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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
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Breast Cancer NCT00433589 Treatment - Endocrine therapy - 2498727v1.0 - Endocrine therapy

- 1/9/15 - 1 form, 3 itemgroups, 14 items, 1 language
Itemgroups: Header,Endocrine therapy,Footer Module
Endocrine therapy Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19677A9A-FFBD-2E6F-E044-0003BA3F9857

Infection Episode

- 9/20/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Infection Episode
Information summarizing episodes of infection associated with treatment. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ACFF6F4C-B15B-1776-E040-BB89AD43285B

UKHD - Universitäts-Frauenklinik, Sektion Senologie Verlaufsblatt - Mamma Carcinom - Verlaufsangaben

- 3/9/22 - 10 forms, 3 itemgroups, 38 items, 1 language
Itemgroups: Verlaufsangaben,Präoperative Vorbereitung - Checkliste,OP und Verlauf
Routinedokumentation der Universitäts-Frauenklinik, Sektion Senologie Verlaufsblatt - Mamma Carcinom - Multimodale Brustdiagnostik. Sektionsleiter Senologie: Prof. Dr. med. Jörg Heil, MHBA

Empfehlung des postoperativen Tumorboards

1 itemgroup 26 items

Poststationäre Ergänzungen

1 itemgroup 2 items

Pathologie

3 itemgroups 121 items

Admission Checklist Children Oncology Pediatric Hematology and Oncology UK Muenster

- 11/17/21 - 1 form, 12 itemgroups, 60 items, 2 languages
Itemgroups: Checklist,InInfectivity,Planned therapy,Supportive therapy,Transfusions,Chemotherapy flush,Intensive Care,Laboratories and Diagnostics,Hypersensitivities and Premedication,Next visits,Other,KIONK Physician
Bei Aufnahme eines Patienten außerhalb 17A West und KMT-Station, aber innerhalb des Zentrums für Kinder- und Jugendmedizin. Freigabe zur Verarbeitung durch Frau Prof. Rössig, Quellenangabe: "Pädiatrische Hämatologie und Onkologie, UKM" Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Münster Released for adaption by Frau Prof. Rössig Source:Pediatric Hematology und Oncology, University hospital Münster

KBV Remedy Prescription for Speech Therapy Template 14

- 9/27/21 - 1 form, 13 itemgroups, 79 items, 1 language
Itemgroups: Header,Prescription,Remedy Prescription,Therapy,Diagnosis,Audiogram,Audiogram left,Audiogram right,Laryngological Finding,Approval,Footer,Receipt,Treatment
Muster 14 - Heilmittelverordnung Maßnahmen der Stimm-, Sprech- und Sprachtherapie (Freigabe 29.04.2016). Formulare für die vertragsärztliche Versorgung - Freigabe durch Dezernat 4 - Ärztliche Leistungen und Versorgungsstruktur Geschäftsbereich Sicherstellung und Versorgungsstruktur Abteilung Sicherstellung Herbert-Lewin-Platz 2 10623 Berlin Tel: + 49 (0) 30 - 4005 -1418 Fax: + 49 (0) 30 - 4005 - 271418 Email: SJohn@KBV.de Web: www.kbv.de Quelle: http://www.kbv.de/html/formulare.php --- Template 14 - Remedy Prescription for Speech Therapy (Released 04-29-2016). Released by Department 4 - Medical treatment and structure of supply, division ensurance and structure of supply, department ensurance Herbert-Lewin-Platz 2 10623 Berlin Tel: + 49 (0) 30 - 4005 -1418 Fax: + 49 (0) 30 - 4005 - 271418 Email: SJohn@KBV.de Web: www.kbv.de Source: http://www.kbv.de/html/formulare.php

Esophageal Cancer NCT00655876 Treatment - TF: Radiation Therapy Oncology Group Phase III Esophagus Systemic Treatment Summary Form - 2598533v1.0 - TF: Radiation Therapy Oncology Group Phase III Esophagus Systemic Treatment Summary Form

- 9/27/21 - 1 form, 6 itemgroups, 56 items, 1 language
Itemgroups: MODULE 1,Summary of Systemic Treatment,Summary of Systemic Treatment,Protocol Specific Adverse Events Evaluation,REPORT ALL CONTINUING OR NEW ADVERSE EVENTS,Footer
TF: Radiation Therapy Oncology Group Phase III Esophagus Systemic Treatment Summary Form Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A02FE34-6EF5-5B5C-E044-0003BA3F9857

Treatment - Infection Episode - 3277947v1.0 - Infection Episode

- 9/27/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Infection Episode
Information summarizing episodes of infection associated with treatment. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ACFF6F4C-B15B-1776-E040-BB89AD43285B

ICHOM Localized Prostate Cancer - Clinical Form annually after treatment initiation

- 9/20/21 - 1 form, 4 itemgroups, 52 items, 1 language
Itemgroups: 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

- 9/20/21 - 1 form, 3 itemgroups, 48 items, 1 language
Itemgroups: 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.

Treatment Summary NSCLC Stage III RTOG NCT00533949

- 9/20/21 - 1 form, 3 itemgroups, 36 items, 1 language
Itemgroups: RTOG clinical trial administrative data,Assessment of Chemotherapy,REPORT ALL CONTINUING OR NEW ADVERSE EVENTS
NCT00533949 TF: Radiation Therapy Oncology Group Phase III High-dose Vs Standard-dose Conformal XRT with Chemotherapy Treatment Summary Form High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24FB4F78-9A8F-669C-E044-0003BA3F9857

Prior Radiation Supplement

- 9/20/21 - 1 form, 1 itemgroup, 12 items, 1 language
Itemgroup: Prior Radiation Supplement
Details of prior radiation therapy related to the disease being studies by the protocol or when the details would be clinically significant for the evaluation of this study. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD011733-7341-F6FC-E040-BB89AD436515

AMC-070 Interventions Form (RK5)

- 9/20/21 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Header - Interventions Form,Interventions,Comments
AMC-070 Interventions Form (RK5) Lenalidomide in Treating Patients With AIDS-Related Kaposi Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91E37C30-3E56-3E5F-E040-BB89AD43368B

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