Keywords
Therapeutics ×
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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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- 9/20/21 - 3 forms, 25 itemgroups, 116 items, 2 languages
Itemgroups: Ein-Ausschlusskriterien, Patientendaten, Krankheitsspezifische Angaben, EDSS-Score vor 12 Monaten, Heutige Scores der Funktionssysteme, Frühere verlaufsmodifizierende MS-Therapien, Aktuelle MS-Therapie, WeitereErkrankungen, Herz- / Kreislauferkrankungen, Stoffwechselerkrankungen, Infektionserkrankungen, Gastrointestinale Erkrankungen, Neurologische / Psychiatrische Erkrankungen, Allergien, Urogenitale Erkrankungen, Autoimmunerkrankungen, Blutbild / Labor, Allgemeine Symptome, Operation, Krebserkrankungen, Welche Therapien wurden aufgrund der Krebserkrankung durchgeführt?, Andere Erkrankung, Keine Vorerkrankungen aus diesen obigen Krankheitsgruppen/Erkrankungen bekannt, Schwangerschaft, Biologisches Material (z.B. Blut)

Baseline Pregnancy Part 1

5 itemgroups, 24 items

Baseline Pregnancy Part 2

5 itemgroups, 21 items
- 9/20/21 - 1 form, 24 itemgroups, 278 items, 1 language
Itemgroups: Date of visit, ECG, Vital signs, Pharmacokinetics, Blood Sample, Paliperidone, Lab Sample Central Lab, Physical Examination, Abnormal Involuntary Movement Scale, Barnes Akathisia Rating Scale, Simpson Angus Rating Scale, Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version, Investigator Evaluation of lnjection site, Positive and Negative Syndrome Scale for Schizophrenia, Clinical Global Impression - Severity, Personal and Social Performance Scale, Medication Preference Questionnaire, Involvement Evaluation Questionnaire (Post-Baseline), Resource Use Questionnaire A Hospitalisation, Resource Use Questionnaire B Emergency room visits without hospitalisation, Resource Use Questionnaire C Day clinic, Resource Use Questionnaire D Night clinic, Resource Use Questionnaire E Outpatient treatment, Resource Use Questionnaire F Daily living, Resource Use Questionnaire G Productivity of subject, Evaluation of relapse
- 9/20/21 - 1 form, 28 itemgroups, 277 items, 1 language
Itemgroups: Date of visit, Randomization, ECG, Vital signs, Pharmacokinetics, Blood Sample, Paliperidone, Lab Sample Central Lab, Urine Dipstick Pregnancy Test, Physical Examination, Abnormal Involuntary Movement Scale, Barnes Akathisia Rating Scale, Simpson Angus Rating Scale, Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version, Investigator Evaluation of lnjection site, Subject Evaluation of lnjection site, Positive and Negative Syndrome Scale for Schizophrenia, Clinical Global Impression - Severity, Personal and Social Performance Scale, Administration of trial medication, Medication Preference Questionnaire, Involvement Evaluation Questionnaire (Post-Baseline), Resource Use Questionnaire A Hospitalisation, Resource Use Questionnaire B Emergency room visits without hospitalisation, Resource Use Questionnaire C Day clinic, Resource Use Questionnaire D Night clinic, Resource Use Questionnaire E Outpatient treatment, Resource Use Questionnaire F Daily living, Resource Use Questionnaire G Productivity of subject, Medication Kit Dispensation
- 9/20/21 - 1 form, 13 itemgroups, 100 items, 1 language
Itemgroups: Hematology Day 7 Pre-Dose, Clinical chemistry Day 7 Pre-Dose, Urinalysis Day 7 Pre-Dose, Investigational Product Day 7, Vital Signs Day 7, 12-Lead Electrocardiogram Day 7, FEV1 Day 7, Pharmacokinetic sampling Day 7, Potassium and Glucose Day 7, Pharmacokinetic Urine lnterval Collection Data Day 7, Hematology Day 7 Post-Dose, Clinical chemistry Day 7 Post-Dose, Urinalysis Day 7 Post-Dose
- 9/20/21 - 1 form, 16 itemgroups, 123 items, 1 language
Itemgroups: Investigational Product Day 1, Investigational Product Day 2, Hematology Day 1 Pre-Dose, Clinical chemistry Day 1 Pre-Dose, Urinalysis Day 1 Pre-Dose, Vital Signs Day 1, Vital Signs Day 2, 12-Lead Electrocardiogram Day 1, 12-Lead Electrocardiogram Day 2, FEV1 Day 1, Pharmacokinetic sampling Day 1, Potassium and Glucose Day 1, Pharmacokinetic Urine lnterval Collection Data Day 1, Hematology Day 1 Post-Dose, Clinical chemistry Day 1 Post-Dose, Urinalysis Day 1 Post-Dose
- 9/20/21 - 1 form, 13 itemgroups, 100 items, 1 language
Itemgroups: Hematology Day 7 Pre-Dose, Clinical chemistry Day 7 Pre-Dose, Urinalysis Day 7 Pre-Dose, Investigational Product Day 7, Vital Signs Day 7, 12-Lead Electrocardiogram Day 7, FEV1 Day 7, Pharmacokinetic sampling Day 7, Potassium and Glucose Day 7, Pharmacokinetic Urine lnterval Collection Data Day 7, Hematology Day 7 Post-Dose, Clinical chemistry Day 7 Post-Dose, Urinalysis Day 7 Post-Dose