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ItemMetadata
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eosreast | other reason at End of Study | string | 720 | other reason at End of Study | End of Study | ||||||
eosdreas | reason for death at EOS | integer | 8 | reason for death at EOS | 1, 2, 3, 4, 5, 6, 7, 8, 99 | refraktärer septischer Schock, Sepsis induziertes Multiorganversagen, akute respiratorische Insuffizienz, kardiale Arrhythmie, Myokardinfarkt, kardiogener Schock, durch andere Grunderkrankung, anderer Grund, unbekannt | End of Study | ||||
eosdreasoth | other reason for death at EOS | string | 720 | other reason for death at EOS | End of Study | ||||||
histsurg | History of Surgery | integer | 8 | History of Surgery | 0, 1 | No, Yes | Patientendaten | ||||
anz_od | Number of Organ Dysfunctions | integer | 8 | Number of Organ Dysfunctions | Einschluss - Organdysfunktion | ||||||
sevsepss | Severity of Sepsis | integer | 8 | Severity of Sepsis | 0, 1, 2 | no severe sepsis [Ex crit], severe sepsis, septic shock | Schwergrad der Sepsis | ||||
grneur | Neurological reason for ICU admission | integer | 8 | Neurological reason for ICU admission | 0, 1 | No, Yes | Organsystembezogene Gründe | ||||
grresp | Respiratory reason for ICU admission | integer | 8 | Respiratory reason for ICU admission | 0, 1 | No, Yes | Organsystembezogene Gründe | ||||
grkard | Cardiological reason for ICU admission | integer | 8 | Cardiological reason for ICU admission | 0, 1 | No, Yes | Organsystembezogene Gründe | ||||
grren | Renal reason for ICU admission | integer | 8 | Renal reason for ICU admission | 0, 1 | No, Yes | Organsystembezogene Gründe | ||||
grhaem | Haematological reason for ICU admission | integer | 8 | Haematological reason for ICU admission | 0, 1 | No, Yes | Organsystembezogene Gründe | ||||
grgast | Gastrointestinal reason for ICU admi... | integer | 8 | Gastrointestinal reason for ICU admission | 0, 1 | No, Yes | Organsystembezogene Gründe | ||||
grmeta | Metabolic reason for ICU admission | integer | 8 | Metabolic reason for ICU admission | 0, 1 | No, Yes | Organsystembezogene Gründe | ||||
groth | Other Reason reason for ICU admission | integer | 8 | Other Reason reason for ICU admission | 0, 1 | No, Yes | Organsystembezogene Gründe | ||||
death | Deceased | integer | 8 | Deceased | 0, 1 | No, Yes | Survival | ||||
dsd | Study Day of death | integer | 8 | Study Day of death | Survival | ||||||
lconsd | study day of last contact | integer | 8 | study day of last contact | Survival | ||||||
death_28 | 28d mortality | integer | 8 | 28d mortality | 0, 1 | Survivor, Non-Survivor | Survival | ||||
death_90 | 90d Mortalitaet | integer | 8 | 90d Mortalitaet | 0, 1 | Survivor, Non-Survivor | Survival | ||||
lits | ICU length of stay | d | integer | 4 | ICU length of stay [d] | Liegedauer | |||||
lkh | Hospital length of stay | d | integer | 4 | Hospital length of stay [d] | Liegedauer | |||||
adr_dsi | höchste Dosis Adrenalin | ug/kg/min | float | 8.2 | höchste Dosis Adrenalin [µg/kg/min] | Vasopressoren und Inotropika | |||||
noradr_dsi | höchste Dosis Noradrenalin | ug/kg/min | float | 8.2 | höchste Dosis Noradrenalin [µg/kg/min] | Vasopressoren und Inotropika | |||||
dop_dsi | höchste Dosis Dopamin | ug/kg/min | float | 8.2 | höchste Dosis Dopamin [µg/kg/min] | Vasopressoren und Inotropika | |||||
dobu_dsi | höchste Dosis Dobutamin | ug/kg/min | float | 8.2 | höchste Dosis Dobutamin [µg/kg/min] | Vasopressoren und Inotropika | |||||
lakmax_si | Laktat | mmol/L | float | 8.2 | Laktat [mmol/l] | Routinelabor | |||||
tpzmin_si | Thrombozyten, min | G/L | float | 8.2 | Thrombozyten, min [G/l] | Routinelabor | |||||
tpzmax_si | Thrombozyten, max | mg/L | float | 8.2 | Thrombozyten, max [G/l] | Routinelabor | |||||
crpmax_si | CRP | mg/L | float | 8.2 | CRP [mg/l] | Routinelabor | |||||
albmin_si | Albumin | h/L | float | 8.2 | Albumin [g/l] | Routinelabor | |||||
hbmin_si | Haemoglobin | mmol/L | float | 8.2 | Haemoglobin [mmol/l] | Routinelabor | |||||
foksandy | study days with focus sanitation | integer | 4 | study days with focus sanitation | Fokussanierung | ||||||
fsan_sum | number of procedures for focus control | integer | 4 | number of procedures for focus control | Fokussanierung | ||||||
fsan_21d | focus sanitation until EOS | integer | 8 | focus sanitation until EOS | 0, 1 | No, Yes | Fokussanierung | ||||
dv_sum | number of procedures to diagnose infe... | integer | 4 | number of procedures to diagnose infection | Fokussanierung | ||||||
dv_21d | procedures to diagnose infection unti... | integer | 8 | procedures to diagnose infection until EOS | 0, 1 | No, Yes | Fokussanierung | ||||
pa4_cond | PCT algo conducted day 4 | integer | 8 | PCT algo conducted day 4 | 0, 1 | No, Yes | PCT-Algorithmus | ||||
pa7_cond | PCT algo conducted day 7 | integer | 8 | PCT algo conducted day 7 | 0, 1 | No, Yes | PCT-Algorithmus | ||||
pa10_cond | PCT algo conducted day 10 | integer | 8 | PCT algo conducted day 10 | 0, 1 | No, Yes | PCT-Algorithmus | ||||
pa14_cond | PCT algo conducted day 14 | integer | 8 | PCT algo conducted day 14 | 0, 1 | No, Yes | PCT-Algorithmus | ||||
pa_cond | at least one PCT algo conducted | integer | 8 | at least one PCT algo conducted | 0, 1 | No, Yes | PCT-Algorithmus | ||||
pctalg | Causal Therapy | integer | 8 | Causal Therapy | 1, 2 | PCT_guided, not_PCT_guided | PCT-Algorithmus | ||||
bilmax_si | Bilirubin max. | umol/L | float | 8.2 | Bilirubin max. [µmol/l] | Routinelabor | |||||
harn_si | Urea max. | mmol/L | float | 8.2 | Urea max. [mmol/l] | Routinelabor | |||||
leukomin_si | WBC min. | G/L | float | 8.2 | WBC min. [G/l] | Routinelabor | |||||
leukomax_si | WBC max. | G/L | float | 8.2 | WBC max. [G/l] | Routinelabor | |||||
skmin_si | Serum Potassium min. | mmol/L | float | 8.2 | Serum Potassium min. [mmol/l] | Routinelabor | |||||
skmax_si | Serum Potassium max. | mmol/L | float | 8.2 | Serum Potassium max. [mmol/l] | Routinelabor | |||||
snamin_si | Serum Sodium min. | mmol/L | float | 8.2 | Serum Sodium min. [mmol/l] | Routinelabor | |||||
snamax_si | Serum Sodium max. | mmol/L | float | 8.2 | Serum Sodium max. [mmol/l] | Routinelabor | |||||
pfratio_si | paO_2/FiO_2-Ratio | mm[Hg] | float | 8.2 | paO_2/FiO_2-Ratio [mmHg] | Routinelabor | |||||
pao2_si | paO_2 | mm[Hg] | float | 8.2 | paO_2 [mmHg] | Routinelabor | |||||
paco2_si | paCO_2 | mm[Hg] | float | 8.2 | paCO_2 [mmHg] | Routinelabor | |||||
urin24_b | diurese (ml/24h) | mL/24h | float | 8.2 | diurese (ml/24h) | Routinelabor | |||||
skreamax_si | Serum Creatinine, max | umol/L | float | 8.2 | Serum Creatinine, max [µmol/l] | Routinelabor | |||||
skreamin_si | Serum-Kreatinin, min | umol/L | float | 8.2 | Serum-Kreatinin, min [µmol/l] | Routinelabor | |||||
skreamin_md | Serum Creatinine, min | mg/dL | float | 8.2 | Serum Creatinine, min [mg/dl] | Routinelabor | |||||
gcs | GCS | integer | 8 | GCS | Klinische Daten | ||||||
saps | SAPS II (without Imputation) | integer | 4 | SAPS II (without Imputation) | Scores | ||||||
net_vmin | renal replacement therapy at study in... | integer | 8 | renal replacement therapy at study inclusion | 0, 1 | No, Yes | Vorbehandlung | ||||
ce11 | liver insufficiency | integer | 8 | liver insufficiency | Nebendiagnosen und Immunsuppression | ||||||
ce12 | NYHA IV | integer | 8 | NYHA IV | Nebendiagnosen und Immunsuppression | ||||||
ce13 | severe lung disease | integer | 8 | severe lung disease | Nebendiagnosen und Immunsuppression | ||||||
ce14 | chronic dialysis | integer | 8 | chronic dialysis | Nebendiagnosen und Immunsuppression | ||||||
ce15 | Immuno Compromised | integer | 8 | Immuno Compromised | Nebendiagnosen und Immunsuppression | ||||||
aado2 | Alveolo-arterielle Suaerstoffdifferenz | float | 8.2 | Alveolo-arterielle Suaerstoffdifferenz | Routinelabor | ||||||
apache | APACHE II (without imputation) | integer | 4 | APACHE II (without imputation) | Scores | ||||||
sofacir_b | SOFA Subscore Circulation at baseline | integer | 8 | SOFA Subscore Circulation at baseline | Scores | ||||||
sofapul_b | SOFA Subscore Pulmo at baseline | integer | 8 | SOFA Subscore Pulmo at baseline | Scores | ||||||
sofacoa_b | SOFA Subscore Coagulation at baseline | integer | 8 | SOFA Subscore Coagulation at baseline | Scores | ||||||
sofaren_b | SOFA Subscore Renal at Baseline | integer | 8 | SOFA Subscore Renal at Baseline | Scores | ||||||
sofahep_b | SOFA Subscore Liver at Baseline | integer | 8 | SOFA Subscore Liver at Baseline | Scores | ||||||
sofacns_b | SOFA Subscore CNS at Baseline | integer | 8 | SOFA Subscore CNS at Baseline | Scores | ||||||
sofa_b | SOFA Score at baseline | integer | 4 | SOFA Score at baseline | Scores | ||||||
msofa_21d | meanSOFA until day 21 | float | 8.2 | meanSOFA until day 21 | Scores | ||||||
msofacir_21d | meanSOFA Subscore circulation until d... | float | 8.2 | meanSOFA Subscore circulation until day 21 | Scores | ||||||
msofapul_21d | meanSOFA Subscore pulmo until day 21 | float | 8.2 | meanSOFA Subscore pulmo until day 21 | Scores | ||||||
msofacoa_21d | meanSOFA Subscore coagulation until d... | float | 8.2 | meanSOFA Subscore coagulation until day 21 | Scores | ||||||
msofaren_21d | meanSOFA Subscore renal until day 21 | float | 8.2 | meanSOFA Subscore renal until day 21 | Scores | ||||||
msofahep_21d | meanSOFA Subscore hepatic until day 21 | float | 8.2 | meanSOFA Subscore hepatic until day 21 | Scores | ||||||
msofacns_21d | meanSOFA Subscore CNS until day 21 | float | 8.2 | meanSOFA Subscore CNS until day 21 | Scores | ||||||
msof_sub01_21d | meanSOFA without renal subscore until... | float | 8.2 | meanSOFA without renal subscore until day 21 | Scores | ||||||
msof_sub02_21d | meanSOFA without CNS subscore until d... | float | 8.2 | meanSOFA without CNS subscore until day 21 | Scores | ||||||
sofa_eot | SOFA at EOT | integer | 4 | SOFA at EOT | Scores | ||||||
sofa_eos | SOFA at EOS | integer | 4 | SOFA at EOS | Scores | ||||||
cc_d4 | Clinical Cure Day 4 | string | 3 | Clinical Cure Day 4 | 0, 1, 2, 3, 4, 5, 6 | Missing, Clinical Resolution, Improvement, Clinical Failure, Death prior to assessment, Discharge prior to assessment, EOS (any oth reason) prior to assessment | Clinical Cure | ||||
cc_d7 | Clinical Cure Day 7 | string | 3 | Clinical Cure Day 7 | 0, 1, 2, 3, 4, 5, 6 | Missing, Clinical Resolution, Improvement, Clinical Failure, Death prior to assessment, Discharge prior to assessment, EOS (any oth reason) prior to assessment | Clinical Cure | ||||
cc_d10 | Clinical Cure Day 10 | string | 3 | Clinical Cure Day 10 | 0, 1, 2, 3, 4, 5, 6 | Missing, Clinical Resolution, Improvement, Clinical Failure, Death prior to assessment, Discharge prior to assessment, EOS (any oth reason) prior to assessment | Clinical Cure | ||||
cc_d14 | Clinical Cure Day 14 | string | 3 | Clinical Cure Day 14 | 0, 1, 2, 3, 4, 5, 6 | Missing, Clinical Resolution, Improvement, Clinical Failure, Death prior to assessment, Discharge prior to assessment, EOS (any oth reason) prior to assessment | Clinical Cure | ||||
do_th | Premature Termination of Treatment | integer | 8 | Premature Termination of Treatment | 1, 7, 10, 11, 12, 13, 14, 15, 19, 21, 99 | therapy per protocol, SAE related to IMP, toxicity related to IMP, decision of investigator, withdrawal of IC, IC not obtainable, IC refused by patient, IC refused by court appointed guardian, IC refused by legal representative, no central venous catheter available, other reason for EOT | End of Therapy | ||||
abd_21d | Days with AMT until day 21 | integer | 4 | Days with AMT until day 21 | Antimikrobielle Therapie | ||||||
abdpi21d | AMT days for primary infection until ... | integer | 4 | AMT days for primary infection until day 21 | Antimikrobielle Therapie | ||||||
abdch21d | Number of AMT Days until Change of AMT | integer | 4 | Number of AMT Days until Change of AMT | Antimikrobielle Therapie | ||||||
secinf | Secondary Infection | integer | 8 | Secondary Infection | 0, 1 | No, Yes | Infektion: Ursprung und Lokalisation | ||||
ttsecinf | Time to Secondary Infection | d | float | 8.2 | Time to Secondary Infection [d] | Infektion: Ursprung und Lokalisation | |||||
ventd_eos | Days with mech vent until EOS | integer | 4 | Days with mech vent until EOS | Beatmung | ||||||
ventd_28d | Days with mech ventilation until D28 ... | d | integer | 4 | Days with mech ventilation until D28 (on ICU) | Beatmung | |||||
ventd_90d | Days with mech ventilation until D90 ... | d | integer | 4 | Days with mech ventilation until D90 (on ICU) | Beatmung | |||||
mb_90d | Patients with mech ventilation until ... | integer | 8 | Patients with mech ventilation until day 90 | 0, 1 | No, Yes | Beatmung | ||||
mb_28d | Patients with mech ventilation until ... | integer | 8 | Patients with mech ventilation until day 28 | 0, 1 | No, Yes | Beatmung | ||||
rrtd_28d | Days with RRT until D28 (on ICU) | d | integer | 4 | Days with RRT until D28 (on ICU) | Nierenersatztherapie | |||||
rrtd_90d | Days with RRT until D90 (on ICU) | d | integer | 4 | Days with RRT until D90 (on ICU) | Nierenersatztherapie | |||||
rrt_90d | Patients with RRT until day 90 | integer | 8 | Patients with RRT until day 90 | 0, 1 | No, Yes | Nierenersatztherapie | ||||
rrt_28d | Patients with RRT until day 28 | integer | 8 | Patients with RRT until day 28 | 0, 1 | No, Yes | Nierenersatztherapie | ||||
vpd_d0_eos | Days with Vasopressors from day 0 to EOS | integer | 4 | Days with Vasopressors from day 0 to EOS | Vasopressoren und Inotropika | ||||||
vpd_28d | Days with Vasopressor Use until D28 (... | d | integer | 4 | Days with Vasopressor Use until D28 (on ICU) | Vasopressoren und Inotropika | |||||
vpd_90d | Days with Vasopressor Use until D90 (... | d | integer | 4 | Days with Vasopressor Use until D90 (on ICU) | Vasopressoren und Inotropika | |||||
vp_90d | Patients with Vasopressoren until day 90 | integer | 8 | Patients with Vasopressoren until day 90 | 0, 1 | No, Yes | Vasopressoren und Inotropika | ||||
vp_28d | Patients with Vasopressors until day 28 | integer | 8 | Patients with Vasopressors until day 28 | 0, 1 | No, Yes | Vasopressoren und Inotropika | ||||
abd_28d | Days with AMT until D28 (on ICU) | d | integer | 4 | Days with AMT until D28 (on ICU) | Antimikrobielle Therapie | |||||
abd_90d | Days with AMT until D90 (on ICU) | d | integer | 4 | Days with AMT until D90 (on ICU) | Antimikrobielle Therapie | |||||
ab_90d | Patients with AMT until day 90 | integer | 8 | Patients with AMT until day 90 | 0, 1 | No, Yes | Antimikrobielle Therapie | ||||
ab_28d | Patients with AMT until day 28 | integer | 8 | Patients with AMT until day 28 | 0, 1 | No, Yes | Antimikrobielle Therapie | ||||
droth | Other Reason for Death | string | 720 | Other Reason for Death | Survival | ||||||
dreas | Reason for Death | integer | 8 | Reason for Death | 1, 2, 3, 4, 5, 6, 7, 8, 99 | refraktärer septischer Schock, Sepsis induziertes Multiorganversagen, akute respiratorische Insuffizienz, kardiale Arrhythmie, Myokardinfarkt, kardiogener Schock, durch andere Grunderkrankung, anderer Grund, unbekannt | Survival | ||||
infloc12 | Abdominal | integer | 8 | Abdominal | 0, 1 | No, Yes | Infektion: Ursprung und Lokalisation | ||||
infloc13 | other localisation (incl. Catheterinf... | integer | 8 | other localisation (incl. Catheterinfect., CNS, card.vask, other) | 0, 1 | No, Yes | Infektion: Ursprung und Lokalisation | ||||
infloc1 | Respiratory Tract | integer | 8 | Respiratory Tract | 0, 1 | No, Yes | Infektion: Ursprung und Lokalisation | ||||
anz_infloc | Anzahl Lokalisationen der Infektion z... | integer | 4 | Anzahl Lokalisationen der Infektion zu BL [sonst Atemwege extra] | Infektion: Ursprung und Lokalisation | ||||||
infloc_gr02 | Gruppierung lt Infektion zu BL | integer | 8 | Gruppierung lt Infektion zu BL | 1, 2, 3 | resp_tract, abdomen, all_others | Infektion: Ursprung und Lokalisation | ||||
ab_bl | AMT prior to inclusion | integer | 8 | AMT prior to inclusion | 0, 1 | No, Yes | Antimikrobielle Therapie | ||||
ab_eos | AMT after inclusion until EOS | integer | 8 | AMT after inclusion until EOS | 0, 1 | No, Yes | Antimikrobielle Therapie | ||||
ab_21d | AMT after inclusion until EOS | integer | 8 | AMT after inclusion until EOS | 0, 1 | No, Yes | Antimikrobielle Therapie | ||||
foksandy_7d | study days with focus sanitation unti... | integer | 4 | study days with focus sanitation until day 7 | Fokussanierung | ||||||
fsan_sum_7d | number of procedures for focus contro... | integer | 4 | number of procedures for focus control until day 7 | Fokussanierung | ||||||
fsan_7d | focus sanitation until day 7 | integer | 8 | focus sanitation until day 7 | 0, 1 | No, Yes | Fokussanierung | ||||
dv_sum_7d | number of procedures to diagnose infe... | integer | 4 | number of procedures to diagnose infection until day 7 | Fokussanierung | ||||||
dv_7d | procedures to diagnose infection unti... | integer | 8 | procedures to diagnose infection until day 7 | 0, 1 | No, Yes | Fokussanierung | ||||
pct_central_d0 | centrally measured PCT day 0 | ng/mL | float | 8.2 | centrally measured PCT [ng/ml] day 0 | zentrale Labormessungen | |||||
proadm_central_d0 | centrally measured proADM day 0 | nmol/mL | float | 8.2 | centrally measured proADM [nmol/l] day 0 | zentrale Labormessungen | |||||
sel_central_d0 | centrally measured Selen day 0 | umol/L | float | 8.2 | centrally measured Selen [µmol/l] day 0 | zentrale Labormessungen | |||||
pct_central_ln_d0 | nat log of centrally measured PCT day 0 | ng/mL | float | 8.2 | nat log of centrally measured PCT [ng/ml] day 0 | zentrale Labormessungen | |||||
proadm_central_ln_d0 | nat log of centrally measured proADM ... | nmol/mL | float | 8.2 | nat log of centrally measured proADM [nmol/l] day 0 | zentrale Labormessungen | |||||
crpmax_si_ln | nat log of CRP | mg/L | float | 8.2 | nat log of CRP [mg/l] | zentrale Labormessungen | |||||
lakmax_si_ln | nat log of Lactate | mmol/L | float | 8.2 | nat log of Lactate [mmol/l] | zentrale Labormessungen | |||||
sel_central_gr01_max | centrally measured Selen | integer | 8 | centrally measured Selen | 0, 1, 2 | < LNV, NORMAL, > UNV | zentrale Labormessungen | ||||
ab_cost_sum | Cost of AMT [EUR] | EUR | float | 8.2 | Cost of AMT [EUR] | Antimikrobielle Therapie | |||||
bmi | BMI | kg/m2 | float | 8.2 | BMI [kg/m^2] | Patientendaten | |||||
bmi_gr01 | BMI [kg/m^2] in Kategorien | integer | 8 | BMI [kg/m^2] in Kategorien | 0, 1, 2, 3 | BMI < 25, BMI >= 25 bis < 30, BMI >= 30 bis < 40, BMI >= 40 | Patientendaten | ||||
bmi_gr02 | BMI [kg/m^2] in Kategorien | integer | 8 | BMI [kg/m^2] in Kategorien | 0, 1, 2, 3 | BMI < 20, BMI >= 20 bis < 25, BMI >= 25 bis < 30, BMI >= 30 | Patientendaten | ||||
bmi_gr03 | BMI [kg/m^2] in Kategorien | integer | 8 | BMI [kg/m^2] in Kategorien | 0, 1, 2 | BMI < 18, BMI >= 18 bis < 26, BMI >= 26 | Patientendaten | ||||
diab | Diabetes mell Typ 1 and 2 | integer | 8 | Diabetes mell Typ 1 and 2 | 0, 1 | No, Yes | Nebendiagnosen und Immunsuppression | ||||
nyha | Heart Failure | integer | 8 | Heart Failure | 0, 1 | No, Yes | Nebendiagnosen und Immunsuppression | ||||
rendys | renal dysfunction | integer | 8 | renal dysfunction | 0, 1 | No, Yes | Nebendiagnosen und Immunsuppression | ||||
cci | Charlson Comorbidity Index | integer | 4 | Charlson Comorbidity Index | Nebendiagnosen und Immunsuppression | ||||||
death_icu | ICU mortality | integer | 8 | ICU mortality | 0, 1 | Survivor, Non-Survivor | Survival | ||||
death_kh | Hospital mortality | integer | 8 | Hospital mortality | 0, 1 | Survivor, Non-Survivor | Survival |
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Metavariable | Value | Comment | |||||||
ODM_FileOID | SISPCT.xml | A unique identifier for this file. | |||||||
ODM_Description | Information that will help the receiver interpret the document correctly. | ||||||||
ODM_ProtocolName | SISPCT | This is the sponsor's internal name for the protocol. Defaults to StudyName. | |||||||
ODM_StudyDescription | SISPCT | This is a free-text description of the study. Defaults to StudyName. | |||||||
ODM_StudyName | SISPCT | This is a short external name for the study, is also used as OID | |||||||
ODM_StudyEventMandatory | Yes | Indicates that the clinical data for the containing MetaDataVersion would be incomplete without an instance of this type of Study Event | |||||||
ODM_StudyEventName | Event | Unique Name, is also used as OID. Defaults to 'Event'. | |||||||
ODM_StudyEventOrderNumber | 1 | ||||||||
ODM_StudyEventRepeatKey | empty if non repeating, <AUTOMATIC> for automatic counter otherwise Variable Reference (Variable.<Name>) | ||||||||
ODM_MetaDataVersionName | Name of Metadata version | ||||||||
ODM_MetaDataVersionOID | v1.0.0 | Metadata version ID. | |||||||
ODM_FormMandatory | Yes | Indicates that the clinical data for an instance of the containing study event would be incomplete without an instance of this type of form | |||||||
ODM_FormName | Form | Unique Name, is also used as OID. Defaults to 'Form'. | |||||||
ODM_FormRepeatKey | empty if non repeating, <AUTOMATIC> for automatic counter otherwise Variable Reference (Variable.<Name>) | ||||||||
ODM_ItemGroupMandatory | Yes | Indicates that the clinical data for an instance of the containing form would be incomplete without an instance of this type of item group | |||||||
ODM_ItemGroupRepeatKey | empty if non repeating, <AUTOMATIC> for automatic counter otherwise Variable Reference (Variable.<Name>) | ||||||||
ODM_ItemMandatory | Yes | Indicates that the clinical data for an instance of the containing item group would be incomplete without an instance of this type of item. | |||||||
Source_CSV_Charset | ISO-8859-1 | Data source file encoding. | |||||||
Source_CSV_Delimiter | ; | Data source file delimiter. | |||||||
Source_CSV_Header | Yes | Data source first row contains header. | |||||||
Source_CSV_Quote | " | Data is enclosed in | |||||||
ODM_AsOfDateTime | 2018-10-16T18:02:28 | ||||||||
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DO NOT CHANGE THIS SHEET | |||||||||
DataType | date | datetime | float | integer | partialDate | text | time | ||
YesNo | Yes | No | |||||||
Source_CSV_Charset | ISO_8859_1 | UTF-8 | |||||||
Source_CSV_Delimiter | \t | , | ; | ||||||
STDM | AGE | SEX | STUDYID | ARMCD | VISITNUM | BRTHDTC | SVSTDTC | SVENDTC | SUBJID |