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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    2. 1.2. Medical History
    3. 1.3. Physical Examination
    4. 1.4. Assessment Score
    5. 1.5. Apparative Diagnostics
    6. 1.6. Laboratory
    7. 1.7. Pathology/Histology
    8. 1.8. Consent
    9. 1.9. Therapy
    10. 1.10. Operative Report
    11. 1.11. Adverse Event
    12. 1.12. Follow-Up
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
Selected data models

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15392 Search results.

EHR4CR CTE Data Inventory

- 4/21/18 - 1 form, 14 itemgroups, 133 items, 1 language
Itemgroups: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs
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

Eligibility Type 2 Diabetes NCT00641251

- 4/21/18 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00641251

Eligibility Type 2 Diabetes NCT00508599

- 4/21/18 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
The Effects of Two Days of Bedrest on Insulin Resistance in Type 2 Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT00508599

Eligibility Leukemia, Myeloid NCT00512083

- 1/10/18 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00512083

Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Baseline Visit

- 11/14/17 - 1 form, 10 itemgroups, 71 items, 2 languages
Itemgroups: Physical Examination / Medical History taking, Signs and Symptoms of heart failure, Cardiovascular Diseases, Comorbidities, Current medication, Cardiovascular interventions, Implantation of a cardiac device, Hematology, ECG, Baseline visit
Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Baseline Visit (BV-Form)

Informed consent Visit 1 Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381 - Informed consent Visit 1

- 7/16/17 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: Informed consent
Study part: Informed consent Visit 1. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Screening - GSK Milveterol COPD 100527

- 6/18/17 - 1 form, 9 itemgroups, 132 items, 1 language
Itemgroups: Inclusion/Exclusion criteria, Demography, Duration of Asthma, Vital Signs, 12-Lead Electrocardiogram, Pulmonary function, Hematology, Clinical Chemistry, Urinalysis
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069 - Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

- 5/24/16 - 4 forms, 7 itemgroups, 31 items, 1 language
Itemgroups: Administration and Instructions for CRF Completion, Demographic Data, Blood pregnancy test, Testing for JC virus antibodies, Medical History, MS Medical History, MS Treatment History
Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

NON-MS Treatment and symptomatic MS Treatment

4 itemgroups, 19 items31

Blood samples for safety laboratory tests

4 itemgroups, 16 items31

Eligibility

3 itemgroups, 31 items31

CDASH Lab Result Assessment (Scenario 3, Part 2) - CDASH LAB Result Assessment (Scenario 3, Part 2)

- 6/20/18 - 1 form, 1 itemgroup, 2 items, 2 languages
Itemgroup: LAB Abnormal result
modified from http://www.cdisc.org

EHR4CR data inventory for patient identification and recruitment

- 5/21/15 - 1 form, 10 itemgroups, 150 items, 2 languages
Itemgroups: Demographics, Medical History, Medical device, Diagnosis, Procedure, Findings, Laboratory Findings, Medication, Scores&Classifications, Patient Characteristics
EHR4CR data inventory for patient identification and recruitment Referenced by https://www.ncbi.nlm.nih.gov/pubmed/25991199

Breast Cancer NCT00433589 Treatment - Endocrine therapy - 2498727v1.0 - Endocrine therapy

- 1/9/15 - 1 form, 3 itemgroups, 14 items, 1 language
Itemgroups: Header, Endocrine therapy, Footer Module
Endocrine therapy Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19677A9A-FFBD-2E6F-E044-0003BA3F9857

NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template - 2748814v1.0 - NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template

- 2/5/19 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Mandatory Adverse Event Questions, Conditional Adverse Event Questions, Optional Adverse Event Questions, Optional Serious Adverse Event Questions
The collection of CDEs used in the Adverse Events/Serious Adverse Events module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4D0BC7DD-57DD-63BE-E044-0003BA3F9857