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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

Lab: Cytology/Cytogenetics/Cytochemistry

3 itemgroup 11 items

Apparatus-based Diagnostics

3 itemgroup 11 items

Lab: Immunophenotyping

3 itemgroup 11 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: Repitition of AssessmentsMSFC Multiple Sclerosis ALAIN01 NCT02419378

- 9/20/21 - 18 forms, 4 itemgroups, 28 items, 1 language
Itemgroups: MSFC,Timed 25-Foot Walk,9-Hole Peg Test,PASAT
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 1st cycle Trial Medication Multiple Sclerosis ALAIN01 NCT02419378

4 itemgroups 28 items

Baseline: Evoked Potentials Multiple Sclerosis ALAIN01 NCT02419378

4 itemgroup 28 items

Baseline: Repitition of Assessments: MRI Multiple Sclerosis ALAIN01 NCT02419378

4 itemgroup 28 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

ATC N - Nervous System

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 2 languages
Itemgroup: Nervous 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 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 V - Various

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 2 languages
Itemgroup: Various
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 L - Antineoplastic and immunomodulating agents

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 2 languages
Itemgroup: Antineoplastic and immunomodulating agents
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 M - Musculo-skeletal System

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 2 languages
Itemgroup: Musculo-skeletal 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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