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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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

7. 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.

8. How to enroll and pay the fee?
   To enroll, you simply need to view the link HOW TO ENROLL.

9. 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.