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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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Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Treatment Week 24 - Visit 7

- 2/8/18 - 1 form, 5 itemgroups, 16 items, 1 language
Itemgroups: Adverse Events, Concomitant Medications, Vital Signs, Central Laboratory, Investigational Product Compliance
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Treatment Week 24 - Visit 7

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Treatment Week 8 - Visit 5

- 2/8/18 - 1 form, 5 itemgroups, 15 items, 1 language
Itemgroups: Adverse Events, Concomitant Medications, Vital Signs, Central Laboratory, Investigational Product Compliance
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Treatment Week 8 - Visit 5

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Treatment Week 16 - Visit 6

- 2/8/18 - 1 form, 5 itemgroups, 15 items, 1 language
Itemgroups: Adverse Events, Concomitant Medications, Vital Signs, Central Laboratory, Investigational Product Compliance
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Treatment Week 16 - Visit 6

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Run-In - Visit 3

- 2/8/18 - 1 form, 6 itemgroups, 16 items, 1 language
Itemgroups: Adverse Events, Concomitant Medications, Vital Signs, Central Laboratory, Inclusion Criteria, Subject Continuation
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Run-In - Visit 3

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Pancreatitis Patient Data

- 11/19/18 - 1 form, 8 itemgroups, 41 items, 1 language
Itemgroups: Administrative data, Pancreatitis, Alcohol, Family History of Pancreatitis, Recent Trauma/Vascular Invasive Procedures or Surgery, Concomitant Medications, Symptoms of Gatrointestinal Illness Associated with Pancreatitis, Other Symptoms Associated with Pancreatitis
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

On-Study - Unresectable Pancreatic Cancer - On-Study Form - 2020206v2.31 - Unresectable Pancreatic Cancer - On-Study Form

- 1/8/15 - 1 form, 3 itemgroups, 25 items, 1 language
Itemgroups: CRF Header, PANCREATIC: FORM ADMINISTRATION, PANCREATIC: DISEASE DESCRIPTION
Unresectable Pancreatic Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A9AC-3FA4-E034-080020C9C0E0

On-Study - Resectable Pancreatic Cancer - On-Study Form - 2020205v2.31 - Resectable Pancreatic Cancer - On-Study Form

- 1/8/15 - 1 form, 3 itemgroups, 25 items, 1 language
Itemgroups: CRF Header, PANCREATIC: FORM ADMINISTRATION, PANCREATIC: DISEASE DESCRIPTION
Resectable Pancreatic Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A9AA-3FA4-E034-080020C9C0E0

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Liver Event Form: General Data

- 11/20/18 - 1 form, 3 itemgroups, 24 items, 1 language
Itemgroups: Administrative data, Liver Events Assessment, Liver Event Description
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 41: Predose - Pharmacokinetic Blood Collection

- 11/16/18 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Administrative data, Pharmacokinetic Blood Collection
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 Run-ln Height and Weight NCT01117584

- 1/28/17 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: General Information
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Visit 1 Run-ln Laboratory Test: Central Lab NCT01117584

- 1/28/17 - 1 form, 1 itemgroup, 3 items, 1 language
Itemgroup: General Information
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

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

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