Latest SOCRA CCRP Practice Questions BY English

Drug storage conditions are essential to maintaining investigational product (IP) integrity. According to ICH:

ICH E6(R2) 5.13.3: ''The sponsor should ensure that investigational products are stored... under appropriate conditions as specified by the sponsor and in accordance with applicable regulatory requirement(s).''

ICH E6(R2) 4.6.4: ''The investigator/institution should store the investigational product(s) as specified by the sponsor (and in accordance with applicable regulatory requirement(s)), and ensure that product(s) are used only in accordance with the approved protocol.''

During site qualification/selection, the monitor evaluates storage conditions --- particularly temperature ranges --- to ensure the site can meet the stability requirements for the IP. Factors like staff numbers, space, and cost are operational considerations but not regulatory determinants of site qualification.

Thus, the correct answer is C (Storage facility temperature range). This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.

ICH E6(R2), 5.13.3 (Product storage requirements).

ICH E6(R2), 4.6.4 (Investigator product storage responsibilities).