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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
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
    1. 7.3. ENT
    1. 7.4. Geriatrics
    1. 7.5. Gynecology/Obstetrics
    1. 7.6. Internal Medicine
      1. Hematology
      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
    1. 7.8. Ophthalmology
    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
    1. 7.14. Surgery
      1. General/Visceral Surgery
      1. Neurosurgery
      1. Plastic Surgery
      1. Thoracic Surgery
      1. Trauma/Orthopedics
      1. Vascular Surgery
    1. 7.15. Urology
    1. 7.16. Dental Medicine/OMS
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ICHOM Chronic Kidney Disease - Demographics, Smoking Status (Patient reported)

- 4/30/20 - 1 form, 3 itemgroups, 5 items, 1 language
Itemgroups: Patient ID, Demographic Factors, Baseline Characteristics
CHRONIC KIDNEY DISEASE DATA COLLECTION REFERENCE GUIDE Version 1.0.0 Revised October 25th, 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Chronic Kidney Disease Stage G3a/A3 | Chronic Kidney Disease StageG 3b/A2/A3 | Chronic Kidney Disease Stage G4 | Chronic Kidney Disease Stage G5 (KDIGO 2012 Stages) Treatment Approaches: Pre-RRT = Pre-Renal Replacement Therapy | HD = Haemodialysis | PD = Peritoneal Dialysis | Tx = Renal Transplantation | CC = Conservative Care This ODM-file contains Patient reported Forms for Demographics and Smoking Status. To be collected at Baseline Visit. Surveys used: The OptumTM SF-36v2® Health Survey: The SF-36v2 Health Survey requires a license agreement prior to the use or reprodution of the tool. Information on how to obtain a license can be found here: bit.ly/SF36LIC . The scoring guide for the SF36v2 is only available upon a license agreement being made. Due to the requirement of a license the Score cannot be found in this version of the standard set. PROMIS-Global Health and PROMIS-29: Free for use in clinical practice and a license is not required. Information http://www.nihpromis.org/measures/translations . The scoring guides for the two PROMIS Scores can be found at bit.ly/PROMISGLOBALSCORE and bit.ly/PROMIS29SCORE . RAND-36: Free for use in clinical practice and a license is not required. The RAND-36 is available in English and Arabic. https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html . The Scoring guide can be found at bit.ly/RAND36Score . Publication: Verberne WR, Das-Gupta Z, Allegretti AS, et al. Development of an International Standard Set of Value-Based Outcome Measures for Patients With Chronic Kidney Disease: A Report of the International Consortium for Health Outcomes Measurement (ICHOM) CKD Working Group. American Journal of Kidney Diseases. Volume 73, Issue 3, 2019, Pages 372-384, ISSN 0272-6386, https://doi.org/10.1053/j.ajkd.2018.10.007 ICHOM was supported for the Chronic Kidney Disease Standard Set by NSW Agency for Clinical Innovation, Providence Health and Services, ERCPA, santeon and Dutch Kidney Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Colorectal Cancer NCT00077233 Demographic - CALGB: 80203 BACKGROUND INFORMATION FORM - 2171121v3.0 - CALGB: 80203 BACKGROUND INFORMATION FORM

- 1/9/15 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: CCRR MODULE
CALGB: 80203 BACKGROUND INFORMATION FORM Fluorouracil and Leucovorin Plus Either Irinotecan or Oxaliplatin With or Without Cetuximab in Treating Patients With Previously Untreated Metastatic Adenocarcinoma of the Colon or Rectum Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BFD5AAD1-D500-39A2-E034-0003BA12F5E7

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

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

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - Demography

- 10/20/20 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Administrative data, Demography
Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Demography) is to be filled out at the Screening (Visit 1).

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Date of visit/ assessment, Subject Identification, Demography, Eligibility Question, Screen Failure, Investigator Signature, Previous Clinical Trial Participation - Screening

- 11/9/18 - 1 form, 9 itemgroups, 25 items, 1 language
Itemgroups: Inform Screening, Inform Enrollment, Date of Visit/ Assessment, Subject Identification, Demography, Eligibility Question, Screen Failure, Investigator Siganture, Previous Clinical Trial Participation
Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Acute Myeloid Leukemia - Treatment Details

- 9/20/21 - 13 forms, 6 itemgroups, 39 items, 1 language
Itemgroups: Therapeutic procedure; Details, Adverse Event, Hemopoietic stem cell transplant, Platelet Engraftment, Neutrophil Engraftment, Therapeutic procedure; Status
Acute Myeloid Leukemia Common Data Elements Holz

Medical History

6 itemgroups 20 items

Lab: Cytology/Cytogenetics/Cytochemistry

3 itemgroups 43 items

Lab: Molecular Genetics, Immunophenotyping, Cytogenetics

1 itemgroup 1 item

Physical Examination/Follow-up

4 itemgroups 27 items

Lab: Infectiology

1 itemgroup 11 items

Lab: Molecular Genetics

1 itemgroup 23 items

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Screening - Demography; Inclusion Criteria; Exclusion Criteria

- 9/20/21 - 1 form, 4 itemgroups, 34 items, 1 language
Itemgroups: Administrative, Demography, Inclusion Criteria, Exclusion Criteria
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Lung Cancer Smoking Survey NCT00324805 - Follow Up Smoking Survey Lung Cancer NCT00324805 ECOG-E1505

- 3/25/15 - 1 form, 3 itemgroups, 21 items, 1 language
Itemgroups: Header, Smoking status, Nic Alert Test Result
ECOG-E1505 Follow Up Smoking Survey Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery NCT00324805 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0745B0C2-1A2A-5046-E044-0003BA3F9857

Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877 - Informed consent, demography

- 11/16/18 - 1 form, 4 itemgroups, 15 items, 1 language
Itemgroups: Administrative data, Informed consent, Demography, Demography for Females
Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma 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: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the informed consent form and demography of subject. It has to be filled in for Session 1.

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; Subject Identification; Electronically Transferred Lab Data

- 8/14/19 - 1 form, 8 itemgroups, 34 items, 1 language
Itemgroups: Inform Screening, Subject number, Date of Visit/ Assessment, Demography, 12-Lead ECG, Vital Signs, Subject identification, 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

Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125 - Inform Screening, Enrolment, Date of visit, Demography

- 10/11/18 - 1 form, 4 itemgroups, 9 items, 1 language
Itemgroups: inform; Screening, inform; Enrollment in clinical trial, Date of visit, Demography
Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

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