Clinical Research & Quality Assurance /GCP Audits & Inspections

Clinical Research & Quality Assurance /GCP Audits & Inspections Syllabus

Clinical Research & Quality Assurance /GCP Audits & Inspections

Global Institute of Health Science is a pioneer in health science education, especially in distance and online learning. The institute is ISO 21001:2018 certified and globally acclaimed, with copyright approval from IPR Government of India and international certification from UASL UK for Quality Control Management Systems.

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Syllabus

Table of Content

Clinical Research
Introduction of clinical research
Clinical Trial Phases / Pharmacological Principle of Clinical Research
Drug Development and Launch
Indian Regulation (domestic regulation)
- ICH GCP
- Schedule Y
- ICMR
- Indian GCP
Key Stakeholders in Clinical Research
- Ethics Committees and Institutional Review Board
- Responsibilities of Sponsor
- Responsibilities of Investigator
Responsibilities
- Responsibilities of Sponsor – Investigator
- Responsibilities of Sponsor – Vendor
Clinical Trial Design and Project Management
- Clinical Trial Design
- Vendor Selection and Management
- Project Planning
- Project Management
Principles of Good Clinical Practices
- Protocol Design
- CRF Design
Essential Documents in Clinical Research and Regulatory Requirements
- Essential Documents
- IND Application
- Clinical Study Report
- NDA Application
- Informed Consent Process and Documentation
Study Setup Process
- Site Selection and Pre-Study Visits
- Site Initiation
- Subject Recruitment and Retention Planning
- Site Contract and Budgeting
Quality Assurance
- GCP Audits & Inspections
- QC & QA
- Compliance & Auditing & Inspections
- 21 CFR Part 11
- Site Auditing
- Sponsor Compliance and Auditing
- SOP for Clinical Research
Roles & Responsibilities
- Lead Investigator
- Principal Investigator
Clinical Monitoring Activities
- CRF Review & Source Data Verification
- Drug Safety Reporting
- Drug Accountability Work
- Routine Site Monitoring
- Site Close-Out Visit
GCP Audits & Inspection

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Clinical Research & Quality Assurance /GCP Audits & Inspections

Clinical Research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical Research is different than clinical practice. In clinical practice, one used established treatments while in clinical research evidence is collected to establish a treatment. This GIHS Clinical Research Program designed to provide total overview and skill globally in the field of clinical research. It would help professionals to upgrade & develop their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical research & trial management. An Audit is a “systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor’s SOPs, GCP, and the applicable regulatory requirements.” An Inspection is “an act by a Competent Authority of conducting an official review of documents, facilities, records and other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the trial site, at the sponsor and/or contract research organisation’s facilities or at other establishments deemed appropriate by the Regulatory Authority.” This program deals with preparation for audits and inspections.

Course Objective

This GIHS objective is to understand the key concepts in the responsible conduct of research and be able to conduct research that conforms to the highest standards for the protection of human research subjects. It can be able to critically appraise the medical scientific literature, including the methodology of published and proposed investigations. It can be able to independently formulate a research question, as well as be able to design and conduct a study to address that question. It can be able to present and publish the results of one’s scholarly work. It is to identify a focus for future research and scholarly work, and to develop special expertise in the corresponding clinical domain and/or research methods.

Eligibility

Mode or Methodology

Certification

Examination

Placement Assurance

Career Options

Director

Associate Director

Clinical Research Associate

QA Auditor

Fees, Payment & Program Duration

Certificate Program

Foundation-level program
Core concept learning
Industry awareness focus
Expert-designed syllabus
Research-based curriculum
Academic & tech support
Skill development course
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Global accreditation & recognition
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*Fees subject to taxes & exchange rates.

Post Graduate Diploma Program

Advanced-level professional course
Comprehensive concept mastery
Research-based modules
Lifetime expert support
Job & career assistance
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High employment potential
Govt-recognized program
Global accreditation & recognition
Globally ISO certified

*Fees subject to taxes & exchange rates.

Fast Track PG Diploma Program

Accelerated PG-level program
Flexible learning format
Self-paced completion
Lifetime expert support
Research-driven curriculum
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Job-oriented training
Govt-recognized program
Global accreditation & recognition
Globally ISO certified

*Fees subject to taxes & exchange rates.

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Sarah Lilly-MBA

08:37 10 Apr 26

From the day 1 to till date Chethan assisted very well and had a smooth journey till I had received my certificates through courier. And the studies are very detailed and made interesting. Thank you😊

Brandon SJ

09:55 04 Apr 26

I took an EEG course through GIHS that I really enjoyed. The course expanded my mind and pushed me in a lot of ways to capture complex nuances to the process and machinations of EEG and how it works giving me the confidence needed when as I embark on this field. In addition to the learning materials - the communication was exceptional from officials and anything that you needed help with they were there willing and ready able to assist. Thank you so much GIHS!

Kirti Saxena

09:02 19 Mar 26

"Great experience! The faculty is knowledgeable and approachable. The resources and facilities are top-notch. Would definitely recommend."

Andrea Del Pilar

13:31 18 Mar 26

They have a very good independent study methodology and the subject matter is really good; in my personal case, since this specialization is not available in my country, the Institute of Health was a wise choice.

Vinitha Siva

12:35 18 Mar 26

Assistance is good 24/7 , the content of the course can be improved slightly, other than that it was great . Thanks for the support

Samridhi Sharma

11:02 22 Dec 25

The PG Diploma in Nutrition course covers the basic concepts clearly. Teaching is satisfactory and the study material is useful for understanding nutrition fundamentals. Overall, it is a decent course for those looking to gain knowledge in this field.

A V

08:01 08 Oct 25

One of the best institutions. I have recently completed my PG Diploma in Clinical Research and Pharmacology. Course is carefully structured and detailed. Management is very well organised and prompt in assistance.

I would highly recommend this institution.

Akram Sabiq

17:49 05 Oct 25

"I'm impressed with the comprehensive coverage of international standards and laboratory skills, which were not adequately addressed in my previous academic programs. This course has been a game-changer for me, providing the knowledge and skills necessary to succeed as a lab technician on a global platform."

susigarans

10:53 29 Aug 25

My Experience with GIHSS and the PG Diploma in Health Informatics & Management

I am grateful for the opportunity to pursue the PG Diploma in Health Informatics & Management at GIHSS. Throughout the course, I learned a wealth of knowledge that has significantly enhanced my understanding of the healthcare industry and the role of technology in improving patient care.

The curriculum was comprehensive, covering essential topics such as health information systems, data management, healthcare analytics, and health policy. The faculty were highly experienced and supportive, always ready to clarify doubts and encourage practical learning. The program also emphasized real-world applications, which helped me develop critical skills needed in the healthcare sector.

Thanks to GIHSS, I now have a solid foundation in health informatics, enabling me to contribute effectively to healthcare organizations. Overall, this course has been a valuable stepping stone in my professional development, and I highly recommend it to anyone interested in bridging healthcare and technology.

Wishing everyone success in their learning journey! Best wishes to all future students.

Sincerely

Denis

Dr Fatema Ebrahim

10:43 25 Jul 25

I recently completed my Post Graduation in Pregnancy and Child Care from GIHS and it was a wonderful experience. The course was well-structured, and the faculty was supportive and knowledgeable. I gained in-depth knowledge about all the aspects of pregnancy and childcare, that have prepared me to confidently support mothers and babies. Highly recommended .

Frequently Asked Questions

Does regulatory affairs pay well?

While the specifics may depend on different factors, generally regulatory affairs professionals are well-compensated. This is because of the critical role they play in ensuring compliance with regulations and facilitating the approval of products.

What is the role of regulatory affairs?

The role of regulatory affairs involves ensuring that products comply with regulatory requirements, especially in industries like pharmaceuticals, biotechnology, and medical devices.

Is there a scope for regulatory affairs?

Yes, there is significant scope for regulatory affairs professionals, especially in industries like pharmaceuticals and healthcare. As regulatory requirements continue to evolve, companies are looking for professionals who can help them abide by complex regulations.

What is the scope of IPR in the pharma industry?

IPR or intellectual property rights in the pharma industry are crucial for protecting innovations, inventions, and proprietary knowledge related to drugs and healthcare products. Professionals in the field play a key role in securing patents, trademarks, and copyrights.

Is IPR a good career in India?

Yes, IPR is a promising career in India, especially in industries like pharmaceuticals where innovation and protection of intellectual property are critical. With the increasing emphasis on research and development, the demand for professionals with expertise in IPR, including patent agents and attorneys, is growing in India.

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Clinical Research & Quality Assurance /GCP Audits & Inspections

Clinical Research & Quality Assurance /GCP Audits & Inspections Syllabus

Clinical Research & Quality Assurance /GCP Audits & Inspections

The GIHS Advantage

Syllabus

Clinical Research & Quality Assurance /GCP Audits & Inspections

Course Objective

Eligibility

Mode or Methodology

Certification

Examination

Placement Assurance

Career Options

Director

Associate Director

Clinical Research Associate

QA Auditor

Fees, Payment & Program Duration

Certificate Program

Post Graduate Diploma Program

Fast Track PG Diploma Program

Join GIHS Programs now and unlock an exclusive FREE TopCV Coach access worth ₹9,999/-

Frequently Asked Questions

While the specifics may depend on different factors, generally regulatory affairs professionals are well-compensated. This is because of the critical role they play in ensuring compliance with regulations and facilitating the approval of products.

The role of regulatory affairs involves ensuring that products comply with regulatory requirements, especially in industries like pharmaceuticals, biotechnology, and medical devices.

Yes, there is significant scope for regulatory affairs professionals, especially in industries like pharmaceuticals and healthcare. As regulatory requirements continue to evolve, companies are looking for professionals who can help them abide by complex regulations.

IPR or intellectual property rights in the pharma industry are crucial for protecting innovations, inventions, and proprietary knowledge related to drugs and healthcare products. Professionals in the field play a key role in securing patents, trademarks, and copyrights.

Other Related Courses

Pharmacovigilance & Medical/Scientific Writings

Clinical Trial Management

Clinical Research and Pharmacovigilance

Regulatory affairs IPR & Patents

Real Stories. Real Achievements

Where Our Graduates Are Making an Impact

Why Choose GIHS?

Bringing Excellence To Health Professionals

15+ Years Of Industry Experience

ISO & Government Certified Institute

Personalized Tutoring For Success

Request More Information

Request More Information

Enquire Today

Clinical Research & Quality Assurance /GCP Audits & Inspections

Clinical Research & Quality Assurance /GCP Audits & Inspections

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