Patient Enrollment

• IDS will communicate with the investigator or study coordinator to ensure that patient enrollment, drug dispensing, and drug administration are consistent with the protocol.
• Randomization of the patient to determine the correct drug and treatment regimen will occur promptly. The IDS can develop a patient randomization schedule if one is not provided in the study protocol.
• Preparation of doses as described in the protocol. All study drugs are packaged to maintain blinding when required and to promote safe administration.
• Patient counseling about the study drug's mechanism of action, side effects, food and drug interactions, and dosing regimen can be provided to all patients at their entry into a study.
• Patients will be recorded at entry onto an enrollment log to track each patients; entry date and randomization.