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  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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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

Lab: Cytology/Cytogenetics/Cytochemistry

1 itemgroup 29 items

Lab: Immunophenotyping

1 itemgroup 17 items

Lab: Molecular Genetics

1 itemgroup 27 items

Study SHIP-NEXT_metadata_20240913_NEXT|NEXT0|PHA - x0.pha_quest

- 10/8/24 - 4 forms, 1 itemgroup, 6 items, 2 languages
Itemgroup: x0.pha_quest
Item catalog SHIP-NEXT part 8

x0.pha_ident

1 itemgroup 20 items

x0.pha_take

1 itemgroup 7 items

x0.pha_odm

1 itemgroup 5 items

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Sputum collection

- 9/27/21 - 1 form, 7 itemgroups, 24 items, 1 language
Itemgroups: Administrative data, Dosing date and time, Sputum induction, Sputum sample quality, Sputum sample preparation and hemacytometry, Sample collection summary, Sputum slide results
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 Sputum collection form. It has to be filled in for V2b, V5 and if requiered for logs/ repeats. This document can be filled in as often as necessary for logs/ repeats.

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.

ATC A - Alimentary Tract and Metabolism

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 2 languages
Itemgroup: Alimentary Tract and Metabolism
modified from epSOS value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 http://www.epsos.eu http://www.whocc.no/atc_ddd_index/ WHO Collaborating Centre for Drug Statistics Methodology, ATC classification index with DDDs 2015. Oslo, Norway 2014 Copyright ATC index: WHO Collaborating Centre for Drug Statistics Methodology, Oslo, Norway Copying and distribution for commercial purposes is not allowed. German ATC Codes: Datenquelle des amtlichen ATC-Index mit DDD-Angaben: GKV-Arzneimittelindex im Wissenschaftlichen Institut der AOK (WIdO), AOK Bundesverband GbR Stand September 2015. Nur nicht-kommerzielle Nutzung zulässig

Eligibility HOMe aFers 1 NCT02905539

- 9/20/21 - 1 form, 4 itemgroups, 36 items, 2 languages
Itemgroups: Inclusion criteria, Exclusion criteria, Result of eligibility criteria verification, Administrative data
Eligibility form Prüfung der Eignung zur Studienteilnahme NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Multiple sclerosis studies NCT02461069 NCT02419378 - Baseline 1st cycle Trial Medication Multiple Sclerosis ALAIN01 NCT02419378

- 9/20/21 - 18 forms, 2 itemgroups, 16 items, 1 language
Itemgroups: Medication, Trial Medication RQG
Screening, Baseline and Visit 1 CRFs of DIMAT-MS and ALAIN studies for semantic analysis of Multiple Sclerosis study documentation. Provided by Prof. Dr. Luisa Klotz of the Department of Neurology of the University Hospital Muenster.

Baseline: Repitition of Assessments: MRI Multiple Sclerosis ALAIN01 NCT02419378

1 itemgroup 15 items

Baseline: MRI Multiple Sclerosis ALAIN01 NCT02419378

1 itemgroup 15 items

Baseline: CSF Multiple Sclerosis ALAIN01 NCT02419378

1 itemgroup 32 items

Visit 1 (Screening) Part 2/2, Lab; Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

7 itemgroups 40 items

Pharmacokinetics

- 9/20/21 - 1 form, 1 itemgroup, 23 items, 1 language
Itemgroup: Pharmacokinetics
Record detailed information about the collection of biological samples for analysis of the presence and quantity of the study agent and/or its metabolites. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD257392-F827-EFBD-E040-BB89AD434E1E

Medication Form Melanoma (NCT01274338)

- 9/20/21 - 1 form, 6 itemgroups, 35 items, 1 language
Itemgroups: Header, On Treatment Reporting Period, OFF TREATMENT, Corticosteroid Medication, Immunosuppressant Medication, Hormonal Replacement Therapy Medication
E1609 Corticosteroid/Immunosuppressant/Hormone Replacement Medication Form Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III or Stage IV Melanoma That Has Been Removed by Surgery NCT01274338 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1F0BB2E-39FF-B3FA-E040-BB89AD430140

ATC J - Antiinfectives for systemic use

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 2 languages
Itemgroup: Antiinfectives for systemic use
modified from epSOS value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 http://www.epsos.eu http://www.whocc.no/atc_ddd_index/ WHO Collaborating Centre for Drug Statistics Methodology, ATC classification index with DDDs 2015. Oslo, Norway 2014 Copyright ATC index: WHO Collaborating Centre for Drug Statistics Methodology, Oslo, Norway Copying and distribution for commercial purposes is not allowed. German ATC-Index: Datenquelle des amtlichen ATC-Index mit DDD-Angaben: GKV-Arzneimittelindex im Wissenschaftlichen Institut der AOK (WIdO), AOK Bundesverband GbR Stand September 2015. Nur nicht-kommerzielle Nutzung zulässig

ATC R - Respiratory System

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 2 languages
Itemgroup: Respiratory System
modified from epSOS value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 http://www.epsos.eu http://www.whocc.no/atc_ddd_index/ WHO Collaborating Centre for Drug Statistics Methodology, ATC classification index with DDDs 2015. Oslo, Norway 2014 Copyright ATC index: WHO Collaborating Centre for Drug Statistics Methodology, Oslo, Norway Copying and distribution for commercial purposes is not allowed. German ATC-Index: Datenquelle des amtlichen ATC-Index mit DDD-Angaben: GKV-Arzneimittelindex im Wissenschaftlichen Institut der AOK (WIdO), AOK Bundesverband GbR Stand September 2015. Nur nicht-kommerzielle Nutzung zulässig

ATC C - Cardiovascular System

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 2 languages
Itemgroup: Cardiovascular System
modified from epSOS value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 http://www.epsos.eu http://www.whocc.no/atc_ddd_index/ WHO Collaborating Centre for Drug Statistics Methodology, ATC classification index with DDDs 2015. Oslo, Norway 2014 Copyright ATC index: WHO Collaborating Centre for Drug Statistics Methodology, Oslo, Norway Copying and distribution for commercial purposes is not allowed. German ATC Index: Datenquelle des amtlichen ATC-Index mit DDD-Angaben: GKV-Arzneimittelindex im Wissenschaftlichen Institut der AOK (WIdO), AOK Bundesverband GbR Stand September 2015. Nur nicht-kommerzielle Nutzung zulässig

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