Diploma in Clinical Research

The Diploma in Clinical Research is a comprehensive online program designed to build knowledge and practical skills across the clinical trial lifecycle. Through flexible, self-paced eLearning, the program covers essential clinical research concepts, processes, regulations and standards.

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Key Features

Here’s how you learn

Optional Hands-On Oracle Siebel Clinical Training

Choose the eLearning + software option to gain hands-on experience using Oracle Siebel Clinical CTMS and apply clinical trial management concepts in a practical software environment.

Recorded Sessions

Learn through recorded sessions covering key clinical research concepts, processes, regulations and clinical trial management activities.

Multimedia Tutorials

Access structured multimedia tutorials designed to support flexible, self-paced learning.

Quizzes and Assessments

Reinforce your learning through quizzes, graded assessments and practical assignments across the program.

Discussion Forums

Ask questions and interact with instructors through course discussion forums and learner support.

Certificate of Completion

Receive a ClinSkill Certificate of Completion after successfully meeting the program completion requirements.

Choose Your Learning Option

Choose a Learning style that suits you.

Diploma in Clinical Research – eLearning

$499
  •                   —
  • Multimedia Tutorials
  • Recorded Lectures
  • Graded Assessments and Quizzes
  • Discussion Forums
  • Certificate of Completion
Enroll now

Diploma in Clinical Research + Oracle Siebel Clinical

$799
  • 24×7 access to Oracle Siebel Clinical
  • Multimedia Tutorials
  • Recorded Lectures
  • Graded Assessments and Quizzes
  • Discussion Forums
  • Certificate of Completion
Enroll now

Curriculum

Here’s what you learn

Module 1 : Introduction to Clinical Research

This module will introduce you to the filed of Clinical Research. You will learn about the origin of Clinical Research and the various stakeholders. You will also learn about the core principles and the regulatory bodies that govern this field.

7 chapters.

Module 2 : Epedemiology and Evidence Based Medicine

This module will introduce you to the field of Epidemiology and Epidemiological study designs. You shall also learn the concept of Evidence based medicine.

5 chapters.

Module 3 : Pharmaceutical Medicine

This module will cover the various areas of Pharmaceutical medicine, including the process of pre-clinical development, clinical development, Toxicology, Study Designs, Intellectual property rights and Personalised medicine. The fields of Drug Safety, Genetic studies, Stem cell Research etc. shall also be discussed.

16 chapters.

Module 4 : Therapeutic Areas

This module introduces students to various Therapeutic areas for which clinical trials are conducted. The objective of this chapter is to understand the core terminologies and functioning of various body systems.

11 chapters.

Module 5 : Ethics in Clinical Research

This module covers the process of obtaining Informed Consent from study subjects and ethical considerations in clinical research. It shall also cover the ICH-GCP guidelines that form the basis of conducting clinical trials ethically while referencing other guidelines used in clinical research such as Schedule-Y and ICMR guidelines.

5 chapters.

Module 6 : Roles and Responsibilities

This module covers the roles and responsibilities of the Investigator, Sponsor,  Institutional Review Board and all other stakeholders and personel involved in conducting clinical research.

4 chapters.

Module 7 : Clinical Trial Preparation

This module covers the process of designing and writing a study protocol and Case Report forms that are used to collect data of the study subject in a clinical trial.

2 chapters.

Module 8 : Essential Documents and Regulatory submission

This module covers the Essential documents that are used during the conduct of the clinical trial. It also covers the process of submission and contents of an Investigational New Drug Application (IND), New Drug Application (NDA) as well as writing a Clinical Study Report (CSR).

4 chapters.

Module 9 : Study start-up

This module shall cover the process of conducting various study startup activities including Site selection, conducting pre-study visits, Site Initiation,  obtaining Informed Consent, Recruitment of study subjects as well as the importance of developing and maintaining a Trial master file.

6 chapters.

Module 10 : Clinical Trials Monitoring

This module shall cover the process of monitoring a clinical trial. It shall describe the activities such as Routine Site Monitoring, CRF Review and Source Data Verification, maintaining drug accountability, reporting drug safety data in stipulated timelines and performing a study closeout.

5 chapters.

Module 11 : Compliance and Audits

This module shall cover the process of ensuring compliance with regulatory guidelines through performing Site Audits and ensuring conformance with SOPs. It shall also cover the use of electronic records and signatures in clinical trials and how to deal with conflict of interest in a clinical trial.

5 chapters.

Module 12 : Data Management and Biostatistics

This module covers the various clinical data management and Biostatistics activities conducted in a clinical trial. The process of Data Analysis and Reporting shall also be discussed.

3 chapters.

Module 13 : Regulatory Affairs in Clinical Research

This module covers the Regulatory Environment in US, Europe and India and the governing regulations for clinical trials conducted in these countries.

3 chapters.

Module 14 : Medical Device Trials

This module covers the processes, strategies and considerations governing the conduct of clinical trials that involve the research of Medical devices.

3 chapters.

Module 15 : Project and Vendor Management

This module will cover the Fundamentals of Project Management, Vendor Selection and Management and Management of Clinical Trial Supplies in an outsourced clinical trial.

5 chapters.

Module 16 : Financial Management of Clinical Trials

This module will cover the concepts of Accounting for Managers, managing clinical trial budgets, marketing trials and managing compensation of key parties in a trial.

4 chapters.

Module 17 : Personality Development and Communication

This module will cover the various concepts of personality development and communication skills. It will cover the concepts of Attitude, Leadership and Group dynamics and Team building that are key to the success of a clinical trial.

11 chapters.

Module 18 : Oracle Siebel Clinical CTMS

This module introduces Oracle Siebel Clinical for clinical trial management and provides learners with exposure to clinical trial management workflows and activities within the application. Hands-on Oracle Siebel Clinical login access is included with the eLearning + software option.

5 chapters.

Course Completion

This course completion module, includes a Final Quiz that you will need to take to complete this course. The marks of the final quiz will be added to the marks of all other graded activities of this course. If your total score in the course is 75% and above, you will be able to see a Course completion certificate which you can then download.

Final Assessment.

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Ian D'Souza

Student

 

“The program was really detailed. It covered all the topics of clinical research. The multimedia tutorials made learning simple. Quizzes helped me assess myself. Instructor cleared all doubts through the dicsussion forum. Oracle Siebel Clinical software access helped me practice and get practical experience in managing trial data. Support was outstanding. Extremely satisfied with this program offered by ClinSkill “

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FAQ

Here are some questions we get asked often about this course
What is Clinical Research?

Clinical research is the systematic study of health, diseases, medicines, medical devices and other interventions involving human participants or health-related data. Clinical trials form an important part of clinical research and are conducted according to defined protocols, ethical principles and regulatory requirements.

What does the Diploma in Clinical Research cover?

The program provides structured learning across key areas of the clinical trial lifecycle, including clinical research fundamentals, ethics and Good Clinical Practice, trial preparation, study start-up, monitoring, regulatory requirements, compliance, data management and biostatistics.

Does the program include access to Oracle Siebel Clinical?

Software access depends on the learning option selected.

The eLearning + software option includes 24×7 access to Oracle Siebel Clinical for hands-on practice. The eLearning-only option includes the core clinical research training and relevant software learning content but does not include software login access.

What is the difference between the two learning options?

Both options include the same core clinical research curriculum, multimedia tutorials, recorded learning content, assessments and Certificate of Completion.

The eLearning + software option additionally includes 24×7 access to Oracle Siebel Clinical for hands-on practice, while the eLearning-only option does not include software login access.

How long do I have access to the program and Oracle Siebel Clinical?

The program duration is 3 months, with flexible, self-paced access to the online learning portal.

Learners choosing the eLearning + software option also receive Oracle Siebel Clinical access for the duration of the program.

Will I receive a Certificate of Completion?

Upon successful completion of the program and final assessment, learners receive a ClinSkill Certificate of Completion.

What career areas can this program help me explore?

The program helps learners develop knowledge relevant to clinical research operations, clinical trial coordination, study start-up, monitoring, site management and clinical trial management. Depending on your qualifications, experience and employer requirements, this knowledge may support your exploration of roles and career pathways in clinical research.

I deliberately retained the careful career wording used in the modernized Pharmacovigilance page rather than making employment or job-readiness guarantees.

Ready to get started?

Build your knowledge of clinical research and develop practical skills across the clinical trial lifecycle. Choose the learning option that suits your goals and start learning at your own pace.

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