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Advanced Diploma in Clinical Data Management

More   6 Months Advanced Diploma ( Course Starts from 27  December  2009)

Pharmaceutical companies use clinical data management to support data management functions, such as collection, normalization, edit checking, query resolution and auditing. A centralized database serves as a common repository for all clinical trial activity. This clinical trial management database will be populated with information from different data sources. Electronic tools are required to gather data from traditional  case report forms (CRFs), and electronic information capture tools, standardize the format and track access. All systems (hardware and software) used in Data Management process should be 21 CFR Part 11 compliant. Adherence to the Clinical Data Interchange Standards Consortium (CDISC) definition for the operational  data model makes data management products more efficient and "regulatory ready."

• Planning
> Protocol Development & ICF
> Statistical Analysis Plan Development
> Data Management Plan Development

• Design
> CRF Design/ eCRF design
> Database Setup
> Validation/Derivation Procedure Development

• Data Capture
> Data Entry
> Data Load in-case of Electronic CRF systems

• Data Review
> Discrepancy Resolution
> Query management(DCF management)
> Coding
> External data Managing
> Clean Patient Delivery
> Database Lock

• Reporting
> Statistical Analysis
> Safety Reports
> Efficacy Reports

Clinical Data Management Syllabus:

• Introduction to Clinical Data Management
• Clinical Data Management Process and Life cycle.
• 21 CFR Part 11 Regulations
• Protocol Designing
• CRF /e CRF Designing
• SAP Development (Statistical Analysis Plan Document Preparation
• SOP Preparation (Standard Operating Procedure)
• Database Design
• ISS and  ISE
• Data Management Plan Development document
• Data Validation programming and standarads
• Data Collection
• Electronic Data Capture and Remote Data Capture.
• Data Clean up
• Data Analysis & Reporting
• Data Processing
• Management of Medical Dictionaries(MeDDra, WhoDD)
• Data Review, Discrepancy Resolution
• Query management(DCF management) Coding
• External data Managing(e, g: Lab data, ECG, BMD etc)
• Clean Patient Delivery
• Database Lock, Freeze.
• Bio statistics
• Statistical Analysis reports
• Edit check specification documents
• DCF and DCI books preparation.

Who is Eliglible:
Applicants for the Clinical  data management  Training Program are recommended to have one of the following:
Bachelor's, Masters, or a Ph.D. in a Science or Allied Health Field; OR Healthcare Professional  Medical Technologist, B.sc, M.sc life sciences.Pharmacy, Biotech, Computer.

Hands on Training on Clinical Data Managment Software

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