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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
Selected data models

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259 Search results.

EHR4CR CTE Data Inventory

- 4/21/18 - 1 form, 14 itemgroups, 133 items, 1 language
Itemgroups: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs
Data Inventory for Clinical Trial Execution in the EHR4CR project. https://www.ncbi.nlm.nih.gov/pubmed/27875988 DOI for citation: 10.21961/MDM:17994

26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Lab: Cytology/Cytogenetics/Cytochemistry

- 4/21/18 - 13 forms, 1 itemgroup, 29 items, 1 language
Itemgroup: Cytology/Cytogenetics/Cytochemistry
Common Data Elements Myeloid Leukemia (MDS, AML, CML) for use in clinical routine and clinical trial documentation. https://www.ncbi.nlm.nih.gov/pubmed/27577388

Lab: Molecular Genetics

1 itemgroup, 27 items31

Bone Marrow Transplant

1 itemgroup, 13 items31

GVHD

3 itemgroups, 11 items31

Global Disease Course

3 itemgroups, 11 items31
8 more forms meeting the search are available in the detailed view.

CDASH Subject Characteristics

- 6/20/18 - 1 form, 1 itemgroup, 5 items, 2 languages
Itemgroup: Subject Characteristics
modified from http://www.cdisc.org

CDASH Demographics - Demographics

- 6/20/18 - 1 form, 1 itemgroup, 9 items, 2 languages
Itemgroup: Demographics
modified from http://www.cdisc.org

CDASH Subject Characteristics - CDASH LAB (Scenario 2)

- 6/20/18 - 1 form, 16 itemgroups, 95 items, 1 language
Itemgroups: LAB Information, CBC LAB Results – Leukocytes, CBC LAB Results – Neutrophils, CBC LAB Results – Lymphocytes, CBC LAB Results – Monocytes, CBC LAB Results – Eosinophils, CBC LAB Results – Basophils, CBC LAB Results – Erythrocytes, CBC LAB Results – Hemoglobin, CBC LAB Results – Hematocrit, CBC LAB Results - Platelet Count, CBC LAB Results - Ery. Mean Corpuscular Volume, CBC LAB Results - Mean Platelet Volume, CBC LAB Results - Ery. Mean Corpuscular Hemoglobin, CBC LAB Results - Ery. Mean Corpuscular HB Concentration, CBC LAB Results - Erythrocytes Distribution Width
modified from http://www.cdisc.org

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use; Serology

- 6/26/20 - 1 form, 6 itemgroups, 17 items, 1 language
Itemgroups: Administrative, Demography, Medical Conditions, Alcohol intake, History of Tobacco Use, Serology
Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use

- 6/12/20 - 1 form, 5 itemgroups, 15 items, 1 language
Itemgroups: Administrative, Demography, Medical Conditions, Alcohol intake, History of Tobacco Use
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Demography

- 6/10/20 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Administrative Data, Demography, Race
Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Demography Form has to be filled in at the Screening visit. Centre Number from Cover Sheets is included.

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Demography Screen 2

- 6/7/20 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Demography, Geographic ancestry
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Screen

- 5/31/20 - 1 form, 19 itemgroups, 203 items, 1 language
Itemgroups: Screening procedure, Enrollment, Date of visit, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, Clinical Trial Subject Unique Identifier, Vital signs, 12 lead ECG, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Urinalysis, Laboratory Procedures, Hormones, Laboratory Procedures, Free Testosterone Measurement, Laboratory Procedures, Prolactin measurement, Nervous system structure, Evaluation, Ophthalmic examination and evaluation, Ejaculation, Response Latency, Time, Intravaginal
Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Administrative and Demography Form

- 4/30/20 - 1 form, 5 itemgroups, 15 items, 1 language
Itemgroups: Inform Screening, Inform Enrollment, Date of Visit/ Assessment, Subject Identification, Demography Data
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Demography Data

- 4/30/20 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Administrative data, Demography
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension