What This Document Is
This document is a redlined clinical protocol – specifically, Amendment 1 – for a Phase I trial of Vilazodone Hydrochloride, prepared for Northeastern University’s RGA 6201 course, “New Drug Development: A QA/Regulatory Overview.” It represents a team project completed by students Parchuri Tejasri, Bhuptani Unnati, Tsai Kai-Cheng, Vichare Prachiti, and Kulkarni Akshay. The redlining indicates revisions to a previous version of the protocol.
Why This Document Matters
This assignment is intended for students learning about the regulatory and quality assurance aspects of new drug development. Clinical protocols are foundational documents in pharmaceutical research, outlining how trials are conducted to ensure patient safety and data integrity. Understanding protocol structure and the amendment process is crucial for professionals in the field.
What This Document Provides
The document includes a draft clinical protocol covering aspects such as sponsor information (TWIND PHARMACEUTICALS PVT. LTD.), investigator details, a protocol agreement, objectives related to bioavailability and safety of Vilazodone, inclusion/exclusion criteria for study participants, and sections outlining statistical methods and data handling. It also provides a table of contents indicating further sections on administrative, ethical, and regulatory considerations, as well as references. This preview *does not* include the full details of the study design, statistical analysis plans, or complete safety reporting procedures. It is a partial view of a larger, comprehensive document.
