I have prepared a list of terms used in clinical research with explanations, which may help those interested in clinical research to...

Case 1: Allergic Reactions in Phase I Study Situation: In a Phase I study of a new antibiotic drug, unexpected severe allergic reactions...

This article provides a comprehensive guide for organizing and maintaining the Investigator Site File (ISF). The ISF is crucial for...

This diagram illustrates how adverse events and reactions occurring during clinical trials should be reported and evaluated: Safety...

Caso 1: Effetti Collaterali Gravi Improvvisi nello Studio di Fase I Situazione:  Durante uno studio di Fase I su un nuovo farmaco per il...

This document summarizes the "Exceptional Case Detection Application Process Flowchart." The process is as follows: Exceptional Case...

This diagram illustrates how changes during clinical trials should be managed. The process includes the following steps: Determining the...

Flowchart of the Initial Eligibility Process: The summarized view of the process is as follows: Initiation:  The process begins with an...

This flowchart lists the application processes according to the quality requirements for human medicines. The steps described in the...

Case 1: Allergic Reactions in a Phase I Trial Situation: In a Phase I trial of a new antibiotic, several healthy volunteers develop...

This flowchart shows the decision tree used to determine the labeling requirements for medicinal products or auxiliary medicinal products...

Clinical research has an important place in health sciences and contributes to the development of innovative treatment modalities and...

Clinical research plays a critical role in advancing medical science, and recent developments in this field have positioned Turkey as an...

Clinical research is a cornerstone of modern medicine, leading to the development of new treatments, drugs, and therapies that improve...

The rapid advancement of technology is profoundly transforming clinical research, making it more efficient, precise, and...

1. Regulatory approvals required for clinical research Before any clinical trial can begin, it must obtain legal approvals from relevant...

Clinical research is fundamental to medical science, aiming to determine the safety and efficacy of new treatments. This process is...

Clinical research refers to scientific studies conducted to improve human health by preventing, diagnosing, or treating diseases. These...