Post Graduate Diploma in Clinical Research & Quality Assurance /GCP Audits & Inspections

Global Institute of Health Science

Postgraduate

Blended learning in Ahmadābād (India)

£ 305.91 VAT inc.

*Indicative price

Original amount in INR:

₹ 32,000

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Description

  • Type

    Postgraduate

  • Methodology

    Blended

  • Location

    Ahmadābād (India)

  • Duration

    Flexible

  • Online campus

    Yes

  • Delivery of study materials

    Yes

  • Support service

    Yes

  • Personal tutor

    Yes

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.

Facilities

Location

Start date

Ahmadābād (India)
See map
21 Shri Hari Nirant cross road, 382415

Start date

Different dates availableEnrolment now closed

About this course


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.


Career Options:
Director
Associate Director
Project Manger
Asst. Project Manager
Clinical Research Associate
Clinical Trial Assistant

Eligibility: All Science Graduates, MBBS, BDS, BHMS, BAMS, BPT, BUMS, Bpharm, Mpharm, Pharmacy, Occupational Therapist, Bsc, Msc, Life science, Medical IT Professionals, Medical Laboratory, Nursing, Microbiology, Biomedical, Biotech and all professionals working with Hospitals & Healthcare Organizations.

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Reviews

Subjects

  • Protocol
  • Intellectual Property
  • Audit
  • Quality Assurance
  • Quality
  • Design
  • Clinical Research
  • Clinical Trial
  • Quality Training
  • Regulatory Affairs
  • Clinical data

Teachers and trainers (1)

Professional Coordinator

Professional Coordinator

Healthcare Specialist

Course programme

Global Institute of Health Science is a pioneer in health science education especially in distance & online education. Global Institute of Health Science is the INDIA’s first Online Institute and an ISO 9001:2008 Certified health science Institute, also certified with copyright approval from MHRD (Higher Education) Government of INDIA. GIHS have certification from UK for Quality Control Management System.

Syllabus

Clinical Research

· Introduction of clinical research

Clinical Trial Phases

Pharmacological Principal 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 Of Sponsor – Investigator
Responsibilities Of Sponsor – Vendor

· Clinical Trial Design And Project Managements
Clinical Trial Design
Vendor Selection And Managements
Project Planning
Project Managements

· 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 CRF Part 11
Site Auditing
Sponsor Compliance And Auditing
SOP For Clinical Research

Roles & Responsibility Lead & Principle 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

Additional information

Clinical Research Quality Assurance GCP Audits/Inspections  

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  

Online Registration & Admission Process:

Candidate have to fill the online registration form and have to upload passport photograph and signature. After the submission of online registration form candidate will receive mail regarding Acknowledgement Letter & Fee Payment Instructions.  Candidate have to pay the program fee within 7 working days on given bank information.

After fee payment candidate have to send scan copy of Bank Deposit Slip and Final year Mark-sheet or Degree Certificate or Provisional Certificate with your Admission Details (Application ID & Name) at Email: info@gihsonline.com.

MODE OF EXAMS Our IT department will provide you ID & Password for online examinations after completion of program.  You will have 7 days to appear online exams.  Your examination pattern would be Multiple Choice question MCQ and also need to submit power point project of minimum 30 pages of your own selected topic. After qualifying the exams, GIHS will deliver the two certification one would be DEGREE & second would be TRANSCRIPTIONAL Degree.

See related categories

  • Intellectual Property Postgraduate Degrees
  • Audit Postgraduate Degrees
  • Quality Assurance Postgraduate Degrees
  • Other Health Postgraduate Degrees
  • Distance learning Other Health Postgraduate Degrees
  • Global Institute of Health Science Postgraduate Degrees

Post Graduate Diploma in Clinical Research & Quality Assurance /GCP Audits & Inspections

£ 305.91 VAT inc.

*Indicative price

Original amount in INR:

₹ 32,000

The best Other Health courses

See all

See all