Documentation clinical dosage form

For certain medicines and dosage forms, in vivo documentation of equivalence, through either a pharmacokinetic bioequivalence study, a comparative pharmacodynamic study or a comparative clinical trial, is regarded as especially important. In vivo documentation of equivalence is needed when there is a risk that possible differences in bioavailability may result in therapeutic inequivalence (2). Examples are listed below. 

Clinical research coordinators (CRCs) are the research personnel who assist with pahent visits, and perform study-related procedures that do not require a physician (phlebotomy, vital signs, adverse event, and concomitant medicahon discussions, etc.). CRCs provide the PI or physician with data required for interpretation, medical decisions (inclusion/exclusion, dosage adjustment, patient withdrawal, adverse event causality, etc.), and trial oversight. In addition, CRCs are usually responsible for transcribing source documentation (medical records, clinic notes, laboratory reports, etc.) into case report forms (CRF) supplied by the study sponsor. 

Medication and/or dosage changes will be made, if necessary, based on the pharmacists assessment, and patients will be counseled on these changes. The physician communication form will be used to communicate clinical recommendations regarding drug therapy. Also, patient education will be reinforced and documented. Patients will be instructed on when to return to the clinic, and referrals to physicians will occur as needed. The referrals are based on patient complications of therapy or condition and patient resistance to therapy. 

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