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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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224 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) - Global Disease Course

- 4/21/18 - 13 forms, 3 itemgroups, 11 items, 1 language
Itemgroups: Global Disease Course, Red Cell Transfusion, Platelet Cell Transfusion
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

Physical Examination/Follow up

3 itemgroups, 14 items31

Administrative/Demographic Details

1 itemgroup, 11 items31

Apparatus-based Diagnostics

1 itemgroup, 4 items31

Medical History

3 itemgroups, 9 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

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Eligibility Question; Subject Identification; Electronically Transferred Lab Data

- 4/23/19 - 1 form, 9 itemgroups, 37 items, 1 language
Itemgroups: Inform Screening, Subject number, Date of Visit/ Assessment, Demography, 12-Lead ECG, Vital Signs, Eligibility Question, Subject idetification, Electronically Transferred Lab Data
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb; NCT00518336 - Visit 1

- 4/22/19 - 1 form, 9 itemgroups, 23 items, 1 language
Itemgroups: Administrative documentation, Exclusion Criteria, Informed Consent, Demographics Domain, Eligibility Determination, Inclusion, Exclusion Criteria, Adverse Event, Colposcopy
Study ID: 109616 (Y7) Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 15) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

- 4/15/19 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Administration, Demographics, Laboratory Tests, Serology Conclusion of the Blood Sampling Timepoint Year 14
Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 14) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

- 4/11/19 - 1 form, 5 itemgroups, 19 items, 1 language
Itemgroups: Administration, Demographics, Serious Adverse Events, Laboratory Tests, Serology Conclusion of the Blood Sampling Timepoint Year 13
Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 12, Visit 1) - Informed Consent; Demographics; General medical history/ Physical examination; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

- 4/11/19 - 1 form, 12 itemgroups, 101 items, 1 language
Itemgroups: Administration, Demographics, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Blood Sample Conclusion, Vaccine Administration, Vaccine Administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms
Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 13) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

- 4/11/19 - 1 form, 5 itemgroups, 17 items, 1 language
Itemgroups: Administration, Demographics, Serious Adverse Events, Laboratory Tests, Serology Conclusion of the Blood Sampling Timepoint Year 12
Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Demographic Details, demography for females

- 4/9/19 - 1 form, 5 itemgroups, 27 items, 1 language
Itemgroups: Administrative data, Demographic Details, Racial group, Childbearing potential, Pregnancy Test
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 Demographic Details and demography for females form. It has to be filled in for screening.