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The Beginners Course For Clinical Research(Audio+Test+Cert.)
Rating: 4.4 out of 5(22 ratings)
38 students

The Beginners Course For Clinical Research(Audio+Test+Cert.)

Foundational Modules for Freshers and Aspiring Clinical Researchers
Created byProRelix Education
Last updated 4/2024
English
English [Auto],

What you'll learn

  • Introduction & History Of Clinical Research
  • Clinical Trial Phases
  • Ethical Guidelines
  • Stakeholders in Clinical Research & their Roles
  • Introduction of ICH GCP & its Principles
  • Key Terminologies

Course content

3 sections • 10 lectures • 2h 12m total length

  • Introduction3:14

    Discover the fundamentals of clinical research, from history and preclinical work to trial phases, ICH GCP, informed consent, roles, terminology, and assessment through practice tests and certification.

  • Module 1: Introduction & History Of Clinical Research17:04

    Explore the introduction and history of clinical research, tracing disasters, trials, and ethical milestones from ancient experiments to the Nuremberg Code, Declaration of Helsinki, and Belmont Report.

  • Practice Quiz for Introduction & History Of Clinical Research
  • Module 2: Introduction To Preclinical Trial12:03

    Explore the drug discovery and development pipeline, focusing on preclinical testing and the in vitro and in vivo methods used to assess safety and efficacy.

  • Practice Quiz for Introduction To Preclinical Trial
  • Module 3: Clinical Trial Phases15:22

    Explore the four clinical trial phases—phases one through four—and the preclinical groundwork, IND filing, and regulatory steps from preclinical data to NDA and post-marketing surveillance.

  • Practice Quiz for Clinical Trial Phases
  • Module 4: What is ICH-GCP8:16

    Discover the history, structure, and objectives of ICH-GCP, its parties, and global harmonization to protect trial participants and ensure safety, quality, and efficacy of medicines.

  • Practice Quiz for ICH GCP
  • Module 5: Clinical Trial Stake Holders26:37

    Identify key clinical trial stakeholders, including the principal investigator, sponsor, CRO, and regulatory authorities, and map their responsibilities from protocol compliance to safety reporting.

  • Practice Quiz for Clinical Trial Stake Holders
  • Module 6: Informed Consent Process10:12

    Explore the informed consent process, including when it is obtained, who can sign, ongoing consent, and the patient information sheet, consent form, and a template of the consent form.

  • Practice Quiz for Informed Consent Process
  • Module 7: Introduction To IRB/ IEC7:57

    Explore the role and duties of the institutional review board or independent ethics committee, including composition, quorum, approval procedures, and maintaining trial records to protect human subjects.

  • Practice Quiz for Introduction To IRB/IEC
  • Module 8: Different Job Roles In Clinical Trial20:43

    Explore key clinical research roles, including CRA, CTA, CRC, and CDA, and learn how each role ensures trial integrity, compliance, and effective site coordination.

  • Practice Quiz for Different Job Roles In Clinical Trial

Requirements

  • Graduate or postgraduate degree in Pharmacy
  • Graduate or postgraduate degree in Medicine or any healthcare stream
  • Graduate or postgraduate degree in Life Sciences
  • Anyone from or related to healthcare, pharma, biotech and clinical research industry

Description

The objective of " The Beginners Course for Clinical Research" is to provide essentials of Clinical Research for recent graduates as well as experienced professionals in science, medicine & allied disciplines who are looking into careers in clinical research.


This course is developed and structured in a manner considering the beginner-level knowledge required in view of industry expectations.  In this course, you’ll learn the principles and processes of clinical research, and basic clinical trial terminologies, and understand the different job roles of clinical research in developing new treatments and interventions.


Who Should Enroll?

1. Graduate or postgraduate degree in Pharmacy

2. Graduate or postgraduate degree in Medicine or any healthcare stream

3. Graduate or postgraduate degree in Life Sciences

4. Anyone from a related healthcare industry


What This Course Covers?

Module 1: Introduction & History Of Clinical Research

Module 2: Introduction To Preclinical Trial

Module 3: Clinical Trial Phases

   o Phase 1

   o Phase 2

   o Phase 3

   o Phase 4

Module 4: What is ICH-GCP

Module 5: Clinical Trial Stake Holders

   o Investigator

   o Sponsor

   o CRO

   o Regulatory Authority

Module 6: Informed Consent Process

Module 7: Introduction To Institutional Review Board / Institutional Ethics Committee

Module 8: Different Job Roles In Clinical Trials (CRA, CTA, CRC, CDA)

Module 9: Key Clinical Trial Terminologies


What Benefits/ Value Does This Course Offer?

  • Self Paced Learning with full explanation narrated for each module

  • Full lifetime access

  • Access on mobile and TV

  • Practice questions in all modules and a final assessment quiz

  • Certificate of completion

  • Content Developed By Industry People with 15+ years of experience


What are the job opportunities related to this course?

Below are a few job designations:

  • Clinical Research Co-ordinator (CRC)

  • Clinical Research Associate(CRA)

  • Clinical Trial Assistant (CTA)

  • Clinical Data Co-ordinator (CDC)

  • Clinical Research Data Specialist

  • Clinical Investigator or Clinical Researcher

  • Research Pharmacist

  • Clinical Project Manager

  • Medical/Scientific Writer

  • Clinical Trial Monitor

  • Pharmacovigilance Associate

  • Regulatory Affairs Associate

  • Centralized Monitor

  • Documentation Specialist

  • Trial Master File (TMF) Specialist

  • Clinical Trial Auditor



Who this course is for:

  • Suited for people aspiring to start career in clinical research
  • Suited for clinical trial professionals for refresher training
  • Suited for CROs, Pharma, Hospitals, Ethics Committees, Corporate Training
  • Suited for people interested to learn basics of clinical research

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