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Clinical Research & Quality Assurance /GCP Audits & Inspections

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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 Objectives: 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: All Science Graduates, MBBS, BDS, BHMS, BAMS, BPT, BUMS, B. Pharm, M. Pharm, Occupational Therapist, B.Sc., M.Sc., Life science, Medical IT Professionals, Medical Laboratory, Nursing, Microbiology, Biomedical, Biotech and all professionals working with Hospitals & Healthcare Organizations.
Mode or Methodology: Online & Distance Learning
Examination: Online & Distance Exams (MCQ / Theoretical) / Project
Placement Assurance: Successful candidates would get the placement support. CVs of successful candidates would be forwarded to various Organizations.
Certification: GIHS Certificate would be awarded to only successful candidates.

Career Options

  • Director

    To oversee the organisational practice is as per the standard practice and regulatory compliance.

  • Associate Director

    To guide the team and to ensure that organisation is compliance to the regulatory and organizational standard practice. To meet the client’s requirements and guide the team to achieve the ...

  • Project Manger

    Responsible for a specific project or several projects within an organization. Oversees the smooth conduct of the clinical study by proper planning and execution.

  • Asst. Project Manager

    Track work to be done, set desired deadlines and delegate tasks to team, identifying any potential risks.

  • Clinical Research Associate

    Responsible for setting up, coordinating and supervising clinical studies (trials). Coordinates with executing sites for work. Verify the data collected. Ensures the compliance to regulatory...

  • Clinical Trial Assistant

    Clinical Research Associate (CRAs) are responsible for coordinating and overseeing the execution of studies and clinical trials by supporting the CRAs and PM.

  • QA Auditor

    To perform Clinical audit at the research site for the clinical study projects and to verify the standard practice as well as regulatory compliance. To perform Database Audit of EDC tool dat...

Gihsonline Advantage

GIHS provides the best courses helps you to get the start up in the healthcare field. These courses are ad-hoc to your professional career and provide you the additional benefit to be the part of an organization.









Fees, Payment & Program Duration

Certificate 3 Months- 22000/- INR & Fees for International Candidates – 450$ USD

Post Graduate Diploma Program (One Year) – 32000/- INR & Fees for International Candidates – 699 $ USD

Fast Track PG Diploma Program (4 Months) – 36000/- INR & Fees for International Candidates – 750 $ USD

Cheque / Demand Draft/Cash in the name of “Global Institute of Health Science”

Online Transfer through NEFT or RTGS

Fee can also be deposited in GIHS bank account (For more details Click Here).

Disclaimer: This course details are for the purpose of awareness about the program and career opportunities.

The exact information on course structure may vary from this information.

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    Het Upadhyay

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    Master Kamal

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    Stella Jeyam Corner

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    Kanika Bhatt

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    Abhishek Purkayastha

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    Dr.Akhileshwar Rathore

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    Parmar Dipak

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    Chakradhar Maddela Neonatologist

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    Shaik Asif Quadry

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    Kavita Nariya

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    Nishanth Jaladi

  • Very good support was provided by Dr. Vijay. I am amazed at how he has got the time to follow up with us. Even if I forget, he doesnt forget about my schedules and reminded me so many times during my course. Furthermore, he advised me the appropriate course I should be choosing. Very much a service oriented person and institute.

    Sivasothy Nanthagopal

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    Dr. Farheen Alam

  • 5 Star Ratings

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    Dr.Nidhi Pathak

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    TushR Panchal

  • Good


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    Jason Anudeep

  • Great to study in Global Institute of Health Science ranked No.1 for Clinical Research. Thanks to GIHS for providing knowledge on such a vast subject in a crisp & in short period.

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    Dr. Pooja Sankhe

  • Global Institute Of Health Science Great platform to explore a vast knowledge base and a wonderful learning experience..I Personally thanks to staff members and coordinator every one is very cooperative.

    Dietitian Malini Dahiya

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    Sonali Labhade

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    Chirag Budhiraja

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    Riya Kapoor

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    Pravin Raj

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    Falguni Patel

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    Motsumi Phillip Modise

  • Doing a Post Graduate Diploma in Health Informatics with GIHS was a fulfilling. I found the study material both informative and up to date. I would recommend anyone to study with the Institution. ??

    Sympathy Mpofu

  • Very good support regarding to knowledge material

    Ameya Samel

  • Informative course with a helpful management. Thank you!

    Manjari Dixit

  • This Arshad Hussain, Working with TASNEE company on the position of Senior Specialist- Laboratory & QA/QC. I did PGDRA course from GIHS. The materials provided by GIHS to cover the PGDRA course was sufficient to understand & getting well skilled about Regulatory Affairs.. I am very thankful to GIHS & their coordinators for their cooperation & well communication during the course.


  • I am an Ayurvedic practitioner...GIHS is the only institute in my knowledge which runs a diploma in Ayurvedic Gharbhasanskar.. I am very happy and satisfied with the way they conduct the course..they are always available to help in any field during the curriculum..be it academic or management.. highly recommended

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    Siva Manasa

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    Saaka Rauf

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    Syed Abdul Razzak

  • Hi, I'm a Dentist and I got enrolled in the 1Year PG Dip-Health Informatics course. The whole experience of this online education was quite simple and easy. The topics in the books are explained in details. You don't need extra guidance to understand. There is prompt support team. Dr.Vijay was very helpful. Thank you so much GIHS Team. Good Luck

    Dr.Priscila Recommends #CUREēKINDNESS

  • Dear Sir, I learned a lot about my course "Regulatory affairs". Thank you for your support and encouragement to get the best results in the exam at the end of course. Thank & regards, K.M.Subrahmanyam.


  • ZYDUS HOSPITALS Global Institute of Health Science Impart successful training and certification course to 11 members of Ethics Committee on Clinical Research & Regulatory Guidlines with ZYDUS Hospitals"

    Clinical Research (Ethics Committee)

  • I am from Indore and i have done Health Informatics. I really thankful to GIHS as GIHS delivered the best skillful distance program with recent up gradation of IT Medics. With the help of this program i came to learn IT implementation in healthcare industry which is greatly helpful to my Job.

    Manish Thakkar

  • I have done Diploma in Maternal & Child Health from GIHS. This course helped me out with my current job as i am working in government health scheme in Udaipur city.

    Rupal Sharma

  • My journey with Clinical Research Program in GIHS was too good as it is very precisely developed course which was beneficial to get my current Job in CRO. Also it is compatible with current scenario in CR Industry.

    Divyesh Shukla

  • I have done Nursing management from GIHS. I am working as a Male Nurse and recently my hospital enrolled for NABH accreditation. GIHS is the only one organization who is providing this unique course in Nursing management. It is very helpful to understand the quality task in Hospital industry.

    Manoj Solanki

Frequently Asked Questions

Medical radiology technology involves the use of medical imaging equipment such as X-rays, CT scans, MRIs, and ultrasound to create detailed images of the internal structures of the body. This imaging is done to assist in the diagnosis and treatment of medical conditions.
Quality management in radiology involves implementing processes and standards to ensure the accuracy, safety, and effectiveness of radiologic procedures.
To become a radiology manager, you may need a bachelor’s degree in radiologic technology or any related field. You can then pursue additional certifications in management and gain relevant experience.
Quality assurance (QA) and quality control (QC) in radiology involve systematic processes to ensure the reliability and accuracy of radiologic imaging. QA focuses on continuous improvement and adherence to standards, while QC focuses on routine checks and tests to maintain equipment performance.
The scope of radiology management includes overseeing the operation of radiology departments, ensuring compliance with safety and quality standards, managing personnel, budgeting, implementing new technologies, and collaborating with healthcare professionals.

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