Svetlana Tsygankova has over 5 years of experience as an echocardiography and vascular technician. She has worked at several hospitals and clinics in New York, including NYU Langone, SUNY Downstate Hospital, and Mount Sinai Manhattan. Her responsibilities have included performing diagnostic echocardiograms, carotid studies, and vascular studies of the extremities. She also explains procedures to patients, documents test results, and communicates with physicians. Svetlana is fluent in Russian, Ukrainian, and English and has a Medical Doctor degree from Ukraine.
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SWP PHARMACEUTICALS, INC. - DATA MANAGEMENT PLANA Prospective,.docxmabelf3
SWP PHARMACEUTICALS, INC. - DATA MANAGEMENT PLAN
A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Clinical Study to Compare the Efficacy and Safety of XYZ Versus Corticosteroid for the Treatment of Lateral Epicondylitis (LE), Protocol Number ASUCNHI/XYZ-LE/16-17/001
Overview
21 CFR 312.50 spells out the responsibilities of the study sponsor in the management of clinical trial data and the verification of study data for completeness and accuracy. Thorough review of source data is important to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity of the clinical investigation data. (FDA, 2013). Sponsor review of source data includes meeting the regulatory requirements for recordkeeping and data verification by use of the ALCOA principle. ALCOA is the acronym for the required components of data. These include:
A = Attributable: originator of the data; who entered the data; audit trail
L = Legible: human readable form, modifications should not obscure original data; audit trail
C = Contemporaneous: time of data entry should be close to when procedure performed; audit trail
O = Original: earliest record, modifications should not obscure original data; audit trail
A = Accurate: correct and complete; valid representation of source data, corrections documented, quality processes/measures used; audit trail.
SWP builds it data management plans around the ALCOA principles with the expectation that chosen study sites comply with ALCOA and the SWP Data Management Plan.
Definitions:
· Data Element - smallest unit of information collected on a clinical trial subject
· Data Originator – original source of the data; may be electronic or human; tied to the data element
· eCRF – electronic Case Report Form
· Source Data - original data (electronic or written)
· EDC - Electronic Data Capture System is provided by the sponsor, data base is created to collected subject data and follows the eCRF format. Data will be either manually entered into the EDC or transferred from a paper form and entered by an individual or automatic transmission from the device into the eCRF.
· Paper - paper forms used to collect subject data
· Electronic - data electronically transferred to the EDC such as EKG results, blood pressure monitors
· Data Element Identifiers – data that identifies the originator including log-in credentials, password, date, time, and subject tied to data.
· Access - Access to study data is limited to study staff who record the data, review the data, and enter the data. For the sponsor, the site monitor generally referred to as a Clinical Research Associate (CRA), statisticians, data entry and data management staff.
· Data Review -
· Data must be reviewed by the study site monitor to verify accuracy and completeness.
· Data reviewed by study coordinator
· Data reviewed by Data entry and data management staff
· Data entered into the EDC must be reviewed and electronically signed off by si.
SWP PHARMACEUTICALS, INC. - DATA MANAGEMENT PLANA Prospective,.docxdeanmtaylor1545
SWP PHARMACEUTICALS, INC. - DATA MANAGEMENT PLAN
A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Clinical Study to Compare the Efficacy and Safety of XYZ Versus Corticosteroid for the Treatment of Lateral Epicondylitis (LE), Protocol Number ASUCNHI/XYZ-LE/16-17/001
Overview
21 CFR 312.50 spells out the responsibilities of the study sponsor in the management of clinical trial data and the verification of study data for completeness and accuracy. Thorough review of source data is important to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity of the clinical investigation data. (FDA, 2013). Sponsor review of source data includes meeting the regulatory requirements for recordkeeping and data verification by use of the ALCOA principle. ALCOA is the acronym for the required components of data. These include:
A = Attributable: originator of the data; who entered the data; audit trail
L = Legible: human readable form, modifications should not obscure original data; audit trail
C = Contemporaneous: time of data entry should be close to when procedure performed; audit trail
O = Original: earliest record, modifications should not obscure original data; audit trail
A = Accurate: correct and complete; valid representation of source data, corrections documented, quality processes/measures used; audit trail.
SWP builds it data management plans around the ALCOA principles with the expectation that chosen study sites comply with ALCOA and the SWP Data Management Plan.
Definitions:
· Data Element - smallest unit of information collected on a clinical trial subject
· Data Originator – original source of the data; may be electronic or human; tied to the data element
· eCRF – electronic Case Report Form
· Source Data - original data (electronic or written)
· EDC - Electronic Data Capture System is provided by the sponsor, data base is created to collected subject data and follows the eCRF format. Data will be either manually entered into the EDC or transferred from a paper form and entered by an individual or automatic transmission from the device into the eCRF.
· Paper - paper forms used to collect subject data
· Electronic - data electronically transferred to the EDC such as EKG results, blood pressure monitors
· Data Element Identifiers – data that identifies the originator including log-in credentials, password, date, time, and subject tied to data.
· Access - Access to study data is limited to study staff who record the data, review the data, and enter the data. For the sponsor, the site monitor generally referred to as a Clinical Research Associate (CRA), statisticians, data entry and data management staff.
· Data Review -
· Data must be reviewed by the study site monitor to verify accuracy and completeness.
· Data reviewed by study coordinator
· Data reviewed by Data entry and data management staff
· Data entered into the EDC must be reviewed and electronically signed off by si.
1. Svetlana Tsygankova, ARDMS,RDCS
Experience
NYU Langone New York, NY
Echocardiography Technician (Temporary) Winston support service 11/2015-12/2015
Calculated, measured, and documented appropriate values on the tests performed for review and
interpretation by physicians
Performed diagnostic echocardiograms carotid arterials and venous studies of upper and lower extremities
Explained procedures to patient to obtain cooperation and reduce anxieties of patient
Reviewed test results with interpreting physician
Communicated with physicians and co-workers as appropriate about changes in patient's clinical conditions
while undergoing echocardiogram or vascular study
Conducted echo and vascular laboratory studies in accordance with the echo/vascular laboratory protocols
Maintained the echo/vascular laboratory quality assurance database
SUNY Downstate Hospital Winston support service Brooklyn, NY
Echocardiography Technician (Temporary) 2/2015-9/2015
Calculated, measured, and documented appropriate values on the tests performed for review and
interpretation by physicians
Performed diagnostic echocardiograms carotid arterials and venous studies of upper and lower extremities
Explained procedures to patient to obtain cooperation and reduce anxieties of patient
Reviewed test results with interpreting physician
Mount Sinai Manhattan New York, NY
Echocardiography Technician Winston support service 2/2014-3/2014
Responsible for performing two-dimensional echocardiographic scans, M-Mode and color Doppler scans
Reviewed the physician's requisitions for completeness of information and check for specific instructions
Brooklyn Heart Care Brooklyn, NY
Cardiovascular Technologist 4/2013-12/2014
Prepared preliminary reports for physician's review
Reviewed the physician's requisitions for completeness of information and check for specific instructions.
Scan well diagnostic company Brooklyn , NY
02/2012-04/2013
Calculated, measured, and documented appropriate values on the tests performed for review and
interpretation by physicians
Performed diagnostic echocardiograms carotid arterials and venous studies of upper and lower extremities
Explained procedures to patient to obtain cooperation and reduce anxieties of patient
Reviewed test results with interpreting physician
Communicated with physicians and co-workers as appropriate about changes in patient's clinical conditions
while undergoing echocardiogram or vascular study
Conducted echo and vascular laboratory studies in accordance with the echo/vascular laboratory protocols
Maintained the echo/vascular laboratory quality assurance database
EducationSanford Brown Institute
Non-Invasive Cardiovascular Technology Certificate
Diagnostic Cardiac Sonographer (CVT) Program 2011-2013
Medical Doctor
Medical school Ukraine Zaporozhye 1997-2003
2. SUMMARY OF SKILLS
Fluent in Russian, Ukrainian, English, Proficient in MS Office
Excellent communication.
Experience in UE/ LE Vascular Imaging.
Cardiac Imaging {Echo, Carotid, TCD.}
LE imaging for Abdominal, Small part, Gynecology/ OB/GYN
Organization skills and ability to communicate with patients efficiently.
Ability to do work constructively.
Proficient in the latest sonographic equipment
REFERENCES
Elena Davidoff supervisor RRA NYU Columbus center 7182619100 ext 78902
Judith Mitchell MD, FACC, FAHA , associate professor of Medicine , of cardiology
SUNNY DOWNSTATE MEDICAL CENTER 718-270-3156 .
Jason Lazar MD , MPH , Professor , director of non-invasive cardiology department SUNNY
DOWNSTATE MEDICAL CENTER 7182703156
Deborah RDCS Mount Sinai Cheif Echo Tech RH 212 5237370
Dr. Nisa Ali. Faculty Instructor. 646-313-4520