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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  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
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Screening - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 9 itemgroups, 132 items, 1 language
Itemgroups: Inclusion/Exclusion criteria, Demography, Duration of Asthma, Vital Signs, 12-Lead Electrocardiogram, Pulmonary function, Hematology, Clinical Chemistry, Urinalysis
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Screening Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/18/22 - 1 form, 18 itemgroups, 97 items, 1 language
Itemgroups: Cover Page, Informed Consent, Inclusion Criteria, Exclusion Criteria, Demographics, Primary Diagnosis, Subject Characteristics, Date of Visit, Tobacco History, Alcohol History, Urinary Tract Infection History, Genital Infection History, Physical Examination, Orthostatic vital signs, 12 Lead ECG 1, Height and Weight, Previous Diabetes Medication Use, Pregnancy Test
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Screening

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Screening Visit - Eligibility Criteria

- 11/17/21 - 1 form, 4 itemgroups, 33 items, 1 language
Itemgroups: Administrative documentation, Eligibility Determination, Inclusion, Exclusion Criteria
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Screening Visite/ Run-In- Phase (Visite 1/ Woche -4) TMP001 Multiple Sclerosis NCT02686788 - Screening Visite/ Run-In- Phase (Visite 1/ Woche -4)

- 9/27/21 - 1 form, 13 itemgroups, 116 items, 1 language
Itemgroups: Administrative documentation, Demography, childbearing potential, Vital signs; Body Temperature, Comorbidity, Physical examination, Urinalysis, Laboratory, Blood sampling, Kurtzke Expanded Disability Status Scale Questionnaire, Inclusion criteria, Exclusion criteria, inclusion
Study part: Screening Visite/ Run-In- Phase (Visite 1/ Woche -4). TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge

- 9/27/21 - 1 form, 8 itemgroups, 41 items, 1 language
Itemgroups: Pulmonary function tests: Pre-Methacholine Challenge, Pulmonary function tests: Methacholine Challenge, Pulmonary function tests: Post-Methacholine Challenge, PC20 (Methacholine Challenge), Skin Prick Test, Pulmonary function tests: pre-asthma-allergen challenge, Pulmonary function tests: asthma-allergen Challenge, Pulmonary function tests: Post-asthma-allergen Challenge
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge.

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194) - Screening

- 9/20/21 - 1 form, 15 itemgroups, 79 items, 1 language
Itemgroups: Administrative documentation, Restless Legs Syndrome, Screening procedure, Medical History, Restless Legs Syndrome, Diagnostic criteria, Demography, Vital Signs, Taking orthostatic vital signs, 12 lead ECG, Physical Examination, Laboratory Procedures, Evaluation, Urine dipstick test, Urine pregnancy test, Medical History, History of surgical procedures, Physical Examination, Prior Medication Usage; Concomitant Agent, Restless Legs Syndrome, Pharmaceutical Preparations, Medical History, Eligibility Determination
Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Screen Part 1: Administrative Data and Demography

- 9/20/21 - 1 form, 4 itemgroups, 19 items, 1 language
Itemgroups: Administrative Data, Demography, Smoking History, Demography for females
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Screen Part 1: Administrative Data and Demography.

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Screening; Prior Medication

- 9/20/21 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Administrative Documentation, Prior Medication, Prior Medication
Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Screening NCT00078572

- 9/20/21 - 1 form, 11 itemgroups, 122 items, 1 language
Itemgroups: Pharmacogenetic Research - Blood - Informed Consent, Pharmacogenetic Research - Tumor - Informed Consent, Inclusion Criteria Worksheet, Exclusion Criteria Worksheet, Inclusion and Exclusion Criteria, Current Medical Conditions / Baseline Signs and Symptoms, Physical Exam (Vital Signs, Weight, Height), ECOG Performance Status, Cardiac Assessments Screening, Hematology, Clinical Chemistry
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Screening Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Electrocardiogram Abnormalities Form - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Electrocardiogram Abnormalities
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

GSK AVA100193 Rosiglitazone in Alzheimer´s Disease - Screening Visit - Screening Visit

- 9/20/21 - 1 form, 15 itemgroups, 90 items, 1 language
Itemgroups: Neuropsychological Tests, Demography, Alzheimers disease diagnosis and course, Vital Signs, Education History, Neurological Examination, Physical Examination, Pedal Edema, Tobacco use, Medical History, Concomitant Medication, Screening summary, Eligibility Inclusion criteria, Eligibility Exclusion criteria, Investigator Signature
A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer's disease.

Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 9/20/21 - 1 form, 27 itemgroups, 251 items, 1 language
Itemgroups: Subject Information, Demography, Child-bearing Potential (Complete for Female Subjects Only), Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only), Local Laboratory Result Data, Medical Conditions, Urine Drug Screen, Alcohol Test, Serology - HIV/Hepatitis Screen, Physical examination, History of tobacco use, Vital signs, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities: A. Rhythm, 12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology, 12-Lead ECG Abnormalities: C. Conduction, 12-Lead ECG Abnormalities: D. Myocardial Infarction, 12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T), 12-Lead ECG Abnormalities: Other Abnormalities, Local laboratory result data (haematology), Local laboratory result data - (clinical chemistry), Urinalysis, Eligibility Question, Inclusion Criteria, Exclusion Criteria, Investigator Comment Log
Documentation Part: Screening An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

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