Advance Diploma In Clinical Research- 4 Months [Online]

101

Fundamental Of Clinical Research

Introduction to clinical research

• Terminologies
• History of clinical research

Clinical development

• Phase 1
• Phase 2 – subtypes
• Phase 3 – subtypes
• Phase 4

Bioavailability and Bioequivalence Studies

Clinical trial essential documents

• Protocol
• CRF
• IB
• SOP’s introduction
• Clinical study report
• Trial master file &amp e-Trial master file
• Clinical Trial logs

Investigator responsibility

Sponsor responsibility

Audit &amp inspections

Clinical Trial Designs

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102

Ethics In Clinical Research And New Drugs And Clinical Trials Rules

Background of ethics:

• Nuremberg code
• Declaration of Helsinki
• Belmont report
• CIOMS guidelines (WHO)

Introduction to ethics committee

• Types of ethics committee
• IRB &amp IEC composition
• Roles &amp responsibilities

Informed consent process

• Audio-Visual recording of informed consent process
• Importance
• Elements
• Personnel involved
• The patient information sheet &amp informed
• Consent form

Privacy &amp confidentiality in clinical research,

Compensation in clinical research

Drug regulations

• New Drugs and Clinical Trials Rules, 2019
• ICMR Guidelines
• ICH GCP
• Patent &amp TRIPS
• CTRI-Clinical trial registry of India

Regulatory Authorities

• USFDA
• DCGI

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103

Role of Clinical Research Organization, Site Management and Monitoring in CR Outline in clinical research

CRO

• Introduction to CRO
• Objectives of CRO
• Role of CRO
• Role of personnel involved

Roles and responsibilities of clinical research associate (CRA)

Roles and responsibilities of (CRC)

Roles and responsibilities of sponsor

Clinical trial monitoring & Types of monitoring

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104

Clinical Data Management an Introduction

Data Management Standards:

21CFR Part 11
CDMS Systems

Setup

• CDMS (eg: Oracle Clinical etc.)
• What is EDC (e CRF, IVRS, IWRS)
• Data management plan
• e CRF Designing
• e CRF Completion Guidelines
• Data Entry Guidelines
• Edit check Specification
• Data Privacy: Implications for Clinical Operations
• User Acceptance Testing

Conduct

• Date Entry- Double Entry &amp Single Entry
• Data Review &amp Validation
• Discrepancy management
• Query Writing
• Data clarification form
• Data review by using standard reports and J-review
• Medical coding
• Last query out
• Last Patient Out (LPO)/ Last patient last visit (LPLV)

Closeout

• Data base lock (Soft lock, Hard lock)
• Data storage and archive

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105

Pharmacovigilance

• Definition , overview and scope
• WHO program for international drug monitoring
• UPPSALA Monitoring centre
• Signal detection in Pharmacovigilance
• Signal generation post marketing surveillance (PMS)
• Pharmacovigilance in India
• Serious adverse reactions
• Applications of pharmacovigilance
• Aims and objectives of pharmacovigilance
• PSUR

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