CLINICAL RESEARCH INTERNSHIP TRAINING BOOK

This book presents a dummy/simulated Phase II clinical trial designed for academic and internship training purposes, focusing on the evaluation of Cisplatin in patients with advanced solid tumors. The study follows a randomized, double-blind, placebo-controlled design conducted over 12 weeks with a sample size of 120 adult participants.

The primary objective is to assess the efficacy of cisplatin in achieving tumor response based on RECIST criteria, while secondary objectives include evaluation of progression-free survival, overall survival, and safety profile. The study outlines detailed procedures for screening, enrollment, treatment administration, monitoring, adverse event reporting, and follow-up.

Developed in accordance with ICH-GCP guidelines, Schedule Y regulations, and ethical principles, this simulated study provides interns with practical exposure to real-world clinical trial documentation, regulatory compliance, and research methodology. It serves as a comprehensive learning tool to build foundational skills required in clinical research and pharmaceutical industries.