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Good Clinical Practice

PC107: Diploma in Good Clinical Practice

Duration: 3 Months

Fee: 12999/-

To learn the applications of Good Clinical Practice (GCP) in clinical research.

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Course Overview

Good Clinical Practice

About this course 

ICH-Good Clinical Practice Guidelines are international standards of ethical and scientific consistency for the preparation, implementation, monitoring, evaluation, analysis, review and reporting of biomedical and behavioral research in the human population. Good clinical practice provides a framework of principles aimed at ensuring the safety of research participants and the integrity and validity of the data. The guideline came into force in 1997 as a guide by a steering group called the Tripartite International Harmonization Council (ICH) which included the regulatory agencies of the three major regions referred to above.

It is compulsory and necessary for a person to undergo training on the Good Clinical Practice guidelines (GCP) before taking part in any clinical research operation. The Professional Certificate in Advanced Good Clinical Practices (GCP) course is designed to prepare clinical research personnel in accordance with the applicable Good Clinical Practice (GCP) guidelines. This on-line training program is covered by 12 quality course modules to do so in-depth training on the ICH-GCP guidelines and related clinical research procedures.


Who should take this course?

  • Clinical Research Professionals
  • Aspirants (students/ working professionals) from following health science background: Pharmacy, Medicine, Dental, Nursing, Public Health, Life-Science, Physiotherapist, Traditional/ Alternative Medicine etc.

What am I going to get from this course?

  • 12 high-quality learning modules with an online exam.
  • In-depth knowledge in applicable ICH-GCP and regulatory guidelines.
  • Learn the application of GCP on various study processes.
  • Learn roles and responsibilities of clinical trial personnel.
  • Certificate and Performance Card on successful completion.
  • Opportunity to explore your career in Clinical Research Operations.

Curriculum

Module 1: Introduction to Clinical Research
Module 2: Evolution of ICH-GCP
Module 3: GCP Guidelines and Code of Federal Regulations (CFR)
Module 4: Roles and Responsibilities
Module 5: Institutional Review Board (IRB)
Module 6: Informed Consent
Module 7: Study Subject Recruitment and Retention
Module 8: Safety Reporting and Adverse Event Management
Module 9: Monitoring and Quality Assurance
Module 10: Research Protocol
Module 11: Essential Research Documents
Module 12: Research Misconduct
Clinical Trials Terminology
Assessment through Online Exam

FAQs

  1. What will be the mode of learning and do I need to visit anywhere to take this course? The mode of learning is completely online and you are not required visit anywhere to take this course. You can easily learn and complete this course from your location. You should have a device (laptop/ desktop) with internet connect.
  1. How will you deliver the course modules? You simply need to log in with the Username and Password at our Online Module Portal to start learning. The access will be granted to you via email within 24 hrs. of fee payment.
  1. I am a student at present; can I take this course along with my studies? Yes, you can take this course along with your regular studies.
  1. Is there any specific timing to take the course modules? We have made it very convenient for you. All the course modules are pre-loaded on the website, so you can learn the modules as per your convenient timings.
  1. How will you conduct the exams? Exams will be online. Once you are through with course modules and want to take examination, you just need to drop a request mail at info@pharma-research.in Request to take the online exam can be sent at any time.
  1. When will I receive the Certificate and Performance Card? Once you attempt and submit your online exam for evaluation, we generally take 7 business days to evaluate and issue Certificate of Completion along with Performance Card
  1. How will you send the Certificate of Completion? The Certificate would be issued through email upon successful completion. The issued certificate would be print-ready but if you wish to receive a hard copy of Certificate then a minimal charge towards processing, printing and courier would be applicable.
  1. How to enroll and pay the fee? To enroll, you simply need to view the link HOW TO ENROLL.
  1. Can I pay the fee in installments? Yes, you can pay the fee in maximum 3 installments. To pay the fee in installments, you need to contact us at info@pharma-research.in

You can also view our FAQs page for further queries.

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Student 1876

Length: 4 weeks

Timings: Self Paced

Language: English

Effort: 55 hrs. approx

Skill Level: All

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