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clinical research

PC101: Advanced PG Diploma in Clinical Research, Pharmacovigilance & Clinical Data Management

1 Year Certification Program

FEE: 19999/-

To learn the applicable clinical research guidelines, personnel & stakeholders responsibilities, clinical trial study processes, Clinical Data management, Pharmacovigilance etc.

Admission Open - For Registration

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About this course

The demand for clinical trials is expected to hit a market value of $64B by 2020 compared to the present value of $38.4B. The market is expected to reflect CAGR at 9% between 2015 and 2020. Currently, ClinicalTrial.gov lists more than 200,000 trials worldwide, creating a number of career options for clinical trial operations and related fields. The Professional Certification in Clinical Research (PCCR) course allows learners to gain in-depth knowledge of the relevant ICH-GCP and regulatory requirements, clinical trial study methods, duties and responsibilities of various stakeholders, reporting procedures, terminology, etc. This course will allow clinical research candidates and working professionals to succeed in their careers as Clinical Trial Operations Coordinator (CRC), Clinical Research Associate or Clinical Trial Investigators.


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 various clinical trial 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.

International authors Clinical research, Phamacovigilance & Clinical Data Management eBooks lifetime accessibility

MODULE -1

  1. Introduction to Clinical Research & Good Clinical Practice
  2. Overview ICH GCP
  3. Good Clinical practice
  4. Clinical Trails
  5. Institutional Reviews board
  6. Investigation Responsibilities in clinical trails
  7. Roles and Responsibilities of Sponsor & Clinical Trial Monitor
  8. Informed Consent Process
  9. Serious Adverse Event (SAE), Adverse event reporting
  10. Site Initiation visit
  11. Site close visit
  12. Test Your Self
  13. Apply Your Certificate

MODULE  -2

  1. Introduction to Clinical Data Management
  2. Clinical Data Management
  3. Medical Coding in Clinical Data
  4. Clinical Data Process
  5. Case Reporting Form
  6. Quality & Regulatory system

MODULE -3

  1. Introduction to Pharmacovigilance
  2. Signal Detection and causality assessment
  3. Statistical reasoning and algorithms in pharmacovigilance
  4. Medical dictionary for Drug Regulatory Activities (MedDRA)
  5. Individual Case Safety Report (lcsrs)
  6. Periodic Safety update report (PSUR)

– Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
– Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
– Any degree in Pharmacy / Pharmaceutical Sciences
– Any degree in Chemistry / Biostatistics / Bioinformatics
– Any degree in Nursing / Allied Health.
– Students in their final year of graduation for the above courses are also eligible to apply.

If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.

  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 Moodle 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.

Student 3200

Length: 4 weeks

Timings: Self Paced

Language: English

Effort: 55 hrs. approx

Skill Level: All

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