SOCRA CCRP Practice Exam

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What is not part of the ICH guidelines for maintaining essential study documents?

Organize into sections and file chronologically
Store in a warm and humid environment
Explain missing documents or documents at another location
Avoid duplicate filing

The correct answer is: Store in a warm and humid environment

The ICH guidelines emphasize the importance of organizing documents into sections and filing them chronologically, as this makes it easier to access relevant information during an audit or inspection. The guidelines also stress the importance of avoiding duplicate filing, as this can cause confusion and potentially lead to the wrong version of a document being used. Furthermore, the guidelines encourage properly explaining any missing documents or documents that are located in a different location, as this helps maintain transparency and accuracy in the study. However, storing documents in a warm and humid environment can damage the integrity of the documents and render them unreadable, making it an incorrect option according to the ICH guidelines.