Description:

Data Inventory for Clinical Trial Execution in the EHR4CR project. https://www.ncbi.nlm.nih.gov/pubmed/27875988 DOI for citation: 10.21961/MDM:17994

Link:

https://www.ncbi.nlm.nih.gov/pubmed/27875988

Keywords:

Laboratories

Clinical Trial

Concomitant Medication

Common Data Elements (CDE)

Demography

Versions (3) ▾

4/5/16
10/13/16
4/21/18

Copyright Holder:

Bruland, Philipp

Uploaded on:

April 21, 2018

DOI:

10.21961/mdm:29819

License:

Creative Commons BY-NC-SA 3.0

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EHR4CR CTE Data Inventory

Details

EHR4CR CTE Data Inventory

StudyEvent: ODM
1. EHR4CR CTE Data Inventory

Adverse Events

Date Of Death

Start Date Time

Outcome

Cause of death

Time of death

Verbatim Description

End Date Time

Severity of Adverse Event

Seriousness of adverse event

Action Taken

In Case Of Death, Autopsy Report

Concomitant Medication

Start date

Frequency

Name of the drug

Dose Unit

Route

Dose Per Administration

Total Daily Dose of Agent (or Drug)

End Date

Reason

Demographics

Date of birth

Gender

Ethnicity

Race

Disease Characteristics

Diagnosis Code

Date of diagnosis

Disposition

Disposition Start Date

Disposition Category

ECG

ECG Clinical Findings

QTCF Interval

QRS Interval / Complex

ECG Heart Rate

QTCB Interval

Sinus Rhythm

QT Interval

PR Interval

Electrocardiogram Date / Time

Laboratory

Albumin

Creatinine

Platelets

Potassium

Lymphocytes

SGPT/ALT

Bilirubin, total

Hemoglobin

Alkaline Phosphatase

Glucose

Calcium

Protein, total

PT,INR

SGOT/AST

TSH

Cholesterol, total

Creatine Kinase (CK, CPK)

Glycated Haemoglobin / Hemoglobin A1C

Triglycerides

Hematocrit

Sodium

Neutrophils (total)

WBC

Mean corpuscular hemoglobin concentration

Red Blood Count

Prothrombin time

Mean Corpuscular Volume

Basophils

Monocytes

Urine Glucose

Urine Protein

Uric acid

Magnesium

Urine Red Blood Cells

Mean Corpuscular Hemoglobin, MCH

Eosinophils

Chloride

Bilirubin direct

Gamma Glutamyl Transpeptidase Measurement

Urine Bilirubin

Urine nitrite

Urine ketone

Urine pH

Lactate Dehydrogenase (LDH)

Bilirubin, indirect

Partial Thromboplastin Time

Troponin T

Urine Urobilinogen

Urine Leucocytes

Troponin I

Erythrocyte Sedimentation Rate

BUN

Brain Natriuretic Peptide

N-terminal prohormone brain natriuretic peptide

Total T4

Inorganic phosphorus measurement

Urine Specific Gravity

Laboratory Data

Laboratory Test Original Result

Laboratory Test

Laboratory Test Original Result Unit

Laboratory date/time sample was taken

Laboratory Test Reference Range Upper Limit Original Unit

Laboratory Test Reference Range Lower Limit Original Unit

Medical History

Medical History Event Start Date Time

Medical History Event End Date Time

Medical History Ongoing

Medical History Reported Term

Patient Reported Outcome

Questionnaire Name

Date / Time Of Assessment

Question Name

Number Of Pack Years

Substance Use

What Is The History Of Smoking Use For This Subject

Cigarettes Smoked Per Day

Alcohol Consumption

How long has it been since you last smoked part or all of a cigarette

How many Ys did you smoke up to now

Substance Use Start Date Time

Substance Use End Date Time

Surgery

Date of procedure

Procedure Name

Indication

Planned Date Of Surgery Procedure

Measurement Of Target Lesion Diameter

Tumor Response

Date Of Assessment

Lesion Location

Lesion Description

Method Of Tumor Measurement

New Lesion Description

Vital Signs

Body weight

Body Height

Date of Assessment

Systolic

Diastolic

Temperature

Pulse

Body position for blood pressure measurement

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EHR4CR CTE Data Inventory

EHR4CR CTE Data Inventory

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