Stichworte
Klinische Studie, Phase II [Dokumenttyp] ×
Inhaltsverzeichnis
  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
Ausgewählte Datenmodelle

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- 15.05.18 - 1 Formular, 16 Itemgruppen, 74 Datenelemente, 1 Sprache
Itemgruppen: Header, Vital signs, ECOG Performance Status, Electronically transferred lab data - CA-125, Physical examination, Concomitant Medication, Adverse Events, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Pharmacokinetics Blood, Investigational Product, Biomarker sample(s), investigational product, Investigational Product, Treatment Confirmation
- 04.05.18 - 1 Formular, 15 Itemgruppen, 68 Datenelemente, 1 Sprache
Itemgruppen: Header, Vital signs, ECOG Performance Status, Electronically transferred lab data - CA-125, Physical examination, Concomitant Medication, Adverse Events, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, tumour tissue sample collection, consent for tumour genetic research, Withdrawal of consent, tumour sample destruction, Biomarker sample(s)
- 14.04.18 - 1 Formular, 24 Itemgruppen, 129 Datenelemente, 2 Sprachen
Itemgruppen: Header, Eligibility Question, Demography, Physical examination, Disease Characteristics, Metastatic Disease Site, local laboratory, Residual toxicities related to previous therapy for cancer, Residual toxicities, Cancer related current medical conditions, Medical Conditions, non-cancer related medical conditions, Medical Conditions, Prior anti-cancer therapy, Prior anti-cancer therapy - medication, Prior anti-cancer therapy - radiotherapy, Vital signs, ECOG Performance Status Scale, 12 LEAD ECG, 12-lead ECG Abnormalities, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Electronically transferred laboratory data