Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

In clinical research, protocol amendments are changes made to the original research protocol after a study has been initiated. These modifications can arise from several factors, including the need for clarification, addressing unforeseen issues, or implementing regulatory changes. A common outcome of such amendments is an increased budget.

When protocol amendments occur, they often lead to adjustments in the scope of the study, which may require additional resources, revised methodologies, or extended timelines. As a result, the overall costs associated with the trial may rise. For instance, if the recruitment strategies need to be altered or the study design broadened to include more participants or to gather additional data, this will inherently increase the budget allocated for the research.

While other outcomes like faster recruitment processes or lower participant risk may seem desirable, they are not typical direct results of protocol amendments. In fact, modifications can sometimes lead to delays in recruitment or the need for additional risk assessments, impacting timelines and participant safety evaluations. Therefore, the expectation of increased budget represents a realistic and frequent consequence of the necessary adjustments made during the clinical research process.