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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
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- 9/27/21 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Administrative data,Adverse event/Concomitant medication/unscheduled assessment check questions,Liver event
- 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
- 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
- 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 Identifier: NCT00996840 See 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.
- 8/24/21 - 1 form, 5 itemgroups, 23 items, 1 language
Itemgroups: Administrative,Occurrence of Serious Adverse Events,Status of Treatment Blind,Elimination Criteria,Investigator's Signature
Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on Identifier: NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria ODM derived from A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum malaria vaccine RTS,S/AS01E (0.5 mL dose) to RTS,S/AS02D (0.5 mL dose) administered IM according to a 0, 1, 2- month vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. For all subjects enrolled, please complete the study conclusion form. The study conclusion should be documented subsequently to clinical visit 7 in separate forms for the double-blind and the single-blind phase respectively. The 'Status of Treatment Blind' item group only needs to be completed within the form for the double-blind phase. Note that informed consent has to be obtained prior to any study procedure.

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