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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
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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DEM

- 9/20/21 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: Patient demographics
DEM Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF1A18C7-58B3-19A7-E034-0003BA3F9857

Leukemia, Myelocytic, Acute null - - CTEP Transplant CDEs - 2444533v1.0 - CTEP Transplant CDEs

- 9/20/21 - 1 form, 1 itemgroup, 131 items, 1 language
Itemgroup: Transplantation
CTEP Transplant CDEs Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0B976B1B-4AB1-64EE-E044-0003BA3F9857

Breast Cancer NCT00659373 Treatment - Ovarian Function Suppression Form (Form 24-OFS) - 2080631v3.0 - Ovarian Function Suppression Form (Form 24-OFS)

- 9/17/21 - 1 form, 5 itemgroups, 44 items, 1 language
Itemgroups: CCRR MODULE, GnRH ANALOGUE, SURGICAL OOPHORECTOMY, BILATERAL OVARIAN RADIATION THERAPY, Confirmation of biochemical evidence of cessation of ovarian function after ovarian radiotherapy is completed.
Ovarian Function Suppression Form (Form 24-OFS) Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG-2402 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B70C65E9-F1BA-21F5-E034-0003BA12F5E7

Treatment - 2450 - Post-Transplant Essential Data (TED) ISO Date Format Version 1 - 2888418v1.0 - 2450 - Post-Transplant Essential Data (TED) ISO Date Format Version 1

- 9/17/21 - 1 form, 19 itemgroups, 107 items, 1 language
Itemgroups: Registry Use Only, Center Identification, Recipient Identification, 100 Day Report Only, Initial ANC Recovery, Initial Platelet Recovery, Graft versus Host Disease, New Malignancy, Lymphoproliferative or Myeloproliferative Disorder - Part 1 of 2, New Malignancy, Lymphoproliferative or Myeloproliferative Disorder - Part 2 of 2, Survival (Part 1 of 2), Survival (Part 2 of 2), Post - HSCT Therapy, HSCT for Non-Malignant Disease ONLY, Malignant Disease Evaluation for This HSCT, First Relapse or Progression After HSCT, Additional Treatment, Method of Latest Disease Assessment, Donor Cellular Infusion (DCI) (Part 1 of 2), Donor Cellular Infusion (DCI) (Part 2 of 2)
Post-Transplant Essential Data (TED) Uses The ISO Date Format Version 1 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6ABDA2AA-191F-5CB2-E040-BB89AD431CF3

Treatment - Lymphoma - Transplant Treatment Form - 2269914v3.0 - Lymphoma - Transplant Treatment Form

- 9/17/21 - 1 form, 6 itemgroups, 65 items, 1 language
Itemgroups: CRF Header, Lymphoma: Form Administration, Lymphoma Transplant: Treatment Plan, Lymphoma Transplant: Donor Lymphocyte Infusions, Lymphoma Transplant: Allogeneic - Donor Information, Comments
Lymphoma - Transplant Treatment Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D5EA8AC6-6F28-703F-E034-0003BA12F5E7

Treatment - 2450 Revision 2 - Post-Transplant Essential Data (TED) - 2898108v1.0 - 2450 Revision 2 - Post-Transplant Essential Data (TED)

- 9/17/21 - 1 form, 20 itemgroups, 109 items, 1 language
Itemgroups: Registry Use Only, Center Identification, Recipient Identification, 100 Day Report Only, Initial ANC Recovery, Initial Platelet Recovery, Graft versus Host Disease, New Malignancy, Lymphoproliferative or Myeloproliferative Disorder - Part 1 of 3, New Malignancy, Lymphoproliferative or Myeloproliferative Disorder - Part 2 of 3, New Malignancy, Lymphoproliferative or Myeloproliferative Disorder Part 3 of 3, Survival (Part 1 of 2), Survival (Part 2 of 2), Post - HSCT Therapy, HSCT for Non-Malignant Disease ONLY, Malignant Disease Evaluation for This HSCT, First Relapse or Progression After HSCT, Additional Treatment, Method of Latest Disease Assessment, Donor Cellular Infusion (DCI) (Part 1 of 2), Donor Cellular Infusion (DCI) (Part 2 of 2)
Revision 2 of Form 2450 Post-Transplant Essential Data (TED) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6B9E8DCD-3CAF-40FC-E040-BB89AD434581

Treatment - 2400 - Pre-Transplant Essential Data (TED) - 2492857v5.0 - 2400 - Pre-Transplant Essential Data (TED)

- 9/17/21 - 1 form, 69 itemgroups, 315 items, 1 language
Itemgroups: CIBMTR Use Only, Center Identification, Recipient Identification: Part 1 of 2, Study ID Number, Recipient Identification: Part 2 of 2, Recipient Race, Disease Classification, Hematopoietic Stem Cell Transplant (HSCT) : Part 1 of 4, Cell Source, Hematopoietic Stem Cell Transplant (HSCT) : Part 2 of 4, Donor Information, Hematopoietic Stem Cell Transplant (HSCT) : Part 3 of 4, Ex Vivo Graft Manipulation Type, Hematopoietic Stem Cell Transplant (HSCT) : Part 4 of 4, Preparative Regimen - Part 1 / 7, Preparative Regimen - Part 2 / 7, Preparative Regimen - Part 3 / 7 (Anthracyclines), Preparative Regimen - Part 4 / 7 (Monoclonal Antibodies), Preparative Regimen - Part 5 / 7 (Radiolabeled MAb), Preparative Regimen - Part 6 / 7 (Intent of Preparative Regimen), Preparative Regimen - Part 7 / 7 (Reason for NST / RIC), Comorbid Conditions, Type of Comorbid Condition, GVHD Prophylaxis, Post-HSCT Disease Therapy Planned as of Day 0, Type of Additional Post-HSCT Therapy, Other Toxicity Modifying Regimen, Pre-Transplant Essential Data Disease Classification Sheet, Acute Myelogenous Leukemia (AML) or Acute Nonlymphocytic Leukemia (ANLL): Part 1 of 2, Type of Therapy Related AML, Acute Myelogenous Leukemia (AML) or Acute Nonlymphocytic Leukemia (ANLL): Part 2 of 2, Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML): Part 1 of 2, CML Prior HSCT Treatment, Chronic Myelogenous Leukemia (CML): Part 2 of 2, Myelodysplastic or Myeloproliferative Disease Classification, Myelodysplastic or Myeloproliferative Diseases: Part 1 of 2, Type of Therapy Related MDS / MPS, Myelodysplastic or Myeloproliferative Diseases: Part 2 of 2, Other Leukemias, Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Plasma Cell Disorders, Breast Cancer, Other Disease, Other Malignancies, Anemia/Hemoglobinopathy, Platelet Disorders, Histiocytic Disorders, Inherited Disorders of Metabolism/Osteopetrosis, Immune Deficiencies, Autoimmune Disorders, Systemic Sclerosis Involvement, Systemic Sclerosis Laboratory Procedures, Systemic Lupus Erythematosus (SLE) Involvement, Systemic Lupus Erythematosus (SLE) Laboratory Procedures, Sjogren Syndrome Involvement, Polymyositis / Dermatomyositis Involvement, Polymyositis / Dermatomyositis Laboratory Procedure, Antiphospholipid Syndrome Involvement, Antiphospholipid Syndrome Laboratory Procedures, Wegener Granulomatosis Involvement, Wegener Granulomatosis Laboratory Procedures, Polyarteritis Nodosa Involvement, Polyarteritis Nodosa Laboratory Procedures, Rheumatoid Arthritis Involvement, Psoriatic Arthritis / Psoriasis Involvement, Multiple Sclerosis (MS) Involvement
Pre-Transplant Essential Data (TED) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=609D5967-37B1-F25E-E040-BB89AD437F88

Treatment - 2400 Revision 1 - Pre-Transplant Essential Data (TED) ISO Date Format - 2892485v2.0 - 2400 Revision 1 - Pre-Transplant Essential Data (TED) ISO Date Format

- 9/17/21 - 1 form, 69 itemgroups, 315 items, 1 language
Itemgroups: CIBMTR Use Only, Center Identification, Recipient Identification: Part 1 of 2, Study ID Number, Recipient Identification: Part 2 of 2, Recipient Race, Disease Classification, Hematopoietic Stem Cell Transplant (HSCT) : Part 1 of 4, Cell Source, Hematopoietic Stem Cell Transplant (HSCT) : Part 2 of 4, Donor Information, Hematopoietic Stem Cell Transplant (HSCT) : Part 3 of 4, Ex Vivo Graft Manipulation Type, Hematopoietic Stem Cell Transplant (HSCT) : Part 4 of 4, Preparative Regimen - Part 1 / 7, Preparative Regimen - Part 2 / 7, Preparative Regimen - Part 3 / 7 (Anthracyclines), Preparative Regimen - Part 4 / 7 (Monoclonal Antibodies), Preparative Regimen - Part 5 / 7 (Radiolabeled MAb), Preparative Regimen - Part 6 / 7 (Intent of Preparative Regimen), Preparative Regimen - Part 7 / 7 (Reason for NST / RIC), Comorbid Conditions, Type of Comorbid Condition, GVHD Prophylaxis, Post-HSCT Disease Therapy Planned as of Day 0, Type of Additional Post-HSCT Therapy, Other Toxicity Modifying Regimen, Pre-Transplant Essential Data Disease Classification Sheet, Acute Myelogenous Leukemia (AML) or Acute Nonlymphocytic Leukemia (ANLL): Part 1 of 2, Type of Therapy Related AML, Acute Myelogenous Leukemia (AML) or Acute Nonlymphocytic Leukemia (ANLL): Part 2 of 2, Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML): Part 1 of 2, CML Prior HSCT Treatment, Chronic Myelogenous Leukemia (CML): Part 2 of 2, Myelodysplastic or Myeloproliferative Disease Classification, Myelodysplastic or Myeloproliferative Diseases: Part 1 of 2, Type of Therapy Related MDS / MPS, Myelodysplastic or Myeloproliferative Diseases: Part 2 of 2, Other Leukemias, Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Plasma Cell Disorders, Breast Cancer, Other Disease, Other Malignancies, Anemia/Hemoglobinopathy, Platelet Disorders, Histiocytic Disorders, Inherited Disorders of Metabolism/Osteopetrosis, Immune Deficiencies, Autoimmune Disorders, Systemic Sclerosis Involvement, Systemic Sclerosis Laboratory Procedures, Systemic Lupus Erythematosus (SLE) Involvement, Systemic Lupus Erythematosus (SLE) Laboratory Procedures, Sjogren Syndrome Involvement, Polymyositis / Dermatomyositis Involvement, Polymyositis / Dermatomyositis Laboratory Procedure, Antiphospholipid Syndrome Involvement, Antiphospholipid Syndrome Laboratory Procedures, Wegener Granulomatosis Involvement, Wegener Granulomatosis Laboratory Procedures, Polyarteritis Nodosa Involvement, Polyarteritis Nodosa Laboratory Procedures, Rheumatoid Arthritis Involvement, Psoriatic Arthritis / Psoriasis Involvement, Multiple Sclerosis (MS) Involvement
Revision 1 of form 2400 - Pre-Transplant Essential Data (TED) Uses The ISO Date Format Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8331F8AF-85A0-6ABF-E040-BB89AD437A3C

Treatment - 2400 Revision 2 - Pre-Transplant Essential Data (TED) - 3002012v2.0 - 2400 Revision 2 - Pre-Transplant Essential Data (TED)

- 9/17/21 - 1 form, 71 itemgroups, 316 items, 1 language
Itemgroups: CIBMTR Use Only, Center Identification, Recipient Identification: Part 1 of 2, Study ID Number, Recipient Identification: Part 2 of 2, Recipient Race, Disease Classification, Hematopoietic Stem Cell Transplant (HSCT) : Part 1 of 4, Cell Source, Autologous HSCT, Hematopoietic Stem Cell Transplant (HSCT) : Part 2 of 4, Donor Information, Hematopoietic Stem Cell Transplant (HSCT) : Part 3 of 4, Ex Vivo Graft Manipulation Type, Hematopoietic Stem Cell Transplant (HSCT) : Part 4 of 4, Preparative Regimen - Part 1 / 7, Preparative Regimen - Part 2 / 7, Preparative Regimen - Part 3 / 7 (Anthracyclines), Preparative Regimen - Part 4 / 7 (Monoclonal Antibodies), Preparative Regimen - Part 5 / 7 (Radiolabeled MAb), Preparative Regimen - Part 6 / 7 (Intent of Preparative Regimen), Preparative Regimen - Part 7 / 7 (Reason for NST / RIC), Comorbid Conditions, Type of Comorbid Condition, GVHD Prophylaxis, Post-HSCT Disease Therapy Planned as of Day 0, Type of Additional Post-HSCT Therapy, Other Toxicity Modifying Regimen, Pre-Transplant Essential Data Disease Classification Sheet, Acute Myelogenous Leukemia (AML) or Acute Nonlymphocytic Leukemia (ANLL): Part 1 of 2, Type of Therapy Related AML, Acute Myelogenous Leukemia (AML) or Acute Nonlymphocytic Leukemia (ANLL): Part 2 of 2, Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML): Part 1 of 2, CML Prior HSCT Treatment, Chronic Myelogenous Leukemia (CML): Part 2 of 2, Myelodysplastic or Myeloproliferative Disease Classification at Diagnosis, Myelodysplastic or Myeloproliferative Disease Status at Transplantation, Myelodysplastic or Myeloproliferative Diseases: Part 1 of 2, Type of Therapy Related MDS / MPS, Myelodysplastic or Myeloproliferative Diseases: Part 2 of 2, Other Leukemias, Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Plasma Cell Disorders, Breast Cancer, Other Disease, Other Malignancies, Anemia/Hemoglobinopathy, Platelet Disorders, Histiocytic Disorders, Inherited Disorders of Metabolism/Osteopetrosis, Immune Deficiencies, Autoimmune Disorders, Systemic Sclerosis Involvement, Systemic Sclerosis Laboratory Procedures, Systemic Lupus Erythematosus (SLE) Involvement, Systemic Lupus Erythematosus (SLE) Laboratory Procedures, Sjogren Syndrome Involvement, Polymyositis / Dermatomyositis Involvement, Polymyositis / Dermatomyositis Laboratory Procedure, Antiphospholipid Syndrome Involvement, Antiphospholipid Syndrome Laboratory Procedures, Wegener Granulomatosis Involvement, Wegener Granulomatosis Laboratory Procedures, Polyarteritis Nodosa Involvement, Polyarteritis Nodosa Laboratory Procedures, Rheumatoid Arthritis Involvement, Psoriatic Arthritis / Psoriasis Involvement, Multiple Sclerosis (MS) Involvement
Revision 2 of form 2400 - Pre-Transplant Essential Data (TED) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=83325950-9451-ACDB-E040-BB89AD4322D7

Treatment - 2450 - Post-Transplant Essential Data (TED) - 2792764v3.0 - 2450 - Post-Transplant Essential Data (TED)

- 9/17/21 - 1 form, 19 itemgroups, 107 items, 1 language
Itemgroups: Registry Use Only, Center Identification, Recipient Identification, 100 Day Report Only, Initial ANC Recovery, Initial Platelet Recovery, Graft versus Host Disease, New Malignancy, Lymphoproliferative or Myeloproliferative Disorder - Part 1 of 2, New Malignancy, Lymphoproliferative or Myeloproliferative Disorder - Part 2 of 2, Survival (Part 1 of 2), Survival (Part 2 of 2), Post - HSCT Therapy, HSCT for Non-Malignant Disease ONLY, Malignant Disease Evaluation for This HSCT, First Relapse or Progression After HSCT, Additional Treatment, Method of Latest Disease Assessment, Donor Cellular Infusion (DCI) (Part 1 of 2), Donor Cellular Infusion (DCI) (Part 2 of 2)
Post-Transplant Essential Data (TED) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=60000F98-92BB-426C-E040-BB89AD43447C

TIME AND EVENTS TABLE Ropinirole Case Report Form GSK RRL100013 - TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

- 9/17/21 - 1 form, 1 itemgroup, 30 items, 2 languages
Itemgroup: TIME AND EVENTS TABLE
Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Treatment - Multiple Myeloma - Transplant Treatment Form - 2273247v3.0 - Multiple Myeloma - Transplant Treatment Form

- 9/17/21 - 1 form, 6 itemgroups, 74 items, 1 language
Itemgroups: CRF Header, Myeloma: Form Administration, Myeloma Transplant: Treatment Plan, Myeloma Transplant: Donor Lymphocyte Infusions, Myeloma Transplant: Allogeneic - Donor Information, Comments
Multiple Myeloma - Transplant Treatment Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D677F87F-A4D6-081D-E034-0003BA12F5E7

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