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Quick Facts

Medium Of InstructionsMode Of LearningMode Of Delivery
EnglishSelf StudyVideo and Text Based

Course Overview

Clinical Trials Management and Advanced Operations is an online certification course designed to familiarise students with the advanced elements involved in managing clinical trials. The online course teaches students the fundamental skills to implement best practices throughout the trial process. The Clinical Trials Management and Advanced Operations certification course is offered by Coursera and is a part of the Clinical Trials Operations Specialization. 

The Clinical Trials Management and Advanced Operations training covers how to plan, manage, anticipate clinical trials and how systematic review and meta-analysis is used to mix evidence from multiple sources. The Clinical Trials Management and Advanced Operations online course helps students gain a firm understanding when it comes to practising advanced operations in clinical trials.

The Highlights

  • Offered by Coursera
  • Completion Certificate
  • 4 hours of learning
  • Beginner-level online course

Programme Offerings

  • Course Readings
  • Practical learning and Exercises
  • Flexible Deadlines

Courses and Certificate Fees

Certificate AvailabilityCertificate Providing Authority
yesJohns HopkinsCoursera

Clinical Trials Management and Advanced Operations Certification Fee Structure 

Course Details

Fee

1 month fee

₹4,038

3 months fee

₹8,076

6 months fee

₹12,115


Eligibility Criteria

Certification Qualifying Details 

To qualify for the Clinical Trials Management and Advanced Operations certification by Coursera, students need to complete the full course and the final assessment. They are also required to attain a qualifying passing grade. 

What you will learn

The Clinical Trials Management and Advanced Operations certification syllabus will help students form a basic understanding of using ethics within clinical trials operations. They will know how to detect and respond to protocol events and recognise and respond to misconduct. 

Upon completion of the Clinical Trials Management and Advanced Operations certification, students will be able to understand how meta-analysis is used in clinical trials and how evidence synthesis plays an important role in this field.


Who it is for

The Clinical Trials Management and Advanced Operations online course is specially designed for clinical research coordinators and clinical psychologists to learn the effective management of clinical trials and use fundamental skills to implement best practices in Clinical Trials Management and Advanced Operations.


Admission Details

To join the Clinical Trials Management and Advanced Operations classes, candidates need to follow these steps:

Step 1: Browse the official URL  https://www.coursera.org/learn/clinical-trials-management-and-advanced-operations

Step 2: Choose the option ‘Enrol’

Step 3: Candidates would be asked to sign up or login on the official website with a primary email address.

Step 4: Thereafter, the payment window will open, allowing the candidates to pay for the course fees. They can also choose the Audit option, which would not provide them with a rewarding certificate, except access to all course readings. 

Application Details

To enrol for the Clinical Trials Management and Advanced Operations training, candidates have to sign up or login to the official website, which asks for details such as their primary email address, name, phone number, and location. 

The Syllabus

Videos
  • Types of Protocol Events
  • Roles and Responsibilities
  • Additional Resources
Reading
  • Welcome to the course!
Practice Exercise
  • Protocol Events

Videos
  • Ethical Oversight of Clinical Trials
  • Federal Ethical Regulations
  • Product-Approval Agencies
  • Trial Misconduct
  • Additional Resources
Practice Exercise
  • Regulatory Affairs and Trial Misconduct

Videos
  • International Council for Harmonisation
  • CONSORT
  • SPIRIT and Trial Registration
  • Additional Resources
Practice Exercise
  • Standardization Transparency and Research Reproducibility

Videos
  • Systematic Reviews
  • Steps in the Systematic Review Process
  • Formulating Questions for Systematic Reviews
  • Searching for and Selecting Studies
  • Data Abstraction and Risk of Bias Assessment
  • Data Analysis and Synthesis
Practice Exercise
  • Evidence Synthesis

Videos
  • Overview
  • Types of Study Document
  • Regulatory Study Documents
  • Study Documents Related to Design and Implementation
  • Participant-Facing Study Documents
  • Data-Related Study Documents
  • Investigational Product
  • Laboratory Information
  • Monitoring
  • Staffing and Training
  • Close-Out
  • Other Documentation
  • Closing
Reading
  • Closing Thoughts
Practice Exercise
  • Study Documents

Evaluation process

To qualify for the Clinical Trials Management and Advanced Operations certification, students are required to clear the final assessment and attain a qualifying passing grade. 

Instructors

Johns Hopkins Frequently Asked Questions (FAQ's)

1: Who is responsible for teaching the Clinical Trials Management and Advanced Operations online course?

This course is taught by some of the leading instructors of Johns Hopkins University who are proficient in this field. 

2: What is the level of Clinical Trials Management and Advanced Operations training?

This online certification is a beginner-level course designed for clinical research coordinators and clinical psychologists. 

3: Is financial aid for the Clinical Trials Management and Advanced Operations certification available?

Yes, financial aid for this online course is available, for which you have to complete all the requisite actions on the official website. 

4: What would be the class timings for the Clinical Trials Management and Advanced Operations certification by Coursera?

The classes for this course would be online, where you could access the recorded videos at your own pace.

5: When is the Clinical Trials Management and Advanced Operations online course available on Coursera?

This course is already available on the official website of Coursera; candidates can enrol themselves at their own convenience. 

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