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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  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
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Basic documentation B1 LeMLAR-Studie Lymphoma NCT01788189 - Basic documentation B1

- 9/22/16 - 1 form, 3 itemgroups, 33 items, 1 language
Itemgroups: diagnosis Histology, Medical pathologist, medical history
Study part: Basic documentation B1 LeMLAR-Studie. Lenalidomide in conjunction with methotrexate, leucovorin, cytarabine and rituximab for the treatment of relapsed or refractory CD20-positive aggressive lymphomas: an open-label, multicenter phase I/II trial. Publication granted by Prof. Dührsen and provided by Claudia Ose, University clinic Essen, NCT01788189, Version 1.3-28.04.2013.doc.

Screening Biopsy GOAL Trial B-cell Lymphoma NCT02499003

- 9/20/21 - 1 form, 3 itemgroups, 22 items, 1 language
Itemgroups: Admininstrative data, Bone marrow biopsy, Biopsy Tumor
NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Pathology - Pathology Report - 3300776v1.0 - Pathology Report

- 9/20/21 - 1 form, 4 itemgroups, 42 items, 1 language
Itemgroups: Pathology Report Proposal, Gross Description, Histology, Microscopic Description
Record Pathology information when required by the protocol. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B129F85E-2400-87F0-E040-BB89AD43726A

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Histology

- 8/11/21 - 1 form, 3 itemgroups, 24 items, 1 language
Itemgroups: Administrative Data, Waldenstrom's Histology, Lymphoplasmacytic lymphoma histology
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. The different parts of this form have to be filled out at the Screening Visit and/or at unscheduled visits.

Pathology - Leukemia Pathology Form - Cytogenetics - 2019350v3.0 - Leukemia Pathology Form - Cytogenetics

- 9/20/21 - 1 form, 3 itemgroups, 47 items, 1 language
Itemgroups: CRF Header, Pathology: Form Administration, Pathology: Cytogenetic Assessment
Leukemia Pathology Form - Cytogenetics Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B4D83AE-8665-6A50-E044-0003BA3F9857

AML Material Submission Form Pathology NCT00049517 - Material Submission Form Pathology AML E1900 NCT00049517

- 9/20/21 - 1 form, 3 itemgroups, 31 items, 1 language
Itemgroups: Header, Completed by submitting institutions, Completed by central lab
E1900 Material Submission Form Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia NCT00049517 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A727E0B4-B257-2F80-E034-0003BA0B1A09

CALGB: 10603 Leukemia Pathology Form - Cytogenetics DRKS00003845 NCT00651261 - CALGB: 10603 Leukemia Pathology Form - Cytogenetics NCT00651261

- 9/20/21 - 1 form, 4 itemgroups, 31 items, 1 language
Itemgroups: Header, Patient demographics, Cytogenetics, Footer Module
CALGB: 10603 Leukemia Pathology Form - Cytogenetics NCT00651261 Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=46C44DBD-4DDE-66EA-E044-0003BA3F9857

Leukemia null Pathology - S0100 SPECIMEN SUBMISSION FORM - 2070809v3.0 - S0100 SPECIMEN SUBMISSION FORM

- 9/17/21 - 1 form, 4 itemgroups, 32 items, 1 language
Itemgroups: SPECIMEN, REASONS FOR SPECIMEN SUBMISSION, For Central Laboratory Use Only, Specimen Submission Form
S0100 SPECIMEN SUBMISSION FORM Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AEB420C1-7F40-419F-E034-0003BA12F5E7

Leukemia null Pathology - S0100 PATHOLOGY SUBMISSION FORM - 2070699v3.0 - S0100 PATHOLOGY SUBMISSION FORM

- 9/17/21 - 1 form, 1 itemgroup, 20 items, 1 language
Itemgroup: Pathology Submission Form
S0100 PATHOLOGY SUBMISSION FORM Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AEB412F0-20C0-418F-E034-0003BA12F5E7

CALGB_40302_TISS_TRCK_FRM NCT00390455

- 9/20/21 - 1 form, 3 itemgroups, 24 items, 1 language
Itemgroups: Header, Patient demographics, TISSUE TRACKING
CALGB: 40302 TISSUE TRACKING FORM NCT00390455 Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F5AC8F60-F3F9-0DB4-E034-0003BA3F9857

North Central Cancer Treatment Group Arms A & D Only Recurrent Research Tissue Submission Form NCT00079274

- 9/20/21 - 1 form, 3 itemgroups, 29 items, 1 language
Itemgroups: Header module, Visit, Instructions
North Central Cancer Treatment Group Arms A and D Only Recurrent Research Tissue Submission Form NCT00079274 Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8BC1F4CF-E66A-E266-E040-BB89AD436B4E

SWOG Leukemia - PATHOLOGY SUBMISSION FORM

- 8/3/17 - 1 form, 1 itemgroup, 21 items, 1 language
Itemgroup: CCRR MODULE
S0100 PATHOLOGY SUBMISSION FORM - LEUKEMIA ADDENDUM Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AEB41C46-31DA-419A-E034-0003BA12F5E7

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