Beschreibung:

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

Stichworte:

Klinische Studie [Dokumenttyp]

Concomitant Medication

Common Data Elements (CDE)

Versionen (3) ▾

05.04.16
13.10.16
21.04.18

Rechteinhaber:

Bruland, Philipp

Hochgeladen am:

21. April 2018

DOI:

10.21961/mdm:29819

Lizenz:

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

Start Date Time

Verbatim Description

Severity of Adverse Event

Seriousness of adverse event

In Case Of Death, Autopsy Report

Concomitant Medication

Name of the drug

Dose Per Administration

Total Daily Dose of Agent (or Drug)

Demographics

Disease Characteristics

Date of diagnosis

Disposition

Disposition Start Date

Disposition Category

ECG

ECG Clinical Findings

QRS Interval / Complex

Electrocardiogram Date / Time

Laboratory

Bilirubin, total

Alkaline Phosphatase

Cholesterol, total

Creatine Kinase (CK, CPK)

Glycated Haemoglobin / Hemoglobin A1C

Neutrophils (total)

Mean corpuscular hemoglobin concentration

Red Blood Count

Prothrombin time

Mean Corpuscular Volume

Urine Red Blood Cells

Mean Corpuscular Hemoglobin, MCH

Bilirubin direct

Gamma Glutamyl Transpeptidase Measurement

Urine Bilirubin

Lactate Dehydrogenase (LDH)

Bilirubin, indirect

Partial Thromboplastin Time

Urine Urobilinogen

Urine Leucocytes

Erythrocyte Sedimentation Rate

Brain Natriuretic Peptide

N-terminal prohormone brain natriuretic peptide

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

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

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

Date of Assessment

Body position for blood pressure measurement

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