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  1. 1. Clinical Trial
  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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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

Eligibility NCT00156338 Fluid Management - Eligibility

- 11/25/11 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00156338

NURSING ASSESSMENT (adult) - HIS

- 6/8/17 - 1 form, 36 itemgroups, 383 items, 2 languages
Itemgroups: Nursing Assessment,Neurological status,GLASGOW COMA SCALE,PUPILS,ORIENTATION,Cardiovascular,Eyes Ear Nose & Throat,EYES,EARS,NOSE,THROAT,Respiratory,Gastrointestinal,Genitourinary,Musculoskeletal,Skin,PRESSURE ULCER ASSESSMENT,Wound(s),INCISION(S),Nutrition,IV Therapy,Safety,Hendrich II Fall Risk Assessment,INTERVENTIONS,IMPAIRED MOBILITY RISK,ALTERED ELIMINATION,HIGH RISK FALL MEDICATIONS (ANTIEPILEPTICS & BENZODIAZEPINES),INTERVENTIONS (FOR ONCOLOGY USE ONLY),ONN Unit specific,Antepartum specific,Post partum specific,Post Surgical,ADOLESCENT INTERACTION,GERIATRIC INTERVENTION (65+),Hendrich Fall Risk,SUGGESTED INTERVENTIONS
Form from HIS OpenVista

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

Quality assurance Follow-up Heart Transplant (AQUA) - Quality assurance Follow-up Liver Transplant (AQUA)

- 9/27/19 - 1 form, 2 itemgroups, 16 items, 2 languages
Itemgroups: Follow-up(auszufüllen nach 1, 2 und 3 Jahren),Überlebensstatus des Empfängers
Documentation form for quality assurance in German Health Care by the Institute for Applied Quality Improvement and Research in Health Care (Aqua), https://www.aqua-institut.de/en/home. Internal Aqua form version: HTXFU Specification 2015 V02

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

Quality assurance Heart Transplant Heart Assist Devices Artificial Heart - Transplant (AQUA)

- 3/17/16 - 1 form, 8 itemgroups, 49 items, 2 languages
Itemgroups: Heart Transplant Heart Assis Devices Artificial Heart - Transplant,Empfängerdaten,Risikoprofil,Immunsuppression initial,Spenderdaten,Befunde Spender,Operation,Postoperativer Verlauf
Documentation form for quality assurance in German Health Care by the Institute for Applied Quality Improvement and Research in Health Care (Aqua), https://www.aqua-institut.de/en/home. Internal Aqua form version: HTXM-T Specification 2015 V02

REGIMS Multiple Sclerosis Immunotherapy Registry Version 2016 - Follow Up Main Sheet

- 9/20/21 - 9 forms, 4 itemgroups, 15 items, 2 languages
Itemgroups: Allgemeines,Grund dieser Visite bzw. dieses Kontaktes (Mehrfachauswahl),Ist seit der letzten Dokumentation für REGIMS (o. REGIMS-Visite)...,Eigene Bemerkungen / Klinischer Verlauf / Kommentar
REGIMS is a registry of the administration, adverse events and benefit of immunotherapeutic agents in patients with Multiple Sclerosis. REGIMS is a project from the Institute of Epidemiology and Social Medicine of the University of Muenster, publication granted by Prof. Dr. Berger. For further information (in German), please view http://campus.uni-muenster.de/index.php?id=6075 or http://www.kompetenznetz-multiplesklerose.de/aktuelle-studien/regims. REGIMS ist ein Immuntherapieregister zur Verbesserung der Arzneimittelsicherheit in der Multiple Sklerose Therapie innerhalb des krankheitsbezogenen Kompetenznetzes MS. Das primäre Ziel von REGIMS ist die Erfassung der Häufigkeit, Charakteristika und Auswirkungen von Nebenwirkungen aktueller und neuer Immuntherapien in der klinischen Routinebehandlung der MS. Sekundäre Ziele sind die Auswertung von Faktoren, die a) mit Nebenwirkungen und b) mit guter Therapie-Adhärenz assoziiert sind. Optional können bei Zustimmung der Patienten Blutproben für die Biobank des KKNMS gesammelt werden. Patienten mit Multipler Sklerose (MS) weisen trotz des chronischen Verlaufs eine große Heterogenität klinischer Symptome, in Befunden der Bildgebung sowie pathophysiologischen Prozessen auf. Faktoren, die zur individuellen Krankheitsprognose beitragen sind kaum bekannt, jedoch hat die Einführung neuer Substanzen die Therapiemöglichkeiten der MS in den letzten Jahren deutlich erweitert. Die Anwendung sogenannter Immuntherapeutika (inklusive der neuen Substanzklasse der Biologika) bietet in der MS-Therapie eine Reihe von Chancen, birgt aber auch Risiken.

Baseline Pregnancy Part 1

5 itemgroups 24 items

Follow Up Pregnancy Part 1

5 itemgroups 24 items

Follow Up Medication Change

3 itemgroups 11 items

Telephone notes Pediatric Hematology and Oncology UK Muenster

- 11/17/21 - 1 form, 3 itemgroups, 24 items, 2 languages
Itemgroups: Telephone notes,Laboratory,Current Medication
Freigabe zur Verarbeitung durch Frau Prof. Rössig, Quellenangabe: "Pädiatrische Hämatologie und Onkologie, UKM" Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Münster Released for adaption by Frau Prof. Rössig Source:Pediatric Hematology und Oncology, University hospital Münster

Emergency protocol- Module Anesthesia - Measures in recovery room

- 9/20/21 - 3 forms, 1 itemgroup, 13 items, 1 language
Itemgroup: Measures in recovery room
Emergency protocol by the DIVI (Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin). ODM derived from “Notaufnahmeprotokoll Modul Anästhesie”.

Anesthesia

3 itemgroups 50 items

Anaesthesia technique

1 itemgroup 5 items

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

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

- 5/24/16 - 4 forms, 4 itemgroups, 19 items, 1 language
Itemgroups: General Instructions,Medical Examination,Expanded disability status scale (EDSS),Signature
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.

Eligibility

3 itemgroups 31 items

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

7 itemgroups 31 items

Blood samples for safety laboratory tests

4 itemgroups 16 items

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