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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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Vital Signs Anal Cancer NCT00324415

- 7/31/15 - 1 form, 3 itemgroups, 13 items, 1 language
Itemgroups: 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

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Subsequent Cycle) - Radium 223 Dichloride (Alpharadin) - Subsequent Cycle

- 2/16/22 - 1 form, 8 itemgroups, 57 items, 1 language
Itemgroups: Subject Visit,Assessment of Disease Progression,Vital Signs,BPI-SF,ECOG Performance Status,Hematology (with DBC),General Chemistry - Serum,Skeletal Related Events
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

Device Accountability Log: CRF Wisconsin Madison

- 11/17/21 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Header,Device Accountability Log: Device Receipt,Device Accountability Log: Device Use,Device Accountability Log: Device Return/Repair/Destruction
ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Device Accountability Log. Case Report Form (CRF)/Source Document templates were created for University of Wisconsin-Madison researchers. These templates are consistent with the FDA's CDASH (Clinical Data Acquisition Standards Harmonization) standards. The CDASH standards identify those elements that should be captured on a Case Report Form (CRF). The forms serve only as templates, and must be edited to meet the study data collection needs as described in the protocol.

On-Study - Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients - 2019420v3.0 - Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients

- 9/27/21 - 1 form, 4 itemgroups, 33 items, 1 language
Itemgroups: CRF Header,AML/MDS: Form Administration,AML/MDS: Disease Description,Comments
Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B24E8B9-F86C-508D-E044-0003BA3F9857

On-Study - Acute Myeloid Leukemia (AML) - On-Study Form - Previously Untreated Patients - 2019404v4.0 - Acute Myeloid Leukemia (AML) - On-Study Form - Previously Untreated Patients

- 9/27/21 - 1 form, 4 itemgroups, 32 items, 1 language
Itemgroups: CRF Header,AML: Form Administration,AML: Disease Description,Comments
Acute Myeloid Leukemia (AML) - On-Study Form - Previously Untreated Patients Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8D071CA6-C045-F391-E040-BB89AD4376C0

Leukemia NCT00085124 On-Study - CALGB: 10201On-Study Form - 2057573v3.0 - CALGB: 10201On-Study Form

- 9/27/21 - 1 form, 6 itemgroups, 39 items, 1 language
Itemgroups: CALGB Form,Patient Description,Organ Involvement,Current Symptoms,Lab data at Study Entry,CCRR MODULE
CALGB: 10201On-Study Form Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD838530-D422-2F4D-E034-0003BA12F5E7

Lung Cancer NCT00113386 On-Study - RTOG-0412 I1: Initial Evaluation Form - 2288131v3.0 - RTOG-0412 I1: Initial Evaluation Form

- 9/27/21 - 1 form, 3 itemgroups, 23 items, 1 language
Itemgroups: MODULE 1,PRE-TREATMENT CHACTERISTICS,LYMPH NODE ASSESSMENT
RTOG-0412 I1: Initial Evaluation Form Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E489FECB-49D8-0477-E034-0003BA3F9857

Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046 - Logs and Repeats

- 9/20/21 - 1 form, 3 itemgroups, 17 items, 1 language
Itemgroups: Administrative Data,Adverse Event/Concomitant Medication/Unscheduled Assessment,Liver Event
Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form is to be filled in at the end of the study (regular follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.

Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061 - Repeat Telemetry Abnormalities

- 9/20/21 - 1 form, 1 itemgroup, 78 items, 1 language
Itemgroup: Repeat Telemetry Abnormalities
Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Repeat Telemetry Abnormalities

Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061 - Holter ECG Results

- 9/20/21 - 1 form, 1 itemgroup, 79 items, 1 language
Itemgroup: Holter ECG Results
Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Holter ECG Results

General Information about Interview: PaReSiS UKH

- 9/20/21 - 1 form, 33 itemgroups, 103 items, 1 language
Itemgroups: Default Itemgroup,1. Beginning of interview,2. Presence of Others, who might interfere,3. Fill, if Interview has to be cancelled,4. Reason for canceling of interview,5. Family,6. Current living situation,7. Statutory supervisor,8. Help with household through Family and Friends,9. Do Friends and Family help with Nursing? If so, who?,10. Do you get other help through friends and family?,11. Would you describe one of them as your,12. Frequency of being supported by that,13. Description of Relationship with that person,14. Aids,15. Change of health insurance,16. Additional private Health insurance,17. Changes about care dependency,18. Care level,19. Is a new care level classification planned?,20. If yes, status of classification,21. Main service of health insurance,22. Changes / adjustments in living circumstances,23. Changes in living circumstances,24. Purchaser,25. Are changes planned?,26. Status,27. Frequency of leaving the house,28. Way of attending doctor´s appointments,29. Type of transportation in case of regular doctor´s appointments,30. Contact to Others,31. Interests and Hobbies,32. Most important interests
General Information about Interview: PaReSiS UKH Rehabilitation Study: "Partizipatives Rehabilitationsprozessmanagement, PaReSiS Schlaganfall in Sachsen-Anhalt" Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät Institut für Gesundheits- und Pflegewissenschaft Projekt: Partizipatives Rehabilitationsprozessmanagement „Schlaganfall in Sachsen-Anhalt“ Magdeburger Straße 8 06097 Halle (Saale), Germany E-Mail: paresis@medizin.uni-halle.de

Visit 7 / Early Termination Diab-MedSat [QS_3] NCT01117584

- 9/20/21 - 1 form, 9 itemgroups, 24 items, 1 language
Itemgroups: General Information,1. Over the past two weeks, how bothered have you been by...,2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?,3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to....,4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with....,5. Thinking about your diabetes medication(s) over the past two weeks....,6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to...,7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ....,8. Overall, based on your current experiences with your diabetes medications...
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

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