Pranav Dixit
Independent Researcher
Madhya Pradesh, India
Abstract
The rising complexity and regulatory oversight in clinical trials necessitate structured training programs tailored for entry-level clinical research professionals. This manuscript explores the development and implementation of training programs based on Good Clinical Practice (GCP) and electronic Case Report Form (eCRF) modules to enhance research competency, regulatory adherence, and data accuracy in clinical trials. Emphasizing practical and theoretical foundations, the study reviews past educational methodologies, identifies gaps in current training frameworks, and introduces a comprehensive curriculum for onboarding novices into clinical research. Using validated instructional design models, the manuscript incorporates case-based learning, simulation environments, and interactive e-learning systems. Results from a pilot implementation demonstrate significant knowledge gains and performance improvements among trainees. This research provides a structured pathway for institutes and sponsors to systematically train and evaluate entry-level clinical research staff, ensuring ethical conduct and data reliability from the ground up.
Keywords
Clinical Research, GCP, eCRF, Training Modules, Entry-Level Professionals, Clinical Trials, Regulatory Compliance, Curriculum Development
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