Certification in Clinical Research

BY
Clini Launch Research Institute

Learn the components of clinical research with the Certification in Clinical Research programme by Clini Launch Research Institute.

Mode

Online

Duration

4 Months

Quick Facts

particular details
Medium of instructions English
Mode of learning Self study, Virtual Classroom +1 more
Mode of Delivery Video and Text Based
Frequency of Classes Weekdays

Course overview

The Certification in Clinical Research is a course designed to equip aspiring professionals with the knowledge and skills essential for success in the dynamic field of clinical research. This course provides a thorough understanding of the fundamental principles, methodologies, and regulatory aspects governing clinical trials and research studies. Students will possess a solid foundation to excel in various roles within the clinical research domain, contributing significantly to advancements in healthcare and medical science.

The Certification in Clinical Research training delves into topics like research ethics, protocol development, data collection and analysis, and Good Clinical Practice (GCP) guidelines. With a focus on the practical application of theoretical concepts, the course incorporates case studies, simulations, and real-world scenarios to ensure a well-rounded learning experience among students. 

The highlights

  • 3/4 months certification course
  • Offered by Clini Launch Research Institute
  • Completion Certificate
  • Interactive classes
  • Hands-on learning experience

Program offerings

  • Course readings
  • Practical learning
  • Daily assessments
  • Cost effective

Course and certificate fees

certificate availability

Yes

certificate providing authority

CLRI

Who it is for

The Certification in Clinical Research course is designed for clinical practitioners such as clinicians and Clinical Research Coordinators to establish themselves in the dynamic and critical field of clinical research. This course provides students with the specialised skill set and knowledge base to launch a successful career in clinical dynamics.

Eligibility criteria

Academic Qualification

To be eligible for the Certification in Clinical Research online course, students are required to have a graduate and postgraduate degree from a recognised university. 

Certification Qualifying Details 

To qualify for the Certification in Clinical Research by Clini Launch Research Institute, candidates are required to complete the full course. 

What you will learn

The Certification in Clinical Research syllabus provides students with a profound understanding of the processes and methodologies that underpin the realm of clinical research. This course will equip you with the skills to design and execute robust clinical trials, ensuring adherence to ethical standards, regulatory requirements, and Good Clinical Practice (GCP) guidelines. 

Upon completion of the Certification in Clinical Research course students will gain proficiency in protocol development, data collection and statistical analysis. The course emphasises practical application, coupled with real-world case studies and many more.

The syllabus

Module 1: Corporate Etiquette and Soft Skill Training

  • 1.1: Introduction to CLRI 
  • 1.2: Five must-have skills for every fresher 
  • 1.3: Soft Skills for Career growth 
  • 1.4: Soft Skills for Career growth 
  • 1.5: SOP standard operating procedures 
  • 1.6: JAM Session (just a minute) 
  • 1.7: Job application

Module 2: Aptitude Preparation

English
  • Vocabulary
  • Synonyms
  • Antonyms
  • Contextual Vocabulary
  • Grammar
  • Error Identification
  • Sentence Improvement and Construction
  • Comprehension
  • Reading Comprehension
  • Fill in the blanks
Qualitative ability
  • Basic Mathematics
  • Divisibility
  • HCF and LCM
  • Numbers
  • Decimal fractions
  • Applied Mathematics
  • Profit and Loss
  • Simple and Compound Interest
  • Time, Speed, and Distance
  • Inverse
  • Permutation and Combinations
  • Probability

Module 3: Clinical Research

  • 3.1: Scope of Clinical Research in India & Global
    • 3.1.1: Historical Guidelines in Clinical Research
    • 3.1.2: Declaration of Helsinki
  • 3.2: Ethics/ Ethics Committee
  • 3.3: Phases of Clinical Trials
  • 3.4: Introduction to ICH, ICH-GCP Guideline
  • 3.5: Drug & Cosmetic Act 1940 & rule 1945
  • 3.6: Clinical Trial Design
  • 3.7: Introduction to Clinical data management

Module 4: Pharmacovigilance

  • 4.1: Introduction to Pharmacology and Pharmacovigilance
  • 4.2: Basic terminologies in Pharmacovigilance
  • 4.3: Reporting of Adverse reaction and Event
  • 4.4: Causality Assessment Criteria
  • 4.5: Methodologies in Pharmacovigilance
  • 4.6: Periodic Safety Update Report (PSUR)
  • 4.7: Signal Detection and Data Mining

Module 5: Clinical Data Management

  • 5.1:Introduction to data management
  • 5.2: Role and responsibilities of CDM
  • 5.3: Protocol Implementation & CRF/eCRF design
  • consideration
  • 5.4: Data Base build and validation
  • 5.5: Data management Plan creation
  • 5.6: Data Collection & acquisitions
  • 5.7:CRF tracking
  • 5.8:Data Entry
  • 5.9:Data validation
  • 5.10: QA QC
  • 5.11: Overview of LAB Data, Examples
  • 5.12: Database Lock

Module 6: Medical Writing

  • 6.1: Introduction to medical writing
  • 6.2: What is Scientific Writing? Examples of Scientific Writing
  • 6.3: Pre-clinical/Non-Clinical writing
  • 6.4: Role of Medical Writing in Clinical Trial
  • 6.5: Overview and Sample of Reports
  • 6.6: Guidelines to publish clinical data
  • 6.7: MEDICO-MARKETING WRITING
  • 6.8: Medical & Scientific Style guides
  • 6.9: What is Data Citation & referencing
  • 6.10: How to Manage Plagiarism & Copyright

Module 7: Regulatory Affairs

  • 7.1: Introduction to Regulatory Affairs
  • 7.2: Drug regulatory and accrediting agencies of the world
  • 7.3: Regulatory Document
  • 7.4: Clinical Trials (E3)
  • 7.5: Guideline for Import of Drugs
  • 7.6.1: Overview related to manufacturing & sale
  • 7.6.2: Labelling and packaging
  • 7.7: DMF- preparation, submission, responding to regulatory deficiencies
  • 7.8: Importance of GMP Compliance
  • 7.9: QA/QC Documentation
  • 7.10: Hatch Waxman Act- 180-day exclusivity
  • 7.11: HIPPA Act

Admission details

To join the Certification in Clinical Research classes, candidates need to follow these steps: 

Step 1: Browse the official URL: https://clinilaunchresearch.in/certification-in-clinical-research/

Step 2: Candidates are required to submit the online application by filling out all the necessary and relevant information such as primary email address, name, phone number, and motivation letter.

Step 3: Thereafter, they are required to pay the course fee in the payment gateway option.

Step 4: Candidates will then have to access the course and start the learning process.


Filling the form

To enrol for the Certification in Clinical Research training, candidates are required to submit the online application which asks for details such as primary email address, name, phone number and a motivation letter.

How it helps

The Certification in Clinical Research benefits the student by providing essential fundamentals to excel in the dynamic and crucial field of clinical research. Firstly, the course provides a comprehensive and up-to-date understanding of the fundamental principles and practices governing clinical trials, ensuring that students are well-equipped to navigate the complexities of this evolving landscape.

FAQs

Is there any eligibility required for the Certification in Clinical Research course?

Candidates need to have a graduate and post-graduate degree from a recognised university.

Is there any scholarship option available for the Certification in Clinical Research by ClinicLaunch Research Institute?

Candidates are not provided with any scholarship option for the course, therefore they have to pay the full amount to enrol for the course.

How can I receive the certificate of the Certification in Clinical Research online training?

Students would receive the certificate after taking completing the full course and the programme.

What are the benefits offered for the Certification in Clinical Research classes?

This course offers a structured and comprehensive curriculum that covers fundamental principles, methodologies, and regulatory aspects of clinical research, ensuring a robust understanding of the subject matter. 

Are there any prerequisites for the Certification in Clinical Research online course?

Candidates do not require any prerequisites for this certification course

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