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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
    1. 5.1. Common Data Elements
      1. Released Standard
      1. Draft Standard
      1. Deprecated Standard
    1. 5.2. Scores & Instruments
      1. Released Standard
      1. Draft Standard
      1. Deprecated Standard
    1. 5.3. Classification
      1. Released Standard
      1. Draft Standard
      1. Deprecated Standard
    1. 5.4. Archetypes
      1. Published
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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276 Search results.
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Breast Cancer DataMart Common Data Elements for Adjuvant Clinical Trials

- 9/20/21 - 1 form, 16 itemgroups, 122 items, 1 language
Itemgroups: Patient Characteristics, Patient Performance Status, Protocol Design, Surgical Procedures, Pathologic Disease Classification, Pathology: Assessment of Lymph Nodes, Margins, Estrogen Status, Progesterone Status, Pathology: Breast Tumor Markers, Pathology: Assessment of Ductal Carcinoma In Situ (DCIS), Pathology: Assessment of Lobular Carcinoma In Situ (LCIS), Endpoints, Tumor Response, Sites of Progression, Notice of New Primary
Treatment - Breast Cancer DataMart Common Data Elements for Adjuvant Clinical Trials - 2719861v1.0 Breast Cancer DataMart Common Data Elements for Adjuvant Clinical Trials Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=43B3F0AE-1119-0B42-E044-0003BA3F9857

Treatment - Breast Cancer DataMart Common Data Elements Surgical Template - 2723098v1.0 - Breast Cancer DataMart Common Data Elements Surgical Template

- 9/20/17 - 1 form, 5 itemgroups, 24 items, 1 language
Itemgroups: Tumor Assessment, Assessment of Lymph Nodes, Surgical Procedures, Margins, Breast Reconstruction
Breast Cancer DataMart Common Data Elements Surgical Template Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=443F4BFB-7974-666C-E044-0003BA3F9857

Treatment - Proposed Breast Cancer DataMart Common Data Elements for Pre-Operative Clinical Trials - 2722335v1.0 - Proposed Breast Cancer DataMart Common Data Elements for Pre-Operative Clinical Trials

- 9/20/12 - 1 form, 7 itemgroups, 53 items, 1 language
Itemgroups: Clinical/Imaging Examination of the Breast, Clinical/Imaging Examination of Lymph Nodes, Pre-operative Surgical Evaluation, Diagnostic Pathology of Breast and Lymph Nodes, Marker Status, Therapeutic Changes, Residual Cancer Burden
Proposed Breast Cancer DataMart Common Data Elements for Pre-Operative Clinical Trials Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=43F0A8A5-2CF0-6BFA-E044-0003BA3F9857

CDASH Lab Result Assessment (Scenario 3, Part 2) - CDASH LAB Result Assessment (Scenario 3, Part 2)

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

CDASH Medical History

- 6/20/18 - 1 form, 4 itemgroups, 13 items, 3 languages
Itemgroups: General information, High Blood Pressure, Appendectomy, Other
modified from http://www.cdisc.org

CDASH Substance use

- 6/20/18 - 1 form, 3 itemgroups, 20 items, 2 languages
Itemgroups: Substance use – Cigarettes, Substance use – Cigars, Substance use – Alcohol
modified from http://www.cdisc.org

CDASH Adverse Event - Adverse Event

- 3/9/20 - 1 form, 2 itemgroups, 18 items, 2 languages
Itemgroups: General information, Details Adverse Event
translated and modified from CDASH Adverse Event 2011-10-24 http://www.cdisc.org/

CDASH ECG – Scenario 2 (local processing) - ECG – Scenario 2 (local processing)

- 6/20/18 - 1 form, 3 itemgroups, 16 items, 2 languages
Itemgroups: General information, ECG Information (Local processing), ECG Results
modified from http://www.cdisc.org

CDASH Vital Signs

- 6/20/18 - 1 form, 2 itemgroups, 14 items, 2 languages
Itemgroups: General information, Vital Sign
modified from http://www.cdisc.org

Subject Off Study: CRF Wisconsin Madison

- 6/20/18 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Header, Subject Off Study
ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Subject Off Study. Case Report Form (CRF)/Source Document templates were created for University of Wisconsin-Madison researchers. These templates are consistent with the FDA's CDASH (Clinical Data Acquisition Standards Harmonization) standards. The CDASH standards identify those elements that should be captured on a Case Report Form (CRF). The forms serve only as templates, and must be edited to meet the study data collection needs as described in the protocol.

CDASH End of Study - End of Study

- 6/20/18 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: End
modified from http://www.cdisc.org

CDASH Concomitant Medication - Concomitant medication

- 6/20/18 - 1 form, 2 itemgroups, 9 items, 2 languages
Itemgroups: General information, Details
translated and modified from CDASH 2011-10-24 http://www.cdisc.org

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