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TEMPLATE INSTRUCTIONS The protocol template is a tool to facilitate rapid protocol development. It is not intended to supersede the role of the Protocol Chair in the authoring and scientific development of the protocol
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Document Date: 2014-07-21 21:23:40

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City

Philadelphia / /

Company

Expedited AE / Integral Laboratory / Hour 5 Calendar Days Expedited AE / Investigators and Associates / AEs / CTEP / Dana / Medidata / /

Country

Laos / /

Currency

pence / /

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Event

FDA Phase / /

Facility

Duke University / Cancer Institute / Rutgers University / University of Texas / Cancer Institute LAO LAO-TX035 / National Cancer Institute / /

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IndustryTerm

protocol web page / Cancer Therapy / Internet connectivity / imaging / food / study-specific commercial imaging agent / human imaging studies / therapy/combination therapy/advanced imaging / combination protocol / Cancer Treatment / combination protocols / chemical / /

MedicalCondition

Neoplasms / HIV / Second Malignancy / cardiac arrhythmia / unstable angina / diarrhea / Hematologic Tumors / illness / leukemia / tumor / measurable disease / Cancer / neutropenia / congenital anomaly/birth defect / vomiting / diseases / allergic reactions / Solid Tumors/Study Disease / infection / SDC disease / metastases / acute myeloid leukemia / chronic lymphocytic leukemia / Solid Tumors / nausea / thrombocytopenia / study disease / neurologic dysfunction / incl cysts / MS / infections / selected hematologic malignancies / congestive heart failure / non-Hodgkin's lymphoma / disease / radiological changes suggesting tumor / progressive disease / /

MedicalTreatment

radiotherapy / surgery / radiation / contraception / alternative therapies / radiation therapy / birth control / premedications / antiretroviral therapy / chemotherapy / /

Organization

University of California / Mayo Clinic Cancer Center / Rutgers University / Last Administration of the Investigational Agent/Intervention1 / Lead Academic Organization / Agent Administration / Duke University / Health Products and Food Branch / University of Pittsburgh / Coordinating Center / University of Chicago / Ohio State University / FDA / Last Administration of the Investigational Agent/Intervention / University of Texas / National Institute of Health / Food and Drug Administration / Harvard / Corresponding Organization / IDF / Yale University / CTEP Protocol and Information Office / NCI Division of Cancer Treatment and Diagnosis / Information Office / Cancer Institute / /

Person

Lee Moffitt / Davis Comprehensive / /

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Position

local treating physician / and the Reporter and Submitter / Name Telephone Fax E-mail address Investigator / P2C contractor / Responsible Data Manager / physician / General / Name Address Investigator / Address Address Telephone Telephone Fax Fax e-mail address e-mail address Responsible Research Nurse / Investigator / Statistician / Principal Investigator / Investigator and Research Associate / Princess / Governor / Supplemental Investigator Data Form / Coordinator / Director / Registrar / The Principal Investigator / Protocol Chair / current Investigator / /

Product

Adverse Event Reporting System / Simplified Disease Classification / General Concomitant Medication / mitomycin / dexamethasone / Agent / information / IND / CIP IND Agent / administration / Class / investigational / X / Other Agent / POSSIBLE DRUG / imaging / IND Agent / other / Name / P2C / Commercial Agent / regimen / /

ProgrammingLanguage

php / /

ProvinceOrState

Ohio / Indiana / Texas / New Jersey / Pennsylvania / /

Technology

radiation / 1 combination protocols / in vitro diagnostics / ETCTN protocol / chemotherapy / treating cancer / combination protocol / 2 protocols / PDF protocol / transplantation / PDF / MRI / combination protocols / pharmacokinetics / local protocol / 1 protocols / /

URL

http /

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