Clinical Research & Quality Assurance /GCP Audits & Inspections

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, analyzed 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 organization’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.
Syllabus

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.

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.