SOCRA CCRP Practice Exam

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What must sponsors provide procedures/instructions on to investigators according to ICH GCP 5.14.3?

Audit strategies
Data management
Handling and storage of investigational products (IP)
Ethics submission

The correct answer is: Handling and storage of investigational products (IP)

Sponsors are responsible for providing investigators with procedures and instructions on how to handle and store investigational products (IP). This means that the sponsor must ensure that all investigational products are properly maintained and stored to guarantee their effectiveness and safety during the duration of the clinical trial. The other options, while also important in the overall conduct of a clinical trial, are not specifically mentioned in ICH GCP 5.14.3. Audit strategies (option A) are not required to be provided to investigators in this section, although it may be covered in other sections of the guideline. Data management (option B) is important for maintaining accurate and complete records, but is not directly related to the handling and storage of investigational products. Ethics submission (option D) is not mentioned at all in this section and is instead covered in ICH GCP 3.1. Therefore, the correct