Clinical Research

70

• What is Clinical Research
• Job Opportunities in Clinical Research
• Day in the Life of a CRA
• Stakeholders in Clinical Research
• Brief history of Clinical Research
• Principles of Good Clinical Practice
• Technologies in Clinical Trial Management
• Clinical Research Regulatory Bodies
• Role of Epidemiology in clinical trials
• Evidence Based Medicine
• Preclinical development of drugs
• Phases of Drug Development
• BA-BE studies
• Pharmacogenetics and Pharmacogenomics
• Toxicology in Clinical Trials
• Clinical Trial Design
• Intellectual Property Rights
• Personalised Medicine
• Endpoints in Clinical Trials
• Clinical Trial Registries
• Ethics in Clinical Research
• Informed Consent Process
• International Conference for Harmonization
• Schedule Y
• ICMR Guidelines
• Investigator Responsibilities
• Sponsor-Vendor Responsibilities
• IRB Responsibilities
• Role of Clinical Research Personnel
• Clinical Study Protocol - Protocol Writing
• CRF Design
• Essential Documents
• IND Submission
• Clinical Study Report (CSR)
• NDA Submission
• Study Feasibility and Site Selection
• Pre-Study Visit
• Site Initiation
• Subject Recruitment and Retention
• Routine Site Monitoring
• Trial Master File
• CRF Review and Source Data Verification
• Drug Accountability
• Safety Reporting and Pharmacovigilance
• Site Close-out
• Site Audit and Overview
• Sponsor Compliance and Audit
• SOP in Clinical Research
• Electronic Records and Signatures
• Conflict of Interest
• Clinical Data Management Overview
• Introduction to Biostatistics
• Data Analysis and Reporting
• Regulatory Environment in the US
• Pharmaceutical Regulatory Environment in Europe
• Pharmaceutical Regulatory Environment in India
• Medical Devices Lifecycle
• Global Regulatory Strategy for Medical Devices
• Medical Device- Trial Design Considerations
• Fundamentals of Project Management
• Integrated Project Management
• Clinical Research Vendor Selection
• Clinical Research Vendor Management
• Clinical Trial Supplies
• Accounting for Managers
• Clinical Trial Budgeting
• Clinical Trials Marketing
• Indemnity and Compensation
• Oracle Siebel Clinical Overview
• Clinical Research Interview Questions
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Clinical Data Management

42

• What is Clinical Data Management
• Job opportunities in Clinical Data Management
• Day in the Life of a Clinical Data Manager
• How is Oracle Clinical used in Clinical Research
• Oracle RDC in clinical trials
• Computers in Pharmaceutical Research & Development
• Data Management Plan
• Case Report Form Design
• Patient Registration in Clinical Trials
• Acquisition of Clinical Data
• Clinical Data Definition and Database Design
• Safety Data Management
• Documentation in Clinical Data Management
• Data Entry Methods and Processes
• Database Validation and Standards
• Database Closure
• Clinical Data Management Audits
• Measuring Performance in CDM
• Data Validation and Query Management
• Process of Drug Development
• Clinical Data Management Process
• Standard Operating Procedures in Data Management
• Clinical Data Management System
• Database Migration and Archival
• Medical Coding Dictionaries and MedDRA
• Software Tools used in Management of Clinical Trials
• Laboratory Data
• Receipt and Review of Data
• Data Presentation
• Oracle Pharmaceutical Application Suite
• Oracle Clinical Navigation
• Oracle Clinical Overview
• Oracle Clinical - Planning a study
• Oracle Clinical - Designing a study
• Oracle Clinical - Global Library
• Oracle Clinical - Definition subsystem
• Oracle Clinical - Validation and Derivation Procedures
• Oracle Clinical - Data Entry
• Oracle Clinical - Discrepancy Management
• Oracle Remote Data Capture (RDC)
• Difference between Oracle Clinical and Oracle RDC
• Clinical Data Management Interview Questions
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Pharmacovigilance

51

• What is Pharmacovigilance
• Job opportunities in Pharmacovigilance
• Day in the Life of a Pharmacovigilance Manager
• Importance of Argus Safety in Pharmacovigilance
• Role of Empirica Signal in Pharmacovigilance
• Aggregate reporting in Pharmacovigilance
• Periodic Reporting in Pharmacovigilance
• Medical Review in Pharmacovigilance
• What is a PSUR
• What is a PADER
• History of Pharmacovigilance (PV)
• Drug Dependence
• Vaccine Vigilance
• Signal Detection in PV
• Communication in Pharmacovigilance
• Post-Marketing Surveillance
• Audits and Inspections in PV
• Role of Pharmacovigilance Department
• Qualified Person for Pharmacovigilance
• Standard Operating Procedures in Pharmacovigilance
• Literature Review in Pharmacovigilance
• What is MedDRA
• Eudravigilance
• Assessment of Compliance
• Softwares used in Pharmacovigilance
• WHO & Safety Reporting
• CIOMS Groups & Functions
• Good Pharmacovigilance Practice
• Safety Reporting
• Individual Case Safety Reports (ICSR)
• Periodic Safety Update Reports (PSUR)
• Indian Regulations with specific reference to Schedule Y
• Regulatory Pharmacovigilance in EU
• Introduction to Pharmacoepidemiology
• Molecular Genetic Pharmacoepidemiology
• Analysis of Pharmacoepidemiological Data
• Studies of Drug Use
• Case Control Studies
• Cohort Studies
• Data Sources in Pharmacovigilance
• Measures of Frequency & Risk
• Advanced Issues in Pharmacoepidemiology
• Errors in Pharmacoepidemiology
• Oracle Argus Safety Navigation
• Overview of Argus Safety Menus
• Case Form Features in Argus Safety
• Drug and Event Coding in Argus Safety
• Case Entry and Processing in Argus Safety
• Advanced Conditions in Argus Safety
• Reporting and Submissions in Argus Safety
• Pharmacovigilance Interview Questions
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Medical Writing

57

• What is Medical Writing
• Job opportunities in Medical Writing
• Day in the Life of a Medical Writer
• Good vs Poor scientific writing
• Role of Statistics in Medical Writing
• Effectively searching for internet literature
• Regulatory medical writing
• Investigational New Drug Application (INDA)
• Investigators Brochure
• NDA BLA and PMA
• Annual reports in medical writing
• Product labelling in medical writing
• Abstracts and Posters for scientific meetings
• Manuscripts for Publication in Scientific Journals
• Intellectual Property issues in Medical Writing
• Common Technical Document and eCTD
• CTD Module 1
• Producing the CTD Modules
• Multi-region submissions & submission standards
• Interfacing with regulatory agencies
• Writing clinical study protocols
• Writing an Investigators Brochure
• Writing case report forms
• Writing Informed Consent Forms
• ICSR - Patient Narratives
• Parts of Clinical Study Report
• Templates & Boilerplate Text
• Writing sections of CSR
• Fundamentals of Sentence Construction
• Controlling Voice of Sentence for Readability
• Correct Punctuation
• Consistency in Tense Use
• Imprecise Words and Phrases
• Word Order and Pronouns
• Subject Verb Agreement
• Aggregate safety reports - PSURs
• Writing Effective Paragraphs
• Using Effective Data Displays
• Using Style Guides for Consistent Medical Writing
• Overcoming Writers Block
• Structure of a Scientific Paper
• Electronic Submissions
• Abstract for Scientific Meeting
• Case Report
• Review in Medical Writing
• Ethics of Publication
• Guidelines of Publication
• Referencing Guidelines and Software Help
• Leave Behind literature, visual aids, and brochures
• Continuing Medical Education for Doctors
• Evidence Based Medicine
• Medical Representative Training Manual
• Web Content, Audio-Visual Aids, CDs
• Effective Review Practices
• Managing Incongruous Comments from Reviewers & Reaching Concurrence
• Process Flow for Managing Regulatory Submissions
• Medical Writing Interview Questions
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Regulatory Affairs

42

• What is Regulatory Affairs
• Job opportunities in Regulatory Affairs
• Day in the Life of a Regulatory affairs Manager
• Medical Ethics and Malpractice
• Legitimacy and Paternity
• Privileged Communication
• Drugs and Cosmetics Act
• Schedules of Drug and Cosmetic Act
• Import Manufacture and Sale of Drugs
• Labeling and Packaging of Drugs
• Introduction to Schedule Y
• Regulatory Affairs in Clinical Trials
• Post Marketing Surveillance and Special Studies
• Appendices in Pharma Regulatory Documents
• Regulatory Authorities in India
• Indian Regulatory Approval Process
• Responsibilities of US FDA
• FDA Centers
• Code of Federal Regulations
• FDA guidelines for Pharma industry
• Roles and Responsibilities of EMEA
• Committees of EMEA
• EU Clinical Directives
• EUDRA CT
• Organization and Function of MHLW
• Pharmaceutical Laws and Regulations in Japan
• Pharmaceutical Regulatory Strategic Planning
• Drug Development in Japan
• ICH Guidelines for Clinical Safety
• Dose Response Studies
• Clinical Evaluation
• General principles of CTD
• CTD Modules with Diagrammatic representation
• eCTD
• IND and NDA applications in US
• IND and NDA Applications in India
• CMC for Phase I
• CMC for Phase II and III
• Global Harmonization Task Force
• Guidelines and Applications of Biosimilars
• Biopharmaceutical Indian Regulations and Guidelines
• Regulatory Affairs Interview Questions
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FAQs

8

• Who will support my learning?
• How long will I have access?
• Can I pause access to my course?
• Can I subscribe for software access only?
• Can I pay for the course in instalments?
• Do you offer scholarships?
• Can I complete my course earlier?
• Do you offer Placement assistance?

Getting Started

6

• Purchasing and enrolling in a course
• Accessing your courses after enrolment
• Accessing the software
• Posting your queries to the course forum
• Login details to the course and software
• Downloading Certificate of Completion

Troubleshooting

5

• Cannot login to my account
• Cannot find credentials to access software
• Unable to retake the Quiz
• Go back to previous question in a Quiz
• Raise a Ticket