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Breast Cancer DataMart Common Data Elements for Adjuvant Clinical Trials

- 20/09/2021 - 1 Formulaire, 16 Groupes Item, 122 Eléments de données, 1 Langue

Groupes Item: 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

- 20/09/2017 - 1 Formulaire, 5 Groupes Item, 24 Eléments de données, 1 Langue

Groupes Item: 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

- 20/09/2012 - 1 Formulaire, 7 Groupes Item, 53 Eléments de données, 1 Langue

Groupes Item: 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

Cancer Treatments Protocol PhenX Toolkit

- 26/04/2016 - 1 Formulaire, 1 Groupe Item, 18 Eléments de données, 1 Langue

Groupe Item: PhenX - cancer treatment protocol

These questions start by asking if the respondent has had cancer. For respondents who have had cancer, detailed follow-up questions ask about the type of cancer treatment, including surgery, chemotherapy, radiation, and hormone therapy. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Early Term: Vital Signs Form

- 19/11/2018 - 1 Formulaire, 2 Groupes Item, 20 Eléments de données, 1 Langue

Groupes Item: Administrative data, Vital Signs

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

ICHOM Localized Prostate Cancer - Clinical Form annually after treatment initiation

- 20/09/2021 - 1 Formulaire, 4 Groupes Item, 52 Eléments de données, 1 Langue

Groupes Item: Patient ID, Treatment Variables, Acute Complications of Treatment, Survival and Disease Control

LOCALIZED PROSTATE CANCER DATA COLLECTION Version 2.0.5 Revised: April 7th , 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: Localized prostate cancer Treatment Approaches: Active Surveillance | Watchful Waiting | Radical Prostatectomy* | External Beam Radiation Therapy* | Androgen Deprivation Therapy (ADT)* | Focal Therapy* | Other* * These should also be collected as salvage treatments where necessary This ODM-file contains a Clinical Form to be used annually after salvage treatment initiation. Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. TEST StudyFor example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. Survey used: Expanded Prostate Cancer Index Composite (EPIC-26): The EPIC-26 is free for all health care organizations, and a license is not needed. The scoring guide may be found at http://www.med.umich.edu/urology/research/EPIC/EPIC-26-Scoring-1.2007.pdf ; Wei J, Dunn R, Litwin M, Sandler H, and Sanda M. "Development and Validation of the Expanded Prostate Cancer Index Composite (EPIC) for Comprehensive Assessment of Health-Related Quality of Life in Men with Prostate Cancer", Urology. 56: 899-905, 2000. For registries choosing to implement the EPIC-CP rather than the EPIC-26, we recommend using the same variable IDs as the corresponding EPIC-26 questions. This means that only questions 2, 3, 4a, 4b, 4d, 4e, 5, 6e, 6b, 7, 8b, 9, 12, 13a, 13c, and 13d of the EPIC-26 are administered. Utilization of Sexual Medications/Devices: The Utilization of Sexual Medications/Devices is free for all health care organizations, and a license is not needed. Refer to http://dx.doi.org/10.1016/j.urology.2006.01.077 for more information European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ- PR25): The EORTC QLQ-PR25 is free for all health care organizations, but a license is needed for use. Therefore it will not be integrated in this Version of the questionnaire. For more information, please visit http://groups.eortc.be/qol/eortc-qlq-c30 . ICHOM was supported for the Localized Prostate Cancer Standard Set by the Movember Foundation. Publication: Martin NE, Massey L, Stowell C, et al. Defining a standard set of patient-centered outcomes for men with localized prostate cancer. Eur Urol. 2015;67(3):460‐467. doi:10.1016/j.eururo.2014.08.075 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Localized Prostate Cancer - Clinical Form within 6 months after treatment initiation

- 20/09/2021 - 1 Formulaire, 3 Groupes Item, 48 Eléments de données, 1 Langue

Groupes Item: Patient ID, Treatment Variables, Acute Complications of Treatment

LOCALIZED PROSTATE CANCER DATA COLLECTION Version 2.0.5 Revised: April 7th , 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: Localized prostate cancer Treatment Approaches: Active Surveillance | Watchful Waiting | Radical Prostatectomy* | External Beam Radiation Therapy* | Androgen Deprivation Therapy (ADT)* | Focal Therapy* | Other* * These should also be collected as salvage treatments where necessary This ODM-file contains a Clinical Form to be used 6 months after primary treatment initiation. Surveys used: Expanded Prostate Cancer Index Composite (EPIC-26): The EPIC-26 is free for all health care organizations, and a license is not needed. The scoring guide may be found at http://www.med.umich.edu/urology/research/EPIC/EPIC-26-Scoring-1.2007.pdf ; Wei J, Dunn R, Litwin M, Sandler H, and Sanda M. "Development and Validation of the Expanded Prostate Cancer Index Composite (EPIC) for Comprehensive Assessment of Health-Related Quality of Life in Men with Prostate Cancer", Urology. 56: 899-905, 2000. For registries choosing to implement the EPIC-CP rather than the EPIC-26, we recommend using the same variable IDs as the corresponding EPIC-26 questions. This means that only questions 2, 3, 4a, 4b, 4d, 4e, 5, 6e, 6b, 7, 8b, 9, 12, 13a, 13c, and 13d of the EPIC-26 are administered. Utilization of Sexual Medications/Devices: The Utilization of Sexual Medications/Devices is free for all health care organizations, and a license is not needed. Refer to http://dx.doi.org/10.1016/j.urology.2006.01.077 for more information European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ- PR25): The EORTC QLQ-PR25 is free for all health care organizations, but a license is needed for use. Therefore it will not be integrated in this Version of the questionnaire. For more information, please visit http://groups.eortc.be/qol/eortc-qlq-c30 . ICHOM was supported for the Localized Prostate Cancer Standard Set by the Movember Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Lung Cancer - At time of treatment decision - Clinical Form

- 30/04/2020 - 1 Formulaire, 2 Groupes Item, 2 Eléments de données, 1 Langue

Groupes Item: Administrative data, Treatment Factors

ICHOM Lung cancer data collection Version 2.3.1 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://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. For Lung Cancer, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Small Cell and Non-Small Cell Lung Cancer Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy | Immunotherapy | Other This document contains At time of treatment decision - Clinical Form. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13). Both are free for all health care organizations, but a license is needed for use. http:// groups.eortc.be/qol/eortc-qlq-c30 is the official distribution site for EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires. Therefore only the total score will be included in this version of the standard set. Publication: Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852–860. doi:10.1183/13993003.02049-2015 For this standard set ICHOM was supported by the Alliance of Dedicated Cancer Centers. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Lung Cancer - Begin of treatment - Clinical Form

- 30/04/2020 - 1 Formulaire, 2 Groupes Item, 3 Eléments de données, 1 Langue

Groupes Item: Administrative data, Other

ICHOM Lung cancer data collection Version 2.3.1 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://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. For Lung Cancer, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Small Cell and Non-Small Cell Lung Cancer Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy | Immunotherapy | Other This document contains Begin of treatment - Clinical Form. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13). Both are free for all health care organizations, but a license is needed for use. http:// groups.eortc.be/qol/eortc-qlq-c30 is the official distribution site for EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires. Therefore only the total score will be included in this version of the standard set. Publication: Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852–860. doi:10.1183/13993003.02049-2015 For this standard set ICHOM was supported by the Alliance of Dedicated Cancer Centers. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Therapeutic direction (EHR Archetype) - openEHR-EHR-CLUSTER.therapeutic_direction.v1

- 08/07/2017 - 1 Formulaire, 1 Groupe Item, 7 Eléments de données, 3 Langues

Groupe Item: openEHR-EHR-CLUSTER.therapeutic_direction.v1.xml

Derived from www.openehr.org . A direction describes one or more sequential therapeutic administration patterns, coupled with an overall direction duration and details of any repetitive pattern of intended administration outside a single day. For example: '1 tab in the morning, 1 tab at night, for 3 weeks, on Mondays, Wednesdays and Fridays'. This cluster allows multiple occurrences to enable representation of a complete set of dosage directions for a single medication order. The cluster can be renamed in template or at run-time to represent a specific dosing event such as 'loading dose', 'bolus'. This archetype will gnerally be used in the context of a parent INSTRUCTION archetype, primarily Medication order but also for transfusion and dialysis orders.

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