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Inhoudsopgave
  1. 1. Essai clinique
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
  5. 5. Standard de données
  6. 6. Questionnaire pour les patients
  7. 7. Spécialité médicale
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Pre-Study - NCI Standard Participant Identification Template - 2729615v1.0 - NCI Standard Participant Identification Template

- 20/09/2021 - 1 Formulier, 2 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Conditional Participant ID Questions, Optional Participant ID Questions
The collection of CDEs used in the Participant ID module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=46716FCE-3AD1-70D5-E044-0003BA3F9857

Registration - NCI Cooperative Group Registration Form - 2263990v3.0 - NCI Cooperative Group Registration Form

- 17/09/2021 - 1 Formulier, 6 Itemgroepen, 37 Data-elementen, 1 Taal
Itemgroepen: Registration Header, Protocol Administration, Patient Demographics/Pre-Treatment Characteristics, Certification of Eligibility, Protocol Design, Initial Patient Consent for Specimen Use
NCI Cooperative Group Registration Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D8879517-2F12-048F-E034-0003BA12F5E7

Pre-Study - PRIOR THERAPY SUPPLEMENT - 2394210v1.0 - PRIOR THERAPY SUPPLEMENT

- 09/01/2015 - 1 Formulier, 2 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: PRIOR THERAPY SUPPLEMENT, COMMENTS
Prior Therapy form for C3D 3.12 Adopters Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF07B012-CA3F-1CA3-E034-0003BA3F9857

Pre-Study - NCI Standard Registration Template - 2745056v1.0 - NCI Standard Registration Template

- 20/09/2012 - 1 Formulier, 3 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Mandatory Registration Questions, Conditional Registration Questions, Optional Registration Questions
The collection of CDEs used in the registration module. Registration consists of the registering institution applying for entry of a consented participant into a specific research study by conveying designated registration information to a central facility that is in charge of accepting participants into the study. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C056DEC-99CB-35E0-E044-0003BA3F9857

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

- 09/01/2015 - 1 Formulier, 3 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: 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

Breast Cancer Adverse Event NCT00382070 - rade 2 and 3 Adverse Event Report Breast Cancer NCT00382070 NSABP B-42

- 20/09/2021 - 1 Formulier, 2 Itemgroepen, 9 Data-elementen, 1 Taal
Itemgroepen: Header, Adverse event
NSABP Protocol B-42 - Grade 2 and 3 Adverse Event (AE) Report Form Worksheet Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer NCT00382070 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17ADF05F-DB75-341D-E044-0003BA3F9857

Vital Signs Anal Cancer NCT00324415

- 31/07/2015 - 1 Formulier, 3 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Header module, Vital Signs, Comments
Anal Cancer NCT00324415 On-Study - AMC-045 Vital Signs Form (F20) - 2937179v1.0 Cisplatin, Fluorouracil, Cetuximab, and Radiation Therapy in Treating Patients With HIV and Stage I, Stage II, or Stage III Anal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7285E88F-E0EF-C8EB-E040-BB89AD437ABB

Eligibility Breast Cancer, Colorectal Cancer NCT01493336

- 30/09/2019 - 1 Formulier, 2 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours; ODM derived from: https://clinicaltrials.gov/show/NCT01493336

Colorectal Cancer Non-Protocol Therapy NCT00303628 - Non-Protocol Therapy Colorectal Cancer NCT00303628 E5204

- 25/03/2015 - 1 Formulier, 2 Itemgroepen, 25 Data-elementen, 1 Taal
Itemgroepen: Header, Non-Protocol Therapy
E5204 Non-Protocol Therapy Form Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Had Surgery for Stage II or Stage III Rectal Cancer NCT00303628 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=089B4967-A7D1-3905-E044-0003BA3F9857

Breast cancer NCT00053898 - PATHOLOGIST'S REPORT FORM (NSABP B-35 NCT00053898)

- 22/03/2015 - 1 Formulier, 2 Itemgroepen, 24 Data-elementen, 1 Taal
Itemgroepen: Header, Pathology report
NSABP PROTOCOL B-35 PATHOLOGIST'S REPORT FORM Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy NCT00053898 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A01C3BB9-FE93-4CD3-E034-080020C9C0E0

Eligibility Breast Cancer, Early Breast Cancer NCT02443467

- 20/01/2017 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02443467

Colorectal cancer metastases (NCT00268463) - Quality of Life Form Colorectal Cancer (NSABP C-09 NCT00268463)

- 20/09/2021 - 1 Formulier, 8 Itemgroepen, 94 Data-elementen, 1 Taal
Itemgroepen: Header, Treatment satisfaction, PHYSICAL WELL-BEING, Social and family well being, EMOTIONAL WELL-BEING, Functional Health, ADDITIONAL CONCERNS, Activity
NSABP Protocol C-09: Quality of Life Form Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer NCT00268463 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FC7E0FCB-064A-58CD-E034-0003BA3F9857

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