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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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NCI Standard Demography Template

- 9/20/21 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Demography,Demography, conditional,Demography, optional
The collection of CDEs used in the demography module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74E63D0F-0BF0-E8D1-E040-BB89AD430251

NINDS CDE Demographics Multiple Sclerosis - Demographics

- 3/15/21 - 1 form, 1 itemgroup, 8 items, 1 language
Itemgroup: Demographics
NINDS Common Data Elements, Multiple Sclerosis Demographics Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Global Disease Course

- 9/20/21 - 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 items

Administrative/Demographic Details

1 itemgroup 11 items

Medical History

3 itemgroups 9 items

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

Demography Screening Ropinirole Parkinson Disease 101468/165 - Demography Screening

- 10/15/17 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: Demography
Study Part: Demography Screening. An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

GSK 100262 Clinical Study Report Demography

- 5/17/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Date of assessment,Demography
GSK 100262 Clinical Study Report Demography

CDASH Demographics - Demographics

- 9/20/21 - 1 form, 1 itemgroup, 9 items, 2 languages
Itemgroup: Demographics
modified from http://www.cdisc.org

CDASH Subject Characteristics

- 6/20/18 - 1 form, 1 itemgroup, 5 items, 2 languages
Itemgroup: Subject Characteristics
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

TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024 - Screening

- 9/27/21 - 1 form, 18 itemgroups, 51 items, 1 language
Itemgroups: Date of Visit/Assessment,Subject Identification,Demography,Demography - Geographic Ancestry,Demography_Contraceptive Methods,Eligibility Question,Inclusion/Exclusion Criteria,Screen Failure,investigator signature,Previous Clinical Trial Participation,Vital Signs,PGx-Pharmacogenetic Research Consent,Medical conditions,IHS Headache Classification,Migraine history,Previous treatment for migraine,Other previous treatment for migraine,Treatment satisfaction
Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 12, Year 9) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 28 items, 1 language
Itemgroups: Administrative,Informed Consent,Demographics,Laboratory Tests,Follow-Up Studies,Tracking Document - Reason for non participation,Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 10, Year 7) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 29 items, 1 language
Itemgroups: Administrative,Informed Consent,Demographics,Laboratory Tests,Follow-Up Studies,Tracking Document - Reason for non participation,Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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

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