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  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
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GSK study: Ropinirole in RLS patients 101468/243 - Day 2

- 7/27/17 - 1 form, 8 itemgroups, 10 items, 1 language
Itemgroups: Study medication record since last visit, RLS Rating Scale, Vital signs, Medical Procedures, Concomitant Medication, Adverse reaction, Instructions for the investigator, Clinical Global impression
Part 2 of Module 3 - Baseline, Day 2, Wk 1-8-Cont/Wthd 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK study: Ropinirole in RLS patients 101468/243 - Week 1

- 7/27/17 - 1 form, 9 itemgroups, 11 items, 1 language
Itemgroups: Study medication record since last visit, RLS Rating Scale, Vital signs, Medical Procedures, Concomitant Medication, Adverse reaction, Instructions for the investigator, Clinical Global impression, Dose reduction
Part 3 of Module 3 - Baseline, Day 2, Wk 1-8-Cont/Wthd 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK study: Ropinirole in RLS patients 101468/243 - Baseline

- 7/25/17 - 1 form, 26 itemgroups, 74 items, 1 language
Itemgroups: Study entry, Vital signs, Medical Procedures, Concomitant Medication, Adverse reaction, Exclusion Criterion, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Healthcare resource utilisation - accident & emergency / emergency room visits, Clinical Global impression, RLS Rating scale, Patient rated scale, Pregnancy information, Study Subject Participation Status, Investigator signature, Orthostatic vital signs, Pre-Dose Reading 1, Pre-Dose Reading 2, Pre-Dose Reading 3, Time of dose, 2 hours Post-Dose Reading 1
Part 1 of Module 3 - Baseline, Day 2, Wk 1-8-Cont/Wthd 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests

- 7/23/17 - 1 form, 15 itemgroups, 45 items, 1 language
Itemgroups: Vital signs, Laboratory Evaluation, Urine Dipstick, Pregnancy dipstick, Medical Procedures, Medical Procedures, Prior and concomitant medication, prior and concomitant medication, Baseline signs and symptoms, Significant medical/surgical history and physical examination, Significant medical/surgical history and physical examination, Study Subject Participation Status, Investigator signature, Repeated Laboratory Evaluation, Repeated Urine dipstick
Module 2 - Screening & Repeat Tests 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK study: Ropinirole in RLS patients 101468/243 - Enrolment, Previous study information and eligibility - GSK study: Ropinirole in RLS patients 101468/243 - Enrolment, Previous study information and eligibility

- 7/23/17 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Previous study information, Inclusion Criteria, Exclusion Criteria
Module 1 - Enrolment - Previous study information and eligibility 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 2 Visit 8 (Week 15) RLS Episode 1

- 6/12/17 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: General Information, PRN Subject Diary, Study Medication
Study ID: 100310 Clinical Study ID: RRL100310 Study Title: A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS) Part 2: Visit 8 (Week 15) RLS Episode 1 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00225862 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome More details on: https://clinicaltrials.gov/ct2/show/NCT00225862

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 16: Visit 3 (Week 5) RLS Episode 4

- 6/12/17 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: General Information, PRN Subject Diary, Study Medication
Study ID: 100310 Clinical Study ID: RRL100310 Study Title: A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS) Part 16: Visit 3 (Week 5) RLS Episode 4 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00225862 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome More details on: https://clinicaltrials.gov/ct2/show/NCT00225862

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 18: Visit 3 (Week 5) RLS Episode 6

- 6/12/17 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: General Information, PRN Subject Diary, Study Medication
Study ID: 100310 Clinical Study ID: RRL100310 Study Title: A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS) Part 18: Visit 3 (Week 5) RLS Episode 6 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00225862 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome More details on: https://clinicaltrials.gov/ct2/show/NCT00225862

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 19: Visit 3 (Week 5) RLS Episode 7

- 6/12/17 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: General Information, PRN Subject Diary, Study Medication
Study ID: 100310 Clinical Study ID: RRL100310 Study Title: A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS) Part 19: Visit 3 (Week 5) RLS Episode 7 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00225862 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome More details on: https://clinicaltrials.gov/ct2/show/NCT00225862

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 20: Visit 3 (Week 5) RLS Episode 8

- 6/12/17 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: General Information, PRN Subject Diary, Study Medication
Study ID: 100310 Clinical Study ID: RRL100310 Study Title: A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS) Part 20: Visit 3 (Week 5) RLS Episode 8 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00225862 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome More details on: https://clinicaltrials.gov/ct2/show/NCT00225862

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 13: Visit 3 (Week 5) RLS Episode 1

- 6/12/17 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: General Information, PRN Subject Diary, Study Medication
Study ID: 100310 Clinical Study ID: RRL100310 Study Title: A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS) Part 13: Visit 3 (Week 5) RLS Episode 1 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00225862 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome More details on: https://clinicaltrials.gov/ct2/show/NCT00225862

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 14: Visit 3 (Week 5) RLS Episode 2

- 6/12/17 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: General Information, PRN Subject Diary, Study Medication
Study ID: 100310 Clinical Study ID: RRL100310 Study Title: A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS) Part 14: Visit 3 (Week 5) RLS Episode 2 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00225862 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome More details on: https://clinicaltrials.gov/ct2/show/NCT00225862

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