Diploma in Clinical Research  3 months

The Post Graduate Diploma in Clinical Research is an eLearning program that comprehensively covers the concepts, processes, regulations and standards in Clinical Research. It also covers the process of management of clinical trial data in Oracle Siebel Clinical.

What you Get by Enrolling

Here’s how you learn

24x7 access to Siebel Clinical

Get hands-on practical experience on conducting clinical trial processes by working on the Oracle Siebel Clinical software.

Recorded Sessions

Get access to recorded video lectures from our expert industry faculty that demonstrate all activities performed in Oracle Siebel Clinical.

Multimedia Tutorials

Our multimedia tutorials are handcrafted for a more holistic learning experience. Access Computer Based Trainings (CBTs) on all Oracle Siebel Clinical activities.

Quizzes and Assessments

The program includes a Quizzes and Practical Assignments for each chapter to assess you understanding of the subject and provide feedback.

Discussion Forums

Each chapter includes a Discussion Forum. Post your Question. Get an answer from our Faculty. Its really that simple!.

Certificate of Completion

Earn Badges as your learn. Download the Certificate of Completion when you meet the course completion criteria for the program.

Program 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

Oracle Siebel Clinical CTMS is the de-facto standard for clinical trial management. In this module we will cover the functionalities and workflow of the Oracle Siebel Clinical application that are used to manage clinical trial data including financial, administrative and regulatory information.

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.

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 “

Course Fee

Choose a Learning style that suits you.

FAQ

Here are some questions we get asked often about this course

What is Oracle Siebel Clinical?

Oracle Siebel Clinical is a software application used for the collection, management and reporting of financial, administrative and regulatory data generated during clinical trials. It is used by most of the Fortune 500 companies. It is a part of a larger suite of applications called the Oracle Pharmaceutical applications suite (OPA)..

Will i get access to Oracle Siebel Clinical software?

Yes, you will be able to access the Siebel Clinical application 24×7 from your home throughout the duration of the program. Your credentials to access the software shall be emailed to instantly on enrollment in the program. The duration of access to the software is 3 months.

Do i receive a Certificate of Completion?

On successful completion of the program, students will be awarded a Certification. We lay a strong focus on the quality of learning. To acheive ceritication, you will need to complete all graded Tutorials, Quizzes, Assignments and a Final Examination at the end of the program.

What is included in Diploma in Clinical Research?

Diploma in Clinical Research is an eLearning program and is designed to be a self-paced learning course. You will get access to our Online Learning Portal and will learn through recorded sessions, tutorials and assignments. You can get your queries answered through Support Tickets and Discussion forums.

Who will answer my Queries?

Every chapter in the course will have a Discussion forum. When you post a query in the Forum, the Course instructor will reply to it. You can also directly message the course instructor from within the Learning portal. For urgent inquires you can also raise a support ticket on our Support Portal.

What jobs am i eligible for after the Course?

On successful completion of the program you will be elligible for the roles of a Clinical Trial Management Associate, Clinical Research Associate, Site Coordinator, Clinical Monitor, Investigator, Clinical Research Analyst, Oracle Siebel Clinical Analyst and Siebel Clinical Functional Consultant.

Ready to get started?

Get in touch, or enroll in the course