Clinical Study Report Shell: A Comprehensive Guide

Clinical Study Report Shell A Comprehensive Guide The clinical study report is an essential part of the regulatory submission process. Its writing and finalization are important milestones. Company sponsors try their best to achieve this milestone as early as the availability of clinical study data (tables, listings, and figures [TLFs]) to meet the planned timelines […]

Informed Consent Forms: Key Elements and Best Practices for Clinical Studies

Informed Consent Forms: Key Elements and Best Practices for Clinical Studies Informed consent form is a process in which competent participants, after receiving and comprehending all research-related information, can voluntarily express their intention to participate in a clinical trial. While clinical trials identify the safety and efficacy of the investigational product,1 the primary goal of IC […]

Standard Operating Procedures in the Regulatory Framework

Standard Operating Procedures in the Regulatory Framework In the regulatory framework, following standard operating procedures (SOPs) can serve two chief purposes, i.e., compliance with regulatory guidelines and generating quality outputs from a big-budgeted clinical trial. However, negligence in following these SOPs can lead to fallbacks during FDA inspections. It has been observed from a cross-sectional […]