Question $3$

Raw data and specimens for each study must be stored for potentially long periods of time. What is the process of control instituted by the U$.$S$.$ Food and Drug Administration $($FDA$)?$

Establish at least one area designated as an archive for secure storage and indexing of raw data under the archivist's control.

Establish at least one area designated as an archive for secure storage and indexing of raw data under the study director's control.

Establish a process of control based on the facility's standard operating procedures.

Establish at least one area designated as an archive for secure storage and indexing of raw data under the quality assurance unit's control.