What is the primary responsibility of the Regulatory Specialist concerning study documentation?

Answer

Preparing and managing essential documents like ethics approvals and maintaining the Investigator Site File (ISF).

The Regulatory Specialist, or Coordinator, is the dedicated expert responsible for navigating the legal and ethical submission landscape required to initiate and maintain a clinical trial. Their paramount duty is to ensure the study remains in full compliance with all governing legal and ethical standards throughout its duration. This involves the critical task of preparing and meticulously managing all essential regulatory documents, such as securing and processing ethics approvals from relevant committees. Moreover, they bear the responsibility for maintaining the Investigator Site File (ISF), which is the comprehensive collection of essential trial documents kept at the site. This file must be kept current and accurate throughout the entire study period to withstand regulatory scrutiny and demonstrate that the site is operating legally and ethically.

What is the primary responsibility of the Regulatory Specialist concerning study documentation?

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