIT.CL1ALBORNRTPUGC.CL1ALBORNRTPUTB CLB01ARSLTSN.0.CL1ALBORNRTPUIT.CL1ALBORNRTPUGC.CL1ALBRANGETPTB DisplayString CLB01ARSLTSN.0.CL1ALBORNRUAUIT.CL1ALBORNRUAUGC.CL1ALBORNRUAUTB CLB01ARSLTSN.0.CL1ALBORNRUAUIT.CL1ALBORNRUAUGC.CL1ALBINRANGEUATB DisplayString CLB01ARSLTSN.0.CL1ALBORNRURUIT.CL1ALBORNRURUGC.CL1ALBORNRURUTB CLB01ARSLTSN.0.CL1ALBORNRURUIT.CL1ALBORNRURUGC.CL1ALBINRANGEURTB DisplayString CLB01ARSLTSN.0.CL1ALBORNRUCDIT.CL1ALBORNRUCDGC.CL1ALBORNRUCDTB CLB01ARSLTSN.0.CL1ALBORNRUCDIT.CL1ALBORNRUCDGC.CL1ALBINRANGECDTB DisplayString CLB01ARSLTSN.0.CL1ALBORNRUCKIT.CL1ALBORNRUCKGC.CL1ALBORNRUCKTB CLB01ARSLTSN.0.CL1ALBORNRUCKIT.CL1ALBORNRUCKGC.CL1ALBINRANGECKTB DisplayString CLB01ARSLTSN.0.CL1ALBORNRUIBIT.CL1ALBORNRUIBGC.CL1ALBORNRUIBTB CLB01ARSLTSN.0.CL1ALBORNRUIBIT.CL1ALBORNRUIBGC.CL1ALBINRANGEIBTB DisplayString CLB01ARSLTSN.0.CL1ALBORNRUTGIT.CL1ALBORNRUTGGC.CL1ALBORNRUTGTB CLB01ARSLTSN.0.CL1ALBORNRUTGIT.CL1ALBORNRUTGGC.CL1ALBINRANGETGTB Version <1.0> Page 8 of 24

9 Albumin Alkaline Phosphatase ALT (Alanine Aminotransferase) Amylase AST (Aspartate Aminotransferase) Bicarbonate Blood Urea Nitrogen Calcium Chloride Cholesterol Creatinine Direct Bilirubin Gamma-GT (Gamma- Glutamyl Transpeptidase) Gluclose LDH (Lactate g/dl,umol/dl,umol/l,g/l,%,g%,mg/dl,mmol/l IU/L,IU/dL,ukat/L,mIU/m L,umol/L/sec,umol/L/min IU/L,IU/dL,ukat/L,mIU/m L,umol/L/sec,umol/L/min IU/L,IU/dL,microkat/L,m IU/mL IU/L,IU/dL,ukat/L,mIU/m L,umol/L/sec,umol/L/min mmol/l,meq/l,mg/dl mg/dl,iu/l,mmol/l,mg%,g /L mg/dl,mmol/l,meq/l,mg%, mg/l mmol/l,mg/dl,mmol/dl,me q/ml,meq/l mg/dl,mmol/l,mg% mg/dl,mmol/l,meq/l,umol /dl,umol/l,mg/l,mg% mg/dl,mmol/l,g/dl,mg%,u mol/l,mg/l IU/L,mIU/mL,ukat/L mg/dl,mmol/l,mmol/dl,g/ dl,mg/ml,mg% DisplayString CLB01RSLTSN.0.CL1LBORNRALUIT.CL1LBORNRALUGC.CL1LBORNRALUTB CLB01RSLTSN.0.CL1LBORNRALUIT.CL1LBORNRALUGC.CL1LBINRANGEALTB DisplayString CLB01RSLTSN.0.CL1LBORNRAPUIT.CL1LBORNRAPUGC.CL1LBORNRAPUTB CLB01RSLTSN.0.CL1LBORNRAPUIT.CL1LBORNRAPUGC.CL1LBINRANGEAPTB DisplayString CLB01RSLTSN.0.CL1LBORNRATUIT.CL1LBORNRATUGC.CL1LBORNRATUTB CLB01RSLTSN.0.CL1LBORNRATUIT.CL1LBORNRATUGC.CL1LBINRANGEATTB DisplayString CLB01RSLTSN.0.CL1LBORNRAMUIT.CL1LBORNRAMUGC.CL1LBORNRAMUTB CLB01RSLTSN.0.CL1LBORNRAMUIT.CL1LBORNRAMUGC.CL1LBINRANGEAMTB DisplayString CLB01RSLTSN.0.CL1LBORNRASUIT.CL1LBORNRASUGC.CL1LBORNRASUTB CLB01RSLTSN.0.CL1LBORNRASUIT.CL1LBORNRASUGC.CL1LBINRANGEASTB DisplayString CLB01RSLTSN.0.CL1LBORNRBIUIT.CL1LBORNRBIUGC.CL1LBORNRBIUTB CLB01RSLTSN.0.CL1LBORNRBIUIT.CL1LBORNRBIUGC.CL1LBINRANGEBITB DisplayString CLB01RSLTSN.0.CL1LBORNRBUUIT.CL1LBORNRBUUGC.CL1LBORNRBUUTB CLB01RSLTSN.0.CL1LBORNRBUUIT.CL1LBORNRBUUGC.CL1LBINRANGEBUTB DisplayString CLB01RSLTSN.0.CL1LBORNRCAUIT.CL1LBORNRCAUGC.CL1LBORNRCAUTB CLB01RSLTSN.0.CL1LBORNRCAUIT.CL1LBORNRCAUGC.CL1LBINRANGECATB DisplayString CLB01RSLTSN.0.CL1LBORNRCLUIT.CL1LBORNRCLUGC.CL1LBORNRCLUTB CLB01RSLTSN.0.CL1LBORNRCLUIT.CL1LBORNRCLUGC.CL1LBINRANGECLTB DisplayString CLB01RSLTSN.0.CL1LBORNRCHUIT.CL1LBORNRCHUGC.CL1LBORNRCHUTB CLB01RSLTSN.0.CL1LBORNRCHUIT.CL1LBORNRCHUGC.CL1LBINRANGECHTB DisplayString CLB01RSLTSN.0.CL1LBORNRCRUIT.CL1LBORNRCRUGC.CL1LBORNRCRUTB CLB01RSLTSN.0.CL1LBORNRCRUIT.CL1LBORNRCRUGC.CL1LBINRANGECRTB DisplayString CLB01RSLTSN.0.CL1LBORNRDBUIT.CL1LBORNRDBUGC.CL1LBORNRDBUTB CLB01RSLTSN.0.CL1LBORNRDBUIT.CL1LBORNRDBUGC.CL1LBINRANGEDBTB DisplayString CLB01RSLTSN.0.CL1LBORNRGTUIT.CL1LBORNRGTUGC.CL1LBORNRGTUTB CLB01RSLTSN.0.CL1LBORNRGTUIT.CL1LBORNRGTUGC.CL1LBINRANGEGTTB DisplayString CLB01RSLTSN.0.CL1LBORNRGLUIT.CL1LBORNRGLUGC.CL1LBORNRGLUTB CLB01RSLTSN.0.CL1LBORNRGLUIT.CL1LBORNRGLUGC.CL1LBINRANGEGLTB IU/L,IU/dL,mIU/mL,ukat/ DisplayString CLB01RSLTSN.0.CL1LBORNRLDUIT.CL1LBORNRLDUGC.CL1LBORNRLDUTB Version <1.0> Page 9 of 24

10 Dehydrogenase) L Lipase Magnesium Phosphorus Potassium Sodium <!--HLB01AFM--> Blasts Blasts/Leukocytes % White Blood Cell Count Red Blood Cell Count Hemoglobin Hematocrit Leukemic Blasts Leukemic Blasts/Lymphocytes % IU/L,IU/dL,microkat/L meq/l,mg/dl,mg/l,mmol/l meq/l,mg/dl,mg/l,mg%,mm ol/l meq/l,mg/dl,mmol/l mmol/l,meq/l,mg/dl /mm[3],/nl,/ul,10[3]/mm [3],10[3]/uL,10[9]/L 10[2]/uL,/nL,/uL,/mm[3],10[3]uL,10[3]/mm[3],10 [9]/L 10[3]/uL,10[3]/mm[3],10 [4]/mm[3],10[4]/uL,10[6 ]/mm[3],10[6]/ul,10[9]/ L,10[12]/L,/uL g/dl,g/l,mg/dl,mmol/l,g m% %,ratio,l/l,volume fraction,g/dl,ml/dl /mm[3],/nl,/ul,10[3]/mm [3],10[3]/uL,10[9]/L CLB01RSLTSN.0.CL1LBORNRLDUIT.CL1LBORNRLDUGC.CL1LBINRANGELDTB DisplayString CLB01RSLTSN.0.CL1LBORNRLIUIT.CL1LBORNRLIUGC.CL1LBORNRLIUTB CLB01RSLTSN.0.CL1LBORNRLIUIT.CL1LBORNRLIUGC.CL1LBINRANGELITB DisplayString CLB01RSLTSN.0.CL1LBORNRMAUIT.CL1LBORNRMAUGC.CL1LBORNRMAUTB CLB01RSLTSN.0.CL1LBORNRMAUIT.CL1LBORNRMAUGC.CL1LBINRANGEMATB DisplayString CLB01RSLTSN.0.CL1LBORNRPHUIT.CL1LBORNRPHUGC.CL1LBORNRPHUTB CLB01RSLTSN.0.CL1LBORNRPHUIT.CL1LBORNRPHUGC.CL1LBINRANGEPHTB DisplayString CLB01RSLTSN.0.CL1LBORNRPOUIT.CL1LBORNRPOUGC.CL1LBORNRPOUTB CLB01RSLTSN.0.CL1LBORNRPOUIT.CL1LBORNRPOUGC.CL1LBINRANGEPOTB DisplayString CLB01RSLTSN.0.CL1LBORNRSOUIT.CL1LBORNRSOUGC.CL1LBORNRSOUTB CLB01RSLTSN.0.CL1LBORNRSOUIT.CL1LBORNRSOUGC.CL1LBINRANGESOTB DisplayString HLB01ARESSN.0.HL1ALBORNRBLUIT.HL1ALBORNRBLUGC.HL1ALBORNRBLUTB HLB01ARESSN.0.HL1ALBORNRBLUIT.HL1ALBORNRBLUGC.HL1ALBINRANGEBLTB DisplayString HLB01ARESSN.0.HL1ALBORNRBKUIT.HL1ALBORNRBKUGC.HL1ALBORNRBKUTB HLB01ARESSN.0.HL1ALBORNRBKUIT.HL1ALBORNRBKUGC.HL1ALBINRANGEBKTB DisplayString HLB01ARESSN.0.HL1ALBORNRFPUIT.HL1ALBORNRFPUGC.HL1ALBORNRFPUTB HLB01ARESSN.0.HL1ALBORNRFPUIT.HL1ALBORNRFPUGC.HL1ALBINRANGEFPTB DisplayString HLB01ARESSN.0.HL1ALBORNRRBUIT.HL1ALBORNRRBUGC.HL1ALBORNRRBUTB HLB01ARESSN.0.HL1ALBORNRRBUIT.HL1ALBORNRRBUGC.HL1ALBINRANGERBTB DisplayString HLB01ARESSN.0.HL1ALBORNRHGUIT.HL1ALBORNRHGUGC.HL1ALBORNRHGUTB HLB01ARESSN.0.HL1ALBORNRHGUIT.HL1ALBORNRHGUGC.HL1ALBINRANGEHGTB DisplayString HLB01ARESSN.0.HL1ALBORNRHCUIT.HL1ALBORNRHCUGC.HL1ALBORNRHCUTB HLB01ARESSN.0.HL1ALBORNRHCUIT.HL1ALBORNRHCUGC.HL1ALBINRANGEHCTB DisplayString HLB01ARESSN.0.HL1ALBORNRLBUIT.HL1ALBORNRLBUGC.HL1ALBORNRLBUTB HLB01ARESSN.0.HL1ALBORNRLBUIT.HL1ALBORNRLBUGC.HL1ALBINRANGELBTB DisplayString HLB01ARESSN.0.HL1ALBORNRLLUIT.HL1ALBORNRLLUGC.HL1ALBORNRLLUTB HLB01ARESSN.0.HL1ALBORNRLLUIT.HL1ALBORNRLLUGC.HL1ALBINRANGELLTB Version <1.0> Page 10 of 24

11 MCV MCH MCHC Metamyelocyte Count Metamyelocyte Count/Leukocytes % Monoblasts Monoblasts/Leukocyt es % Myeloblasts Myeloblasts/Leukocy tes % Promyelocytes Promyelocytes/Leuko cytes % fl,mm[3],micron[3],/mic rol fmol/cell,pg/cell g/dl,%,g/l,gm%,mmol/l /mm[3],/nl,/ul,10[3]/mm [3],10[3]/uL,10[9]/L /mm[3],/nl,/ul,10[3]/mm [3],10[3]/uL,10[9]/L /mm3,/nl,/ul,10[3]/mm[3 ],10[3]/uL,10[9]/L /mm[3],/nl,/ul,10[3]/mm [3],10[3]/uL,10[9]/L RDW % /mm[3],10[3]/mm[3],10[4 ]/mm[3],/nl,/ul,10[3]/u L,10[4]/uL,10[9]/L,10[1 Platelet Count 2]/L Absolute Neutrophil /ul,/mm[3],10[3]/mm[3], 10[9]/L,10[3]/uL,/nL DisplayString HLB01ARESSN.0.HL1ALBORNRMCUIT.HL1ALBORNRMCUGC.HL1ALBORNRMCUTB HLB01ARESSN.0.HL1ALBORNRMCUIT.HL1ALBORNRMCUGC.HL1ALBINRANGEMCTB DisplayString HLB01ARESSN.0.HL1ALBORNRMHUIT.HL1ALBORNRMHUGC.HL1ALBORNRMHUTB HLB01ARESSN.0.HL1ALBORNRMHUIT.HL1ALBORNRMHUGC.HL1ALBINRANGEMHTB DisplayString HLB01ARESSN.0.HL1ALBORNRCHUIT.HL1ALBORNRCHUGC.HL1ALBORNRCHUTB HLB01ARESSN.0.HL1ALBORNRCHUIT.HL1ALBORNRCHUGC.HL1ALBINRANGECHTB DisplayString HLB01ARESSN.0.HL1ALBORNRMLUIT.HL1ALBORNRMLUGC.HL1ALBORNRMLUTB HLB01ARESSN.0.HL1ALBORNRMLUIT.HL1ALBORNRMLUGC.HL1ALBINRANGEMLTB DisplayString HLB01ARESSN.0.HL1ALBORNRMKUIT.HL1ALBORNRMKUGC.HL1ALBORNRMKUTB HLB01ARESSN.0.HL1ALBORNRMKUIT.HL1ALBORNRMKUGC.HL1ALBINRANGEMKTB DisplayString HLB01ARESSN.0.HL1ALBORNRMBUIT.HL1ALBORNRMBUGC.HL1ALBORNRMBUTB HLB01ARESSN.0.HL1ALBORNRMBUIT.HL1ALBORNRMBUGC.HL1ALBINRANGEMBTB DisplayString HLB01ARESSN.0.HL1ALBORNRMNUIT.HL1ALBORNRMNUGC.HL1ALBORNRMNUTB HLB01ARESSN.0.HL1ALBORNRMNUIT.HL1ALBORNRMNUGC.HL1ALBINRANGEMNTB DisplayString HLB01ARESSN.0.HL1ALBORNRMYUIT.HL1ALBORNRMYUGC.HL1ALBORNRMYUTB HLB01ARESSN.0.HL1ALBORNRMYUIT.HL1ALBORNRMYUGC.HL1ALBINRANGEMYTB DisplayString HLB01ARESSN.0.HL1ALBORNRMEUIT.HL1ALBORNRMEUGC.HL1ALBORNRMEUTB HLB01ARESSN.0.HL1ALBORNRMEUIT.HL1ALBORNRMEUGC.HL1ALBINRANGEMETB DisplayString HLB01ARESSN.0.HL1ALBORNRPMUIT.HL1ALBORNRPMUGC.HL1ALBORNRPMUTB HLB01ARESSN.0.HL1ALBORNRPMUIT.HL1ALBORNRPMUGC.HL1ALBINRANGEPMTB DisplayString HLB01ARESSN.0.HL1ALBORNRPLUIT.HL1ALBORNRPLUGC.HL1ALBORNRPLUTB HLB01ARESSN.0.HL1ALBORNRPLUIT.HL1ALBORNRPLUGC.HL1ALBINRANGEPLTB DisplayString HLB01ARESSN.0.HL1ALBORNRRWUIT.HL1ALBORNRRWUGC.HL1ALBORNRRWUTB HLB01ARESSN.0.HL1ALBORNRRWUIT.HL1ALBORNRRWUGC.HL1ALBINRANGERWTB DisplayString HLB01ARESSN.0.HL1ALBORNRPCUIT.HL1ALBORNRPCUGC.HL1ALBORNRPCUTB HLB01ARESSN.0.HL1ALBORNRPCUIT.HL1ALBORNRPCUGC.HL1ALBINRANGEPCTB DisplayString HLB01AWBCDSN.0.HL1ALBORNRANUIT.HL1ALBORNRANUGC.HL1ALBORNRANUTB HLB01AWBCDSN.0.HL1ALBORNRANUIT.HL1ALBORNRANUGC.HL1ALBINRANGEANTB Version <1.0> Page 11 of 24

12 Absolute Band Neutrophil Absolute Lymphocyte Absolute Monocyte Absolute Eosinophil Absolute Basophil Absolute Atypical Lymphocyte /ul,/mm[3],10[3]/mm[3], 10[9]/L,10[3]/uL,/nL /ul,/mm[3],10[3]/mm[3], 10[9]/L,10[3]/uL,/nL /ul,/mm[3],10[3]/mm[3], 10[9]/L,10[3]/uL,/nL /ul,/mm[3],10[3]/mm[3], 10[9]/L,10[3]/uL,/nL /ul,/mm[3],10[3]/mm[3], 10[9]/L,10[3]/uL,/nL /ul,/mm[3],10[3]/mm[3], 10[9]/L,10[3]/uL,/nL Prothrombin Time seconds,%,ratio (/) INR n/a Activated Partial Thromboplastin Time seconds,ratio (/) <!--HLB01FM--> Blasts Blasts/Leukocytes % White Blood Cell Count Red Blood Cell Count Hemoglobin /mm[3],/nl,/ul,10[3]/mm [3],10[3]/uL,10[9]/L 10[2]/uL,/nL,/uL,/mm[3],10[3]uL,10[3]/mm[3],10 [9]/L 10[3]/uL,10[3]/mm[3],10 [4]/mm[3],10[4]/uL,10[6 ]/mm[3],10[6]/ul,10[9]/ L,10[12]/L,/uL DisplayString HLB01AWBCDSN.0.HL1ALBORNRBNUIT.HL1ALBORNRBNUGC.HL1ALBORNRBNUTB HLB01AWBCDSN.0.HL1ALBORNRBNUIT.HL1ALBORNRBNUGC.HL1ALBINRANGEBNTB DisplayString HLB01AWBCDSN.0.HL1ALBORNRALUIT.HL1ALBORNRALUGC.HL1ALBORNRALUTB HLB01AWBCDSN.0.HL1ALBORNRALUIT.HL1ALBORNRALUGC.HL1ALBINRANGEALTB DisplayString HLB01AWBCDSN.0.HL1ALBORNRAMUIT.HL1ALBORNRAMUGC.HL1ALBORNRAMUTB HLB01AWBCDSN.0.HL1ALBORNRAMUIT.HL1ALBORNRAMUGC.HL1ALBINRANGEAMTB DisplayString HLB01AWBCDSN.0.HL1ALBORNRAEUIT.HL1ALBORNRAEUGC.HL1ALBORNRAEUTB HLB01AWBCDSN.0.HL1ALBORNRAEUIT.HL1ALBORNRAEUGC.HL1ALBINRANGEAETB DisplayString HLB01AWBCDSN.0.HL1ALBORNRABUIT.HL1ALBORNRABUGC.HL1ALBORNRABUTB HLB01AWBCDSN.0.HL1ALBORNRABUIT.HL1ALBORNRABUGC.HL1ALBINRANGEABTB DisplayString HLB01AWBCDSN.0.HL1ALBORNRTLUIT.HL1ALBORNRTLUGC.HL1ALBORNRTLUTB HLB01AWBCDSN.0.HL1ALBORNRTLUIT.HL1ALBORNRTLUGC.HL1ALBINRANGETLTB DisplayString HLB01AHTSN.0.HL1ALBORNRPTUIT.HL1ALBORNRPTUGC.HL1ALBORNRPTUTB HLB01AHTSN.0.HL1ALBORNRPTUIT.HL1ALBORNRPTUGC.HL1ALBINRANGEPTTB DisplayString HLB01AHTSN.0.HL1ALBORNRIRUIT.HL1ALBORNRIRUGC.HL1ALBORNRIRUTB HLB01AHTSN.0.HL1ALBORNRIRUIT.HL1ALBORNRIRUGC.HL1ALBINRANGEIRTB DisplayString HLB01AHTSN.0.HL1ALBORNRIAPIT.HL1ALBORNRIAPGC.HL1ALBORNRIAPTB HLB01AHTSN.0.HL1ALBORNRIAPIT.HL1ALBORNRIAPGC.HL1ALBINRANGEAPTB DisplayString HLB01RESSN.0.HL1LBORNRBLUIT.HL1LBORNRBLUGC.HL1LBORNRBLUTB HLB01RESSN.0.HL1LBORNRBLUIT.HL1LBORNRBLUGC.HL1LBINRANGEBLTB DisplayString HLB01RESSN.0.HL1LBORNRBKUIT.HL1LBORNRBKUGC.HL1LBORNRBKUTB HLB01RESSN.0.HL1LBORNRBKUIT.HL1LBORNRBKUGC.HL1LBINRANGEBKTB DisplayString HLB01RESSN.0.HL1LBORNRFPUIT.HL1LBORNRFPUGC.HL1LBORNRFPUTB HLB01RESSN.0.HL1LBORNRFPUIT.HL1LBORNRFPUGC.HL1LBINRANGEFPTB DisplayString HLB01RESSN.0.HL1LBORNRRBUIT.HL1LBORNRRBUGC.HL1LBORNRRBUTB HLB01RESSN.0.HL1LBORNRRBUIT.HL1LBORNRRBUGC.HL1LBINRANGERBTB g/dl,g/l,mg/dl,mmol/l,g DisplayString HLB01RESSN.0.HL1LBORNRHGUIT.HL1LBORNRHGUGC.HL1LBORNRHGUTB Version <1.0> Page 12 of 24

13 m% Hematocrit Leukemic Blasts Leukemic Blasts/Lymphocytes % MCV MCH MCHC Metamyelocyte Count Metamyelocyte Count/Leukocytes % Monoblasts Monoblasts/Leukocyt es % Myeloblasts Myeloblasts/Leukocy tes % Promyelocytes Promyelocytes/Leuko cytes % %,ratio,l/l,volume fraction,g/dl,ml/dl /mm[3],/nl,/ul,10[3]/mm [3],10[3]/uL,10[9]/L fl,mm[3],micron[3],/mic rol fmol/cell,pg/cell g/dl,%,g/l,gm%,mmol/l /mm[3],/nl,/ul,10[3]/mm [3],10[3]/uL,10[9]/L /mm[3],/nl,/ul,10[3]/mm [3],10[3]/uL,10[9]/L /mm3,/nl,/ul,10[3]/mm[3 ],10[3]/uL,10[9]/L /mm[3],/nl,/ul,10[3]/mm [3],10[3]/uL,10[9]/L HLB01RESSN.0.HL1LBORNRHGUIT.HL1LBORNRHGUGC.HL1LBINRANGEHGTB DisplayString HLB01RESSN.0.HL1LBORNRHCUIT.HL1LBORNRHCUGC.HL1LBORNRHCUTB HLB01RESSN.0.HL1LBORNRHCUIT.HL1LBORNRHCUGC.HL1LBINRANGEHCTB DisplayString HLB01RESSN.0.HL1LBORNRLBUIT.HL1LBORNRLBUGC.HL1LBORNRLBUTB HLB01RESSN.0.HL1LBORNRLBUIT.HL1LBORNRLBUGC.HL1LBINRANGELBTB DisplayString HLB01RESSN.0.HL1LBORNRLLUIT.HL1LBORNRLLUGC.HL1LBORNRLLUTB HLB01RESSN.0.HL1LBORNRLLUIT.HL1LBORNRLLUGC.HL1LBINRANGELLTB DisplayString HLB01RESSN.0.HL1LBORNRMCUIT.HL1LBORNRMCUGC.HL1LBORNRMCUTB HLB01RESSN.0.HL1LBORNRMCUIT.HL1LBORNRMCUGC.HL1LBINRANGEMCTB DisplayString HLB01RESSN.0.HL1LBORNRMHUIT.HL1LBORNRMHUGC.HL1LBORNRMHUTB HLB01RESSN.0.HL1LBORNRMHUIT.HL1LBORNRMHUGC.HL1LBINRANGEMHTB DisplayString HLB01RESSN.0.HL1LBORNRCHUIT.HL1LBORNRCHUGC.HL1LBORNRCHUTB HLB01RESSN.0.HL1LBORNRCHUIT.HL1LBORNRCHUGC.HL1LBINRANGECHTB DisplayString HLB01RESSN.0.HL1LBORNRMLUIT.HL1LBORNRMLUGC.HL1LBORNRMLUTB HLB01RESSN.0.HL1LBORNRMLUIT.HL1LBORNRMLUGC.HL1LBINRANGEMLTB DisplayString HLB01RESSN.0.HL1LBORNRMKUIT.HL1LBORNRMKUGC.HL1LBORNRMKUTB HLB01RESSN.0.HL1LBORNRMKUIT.HL1LBORNRMKUGC.HL1LBINRANGEMKTB DisplayString HLB01RESSN.0.HL1LBORNRMBUIT.HL1LBORNRMBUGC.HL1LBORNRMBUTB HLB01RESSN.0.HL1LBORNRMBUIT.HL1LBORNRMBUGC.HL1LBINRANGEMBTB DisplayString HLB01RESSN.0.HL1LBORNRMNUIT.HL1LBORNRMNUGC.HL1LBORNRMNUTB HLB01RESSN.0.HL1LBORNRMNUIT.HL1LBORNRMNUGC.HL1LBINRANGEMNTB DisplayString HLB01RESSN.0.HL1LBORNRMYUIT.HL1LBORNRMYUGC.HL1LBORNRMYUTB HLB01RESSN.0.HL1LBORNRMYUIT.HL1LBORNRMYUGC.HL1LBINRANGEMYTB DisplayString HLB01RESSN.0.HL1LBORNRMEUIT.HL1LBORNRMEUGC.HL1LBORNRMEUTB HLB01RESSN.0.HL1LBORNRMEUIT.HL1LBORNRMEUGC.HL1LBINRANGEMETB DisplayString HLB01RESSN.0.HL1LBORNRPMUIT.HL1LBORNRPMUGC.HL1LBORNRPMUTB HLB01RESSN.0.HL1LBORNRPMUIT.HL1LBORNRPMUGC.HL1LBINRANGEPMTB DisplayString HLB01RESSN.0.HL1LBORNRPLUIT.HL1LBORNRPLUGC.HL1LBORNRPLUTB HLB01RESSN.0.HL1LBORNRPLUIT.HL1LBORNRPLUGC.HL1LBINRANGEPLTB Version <1.0> Page 13 of 24

14 RDW % /mm[3],10[3]/mm[3],10[4 ]/mm[3],/nl,/ul,10[3]/u L,10[4]/uL,10[9]/L,10[1 Platelet Count 2]/L Neutrophil (%) % Band Neutrophil (%) % Lymphocyte (%) % Monocyte (%) % Eosinophil (%) % Basophil (%) % Atypical Lymphocyte (%) % Prothrombin Time seconds,%,ratio (/) INR n/a Activated Partial Thromboplastin Time seconds,ratio (/) <!--OLB01FM--> 5-HIAA Alpha 2-Antiplasmin % mg/gm(creatinine),micro mol/mmol(creat),microgm /mg(creatinine) DisplayString HLB01RESSN.0.HL1LBORNRRWUIT.HL1LBORNRRWUGC.HL1LBORNRRWUTB HLB01RESSN.0.HL1LBORNRRWUIT.HL1LBORNRRWUGC.HL1LBINRANGERWTB DisplayString HLB01RESSN.0.HL1LBORNRPCUIT.HL1LBORNRPCUGC.HL1LBORNRPCUTB HLB01RESSN.0.HL1LBORNRPCUIT.HL1LBORNRPCUGC.HL1LBINRANGEPCTB DisplayString HLB01WBCDPSN.0.HL1LBORNRNTUIT.HL1LBORNRNTUGC.HL1LBORNRNTUTB HLB01WBCDPSN.0.HL1LBORNRNTUIT.HL1LBORNRNTUGC.HL1LBINRANGENTTB DisplayString HLB01WBCDPSN.0.HL1LBORNRBTUIT.HL1LBORNRBTUGC.HL1LBORNRBTUTB HLB01WBCDPSN.0.HL1LBORNRBTUIT.HL1LBORNRBTUGC.HL1LBINRANGEBTTB DisplayString HLB01WBCDPSN.0.HL1LBORNRLYUIT.HL1LBORNRLYUGC.HL1LBORNRLYUTB HLB01WBCDPSN.0.HL1LBORNRLYUIT.HL1LBORNRLYUGC.HL1LBINRANGELYTB DisplayString HLB01WBCDPSN.0.HL1LBORNRMOUIT.HL1LBORNRMOUGC.HL1LBORNRMOUTB HLB01WBCDPSN.0.HL1LBORNRMOUIT.HL1LBORNRMOUGC.HL1LBINRANGEMOTB DisplayString HLB01WBCDPSN.0.HL1LBORNREOUIT.HL1LBORNREOUGC.HL1LBORNREOUTB HLB01WBCDPSN.0.HL1LBORNREOUIT.HL1LBORNREOUGC.HL1LBINRANGEEOTB DisplayString HLB01WBCDPSN.0.HL1LBORNRBSUIT.HL1LBORNRBSUGC.HL1LBORNRBSUTB HLB01WBCDPSN.0.HL1LBORNRBSUIT.HL1LBORNRBSUGC.HL1LBINRANGEBSTB DisplayString HLB01WBCDPSN.0.HL1LBORNRACUIT.HL1LBORNRACUGC.HL1LBORNRACUTB HLB01WBCDPSN.0.HL1LBORNRACUIT.HL1LBORNRACUGC.HL1LBINRANGEACTB DisplayString HLB01HTSN.0.HL1LBORNRPTUIT.HL1LBORNRPTUGC.HL1LBORNRPTUTB HLB01HTSN.0.HL1LBORNRPTUIT.HL1LBORNRPTUGC.HL1LBINRANGEPTTB DisplayString HLB01HTSN.0.HL1LBORNRIRUIT.HL1LBORNRIRUGC.HL1LBORNRIRUTB HLB01HTSN.0.HL1LBORNRIRUIT.HL1LBORNRIRUGC.HL1LBINRANGEIRTB DisplayString HLB01HTSN.0.HL1LBORNRIAPIT.HL1LBORNRIAPGC.HL1LBORNRIAPTB HLB01HTSN.0.HL1LBORNRIAPIT.HL1LBORNRIAPGC.HL1LBINRANGEAPTB DisplayString OLB01RSLTSN.0.OL1LBORNRL5HLIT.OL1LBORNRL5HLGC.OL1LBORNRL5HLTB OLB01RSLTSN.0.OL1LBORNRL5HLIT.OL1LBORNRL5HLGC.OL1LBINRANGE5HTB DisplayString OLB01RSLTSN.0.OL1LBORNRLA2LIT.OL1LBORNRLA2LGC.OL1LBORNRLA2LTB Version <1.0> Page 14 of 24

15 Alpha-Fetoprotein Anion Gap Beta 2- Microglobulin ng/ml,microgm/l,iu/ml,k IU/L,mg/dL meq/l,mmol/l Cancer Antigen U/mL,kIU/L Calcitonin Cancer Antigen 125 U/mL,kIU/L Cancer Antigen 15-3 U/mL,kIU/L Carbohydrate Antigen 19-9 Carcinoembryonic Antigen CD20 CD20/Lymphocytes % CD3 CD3/Lymphocytes % CD3+ CD4+ mg/dl,mg/l,microgm/l,mi crogm/ml,nmol/l pg/ml,ng/l,ng/ml,pmol/l U/mL,kIU/L ng/ml,microgm/l 10[3]/mm[3],/mm[3],/mic rol 10[3]/mm[3],/mm[3],/mic rol 10[3]/mm[3],/mm[3],/mic rol OLB01RSLTSN.0.OL1LBORNRLA2LIT.OL1LBORNRLA2LGC.OL1LBINRANGEA2TB DisplayString OLB01RSLTSN.0.OL1LBORNRLAFLIT.OL1LBORNRLAFLGC.OL1LBORNRLAFLTB OLB01RSLTSN.0.OL1LBORNRLAFLIT.OL1LBORNRLAFLGC.OL1LBINRANGEAFTB DisplayString OLB01RSLTSN.0.OL1LBORNRLAGLIT.OL1LBORNRLAGLGC.OL1LBORNRLAGLTB OLB01RSLTSN.0.OL1LBORNRLAGLIT.OL1LBORNRLAGLGC.OL1LBINRANGEAGTB DisplayString OLB01RSLTSN.0.OL1LBORNRLB2LIT.OL1LBORNRLB2LGC.OL1LBORNRLB2LTB OLB01RSLTSN.0.OL1LBORNRLB2LIT.OL1LBORNRLB2LGC.OL1LBINRANGEB2TB DisplayString OLB01RSLTSN.0.OL1LBORNRLCALIT.OL1LBORNRLCALGC.OL1LBORNRLCALTB OLB01RSLTSN.0.OL1LBORNRLCALIT.OL1LBORNRLCALGC.OL1LBINRANGECATB DisplayString OLB01RSLTSN.0.OL1LBORNRLCTLIT.OL1LBORNRLCTLGC.OL1LBORNRLCTLTB OLB01RSLTSN.0.OL1LBORNRLCTLIT.OL1LBORNRLCTLGC.OL1LBINRANGECTTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCNLIT.OL1LBORNRLCNLGC.OL1LBORNRLCNLTB OLB01RSLTSN.0.OL1LBORNRLCNLIT.OL1LBORNRLCNLGC.OL1LBINRANGECNTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCRLIT.OL1LBORNRLCRLGC.OL1LBORNRLCRLTB OLB01RSLTSN.0.OL1LBORNRLCRLIT.OL1LBORNRLCRLGC.OL1LBINRANGECRTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCHLIT.OL1LBORNRLCHLGC.OL1LBORNRLCHLTB OLB01RSLTSN.0.OL1LBORNRLCHLIT.OL1LBORNRLCHLGC.OL1LBINRANGECHTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCELIT.OL1LBORNRLCELGC.OL1LBORNRLCELTB OLB01RSLTSN.0.OL1LBORNRLCELIT.OL1LBORNRLCELGC.OL1LBINRANGECETB DisplayString OLB01RSLTSN.0.OL1LBORNRLCDLIT.OL1LBORNRLCDLGC.OL1LBORNRLCDLTB OLB01RSLTSN.0.OL1LBORNRLCDLIT.OL1LBORNRLCDLGC.OL1LBINRANGECDTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCLLIT.OL1LBORNRLCLLGC.OL1LBORNRLCLLTB OLB01RSLTSN.0.OL1LBORNRLCLLIT.OL1LBORNRLCLLGC.OL1LBINRANGECLTB DisplayString OLB01RSLTSN.0.OL1LBORNRLC3LIT.OL1LBORNRLC3LGC.OL1LBORNRLC3LTB OLB01RSLTSN.0.OL1LBORNRLC3LIT.OL1LBORNRLC3LGC.OL1LBINRANGEC3TB DisplayString OLB01RSLTSN.0.OL1LBORNRL3LLIT.OL1LBORNRL3LLGC.OL1LBORNRL3LLTB OLB01RSLTSN.0.OL1LBORNRL3LLIT.OL1LBORNRL3LLGC.OL1LBINRANGE3LTB DisplayString OLB01RSLTSN.0.OL1LBORNRL34LIT.OL1LBORNRL34LGC.OL1LBORNRL34LTB OLB01RSLTSN.0.OL1LBORNRL34LIT.OL1LBORNRL34LGC.OL1LBINRANGE34TB Version <1.0> Page 15 of 24

16 CD3+ CD4+/Lymphocytes % CD4 CD4/Lymphocytes % CD8 CD8/Lymphocytes % Choriogonadotropin Beta Choriogonadotropin Beta Tumor Marker Circulating Plasma Cells C-Peptide C-Reactive Protein 10[3]/mm[3],/mm[3],/mic rol,10[6]/l 10[3]/mm[3],/mm[3],/mic rol miu/ml,iu/l IU/L,mIU/mL 10[3]/microL,10[9]/L,/m icrol ng/ml,nmol/l,microgm/l, pmol/l mg/dl,mg/l,nmol/l,ng/ml,microgm/ml,microgm/dl, microgm/l Creatine Kinase BB ng/ml,microgm/l Creatine Kinase BB/Total Creatine Kinase % Creatine Kinase MB ng/ml,microgm/l,ng/dl Creatine Kinase MB/Creatine Kinase % Measured Creatinine ml/min,ml/sec DisplayString OLB01RSLTSN.0.OL1LBORNRL4LLIT.OL1LBORNRL4LLGC.OL1LBORNRL4LLTB OLB01RSLTSN.0.OL1LBORNRL4LLIT.OL1LBORNRL4LLGC.OL1LBINRANGE4LTB DisplayString OLB01RSLTSN.0.OL1LBORNRLC4LIT.OL1LBORNRLC4LGC.OL1LBORNRLC4LTB OLB01RSLTSN.0.OL1LBORNRLC4LIT.OL1LBORNRLC4LGC.OL1LBINRANGEC4TB DisplayString OLB01RSLTSN.0.OL1LBORNRL4YLIT.OL1LBORNRL4YLGC.OL1LBORNRL4YLTB OLB01RSLTSN.0.OL1LBORNRL4YLIT.OL1LBORNRL4YLGC.OL1LBINRANGE4YTB DisplayString OLB01RSLTSN.0.OL1LBORNRLC8LIT.OL1LBORNRLC8LGC.OL1LBORNRLC8LTB OLB01RSLTSN.0.OL1LBORNRLC8LIT.OL1LBORNRLC8LGC.OL1LBINRANGEC8TB DisplayString OLB01RSLTSN.0.OL1LBORNRL8LLIT.OL1LBORNRL8LLGC.OL1LBORNRL8LLTB OLB01RSLTSN.0.OL1LBORNRL8LLIT.OL1LBORNRL8LLGC.OL1LBRANGE8LTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCBLIT.OL1LBORNRLCBLGC.OL1LBORNRLCBLTB OLB01RSLTSN.0.OL1LBORNRLCBLIT.OL1LBORNRLCBLGC.OL1LBINRANGECBTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCMLIT.OL1LBORNRLCMLGC.OL1LBORNRLCMLTB OLB01RSLTSN.0.OL1LBORNRLCMLIT.OL1LBORNRLCMLGC.OL1LBINRANGECMTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCCLIT.OL1LBORNRLCCLGC.OL1LBORNRLCCLTB OLB01RSLTSN.0.OL1LBORNRLCCLIT.OL1LBORNRLCCLGC.OL1LBINRANGECCTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCPLIT.OL1LBORNRLCPLGC.OL1LBORNRLCPLTB OLB01RSLTSN.0.OL1LBORNRLCPLIT.OL1LBORNRLCPLGC.OL1LBINRANGECPTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCVLIT.OL1LBORNRLCVLGC.OL1LBORNRLCVLTB OLB01RSLTSN.0.OL1LBORNRLCVLIT.OL1LBORNRLCVLGC.OL1LBINRANGECVTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCSLIT.OL1LBORNRLCSLGC.OL1LBORNRLCSLTB OLB01RSLTSN.0.OL1LBORNRLCSLIT.OL1LBORNRLCSLGC.OL1LBINRANGECSTB DisplayString OLB01RSLTSN.0.OL1LBORNRLTCLIT.OL1LBORNRLTCLGC.OL1LBORNRLTCLTB OLB01RSLTSN.0.OL1LBORNRLTCLIT.OL1LBORNRLTCLGC.OL1LBINRANGETCTB DisplayString OLB01RSLTSN.0.OL1LBORNRLKMLIT.OL1LBORNRLKMLGC.OL1LBORNRLKMLTB OLB01RSLTSN.0.OL1LBORNRLKMLIT.OL1LBORNRLKMLGC.OL1LBINRANGEKMTB DisplayString OLB01RSLTSN.0.OL1LBORNRLMCLIT.OL1LBORNRLMCLGC.OL1LBORNRLMCLTB OLB01RSLTSN.0.OL1LBORNRLMCLIT.OL1LBORNRLMCLGC.OL1LBINRANGEMCTB DisplayString OLB01RSLTSN.0.OL1LBORNRLMLLIT.OL1LBORNRLMLLGC.OL1LBORNRLMLLTB Version <1.0> Page 16 of 24

17 Clearance Creatinine Clearance Creatinine Clearance 24 Hour Creatinine Clearance Estimation Creatinine Clearance Estimation MDRD Dopamine Epinephrine ml/min/1.73[2],ml/sec/m [2] ml/min/1.73m[2] ml/min,ml/sec ml/min/1.73m[2] pg/ml,pmol/l,microgm/mg (creatinine),micromol/m mol(creat),microgm/gm creatinine pg/ml,pmol/l,microgm/mg (creatinine),micromol/m mol(creat),microgm/gm creatinine Epinephrine 24 Hour microgm/day,nmol/day Fibrin D-Dimer Fibrinogen Free Triiodothyronine Follitropin Globulin Hemoglobin A1C microgm/ml,mg/l,ng/ml,m icrogm/l,mg/l mg/dl,gm/l,mg/ml pg/dl,pmol/l,ng/dl,pg/m L miu/ml,iu/l gm/dl,gm/l,gm% %,mmol/mol OLB01RSLTSN.0.OL1LBORNRLMLLIT.OL1LBORNRLMLLGC.OL1LBINRANGEMLTB DisplayString OLB01RSLTSN.0.OL1LBORNRLCXLIT.OL1LBORNRLCXLGC.OL1LBORNRLCXLTB OLB01RSLTSN.0.OL1LBORNRLCXLIT.OL1LBORNRLCXLGC.OL1LBINRANGECXTB DisplayString OLB01RSLTSN.0.OL1LBORNRL24LIT.OL1LBORNRL24LGC.OL1LBORNRL24LTB OLB01RSLTSN.0.OL1LBORNRL24LIT.OL1LBORNRL24LGC.OL1LBINRANGE24TB DisplayString OLB01RSLTSN.0.OL1LBORNRLESLIT.OL1LBORNRLESLGC.OL1LBORNRLESLTB OLB01RSLTSN.0.OL1LBORNRLESLIT.OL1LBORNRLESLGC.OL1LBINRANGEESTB DisplayString OLB01RSLTSN.0.OL1LBORNREMIT.OL1LBORNREMGC.OL1LBORNREMTB OLB01RSLTSN.0.OL1LBORNREMIT.OL1LBORNREMGC.OL1LBINRANGEEMTB DisplayString OLB01RSLTSN.0.OL1LBORNRLDOLIT.OL1LBORNRLDOLGC.OL1LBORNRLDOLTB OLB01RSLTSN.0.OL1LBORNRLDOLIT.OL1LBORNRLDOLGC.OL1LBINRANGEDOTB DisplayString OLB01RSLTSN.0.OL1LBORNRLEPLIT.OL1LBORNRLEPLGC.OL1LBORNRLEPLTB OLB01RSLTSN.0.OL1LBORNRLEPLIT.OL1LBORNRLEPLGC.OL1LBINRANGEEPTB DisplayString OLB01RSLTSN.0.OL1LBORNRLEHLIT.OL1LBORNRLEHLGC.OL1LBORNRLEHLTB OLB01RSLTSN.0.OL1LBORNRLEHLIT.OL1LBORNRLEHLGC.OL1LBINRANGEEHTB DisplayString OLB01RSLTSN.0.OL1LBORNRLFDLIT.OL1LBORNRLFDLGC.OL1LBORNRLFDLTB OLB01RSLTSN.0.OL1LBORNRLFDLIT.OL1LBORNRLFDLGC.OL1LBINRANGEFDTB DisplayString OLB01RSLTSN.0.OL1LBORNRLFBLIT.OL1LBORNRLFBLGC.OL1LBORNRLFBLTB OLB01RSLTSN.0.OL1LBORNRLFBLIT.OL1LBORNRLFBLGC.OL1LBINRANGEFBTB DisplayString OLB01RSLTSN.0.OL1LBORNRLFTLIT.OL1LBORNRLFTLGC.OL1LBORNRLFTLTB OLB01RSLTSN.0.OL1LBORNRLFTLIT.OL1LBORNRLFTLGC.OL1LBINRANGEFTTB DisplayString OLB01RSLTSN.0.OL1LBORNRLFOLIT.OL1LBORNRLFOLGC.OL1LBORNRLFOLTB OLB01RSLTSN.0.OL1LBORNRLFOLIT.OL1LBORNRLFOLGC.OL1LBINRANGEFOTB DisplayString OLB01RSLTSN.0.OL1LBORNRLGLLIT.OL1LBORNRLGLLGC.OL1LBORNRLGLLTB OLB01RSLTSN.0.OL1LBORNRLGLLIT.OL1LBORNRLGLLGC.OL1LBINRANGEGLTB DisplayString OLB01RSLTSN.0.OL1LBORNRLA1LIT.OL1LBORNRLA1LGC.OL1LBORNRLA1LTB OLB01RSLTSN.0.OL1LBORNRLA1LIT.OL1LBORNRLA1LGC.OL1LBINRANGEA1TB Immunoglobulin G mg/dl,gm/l DisplayString OLB01RSLTSN.0.OL1LBORNRLIGLIT.OL1LBORNRLIGLGC.OL1LBORNRLIGLTB Version <1.0> Page 17 of 24

18 Immunoglobin M Insulin Lactic Acid Lactate Dehydrogenase-1 Isoenzyme LDH Isoenzyme 1/LDH % mg/ml,gm/l,mg/dl,mg/l microiu/ml,pmol/l mg/dl,mmol/l,meq/l IU/L,microkat/L Lipoprotein Lipase miu/ml,iu/l pg/ml,pmol/l,microgm/mg (creatinine),micromol/m mol(creat),microgm/gm Norepinephrine creatinine Norepinephrine 24 Hour Neuron-Specific Enolase Oligoclonal Bands Prostatic Acid Phosphatase Prostate Specific Antigen microgm/day,nmol/day ng/ml,microgm/l n/a Specimen Appearance n/a ng/ml,microgm/l ng/ml,microgm/l OLB01RSLTSN.0.OL1LBORNRLIGLIT.OL1LBORNRLIGLGC.OL1LBINRANGEIGTB DisplayString OLB01RSLTSN.0.OL1LBORNRLIMLIT.OL1LBORNRLIMLGC.OL1LBORNRLIMLTB OLB01RSLTSN.0.OL1LBORNRLIMLIT.OL1LBORNRLIMLGC.OL1LBINRANGEIMTB DisplayString OLB01RSLTSN.0.OL1LBORNRLINLIT.OL1LBORNRLINLGC.OL1LBORNRLINLTB OLB01RSLTSN.0.OL1LBORNRLINLIT.OL1LBORNRLINLGC.OL1LBINRANGEINTB DisplayString OLB01RSLTSN.0.OL1LBORNRLLALIT.OL1LBORNRLLALGC.OL1LBORNRLLALTB OLB01RSLTSN.0.OL1LBORNRLLALIT.OL1LBORNRLLALGC.OL1LBINRANGELATB DisplayString OLB01RSLTSN.0.OL1LBORNRL1ILIT.OL1LBORNRL1ILGC.OL1LBORNRL1ILTB OLB01RSLTSN.0.OL1LBORNRL1ILIT.OL1LBORNRL1ILGC.OL1LBINRANGE1ITB DisplayString OLB01RSLTSN.0.OL1LBORNRLI1LIT.OL1LBORNRLI1LGC.OL1LBORNRLI1LTB OLB01RSLTSN.0.OL1LBORNRLI1LIT.OL1LBORNRLI1LGC.OL1LBINRANGEI1TB DisplayString OLB01RSLTSN.0.OL1LBORNRLLLLIT.OL1LBORNRLLLLGC.OL1LBORNRLLLLTB OLB01RSLTSN.0.OL1LBORNRLLLLIT.OL1LBORNRLLLLGC.OL1LBINRANGELLTB DisplayString OLB01RSLTSN.0.OL1LBORNRLNOLIT.OL1LBORNRLNOLGC.OL1LBORNRLNOLTB OLB01RSLTSN.0.OL1LBORNRLNOLIT.OL1LBORNRLNOLGC.OL1LBINRANGENOTB DisplayString OLB01RSLTSN.0.OL1LBORNRLNHLIT.OL1LBORNRLNHLGC.OL1LBORNRLNHLTB OLB01RSLTSN.0.OL1LBORNRLNHLIT.OL1LBORNRLNHLGC.OL1LBINRANGENHTB DisplayString OLB01RSLTSN.0.OL1LBORNRLNELIT.OL1LBORNRLNELGC.OL1LBORNRLNELTB OLB01RSLTSN.0.OL1LBORNRLNELIT.OL1LBORNRLNELGC.OL1LBINRANGENETB DisplayString OLB01RSLTSN.0.OL1LBORNRLOBLIT.OL1LBORNRLOBLGC.OL1LBORNRLOBLTB OLB01RSLTSN.0.OL1LBORNRLOBLIT.OL1LBORNRLOBLGC.OL1LBINRANGEOBTB DisplayString OLB01RSLTSN.0.OL1LBORNRLPPLIT.OL1LBORNRLPPLGC.OL1LBORNRLPPLTB OLB01RSLTSN.0.OL1LBORNRLPPLIT.OL1LBORNRLPPLGC.OL1LBINRANGEPPTB DisplayString OLB01RSLTSN.0.OL1LBORNRLPALIT.OL1LBORNRLPALGC.OL1LBORNRLPALTB OLB01RSLTSN.0.OL1LBORNRLPALIT.OL1LBORNRLPALGC.OL1LBINRANGEPATB DisplayString OLB01RSLTSN.0.OL1LBORNRLSALIT.OL1LBORNRLSALGC.OL1LBORNRLSALTB OLB01RSLTSN.0.OL1LBORNRLSALIT.OL1LBORNRLSALGC.OL1LBINRANGESATB Thyroglobulin ng/ml,microgm/l DisplayString OLB01RSLTSN.0.OL1LBORNRLTHLIT.OL1LBORNRLTHLGC.OL1LBORNRLTHLTB Version <1.0> Page 18 of 24

19 Thyroglobulin Antibody Thyroxine Total Thyrotropin Vanillylmandelic Acid <!--ULB01AFM--> Hemoglobin ph Specific Gravity Urinalysis <!--ULB01FM--> Leukocyte Esterase Nitrite Protein Glucose Ketones IU/mL,kIU/L microgm/dl,nmol/l microiu/ml,miu/l,iu/ml, miu/ml,microiu/l microgm/mg(creatinine), mmol/mol(creatinine),mg /gm(creatinine) Character Result,mg/dL,mg/L,10[6] /L,/microL,/mL n/a n/a n/a Character Result,/microL,10[6]/L Character Result,mg/dL,micromol/L Character Result,mg/dL,mg/dL,mg/L,gm/L,gm/dL,mg% Character Result,mg/dL,mmol/L,gm/ dl,mg/l,gm/l Character Result,mg/dL,mmol/L OLB01RSLTSN.0.OL1LBORNRLTHLIT.OL1LBORNRLTHLGC.OL1LBINRANGETHTB DisplayString OLB01RSLTSN.0.OL1LBORNRLTALIT.OL1LBORNRLTALGC.OL1LBORNRLTALTB OLB01RSLTSN.0.OL1LBORNRLTALIT.OL1LBORNRLTALGC.OL1LBINRANGETATB DisplayString OLB01RSLTSN.0.OL1LBORNRLTTLIT.OL1LBORNRLTTLGC.OL1LBORNRLTTLTB OLB01RSLTSN.0.OL1LBORNRLTTLIT.OL1LBORNRLTTLGC.OL1LBINRANGETTTB DisplayString OLB01RSLTSN.0.OL1LBORNRLTRLIT.OL1LBORNRLTRLGC.OL1LBORNRLTRLTB OLB01RSLTSN.0.OL1LBORNRLTRLIT.OL1LBORNRLTRLGC.OL1LBINRANGETRTB DisplayString OLB01RSLTSN.0.OL1LBORNRLVALIT.OL1LBORNRLVALGC.OL1LBORNRLVALTB OLB01RSLTSN.0.OL1LBORNRLVALIT.OL1LBORNRLVALGC.OL1LBINRANGEVATB DisplayString ULB01ACRSN.0.UL1ALBORNRHGUIT.UL1ALBORNRHGUGC.UL1ALBORNRHGUTB ULB01ACRSN.0.UL1ALBORNRHGUIT.UL1ALBORNRHGUGC.UL1ALBINRANGEHGTB DisplayString ULB01ACRSN.0.UL1ALBORNRPHUIT.UL1ALBORNRPHUGC.UL1ALBORNRPHUTB ULB01ACRSN.0.UL1ALBORNRPHUIT.UL1ALBORNRPHUGC.UL1ALBINRANGEPHTB DisplayString ULB01ACRSN.0.UL1ALBORNRSGUIT.UL1ALBORNRSGUGC.UL1ALBORNRSGUTB ULB01ACRSN.0.UL1ALBORNRSGUIT.UL1ALBORNRSGUGC.UL1ALBINRANGESGTB DisplayString ULB01ACRSN.0.UL1ALBORNRUUIT.UL1ALBORNRUUGC.ULA1LBORNRUUTB ULB01ACRSN.0.UL1ALBORNRUUIT.UL1ALBORNRUUGC.ULA1LBINRANGEUTB DisplayString ULB01CRSN.0.UL1LBORNRERIT.UL1LBORNRERGC.UL1LBORNRERTB ULB01CRSN.0.UL1LBORNRERIT.UL1LBORNRERGC.UL1LBINRANGELETB DisplayString ULB01CRSN.0.UL1LBORNRLNIT.UL1LBORNRLNGC.UL1LBORNRLNTB ULB01CRSN.0.UL1LBORNRLNIT.UL1LBORNRLNGC.UL1LBINRANGENTB DisplayString ULB01CRSN.0.UL1LBORNRPRUIT.UL1LBORNRPRUGC.UL1LBORNRPRUTB ULB01CRSN.0.UL1LBORNRPRUIT.UL1LBORNRPRUGC.UL1LBINRANGEPRTB DisplayString ULB01CRSN.0.UL1LBORNRGLUIT.UL1LBORNRGLUGC.UL1LBORNRGLUTB ULB01CRSN.0.UL1LBORNRGLUIT.UL1LBORNRGLUGC.UL1LBINRANGEGLTB DisplayString ULB01CRSN.0.UL1LBORNRKTUIT.UL1LBORNRKTUGC.UL1LBORNRKTUTB ULB01CRSN.0.UL1LBORNRKTUIT.UL1LBORNRKTUGC.UL1LBINRANGEKTTB Version <1.0> Page 19 of 24

20 Character Result,mg/dL,u/dL,mmol/ Urobilinogen L,micromol/L Bilirubin Blood Character Result,mg/dL,micromol/L Character Result,/microL,/mL,10[6 ]/L DisplayString ULB01CRSN.0.UL1LBORNRUBUIT.UL1LBORNRUBUGC.UL1LBORNRUBUTB ULB01CRSN.0.UL1LBORNRUBUIT.UL1LBORNRUBUGC.UL1LBINRANGEUBTB DisplayString ULB01CRSN.0.UL1LBORNRBUIT.UL1LBORNRBUGC.UL1LBORNRBUTB ULB01CRSN.0.UL1LBORNRBUIT.UL1LBORNRBUGC.UL1LBINRANGEBTB DisplayString ULB01CRSN.0.UL1LBORNRBLUIT.UL1LBORNRBLUGC.UL1LBORNRBLUTB ULB01CRSN.0.UL1LBORNRBLUIT.UL1LBORNRBLUGC.UL1LBINRANGEBLTB RID 5 IIE-LNMT Configuration This section should be used to configure the content and distribution list for s generated by IIE-LNMT. It is recommended to use address distribution lists instead of individual addresses for easier maintenance. CATEGORY PARAMETERS Success From: <trialname>@webcrf.net To: <Sponsor list> Subject: IIE-LNMT Data Import/Export Success Body: Include tokens: Trial Name Vendor Name File Name Patient Number Patient Initials Site Mnemonic (Patient Number, Initials and Site Mnemonic are available Version <1.0> Page 20 of 24

21 Oracle Recommendations for import process flow and MedML format.) The IIE-LNMT solution will send this category of when data is imported or exported successfully. Oracle recommendations are listed above. Oracle Customer Support should not be listed in the To: section for this category of . Please change this based on the requirements. Configuration Error From To Subject Body Oracle Recommendations <Oracle Customer Support>, <Oracle Technical Consulting> IIE-LNMT Configuration Error Include tokens: Trial Name Vendor Name File Name Patient Number Patient Initials Site Mnemonic (Patient Number, Initials and Site Mnemonic are available for import process flow and MedML format.) The IIE-LNMT solution will send this category of when an import or export error is encountered that is the result of a configuration problem. Oracle recommendations are listed above. This should NOT be sent to Sponsor or Vendor. Please change this based on the Version <1.0> Page 21 of 24

22 Application Error From To Subject requirements. <Sponsor list>, <Vendor list>, <Oracle Customer Support>, <Oracle Technical Consulting> IIE-LNMT Application Error Import Error Body Oracle Recommenda tions From Include tokens: Trial Name Vendor Name File Name Patient Number Patient Initials Site Mnemonic (Patient Number, Initials and Site Mnemonic are available for import process flow and MedML format.) The IIE-LNMT solution will send this category of when an import or export error is encountered during the pre-processing steps. Oracle recommendations are listed above. This should be sent to Sponsor or Vendor. Please change this based on the requirements. Version <1.0> Page 22 of 24

23 To Subject <Sponsor list>, <Vendor list>, <Oracle Customer Support>, <Oracle Technical Consulting> IIE-LNMT Data Import Error Body Oracle Recommendations Include tokens: Trial Name Vendor Name File Name Patient Number Patient Initials Site Mnemonic (Patient Number, Initials and Site Mnemonic are available for import process flow and MedML format.) The IIE-LNMT solution will send this category of when an error is encountered during the data import process. Oracle recommendations are listed above. This should be sent to Sponsor and Vendor. Please change this based on the requirements. Export Error From To <Sponsor list>, <Vendor list>, <Oracle Customer Support>, <Oracle Technical Consulting> Subject IIE-LNMT Data Export Error Body Include tokens: Trial Name Vendor Name Version <1.0> Page 23 of 24

24 Enable Sending s [Required] SMTP Server [Required] Oracle Recommendations File Name Patient Number Patient Initials Site Mnemonic (Patient Number, Initials and Site Mnemonic are available for import process flow and MedML format.) The IIE-LNMT solution will send this category of when an error is encountered during the data export process. Oracle recommendations are listed above. This should be sent to Sponsor and Vendor. Please change this based on the requirements. Default: Enabled Change to override default. Default: Oracle SMTP Server Change to override default. Version <1.0> Page 24 of 24