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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
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  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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End of Study: Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/17/22 - 1 form, 3 itemgroups, 12 items, 1 language
Itemgroups: Subject Identification,Vital Signs,End of Study Survey
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: End of Study

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Logs and Repeats

- 9/27/21 - 1 form, 4 itemgroups, 16 items, 1 language
Itemgroups: Administrative Data,Date of visit/assessment,AE/Concomitant medication/Repeat an assessment check question,Liver event
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Logs and Repeats form.

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Study Conclusion, Pregnancy Information and Investigator Comment Log

- 9/27/21 - 1 form, 5 itemgroups, 14 items, 1 language
Itemgroups: Administrative Data,Pregnancy Information,Study Conclusion,Investigator Comment Log,Investigator's Signature
This ODM file contains the form to document pregnancy information at the end of the study, the study conclusion and also includes an investigator's comment log. Study ID: 101999 Clinical Study ID: 101999 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 Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026 - Logs and repeat

- 9/27/21 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Administrative data,Adverse event/Concomitant medication/unscheduled assessment check questions,Liver event
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 8 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains logs and repeat. It has to be filled in for the end of study.

Status of treatment blind Pazopanib Macular Degeneration MD1103367 - Status of treatment blind

- 9/20/21 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: Treatment Status; Blinded Clinical Study
Study part: Status of treatment blind. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Study Conclusion Pazopanib Macular Degeneration MD1103367 - Study Conclusion

- 9/20/21 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Study Conclusion
Study part: Study Conclusion. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

End of Study/Early Withdrawal - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

- 9/20/21 - 1 form, 24 itemgroups, 278 items, 1 language
Itemgroups: Date of visit,ECG,Vital signs,Pharmacokinetics, Blood Sample, Paliperidone,Lab Sample Central Lab,Physical Examination,Abnormal Involuntary Movement Scale,Barnes Akathisia Rating Scale,Simpson Angus Rating Scale,Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version,Investigator Evaluation of lnjection site,Positive and Negative Syndrome Scale for Schizophrenia,Clinical Global Impression - Severity,Personal and Social Performance Scale,Medication Preference Questionnaire,Involvement Evaluation Questionnaire (Post-Baseline),Resource Use Questionnaire A Hospitalisation,Resource Use Questionnaire B Emergency room visits without hospitalisation,Resource Use Questionnaire C Day clinic,Resource Use Questionnaire D Night clinic,Resource Use Questionnaire E Outpatient treatment,Resource Use Questionnaire F Daily living,Resource Use Questionnaire G Productivity of subject,Evaluation of relapse
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01515423 Sponsor: Janssen Research & Development, LLC Other drug name: TREVICTA®

Study Completion Ropinirole in Parkinson's Disease GSK 101468/196

- 9/20/21 - 1 form, 11 itemgroups, 111 items, 1 language
Itemgroups: Patient Information,Clinical Global Impression,Compliance,Dosage,Orthostatic Blood Pressure,Unified Parkinson's Disease Rating Scale (UPDRS),Physical Examination,Hematology,Serum Chemistry,Pregnancy Test,12-Lead ECG
Study ID: 101468/196 Clinical Study ID: 101468/196 Study Title: 101468/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00650104 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Parkinson DiseaseA Long-Term, Open-Label Continuation Study of Once Daily Adminstration of Ropinirole CR Tablets to Patients with Parkinson's Disease Who Completed the Previous Ropinirole CR Studies - 167 & 164 Study Completion

Note To File: CRF Wisconsin Madison

- 9/20/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Header,Note To File
ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Note To File. Case Report Form (CRF)/Source Document templates were created for University of Wisconsin-Madison researchers. These templates are consistent with the FDA's CDASH (Clinical Data Acquisition Standards Harmonization) standards. The CDASH standards identify those elements that should be captured on a Case Report Form (CRF). The forms serve only as templates, and must be edited to meet the study data collection needs as described in the protocol.

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [1 year follow up]

- 9/20/21 - 1 form, 7 itemgroups, 79 items, 1 language
Itemgroups: Doppler Ultrasonography,Screening: Outcome events,Concomitant medication,NIH Stroke scale,Modified Rankin Scale,structured interview,DemTect A,Completion Form Hospital
Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

End form: Study end / Study dropout VTETumor02 Prophylactic Treatment of Thromboembolism with Enoxaparin EudraCT number: 2007-002036-28 - Study end / Study dropout

- 9/20/21 - 1 form, 3 itemgroups, 17 items, 1 language
Itemgroups: study end,Indication study termination,measures study termination
Study documentation part: Study end / Study dropout, VTETumor02. This is a prospective, randomized, controlled, unicentric, open study on prophylactic treatment of thromboembolism with Enoxaparin in non-surgical oncology patients under systemic antineoplastic therapy. Principal Investigator Prof. Dr. Max E. Scheulen, Clinic and Polyclinic for Internal medicine (Tumor research), University Hospital of Essen, Germany. EudraCT number: 2007-002036-28, Version 0.6 vom 06.08.09.

SB-681323 in ALI/ARDS risk patients - NCT00996840 - Logs and Repeats

- 9/17/21 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Administrative Data,Adverse Event/Concomitant Medication/Repeat Assessment,Liver Event
Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form is to be filled in at the end of the study (regular follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.

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