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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 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
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EHR4CR data inventory for patient identification and recruitment

- 11/17/21 - 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

Screening - GSK Milveterol COPD 100527

- 9/20/21 - 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

NCI Standard Demography Template

- 9/20/21 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Demography,Demography, conditional,Demography, optional
The collection of CDEs used in the demography module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74E63D0F-0BF0-E8D1-E040-BB89AD430251

Sepsis Case Report Form MEDUSA project - SAPS II- Score Report Form

- 11/17/20 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Header module,SAPS II- Score
The MEDUSA project (medical education for sepsis source control and antibiotics) is a scientific study of the integrated research and treatment center "Center for Sepsis Control and Care" (CSCC) of the University Hospital Jena, Thuringia, Germany. Its aim is to investigate whether a multimodal and interdisciplinary training concept for the early recognition and standardized treatment of patients with sepsis improves time to administration of first antibiotic and survival of patients. Original forms obtained from: http://www.medusa.uniklinikum-jena.de/Datenerfassung.html

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

- 9/20/21 - 1 form, 1 itemgroup, 2 items, 2 languages
Itemgroup: LAB Abnormal result
modified from http://www.cdisc.org

Kerndatensatz Herzinsuffizienz DZHI (Core data set heart failure CHFC) - Untersuchung Herzinsuffizienz (Examination heart failure)

- 3/24/20 - 1 form, 5 itemgroups, 90 items, 2 languages
Itemgroups: Logistics ,Physical examination,ECG,6MWT,Echocardiography
Core data set on heart failure, developed by the Comprehensive Heart Failure Center (CHFC). The CHFC researches and treats the complex disease heart failure and its comorbidities in a comprehensive approach. This form contains information about the examination of an heart failure Kerndatensatz zu Herzinsuffizienz, entwickelt vom Deutschen Zentrum für Herzinsuffizienz (DZHI). Das DZHI erforscht und therapiert in einem ganzheitlichen Ansatz die Systemerkrankung Herzinsuffizienz samt ihrer Begleit- und Folgeerkrankungen. Dieses Formular enthält Informationen über die Untersuchung einer Herzinsuffizienz.

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)

Demography Screening Ropinirole Parkinson Disease 101468/165 - Demography Screening

- 10/15/17 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: Demography
Study Part: Demography Screening. An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

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