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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
  7. 7. Medical Specialty
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Eligibility Parkinson's Disease NCT01628965

- 9/20/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01628965

Eligibility Parkinson's Disease NCT00459420

- 9/20/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Caffeine for Excessive Daytime Somnolence in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00459420

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Headache Classification

- 9/20/21 - 1 form, 4 itemgroups, 12 items, 1 language
Itemgroups: Administrative Information, IHS Headache Classification, Migraine History, Subject Recruitment
https://www.gsk-clinicalstudyregister.com/study/101998#rs Study ID:101998 Clinical Study ID :101998 Study Title :A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data :Study Listed on ClinicalStudyDataRequest.com Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form uses the IHS headache classification to evluate the subjects symptoms of headache and migraine and should be filled out at the screening visit.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Eligibility Criteria

- 9/20/21 - 1 form, 4 itemgroups, 41 items, 1 language
Itemgroups: Administrative Information, Eligibility Question, Inclusion Criteria, Exclusion Criteria
https://www.gsk-clinicalstudyregister.com/study/101998#rs Study ID:101998 Clinical Study ID :101998 Study Title :A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data :Study Listed on ClinicalStudyDataRequest.com Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form asks for the inclusion and exclusion criteria of the study and should be filled out at the screening visit.

Eligibility Relapsing- Remitting Multiple Sclerosis NCT01842191

- 9/20/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Efficacy of Fish Oil in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01842191

Eligibility Multiple Sclerosis NCT02419638

- 9/20/21 - 1 form, 2 itemgroups, 20 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS; ODM derived from: https://clinicaltrials.gov/show/NCT02419638

ICHOM Conditions and Treatment Approaches Covered for Stroke - Index event - Clinical

- 9/20/21 - 1 form, 5 itemgroups, 18 items, 1 language
Itemgroups: Administrative data, Demographic factors, Stroke type and severity, Vascular and systemic, Treatment/care related
ICHOM Stroke data collection Version 2.0.1 Revised: June 21th, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For stroke, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Patients who have been hospitalized for an index ischemic stroke (IS) or intracereberal hemorrhage (ICH). Patients with subarachnoid hemorrhage (SAH) are excluded. Inclusion of transient ischemic attack (TIA) or patients with IS or ICH who are evaluated but not hospitalized is not required. Treatment Approaches: IV Thrombolysis | Thrombectomy | Hemicraniectomy This form contains index event clinical form. The items cover the entrance into outcome tracking system for Stroke. If a second stroke occurs between discharge and the “90 day post index” collection, you should reset the measurement scale, treating them as a new patient. Questionnaires used in this standard set: PROMIS-10. It is free for all health care organizations, and a license is not needed. There are translations available for Spanish, French, German,and Dutch. As http://www.nihpromis.org is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Simplified Modified Rankin Scale Questionnaire (smRSq) – Clinician. There is no patent on thes smRSq or fee for using it in clinical practice; however Lippincott Williams & Wilkins (LWW) own the rights to the published article where the smRSq is introduced. Therefore here only the total score is included. The smRSq flow chart can be found at http://stroke.ahajournals.org/content/42/8/2276 “Simplified Modified Rankin Scale Questionnaire Reproducibility Over the Telephone and Validation With Quality of Life” Stroke 2011; 42: 2276-2279 © 2011 American Heart Association, Inc. Wolters Kluwer Health. Publication: Salinas J, Sprinkhuizen SM, Ackerson T, et al. An International Standard Set of Patient-Centered Outcome Measures After Stroke. Stroke. 2015;47(1):180–186. doi:10.1161/STROKEAHA.115.010898 For the Stroke Standard Set ICHOM was supported by the American Heart Association and the American Stroke Association. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Eligibility Multiple Sclerosis NCT02499900

- 9/20/21 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®; ODM derived from: https://clinicaltrials.gov/show/NCT02499900

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Prior Medication

- 9/20/21 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: Administrative, Prior Medication, Prior Medication
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - Logs and Repeats

- 9/20/21 - 1 form, 16 itemgroups, 156 items, 1 language
Itemgroups: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation, Repeat, Liver, Adverse Event, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Laboratory Procedures, Vital signs, Pharmacokinetic aspect, Blood, Repeat, Pulmonary function tests, Repeat, Holter Electrocardiography, Repeat, Holter Electrocardiography, Abnormality, Repeat, Telemetry, Repeat, Telemetry, Abnormality, Repeat, 12 lead ECG, Abnormality, Repeat, 12 lead ECG
Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Prior Medication

- 9/20/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Administrative data, Prior Medication
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the prior medication form. It has to be filled in for screening.

Eligibility Multiple Sclerosis, Relapsing-remitting NCT01080001

- 9/20/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Observational, Prospective Study to Assess the Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina; ODM derived from: https://clinicaltrials.gov/show/NCT01080001

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