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) / Projects
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
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Director
To oversee the organisational practice is as per the standard practice and regulatory compliance.
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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 task.
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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.
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Asst. Project Manager
Track work to be done, set desired deadlines and delegate tasks to team, identifying any potential risks.
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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 requirements.
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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.
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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 data captured.
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.
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Bringing Excellence To Health Professionals
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10+ Years of Experience
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ISO & GOVT Certified
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Personalized Tutoring for Success
Fees, Payment & Program Duration
Certificate 3 Months- 22000/- INR & Fees for International Candidates – 450$ USD
PG DIploma One Year – 32000/- INR & Fees for International Candidates – 699$ USD
FT PG Diploma 4 Months – 36000/- INR & Fees for International Candidates – 750$ USD
Online Transfer through NEFT or RTGS
Fee can also be deposited in GIHS bank account (For more details Click Here).
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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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