Introduction to Clinical Research · History of Clinical Research · Evolution of GCP · Glossary terms · Stake Holders in Clinical Research · Roles & Responsibilities of Sponsor · Roles and Responsibilities of Ethical Committe · Roles & Responsibilities of Clinical Research Associate & Clinical Research Coordinator · Role of Subject in Clinical Trials & Inform Consent process · Role of RA, Biostatistician & Clinical Data Manger in trials · Monitoring in Clinical Trials · Clin...
배울 내용 ; Understand the Clinical Evaluation Report (CER) Writing Process: Learn the essential components and steps involved ; Comprehend Regulatory Requirements: Gain insights into the regulatory landscape governing CERs ; Conduct Device Evaluation and Clinical Data Analysis: Acquire the skills to evaluate medical devices and analyze clinical data to support CER development ; Create Compliant and Comprehensive CERs: Master the art of authoring comprehensive, compliant, and evidence-based CERs tailored to specific device types.
Basic understanding of Clinical Research ; Historical background of US Drug Law and Regulations ; Drug approval process in USA, New drug development-Preclinical Steps, IND, NDA, ANDA ; Essential Documents in Clinical Research
The Clinical Research Certificate provides training in research methods for faculty members, postgraduate residents, international fellows and community-based health care professionals who...
Curriculum Requirements ; The curriculum comprises 4 required courses for a total of 12 semester units (180 hours of instruction). Candidates must pay a nonrefundable certificate registration fee. The Certificate Program in Clinical Research Conduct and Management is taught in both a hybrid format that consists of 50 percent classroom instruction and 50 percent online instruction and a fully online format. You can move freely between the two formats as long as all four courses are completed in sequential order. ...
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Basic understanding and terminologies related to Dug Regulatory Affairs (DRA). ; Why Regulatory Affairs (RA) professional is required in Pharma Industry and essential qualities of RA professionals. ; Understand the role of a Regulatory Affairs Professional in Pharmaceutical industry, Types of companies hiring RA professionals, and DRA objectives. ; Navigation through historical background of US Drug Law and Regulations, and The USFDA regulations for Research and Development (R&D) of Pharmaceuticals.
Duration : 2 or 3 years part time distance, Entry year : September 2025, Campus : Online, Discipline : Healthcare and Medicine
The Certificate in Clinical Ethics is a discipline-specific program for those who have long-term goals in clinical and research ethics. The certificate is intended to build upon the existing experience of health care professionals. It will benefit current health care professionals with additional education while not requiring as much time away from their duties of patient care. The certificate program is designed to meet the Core Competencies for Health Care Ethics Consultation developed by the American Society Bioethics and Humanities (ASBH) . ...
Course Features ; If you are interested in being part of teams and organisations that focus on innovative patient focussed research, this programme is perfect for you. Designed to be accessible by those with a Science background, who wish to gain a competitive employment advantage in order to pursue a career in bio-pharmaceutical research, biotechnology, or within the medical device sector. The online learning environment allows you to study in your own location, while providing you with constant access to the tutors at the UCD Clinical Researc ...