study_number,raw_source_model,raw_dataset,raw_dataset_ordinal,raw_dataset_label,raw_variable,raw_variable_label,raw_variable_ordinal,raw_variable_type,raw_data_format,raw_codelist,study_specific,annotation_ordinal,mapping_is_dataset,annotation_text,target_sdtm_domain,target_sdtm_variable,target_sdtm_variable_role,target_sdtm_variable_codelist_code,target_sdtm_variable_controlled_terms_or_format,target_sdtm_variable_ordinal,origin,mapping_algorithm,entity_sub_algorithm,target_hardcoded_value,target_term_value,target_term_code,condition_ordinal,condition_group_ordinal,condition_left_raw_dataset,condition_left_raw_variable,condition_left_sdtm_domain,condition_left_sdtm_variable,condition_operator,condition_right_text_value,condition_right_sdtm_domain,condition_right_sdtm_variable,condition_right_raw_dataset,condition_right_raw_variable,condition_next_logical_operator,merge_type,merge_left,merge_right,merge_condition,unduplicate_keys,groupby_keys,target_resource_raw_dataset,target_resource_raw_variable
lp_study,e-CRF,MD1,27,Concomitant Medications,,,,,,,FALSE,1,TRUE,CM = 'Concomitant/Prior Medications',CM,DOMAIN,Identifier Variable,C66734,,,Assigned,DATASET_LEVEL,HARDCODE_CT,,CM,C49568,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,,,,,,,FALSE,1,TRUE,CM = 'Concomitant/Prior Medications',CM,DOMAIN,Identifier Variable,C66734,,,Assigned,DATASET_LEVEL,REMOVE_DUP,,CM,C49568,,,,,,,,,,,,,,,,,,"MD1.PATNUM,MD1.MDNUM,MD1.MDRAW,MD1.RAVRFID",,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDREC,Were there any medications taken protocol specific?,1,DropDownList,$3 ,NY_CV1,FALSE,1,FALSE,NOT SUBMITTED,,,,,,,CRF,NOTSUBMITTED,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDNUM,MD number,2,Text,3,,FALSE,2,FALSE,CM.CMGRPID,CM,CMGRPID,Identifier Variable,,,6,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDRAW,Medication,3,LongText,$200 ,,FALSE,1,FALSE,CM.CMTRT,CM,CMTRT,Topic Variable,,,10,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDIND,Indication,4,LongText,$100 ,,FALSE,1,FALSE,CM.CMINDC,CM,CMINDC,Record Qualifier,,,19,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDBDR,Start date,5,DateTime,dd- MMM- yyyy,,FALSE,1,FALSE,CM.CMSTDTC,CM,CMSTDTC,Timing Variable,,ISO 8601,39,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDBDTU,Start date unknown,6,CheckBox,1,,FALSE,1,FALSE,NOT SUBMITTED,,,,,,,CRF,NOTSUBMITTED,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDBTM,Start time,7,DateTime,HH nn,,FALSE,1,FALSE,CM.CMSTDTC,CM,CMSTDTC,Timing Variable,,ISO 8601,39,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDBTMU,Start time unknown,8,CheckBox,1,,FALSE,1,FALSE,NOT SUBMITTED,,,,,,,CRF,NOTSUBMITTED,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDPRIOR,Select if taken prior to study,9,CheckBox,1,,FALSE,1,FALSE,If checked then CM.CMSTRTPT = 'BEFORE',CM,CMSTRTPT,Timing Variable,C66728,(STENRF),50,CRF,IF_THEN_ELSE,HARDCODE_CT,,BEFORE,C25629,1.1,0,MD1,MDPRIOR,,,Checked,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDPRIOR,Select if taken prior to study,9,CheckBox,1,,FALSE,2,FALSE,CM.CMSTTPT = 'SCREENING',CM,CMSTTPT,Timing Variable,,,51,CRF,IF_THEN_ELSE,HARDCODE_NO_CT,SCREENING,,,2.1,0,MD1,MDPRIOR,,,Checked,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDPRIOR,Select if taken prior to study,9,CheckBox,1,,FALSE,3,FALSE,Else NOT SUBMITTED,,,,,,,CRF,IF_THEN_ELSE,NOTSUBMITTED,,,,3.1,0,MD1,MDPRIOR,,,Not_checked,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDEDR,End date,10,DateTime,dd- MMM- yyyy,,FALSE,1,FALSE,CM.CMENDTC,CM,CMENDTC,Timing Variable,,ISO 8601,40,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDETM,End time,11,DateTime,HH nn,,FALSE,1,FALSE,CM.CMENDTC,CM,CMENDTC,Timing Variable,,ISO 8601,40,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDETMU,End time unknown,12,CheckBox,1,,FALSE,1,FALSE,NOT SUBMITTED,,,,,,,CRF,NOTSUBMITTED,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDONG,Select if ongoing,13,CheckBox,1,,FALSE,1,FALSE,If checked then CM.CMENRTPT = 'ONGOING',CM,CMENRTPT,Timing Variable,C66728,(STENRF),52,CRF,IF_THEN_ELSE,HARDCODE_CT,,ONGOING,C53279,1.1,0,MD1,MDONG,,,Checked,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDONG,Select if ongoing,13,CheckBox,1,,FALSE,2,FALSE,CM.CMENTPT = 'DATE OF LAST ASSESSMENT',CM,CMENTPT,Timing Variable,,,53,CRF,IF_THEN_ELSE,HARDCODE_NO_CT,DATE OF LAST ASSESSMENT,,,2.1,0,MD1,MDONG,,,Checked,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDONG,Select if ongoing,13,CheckBox,1,,FALSE,3,FALSE,Else NOT SUBMITTED,,,,,,,CRF,IF_THEN_ELSE,NOTSUBMITTED,,,,3.1,0,MD1,MDONG,,,Not_checked,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,DOS,Dose,14,Text,8.3,,FALSE,1,FALSE,If numeric then CM.CMDOSE,CM,CMDOSE,Record Qualifier,,,22,CRF,IF_THEN_ELSE,ASSIGN_NO_CT,,,,1.1,0,MD1,DOS,,,is_numeric,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,DOS,Dose,14,Text,8.3,,FALSE,2,FALSE,Else CM.CMDOSTXT,CM,CMDOSTXT,Record Qualifier,,,23,CRF,IF_THEN_ELSE,ASSIGN_NO_CT,,,,2.1,0,MD1,DOS,,,is_character,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,DOSU,Dose unit,15,SearchList,$30 ,UNIT_CV1,FALSE,1,FALSE,CM.CMDOSU,CM,CMDOSU,Variable Qualifier,C71620,(UNIT),24,CRF,ASSIGN_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDFORM,Dose form,16,SearchList,$80 ,FRM_CV1,FALSE,1,FALSE,CM.CMDOSFRM,CM,CMDOSFRM,Variable Qualifier,C66726,(FRM),25,CRF,ASSIGN_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDRTE,Route,17,DropDownList,$25 ,ROUTE_CV1,FALSE,1,FALSE,CM.CMROUTE,CM,CMROUTE,Variable Qualifier,C66729,(ROUTE),29,CRF,ASSIGN_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDFRQ,Dose Frequency,18,SearchList,$25 ,FREQ_CV1,FALSE,1,FALSE,CM.CMDOSFRQ,CM,CMDOSFRQ,Variable Qualifier,C71113,(FREQ),26,CRF,ASSIGN_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDPROPH,Given for prophylaxis?,19,CheckBox,1,,FALSE,1,FALSE,If checked then CMPROPH = 'Y' in SUPPCM,CM,CMPROPH,Supplemental Record Qualifier,C66742,(NY),106,CRF,IF_THEN_ELSE,HARDCODE_CT,,Y,C49488,1.1,0,MD1,MDPROPH,,,Checked,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,27,Concomitant Medications,MDPROPH,Given for prophylaxis?,19,CheckBox,1,,FALSE,2,FALSE,Else NOT SUBMITTED,,,,,,,CRF,IF_THEN_ELSE,NOTSUBMITTED,,,,2.1,0,MD1,MDPROPH,,,Not_checked,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,TERMID,TERM_REC_ID,1,Text,$15 ,,FALSE,1,FALSE,NOT SUBMITTED,,,,,,,CRF,NOTSUBMITTED,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,SRCLN,SOURCE_LINE_NUMBER,2,Text,3,,FALSE,1,FALSE,NOT SUBMITTED,,,,,,,CRF,NOTSUBMITTED,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,RAVRFID,RAVE_REFERENCE_ID,3,Text,15,,FALSE,1,FALSE,NOT SUBMITTED,,,,,,,CRF,NOTSUBMITTED,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,MDRAW,Medication,4,LongText,$200 ,,FALSE,1,FALSE,NOT SUBMITTED,,,,,,,CRF,NOTSUBMITTED,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,CMMODIFY,Corrected Term,5,LongText,"$1,500 ",,FALSE,1,FALSE,If different to CM.CMTRT then CM.CMMODIFY,CM,CMMODIFY,Synonym Qualifier,,,11,CRF,IF_THEN_ELSE,ASSIGN_NO_CT,,,,1.1,0,MD1,CMMODIFY,,,Different_to,,CM,CMTRT,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,CMMODIFY,Corrected Term,5,LongText,"$1,500 ",,FALSE,2,FALSE,"If [CM.CMMODIFY] is over 200 characters, split CM.CMMODIFY into CMMODIFn in SUPPCM to the nearest semicolon, where n is 1 to N number of 200-character segments.",CM,CMMODIFY,Synonym Qualifier,,,11,CRF,OTHER,,,,,,,,CMMODIFY,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,CMDRG,WHODrug Drug Name,6,LongText,"$1,500 ",,FALSE,1,FALSE,CMDRG in SUPPCM,CM,CMDRG,Supplemental Variable Qualifier,,WHO DD,109,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,CMDRG,WHODrug Drug Name,6,LongText,"$1,500 ",,FALSE,2,FALSE,"If [MD1C.CMDRG] is over 200 characters, split CMDRG in SUPPCM into CMDRGn in SUPPCM to the nearest semicolon, where n is 1 to N number of 200-character segments.",CM,CMDRG,Supplemental Variable Qualifier,,WHO DD,109,CRF,OTHER,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,CMDRGCD,WHODrug Drug Name Code,7,Text,$30 ,,FALSE,1,FALSE,CMDRGCD in SUPPCM,CM,CMDRGCD,Supplemental Variable Qualifier,,WHO DD,111,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,CMDECOD,WHODrug Preferred Name,8,LongText,"$1,500 ",,FALSE,1,FALSE,CM.CMDECOD,CM,CMDECOD,Synonym Qualifier,,*,12,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,CMDECOD,WHODrug Preferred Name,8,LongText,"$1,500 ",,FALSE,2,FALSE,"If [MD1C.CMDECOD] is over 200 characters, split CM.CMDECOD into CMDECODn in SUPPCM to the nearest semicolon, where n is 1 to N number of 200-character segments.",CM,CMDECOD,Synonym Qualifier,,*,12,CRF,OTHER,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,MD1,28,Concomitant Medications,CMPNCD,WHODrug Preferred Name Code,9,Text,$30 ,,FALSE,1,FALSE,CMPNCD in SUPPCM,CM,CMPNCD,Supplemental Variable Qualifier,,WHO DD,112,CRF,ASSIGN_NO_CT,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,,,,,,,,,,,,,Unique identifier for a study.,CM,STUDYID,Identifier Variable,,,1,Protocol,,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,,,,,,,,,,,,,"Set to USUBJID in SDTM.DM domain. Set to Subject Identifier (SDTM.DM.SUBJID) used for the first trial the subject participated in involving the product.  Taken directly from SDTM IG 3.1.2, p29: ""Unique subject identifier must be unique for each trial participant (subject) across all trials in the submission. This means that no two (or more) subjects across all trials in the submission, may have the same USUBJID. Additionally the same person who participates in multiple clinical trials (when this is known) must be assigned the same USUBJID value in all trials.""  Practical guidance for SMTs to follow in order to ensure we are aligned with the latest regulatory guidance: 1) When we have a planned study design which anticipates enrolling subjects who have participated in a previous study for the same indication, we must add a CRF page to the subsequent study to collect the study id,and subject id from the original study. These data will be used to construct the USUBJID variable in the subsequent study, in order to provide a unique subject identifier across studies for the same study participant.  2) When we discover that we have two or more studies in a submission that may have subjects who have participated in more than one study, we must provide a common value in USUBJID to provide a unique subject identifier across studies. Since this was not planned we must manually construct a dataset to link the IDs of patients in multiple studies. Post-processing is required to amend the study data with this information.",CM,USUBJID,Identifier Variable,,,3,Derived,,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,,,,,,,,,,,,,Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.,CM,CMSEQ,Identifier Variable,,,5,Derived,,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,,,,,,,,,,,,,Sponsor-defined reference number. Examples: a number pre-printed on the CRF as an explicit line identifier or record identifier defined in the sponsor's operational database. Example: line number on a concomitant medication page.,CM,CMSPID,Identifier Variable,,,8,Derived,,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,,,,,,,,,,,,,"1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.",CM,VISITNUM,Timing Variable,,,34,Derived,,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,,,,,,,,,,,,,1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.,CM,VISIT,Timing Variable,,,35,Derived,,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,,,,,,,,,,,,,"Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.",CM,EPOCH,Timing Variable,C99079,(EPOCH),37,Derived,,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,,,,,,,,,,,,,"Taken directly from SDTM IG 3.1.2, p41: --DY = (date portion of --DTC) - (date portion of SDTM.DM.RFSTDTC) + 1 if --DTC is on or after SDTM.DM.RFSTDTC; --DY = (date portion of --DTC) - (date portion of SDTM.DM.RFSTDTC) if --DTC precedes SDTM.DM.RFSTDTC.",CM,CMSTDY,Timing Variable,,,42,Derived,,,,,,,,,,,,,,,,,,,,,,,,,,
lp_study,e-CRF,,,,,,,,,,,,,"Taken directly from SDTM IG 3.1.2, p41: --DY = (date portion of --DTC) - (date portion of SDTM.DM.RFSTDTC) + 1 if --DTC is on or after SDTM.DM.RFSTDTC; --DY = (date portion of --DTC) - (date portion of SDTM.DM.RFSTDTC) if --DTC precedes SDTM.DM.RFSTDTC.",CM,CMENDY,Timing Variable,,,43,Derived,,,,,,,,,,,,,,,,,,,,,,,,,,