PC107: Professional Certificate in
Advanced Good Clinical Practice
To learn the applications of Good Clinical Practice (GCP) in clinical research.
Starts 31st December 2018
About this course
ICH-GCP guidelines are international ethical and scientific quality standard for planning, executing, supervising, documenting, auditing, examining and reporting biomedical and behavioral research studies concerning human population. The good clinical practice provides a framework of principles which aim to ensure the safety of research participants and the integrity and validity of data. The guideline came into effect in 1997 as ‘guidance’ by a steering group termed the Tripartite International Council on Harmonization (ICH) which included regulatory agencies of the three major regions mentioned above.
Before taking part in any clinical research activity it is mandatory and essential for a person to obtain training on GCP guidelines. The course Professional Certificate in Advanced Good Clinical Practices (GCP) is designed to prepare clinical research personnel in compliant with applicable GCP guidelines. This self-paced online training course is covered in 12 quality course modules to provide an in-depth training on ICH-GCP guidelines and related clinical research processes.
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.
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
- 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.
- 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.
- 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.
- 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.
- 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 email@example.com Request to take the online exam can be sent at any time.
- 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
- 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.
- How to enroll and pay the fee? To enroll, you simply need to view the link HOW TO ENROLL.
- 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 firstname.lastname@example.org
- What is money back guarantee? If a student is unable to complete the course successfully, then course fee (excluding the processing fee of USD 5) will be transferred back in their account within 30 days. The guarantee is void:
- After 50 days of enrollment.
- Not attempting the exams or any section of exam
- Not following the instructions properly
- Attempt exam without reading the complete course modules
- Provides incorrect enrollment details
You can also view our FAQs page for further queries.
Length: 8 weeks
Effort: 50 hours
Timings: Self Paced
Skill Level: All
Includes: LifeTime Access Money Back Guarantee