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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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- 11.01.19 - 1 Formular, 15 Itemgruppen, 94 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Hib Vaccination History, Pertussis Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Study Conclusion, Investigator's Confirmation
- 11.01.19 - 1 Formular, 23 Itemgruppen, 137 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Elimination Criteria During The Study, Contraindications To Subsequent Vaccination, Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines, Precautions for Vaccination, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, Randomisation / Treatment Allocation, Physical Examination, Vaccine History, Laboratory Tests - Blood, Vaccine Administration, Vaccine, Vaccine 2, Non-administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - Local Symptoms - Vaccine 2, Solicited Adverse Events, General Symptoms
- 10.01.19 - 1 Formular, 18 Itemgruppen, 78 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Booster Dose - Local Symptoms - Vaccine 1, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Booster Dose - Local Symptoms - Vaccine 2, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Booster Dose - Other Local Symptoms, Booster Dose - General Symptoms, Temperature (General Symptoms), Irritability / Fussiness (General Symptoms), Drowsiness (General Symptoms), Loss of Appetite (General Symptoms), Booster Dose - Other General Symptoms, Booster Dose - Medication, Reminder
- 10.01.19 - 1 Formular, 18 Itemgruppen, 79 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Dose 3 - Local Symptoms - Vaccine 1, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 3 - Local Symptoms - Vaccine 2, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 3 - Other Local Symptoms, Dose 3 - General Symptoms, Temperature (General Symptoms), Irritability / Fussiness (General Symptoms), Drowsiness (General Symptoms), Loss of Appetite (General Symptoms), Dose 3 - Other General Symptoms, Dose 3 - Medication, Reminder
- 10.01.19 - 1 Formular, 18 Itemgruppen, 79 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Dose 2 - Local Symptoms - Vaccine 1, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 2 - Local Symptoms - Vaccine 2, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 2 - Other Local Symptoms, Dose 2 - General Symptoms, Temperature (General Symptoms), Irritability / Fussiness (General Symptoms), Drowsiness (General Symptoms), Loss of Appetite (General Symptoms), Dose 2 - Other General Symptoms, Dose 2 - Medication, Reminder