Clinical Data Management detailed syllabus for Biotechnology & Biochemical Engineering (BBE) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BBE students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Biotechnology & Biochemical Engineering 6th Sem scheme and its subjects, do visit BBE 6th Sem 2021 regulation scheme. For Professional Elective-IV scheme and its subjects refer to BBE Professional Elective-IV syllabus scheme. The detailed syllabus of clinical data management is as follows.
Course Objectives:
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Unit I
INTRODUCTION OF CLINICAL TRIALS 9
Basic statistics for clinical trials, Roles & Responsibilities of Key Stakeholders, Preparations & Planning for Clinical Trials, Essential Documentation in Clinical Research & Regulatory Submissions, Clinical Trials Project Planning & Management, Study Start Up Process, Clinical Monitoring Essentials, Compliance, Auditing & Quality Control in Clinical Research
Unit II
CLINICAL DATA MANAGEMENT 9
Introduction to Data Management, Data Definition & Types, Study Set Up, CRF Design Considerations, Data Entry, Remote Data Entry, Identifying and Managing Discrepancies, Medical Coding, Database Closure, Data Management Plan, Electronic Data Capture, Tracking CRF Data, Managing Lab Data, Collecting Adverse Event Data, Creating Reports and Transferring Data, Enterprise Clinical Data Management Tools.
Unit III
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Unit IV
CLINICAL CASE REPORT FORMS 9
CRF Completion Guidelines, CRF printing and vendor selection, Data validation, programming and standards, Laboratory data handling, External data transfer, Patient -reported outcomes, CDM presentation at investigator meetings, Metrics for clinical trials, Systems Software Validation Issues Clinical Trials Database Environment
Unit V
CLINICAL QUALITY AUDIT & REGULATIONS 9
Audit -Definition, types & procedures, Audit standards, Audit trail & its role in authenticity of data, Audit plan, Audit by regulatory authorities,GMP, GDP & logistics, Preparing and delivering audit reports, what makes a good audit, New product development & GxP Regulations.
Course Outcomes:
The students will be able to
- Outline on clinical trials, data management and preparation
- Describe the analytics and decision support using various tools.
- Utilize enterprise-wide information assets in support of organizational strategies and objectives.
- Inspect the concepts of database architecture and design.
- Interpret the roles and responsibilities of healthcare workspace commodities.
- Elaborate the reliability and accuracy of secondary data sources.
Text Books:
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Reference Books:
- Rondel, R.K., Varley, S.A. and Webb, C.F. eds., Clinical data management. New York: Wiley, 2000
- Smith, Jonathan A., ed. Qualitative psychology: A practical guide to research methods. Sage, 2015.
- Machin, D., Day, S. and Green, S. eds., Textbook of clinical trials. John Wiley & Sons, 2007.
For detailed syllabus of all the other subjects of Biotechnology & Biochemical Engineering 6th Sem, visit BBE 6th Sem subject syllabuses for 2021 regulation.
For all Biotechnology & Biochemical Engineering results, visit Anna University BBE all semester results direct link.