Hands on Practical Training in Oracle Clinical(CDM)
Clinical Data Management training in Oracle Clinical/RDC with Project
BioMed Informatics Medwin Hospitals
(Established in the year of 2000)


BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering full range of Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Pharmacovigilance, Oracle Argus Safety, SAS Clinical, IPR & Regulatory Affairs trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.
hands on training will be provided on Oracle Clinical/RDC. Globally most of the Companies representing IT, Pharmaceutical, Biotechnology, SMO and Contract Research Organizations (CRO) have relied on Oracle Clinical to conduct Clinical Trials, making it the market-leading Clinical Research solution providing highly paid Oracle Clinical Jobs in India, USA, UK, as well as other countries.

Mode of Training: Instructor Led Class room/Online Training
Online Training Features:
? Web based classroom
? One faculty/student
? Placement support
? Regular/Fast track/Weekend batches
? Flexible timings
? Training Mode: Skype/Teamviewer
? Hands-On Training on the Database
? Direct access to Oracle Clinical Database
Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Synowledge, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…
Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.

Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.

Please note that we also provide separate hostel facility assistance for ladies as well as gents.

Contact:

G.V.L.P. Subba Rao
BioMed Informatics (Established in the year of 2000)
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com

Course Curriculum:
• Introduction to Clinical Research
• Introduction to Clinical Data Management
• Guidelines for CDM
• Roles and Responsibilities of CDM Team
• Clinical Data Management Process and Life cycle
• Data Management Plan
• 21 CFR Part 11
• CRF Designing
• CRF Annotation
• Data Capture Methods
• Data Entry
• Edit Checks
• Data Validation Procedures
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Database Locking and Freezing
• Data Storage & Archival
• Data Coding and Medical Dictionaries
• SAE Reconciliation
• Quality Assurance & Quality Control
• Auditing
• CDISC Standards
practical Hands-on Training on Oracle Clinical Database

INTRODUCTION:
• Introduction to OC window
• Subsystems in OC
STUDY PLAN:
• Defining Programs and Projects
• Defining Organization Units
• Defining Regions
• Defining Planned Studies
STUDY DESIGN:
• Easy Study Design
• Creating Intervals
• Creating Events
• Creating treatment patterns
• Creating Investigator, Site Records and Assignments
• Creating Patient Positions and Assignments
GLIB:
• Creating Questions
• Creating Question Groups
• Creating and Maintaining DVG's
• Copy Groups
STUDY DEFINITION:
• Creating DCM's, DCI's & DCI Books
• Validation Procedures
• Derivation Procedures
• Test a Study
• Test Data Entry
DATA ENTRY:
• Initial Login
• Key Changes
• First Pass Entry
• Second Pass Entry
• Comparison Reconciliation
• Update
• Browse
• Patient Enrollment
• Missing DCMs
STUDY CONDUCT:
• Data Validation(Batch validation)
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Data Extract and SAS Extract
• Making Mass Changes
• Locking and Freezing
LAB:
• Labs
• Lab Ranges
• Lab Units
• Lab test questions
• Lab Assignment Criteria
RDC (Remote Data Capture):
• Data entry in RDC
• Discrepancy Management in RDC
• Study and Site Security

You will be extensively involved in:
• Designing of electronic Case Report Forms (eCRFs) in Oracle Clinical
• Creation and maintenance of global library objects like DVGs Questions, Question groups, DCMs and DCIs
• Creating Data Collection Modules and layouts corresponding to CRFs to allow for data entry
• Generating and Testing data entry screens and validate the range, format, date, missing fields
• Conduct study start up activities, like Study design and Defining Sites, investigators and patients
• Creating, generating and testing Data Validation and Derivation procedures
• Writing edit checks or validation procedures using ranges provided or in accordance with the protocol
• Performing User Acceptance Testing (UAT)
• Data Entry like Initial Login, Key Changes, First Pass and Second Pass Data Entry, Comparison Reconciliation and Update
• Test and execute validation procedures (Both single and batch validation)
• Discrepancy management and Query management
• Generating queries based on validation checks to clarify and improve the quality of the data
• Creating DCFs and maintaining Discrepancies
• Resolving queries and updating the database.
• Review of un-resolved discrepancies, raise manual discrepancies wherever required and close where appropriate.
• Improving the quality of the data to ensure an error free, accurate data with no open queries
• Establishing and coordinating the timely completion of the database lock procedures.
• Reviewing clinical data as per SOP, protocol, and study specific guidelines
• Knowledge of Data Extract and SAS extract views
• Maintaining Lab ranges, Lab units, Lab test questions
• Data entry in RDC and Discrepancy Management in RDC
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