Name: Introduction To Clinical Research Training Course I Clinical Research Online Training I Henry Harvin in Boston | Henry Harvin
Uploaded: 2022-11-17 12:10:33

Module 1: Introduction to Clinical Research Industry and Basics of Clinical Trials
In this module the learners will gain an insight on what clinical research is? Find answers to how clinical trials are conducted and why they are of utmost importance. Clinical trials are used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
- Clinical research
- Types of clinical research
- Clinical trials
- Phases of clinical trials
- Quiz Module 1
Module 2: Pharmacology - Concepts and Application in clinical trials
In this module the focus will be on Drugs. Learners will learn about a variety of drugs and their actions and how this concept is used in clinical trials. Concepts and applications in clinical trials deal with any artificial, natural, or endogenous molecule which exerts a biochemical or physiological effect on the cell, tissue, organ, or organism.
- Drug nomenclature
- Routes of administration
- Prescriptions
- Pharmacokinetics
- Pharmacodynamics
- Pharmacology glossary used in trials
Module 3: Drug Development Process
In this module the aim predominantly lies on the drug development process. Understand different stages of the drug development process and how they are all equally important. Learn the purpose of a drug development process to make a drug available to your bedside from the bench.
- Lifecycle of drug development
- Stages of drug development
- Safety monitoring
- Quiz Module 3
Module 4: Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practice (GCP)
In this module understand the intention of a clinical trial. Know the ethical guidelines and how to maintain them while conducting a trial. Understand terms like social and clinical value, fair subject selection, scientific validity, favorable risk-benefit ratio.
- Ethics in Clinical Research
- Importance of Ethics in Clinical Research
- ICH-GCP
- GCP Principles
- Quiz Module 4
Module 5: Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies
In this module find out about the National and International Regulatory Bodies in detail. The history and how they make guidelines to ensure products released to the public are evaluated thoroughly to meet the international standards.
- History: regulations in clinical research
- FDA Regulations
- Regulatory requirements for conducting Clinical Trials in India
- Other regulatory bodies for clinical trials
- Quiz Module 5
Module 6: Outsourcing Clinical Trials, functioning of Clinical Research Organizations
In this module learn about CRO’s (Contract Research Organizations) role and responsibilities when clinical research is outsourced to an external company. Know the list of services included. How outsourcing can reduce the operational challenges and what are the different services provided by the service providers.
- Clinical trial outsourcing
- Types of outsourcing
- CRO and their functions
- Quiz Module 6
Module 7: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))
In this module the focus remains on the importance of Artificial Intelligence (AI) and Machine Learning (ML) in Clinical Trials. Know how AI can identify suitable cohorts for clinical trials by analyzing medical records and social media content. Ways to speed up trial recruitment by using ML technologies to alert medical staff and patients about trial opportunities, as well as simplifying entry criteria to be more accessible for potential participants.
- Role of artificial intelligence in clinical trials
- Application of machine learning methods in clinical trials
- Quiz Module 7
Module 8: Biostatistics- Concepts and Application in Drug Development
In this module analyze the role of biostatistics in designing a drug experiment as well as evaluating its results. Understand how it helps clinical researchers to form reasonable and precise inferences from all collected information to make the correct decisions during the presence of uncertainty.
- Role of Biostatistics in Clinical research
- Biostatistician roles
- Tools in biostatistics
- Trends
- Quiz Module 8
Module 9: Clinical Trials- Phases and Trial Designs
In this module understand and relate to the different phases of clinical trials. Appreciate and Acknowledge the trial design. Know that clinical trials allow the safety and effectiveness of new drugs or treatments to be properly assessed before being approved for use in the general public.
- Clinical trial phases
- Trial designs used in clinical trials
- Quiz Module 9
Module 10: Documentation and Data Management in Clinical Trials
This module will cover the process and importance of documentation and data management in clinical trials. The documentation shows the degree of compliance of the investigators, sponsors and monitors with applicable regulations and GCP guidelines. During audit the data management is a critical part of any clinical trial for maintaining data validity and integrity.
- Clinical Trial Data Management
- Responsibilities in Clinical Data Management
- Data Management Workflow
- The stages of CDM
- Clinical data management systems
- Quiz Module 10
Module 11: Safety Reporting Techniques and Pharmacovigilance
In this module learners will know why and how safety reports are submitted to the regulatory agency, the ethics committee, oversight groups, and the sponsor throughout the lifecycle of a trial. These reports can help maintain safety and also prevent any lapse.
- Safety reporting
- Terminologies of safety reporting
- Serious adverse reaction (SUSAR)
- Coding of Adverse Events (MedDRA)
- Pharmacovigilance
Module 12: Quality Control and Clinical Trial Management
This module deals with QC in Clinical trials. Quality Control and Quality Assurance are the procedures which insure protection of human subjects from research risk, reliability of the data, and thereby assures internal consistency. Learners will understand and implement Good Clinical Practices (GCP).
- Quality control in clinical trials
- Implementing standard processes/procedures
- Implementing GCP
- Operational QC
- Clinical trial management system
- Clinical trial management system and compliance
- Quiz Module 12
Module 13: Clinical Trials - Medical Devices
In this module, learners will learn about MDCTs (Medical Devices Clinical Trials) and why it is very important to conduct their trials. Clinical trials of Medical Devices are investigations or examinations undertaken to assess the safety or the performance of a medical device in terms of its use in treatment, prevention or diagnosis of diseases in human subjects.
- Medical devices
- Guidelines for medical devices
- FDA Regulations
- Approval of medical devices
- Quiz Module 13
Module 14: Protocol Writing and Designing
In this module, an in-depth knowledge on protocol writing and designing will be introduced. Details on the objective, design, methodology, statistical considerations and organization of a clinical trial will be covered. Special tips and tricks to ensure the safety of the trial subjects and integrity of the data collected will be shared.
- Designing a clinical trial
- Clinical Trial Phases & Study Designs
- Clinical Trial Protocol Development
- Quiz Module 14
Module 15: Clinical Trials - Latest Updates : New Drugs and Clinical Trials Rules
This module will help you keep updated with the latest whitepaper, updates and discoveries. Get information on Clinical Trials associated with new drugs and rules and regulations. Keep pace with recent research, blogs, archives, news all associated with Clinical Trials.
- Latest rules in clinical trials
- Accelerated drug trial protocols during covid
- Quiz Module 15

Clinical Research Training Course in Boston

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Curriculum For Clinical Research Training Course in Boston

Module 1: Introduction to Clinical Research Industry and Basics of Clinical Trials

Module 2: Pharmacology - Concepts and Application in clinical trials

Module 3: Drug Development Process

Module 4: Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practice (GCP)

Module 5: Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies

Module 6: Outsourcing Clinical Trials, functioning of Clinical Research Organizations

Module 7: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))

Module 8: Biostatistics- Concepts and Application in Drug Development

Module 9: Clinical Trials- Phases and Trial Designs

Module 10: Documentation and Data Management in Clinical Trials

Module 11: Safety Reporting Techniques and Pharmacovigilance

Module 12: Quality Control and Clinical Trial Management

Module 13: Clinical Trials - Medical Devices

Module 14: Protocol Writing and Designing

Module 15: Clinical Trials - Latest Updates : New Drugs and Clinical Trials Rules

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