Control of Study Medications Devices at Study Sites

Evidence of careful control at the study site is imperative and naturally it is difficult to standardize the situation across many study sites and many countries. Security, correct storage, and accurate documentation of dispensing and inventory are necessary. Systems to ensure and assess compliance with the required use of the product being studied must be established. Monitors must be trained to check on these features and ensure that all site personnel are fully briefed.

The expectations with regard to maintenance of study medications/devices at study sites focus on security and appropriate environmental conditions. Concerns for security require that supplies be maintained under locked conditions. All agreements between the sponsor/CRO and the study site must specify that supplies are only for clinical study subjects—this information must also be clearly stated on the labeling. The main concern for appropriate environmental conditions is usually temperature requirements, but other factors (e.g. light, humidity) might also be important. Terms such as 'room temperature' and 'ambient temperature', which have different meanings in different countries, should always be avoided and specific temperatures must be stated. At each monitoring visit, the monitor will ensure that the correct procedures are being followed.

Compliance with medication/device use (by the study subject) should be assessed in all studies. If supplies are dispensed to subjects for self-administration, methods to assure compliance (e.g., diary cards, instructions on labeling, supervised administration) and methods to check compliance (e.g. tablet counts, plasma/urine assays, diary card review) must be in place. At each study visit, the study subjects should be asked to return all unused supplies and empty containers to the investigator, who will check the supplies for assessment of compliance and store them for return to the sponsor/ CRO. The monitor will review all relevant documents (e.g. source documents, CRFs, medication/ device inventory, dispensing forms) to ensure that the data in the CRFs reflect the subjects' compliance with the study medications/devices.

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