Keywords
Case Reports ×
Table of contents
  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
Selected data models

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- 7/20/19 - 1 form, 6 itemgroups, 55 items, 1 language
Itemgroups: Case data, Medical Department data, Diagnosis details, Procedure Details, PIA-Documentation of services, Modell project
- 9/20/21 - 1 form, 5 itemgroups, 28 items, 1 language
Itemgroups: Identification, General Symptoms, Other General Symptoms, Medication, Administration
- 9/20/21 - 1 form, 27 itemgroups, 251 items, 1 language
Itemgroups: Subject Information, Demography, Child-bearing Potential (Complete for Female Subjects Only), Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only), Local Laboratory Result Data, Medical Conditions, Urine Drug Screen, Alcohol Test, Serology - HIV/Hepatitis Screen, Physical examination, History of tobacco use, Vital signs, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities: A. Rhythm, 12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology, 12-Lead ECG Abnormalities: C. Conduction, 12-Lead ECG Abnormalities: D. Myocardial Infarction, 12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T), 12-Lead ECG Abnormalities: Other Abnormalities, Local laboratory result data (haematology), Local laboratory result data - (clinical chemistry), Urinalysis, Eligibility Question, Inclusion Criteria, Exclusion Criteria, Investigator Comment Log
- 9/17/21 - 14 forms, 14 itemgroups, 129 items, 2 languages
Itemgroups: Case, Medical Department data, Diagnosis details, Procedure Details, PIA-Documentation of services, Modell project, Info Data, Hospital Data, Nursing staff, Mergers, Apprenticeships, Accounting, ICD, Remuneration

Datei Krankenhaus

1 itemgroup 8 items

Datei ICD

1 itemgroup 12 items

Datei Pflegepersonal

1 itemgroup 8 items

Datei Ausbildung

1 itemgroup 28 items

Datei LEI

1 itemgroup 6 items

Datei Abrechnung

1 itemgroup 6 items
- 8/11/21 - 1 form, 7 itemgroups, 195 items, 1 language
Itemgroups: Participant Identification, Summary of clinical features of current illness, Laboratory results, Imaging and pathogen testing, Treatment, Supportive care, Outcome
Preliminary case definition Children and adolescents 0–19 years of age with measured or self-reported fever ≥ 3 days AND two or more of the following: a) Rash or bilateral non-purulent conjunctivitis or muco-cutaneous inflammation signs (oral, hands or feet) b) Hypotension or shock c) Features of myocardial dysfunction, or pericarditis, or valvulitis, or coronary abnormalities (clinical features, ECHO findings, or laboratory markers such as elevated Troponin/NT-proBNP) d) Evidence of coagulopathy (such as abnormal PT, PTT, elevated d-Dimers) e) Acute gastrointestinal problems (such as diarrhoea, vomiting or abdominal pain) AND Elevated markers of inflammation such as ESR, C-reactive protein or procalcitonin AND No other obvious microbial cause of inflammation, including bacterial sepsis, staphylococcal or streptococcal shock syndromes AND Evidence of current or previous COVID-19 (RT-PCR, antigen test or serology positive) or likely contact with patients with COVID NB Consider this syndrome in children with features of typical or atypical Kawasaki disease or toxic shock syndrome. Based on CRF on https://isaric.org/research/covid-19-clinical-research-resources/multisystem-inflammatory-syndrome-mis-c/ This Case Report Form (CRF) has been developed by ISARIC in cooperation with WHO's working group (https://www.who.int/news-room/commentaries/detail/multisystem-inflammatory-syndrome-in-children-and-adolescents-with-covid-19) to use as a standalone CRF for children and adolescents presenting with syndrome of suspected Multisystem Inflammatory Syndrome (MIS-C). This Module is to be completed at time of discharge or death.
- 8/3/21 - 1 form, 10 itemgroups, 188 items, 1 language
Itemgroups: Participant Identification, Demographics, Onset of current illness and vital signs, Possible signs and symptoms of multisystem inflammatory syndrome, Other signs and symptoms of multisystem inflammatory syndrome, Recent history, Co-morbidities, past history, Pre-admission and chronic medication, Laboratory results, Imaging and pathogen testing
Based on CRF on https://isaric.org/research/covid-19-clinical-research-resources/multisystem-inflammatory-syndrome-mis-c/ This Case Report Form (CRF) has been developed by ISARIC in cooperation with WHO's working group (https://www.who.int/news-room/commentaries/detail/multisystem-inflammatory-syndrome-in-children-and-adolescents-with-covid-19) to use as a standalone CRF for children and adolescents presenting with syndrome of suspected Multisystem Inflammatory Syndrome (MIS-C). Preliminary case definition Children and adolescents 0–19 years of age with measured or self-reported fever ≥ 3 days AND two or more of the following: a) Rash or bilateral non-purulent conjunctivitis or muco-cutaneous inflammation signs (oral, hands or feet) b) Hypotension or shock c) Features of myocardial dysfunction, or pericarditis, or valvulitis, or coronary abnormalities (clinical features, ECHO findings, or laboratory markers such as elevated Troponin/NT-proBNP) d) Evidence of coagulopathy (such as abnormal PT, PTT, elevated d-Dimers) e) Acute gastrointestinal problems (such as diarrhoea, vomiting or abdominal pain) AND Elevated markers of inflammation such as ESR, C-reactive protein or procalcitonin AND No other obvious microbial cause of inflammation, including bacterial sepsis, staphylococcal or streptococcal shock syndromes AND Evidence of current or previous COVID-19 (RT-PCR, antigen test or serology positive) or likely contact with patients with COVID NB Consider this syndrome in children with features of typical or atypical Kawasaki disease or toxic shock syndrome. This Module is to be completed when multisystem inflammatory syndrome is suspected, on admission or in-patients.

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