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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
    1. 7.1. Anästhesie
    1. 7.2. Dermatologie
    1. 7.3. HNO
    1. 7.4. Geriatrie
    1. 7.5. Gynäkologie/Geburtshilfe
    1. 7.6. Innere Medizin
      1. Hämatologie
      1. Infektiologie
      1. Kardiologie/Angiologie
      1. Pneumologie
      1. Gastroenterologie
      1. Nephrologie
      1. Endokrinologie/Stoffwechsel
      1. Rheumatologie
    1. 7.7. Neurologie
    1. 7.8. Augenheilkunde
    1. 7.9. Palliativmedizin
    1. 7.10. Pathologie/Rechtsmedizin
    1. 7.11. Kinderheilkunde
    1. 7.12. Psychiatrie/Psychosomatik
    1. 7.13. Radiologie
    1. 7.14. Chirurgie
      1. Allgemein-/Viszeralchirurgie
      1. Neurochirurgie
      1. Plastische Chirurgie
      1. Herz-/Thoraxchirurgie
      1. Unfallchirurgie/Orthopädie
      1. Gefäßchirurgie
    1. 7.15. Urologie
    1. 7.16. Zahnmedizin/MKG
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Medical history Nuclear medicine UKM - Medical history

- 20.09.21 - 1 Formular, 5 Itemgruppen, 69 Datenelemente, 2 Sprachen
Itemgruppen: Patient demographics, Medical history, Eyes, Thyroid gland, Finding
Medical history form converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by Univ.-Prof. Dr. med. Michael Schäfers

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Diary Cards

- 11.03.19 - 1 Formular, 19 Itemgruppen, 85 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, LOCAL SYMPTOMS (at injection site), Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Induration, Local Symptoms - Ecchymosis, Local Symptoms - Pain, OTHER LOCAL SYMPTOMS (from Day 0 to Day 20), MEDICATION, GENERAL SYMPTOMS, General Symptoms - Temperature, General Symptoms - Fatigue, General Symptoms - Headache, General Symptoms - Myalgia, General Symptoms - Shivering, General Symptoms - Arthralgia, General Symptoms - Sweating increase, OTHER GENERAL SYMPTOMS, Reminder
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Visit "Day 0" Vaccination

- 11.03.19 - 1 Formular, 29 Itemgruppen, 196 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, ELIMINATION CRITERIA, INFORMED CONSENT, DEMOGRAPHICS, ELIGIBILITY CHECK, INCLUSION CRITERIA, EXCLUSION CRITERIA, TREATMENT ALLOCATION, GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION, HISTORY OF INFLUENZA VACCINATION, LABORATORY TESTS, HCG URINE PREGNANCY TEST, VACCINE ADMINISTRATION, VACCINE NON-ADMINISTRATION, SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Induration, Local Symptoms - Ecchymosis, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, General Symptoms - Temperature, General Symptoms - Fatigue, General Symptoms - Headache, General Symptoms - Myalgia, General Symptoms - Shivering, General Symptoms - Arthralgia, General Symptoms - Sweating increase, UNSOLICITED ADVERSE EVENTS
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Visit 1 - Day 0 - Dose 1

- 06.03.19 - 1 Formular, 25 Itemgruppen, 142 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, CHECK FOR STUDY CONTINUATION, HEMATOLOGY / BIOCHEMISTRY, HEMATOLOGY, BIOCHEMISTRY, LDH, URINALYSIS, Urinalysis (Dipstick) Test, RANDOMISATION / TREATMENT ALLOCATION, VACCINE ADMINISTRATION, VACCINE, VACCINE NON-ADMINISTRATION, IMMEDIATE POST-VACCINATION OBSERVATION, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, Temperature, Fatigue, Headache, Gastrointestinal symptoms, Malaise, Myalgia, UNSOLICITED ADVERSE EVENTS
Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

NINDS CDE Symptoms, Frequency and Severity - Headache - Symptoms, Frequency and Severity - Baseline

- 15.06.16 - 1 Formular, 2 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Demographics, Symptoms, Frequency and Severity - Baseline
NINDS Common Data Elements (Symptoms, Frequency and Severity - Baseline; Headache) Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

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