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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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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Liver Event Details; Global Assessment of Change (Asthma Symptoms And Rescue Medication Use), Medical Problems/ Medications taken diary, Medications taken diary, Unscheduled Asthma Healthcare Contacts

- 11/24/18 - 1 form, 14 itemgroups, 116 items, 1 language
Itemgroups: Liver events, Investigational Product (Liver), Alcohol intake at onset of liver event , Medical conditions at onset of liver event , Drug related liver disease , Other Liver Disease Conditions , Other medical conditions , Pharmacokinetics (Liver) , Liver imaging , Liver biopsy , Global Assessment of Change (Asthma Symptoms And Rescue Medication Use), Medical Problems/ Medications taken diary, Medications taken diary, Unscheduled Asthma Healthcare Contacts
Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Liver Biopsy

- 1/2/19 - 1 form, 4 itemgroups, 31 items, 1 language
Itemgroups: Administrative data, Liver Biopsy pt 1, Liver Biopsy pt 2, Liver Biopsy pt 3
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

Vaccination against pneumonia and otitis media, NCT00466947 - Solicited adverse events - local and general symptoms

- 10/26/18 - 1 form, 3 itemgroups, 28 items, 1 language
Itemgroups: Administrative data, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS
Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com https://clinicaltrials.gov/ct2/show/NCT00466947?term=NCT00466947 Clinicaltrials.gov Identifier: NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains report of solicited adverse events for local and general symptoms. It has to be filled in for workbook 1 and 2 in visit 1,2,3 and 6. It refers only to immuno and reacto subset.

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Various Adverse Events: Hypoglycemia, Injection Site Reaction, Pancreatitis, Thyroid Nodes

- 1/2/19 - 1 form, 37 itemgroups, 183 items, 1 language
Itemgroups: Administrative data, (Serious) Hypoglycaemic Events, Serious Adverse Events, Injection Site Reaction, Pancreatitis, Symptoms of Gastrointestinal Illness Associated with Pancreatitis, Pain in the Epigastrium, Pain in the Periumbical Region, Pain in the Right Upper Quadrant, Pain in the Left Upper Quadrant, Pain in the Left Lower Quadrant, Pain in the Right Lower Quadrant, Pain in the Right Flank, Pain in the Left Flank, Pain in the Back, Other Symptoms, Nausea, Vomiting, Fever, Biochemistry, Alkaline phosphatase, Total bilirubin, Direct bilirubin, Creatinine, Other lab test, Diagnostic Studies - Pancreatitis, Abdominal CT Scan, MRI, New Thyroid Nodules, Bidimensional Measurement, Thyroid Nodules AE Details, Thyroid function tests, Free T4, T4, TSH, Free T3, T3 Uptake
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

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Visit 5 - Day 60 - Dose 2

- 3/7/19 - 1 form, 25 itemgroups, 142 items, 1 language
Itemgroups: 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

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

- 3/6/19 - 1 form, 25 itemgroups, 142 items, 1 language
Itemgroups: 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

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Diary Cards (Day 0 to Day 6) Dose 1

- 3/7/19 - 1 form, 15 itemgroups, 90 items, 1 language
Itemgroups: Administrative data, Local Symptoms - Redness (at injection site), Local Symptoms - Swelling (at injection site), Local Symptoms - Pain (at injection site), Other Local Symptoms, MEDICATION, GENERAL SYMPTOMS, Temperature, Fatigue, Headache, Gastrointestinal symptoms, Malaise, Myalgia, Other Symptoms, Medication
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

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Diary Cards (visit 4 to visit 5)

- 3/7/19 - 1 form, 15 itemgroups, 90 items, 1 language
Itemgroups: Administrative data, Local Symptoms - Redness (at injection site), Local Symptoms - Swelling (at injection site), Local Symptoms - Pain (at injection site), Other Local Symptoms, MEDICATION, GENERAL SYMPTOMS, Temperature, Fatigue, Headache, Gastrointestinal symptoms, Malaise, Myalgia, Other Symptoms, Medication
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

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Diary Cards Dose 2

- 3/7/19 - 1 form, 15 itemgroups, 90 items, 1 language
Itemgroups: Administrative data, Local Symptoms - Redness (at injection site), Local Symptoms - Swelling (at injection site), Local Symptoms - Pain (at injection site), Other Local Symptoms, MEDICATION, GENERAL SYMPTOMS, Temperature, Fatigue, Headache, Gastrointestinal symptoms, Malaise, Myalgia, Other Symptoms, Medication
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Injection Site Reaction

- 11/19/18 - 1 form, 4 itemgroups, 25 items, 1 language
Itemgroups: Administrative data, Injection Site Reaction, Local reaction symptoms, Subjects with a severe injection site reaction or a severe systemic allergic reaction must have three 1mL serum samples obtained for immunogenicity testing.
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

Visit 1 GIMEMA CML0408 NCT00769327 - Visit 1

- 9/20/21 - 1 form, 15 itemgroups, 150 items, 2 languages
Itemgroups: Previous chemotherapy, Comorbidities, Symptoms, Physical Examination, Complete Blood Count, Biochemistry, Serum Proteins, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 1 Form

Visit 0 GIMEMA CML0408 NCT00769327 - Visit 0

- 9/20/21 - 1 form, 4 itemgroups, 55 items, 2 languages
Itemgroups: Enrollment, Symptoms, Physical Examination, Complete Blood Count
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the visit 0 form.

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