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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
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
    1. 7.3. ENT
    1. 7.4. Geriatrics
    1. 7.5. Gynecology/Obstetrics
    1. 7.6. Internal Medicine
      1. Hematology
      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
    1. 7.8. Ophthalmology
    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
    1. 7.14. Surgery
      1. General/Visceral Surgery
      1. Neurosurgery
      1. Plastic Surgery
      1. Thoracic Surgery
      1. Trauma/Orthopedics
      1. Vascular Surgery
    1. 7.15. Urology
    1. 7.16. Dental Medicine/OMS
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day 7 - 35: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Albiglutide), Electrocardiogram

- 11/29/20 - 1 form, 5 itemgroups, 35 items, 1 language
Itemgroups: Administrative, Vital Signs (sitting) - Day 7 - 35, Study Drug Administration (50 mg Albiglutide) - Day 7 - 35, Pharmacokinetic Blood Collection (Albiglutide) - Day 35, Electrocardiogram (Day 14)
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day 37 - 42, Follow-Up: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection, Central Laboratory

- 11/29/20 - 1 form, 13 itemgroups, 72 items, 1 language
Itemgroups: Administrative, Vital Signs (sitting) - Day 37 - 42, Follow up, Electrocardiogram (Day 37), Central Laboratory - Haematology (Day 37), Central Laboratory - Chemistry (Day 37), Central Laboratory - UA/UDS/Urine HCG/ Urine Chem (Day 37), Study Drug Administration (80 mg Simvastatin) - Day 38, Pharmacokinetic Blood Collection (Simvastatin) - Day 38, Pharmacokinetic Blood Collection (Albiglutide) - Day 38, Pharmacokinetic Blood Collection (Simvastatin) - Day 39, Pharmacokinetic Blood Collection (Simvastatin) - Day 40, Pharmacokinetic Blood Collection (Simvastatin) - Day 41, Pharmacokinetic Blood Collection (Simvastatin) - Day 42
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day -1 - Admission Criteria; Vital Signs; Electrocardiogram; Central Laboratory

- 11/29/20 - 1 form, 7 itemgroups, 39 items, 1 language
Itemgroups: Administrative, Admission Criteria, Vital Signs (sitting) , Electrocardiogram, Central Laboratory - Haematology , Central Laboratory - Chemistry, Central Laboratory - UA/ UDS/ Urine HCG/ Urine Chem
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day 1 - 5: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Simvastatin)

- 11/29/20 - 1 form, 8 itemgroups, 42 items, 1 language
Itemgroups: Administrative, Vital Signs (sitting) - Day 1 - 5, Study Drug Administration (80 mg Simvastatin) - Day 1, Pharmacokinetic Blood Collection (Simvastatin) - Day 1, Pharmacokinetic Blood Collection (Simvastatin) - Day 2 , Pharmacokinetic Blood Collection (Simvastatin) - Day 3, Pharmacokinetic Blood Collection (Simvastatin) - Day 4, Pharmacokinetic Blood Collection (Simvastatin) - Day 5
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 11/2/16 - 1 form, 8 itemgroups, 61 items, 2 languages
Itemgroups: In-/Exclusion Criteria, Demographics, Vital Signs and Examinations, Circulatory Symptoms, One year transfusion history, Preexisting and concomitant diseases, Preexisting and concomitant, Visit 0 - FACIT, Visit 0 - SF36
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 13 (Visit 110): Pharmacodynamics, Vital Signs, Drug Administration

- 12/21/18 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Administrative data, Study Drug Administration, Vital Signs, Pharmacodynamic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Screening Visit: Vital Signs Form

- 11/14/18 - 1 form, 2 itemgroups, 20 items, 1 language
Itemgroups: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Unscheduled Visit: Vital Signs, Physical Examination,

- 12/28/18 - 1 form, 14 itemgroups, 69 items, 1 language
Itemgroups: Administrative data, Vital Signs, Blood Pressure, Heart Rate, Respiratory Rate, Temperature, Physical Examination, Assessment, Electrocardiogram, ECG Details, Overall Interpretation of ECG, Central Laboratory Tests, Blood, Urine
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 22+26 (Visit 160-170): Vital Signs, Drug Administration, ECG, Laboratory Tests

- 12/24/18 - 1 form, 11 itemgroups, 57 items, 1 language
Itemgroups: Administrative data, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration, Pharmacokinetic Blood Collection, Period 1 - Day 26, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 14 (Visit 120): Pharmacodynamics, Vital Signs, Drug Administration

- 12/21/18 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Administrative data, Study Drug Administration, Vital Signs, Pharmacodynamic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 11 (Visit 90): Vital Signs, Pharmacogenetics, Pharmacodynamics, Drug Admission

- 12/21/18 - 1 form, 6 itemgroups, 36 items, 1 language
Itemgroups: Administrative data, Admission Criteria, Study Drug Administration, Pharmacogenetic Blood Collection, Vital Signs, Pharmacodynamic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 21 + Day 22

- 12/27/18 - 1 form, 13 itemgroups, 69 items, 1 language
Itemgroups: Administrative data, Day 21, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Laboratory Test - Urine HCG, Pharmacodynamic Blood Collection, Pharmacokinetic Blood Collection, Day 22, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Pharmacokinetic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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