An essential aspect of the conduct of clinical research is monitoring. All aspects of these investigations must be open and verifiable upon independent audit.

Accountability of the drug dispensed to the patients includes surveillance of the expiry date, lot numbers, stability and storage conditions. Compliance with the study medication requirements should be assessed by direct questioning and/or pill counts. All unused medication should be returned to the investigator.

The patient's condition before, during and after the treatment period, laboratory data, concomitant therapy, and adverse events should be accurately recorded using standardized procedures at specified times. Information that is recorded in the case report form should be consistent with information documented in the patient's medical record. Principles of good clinical practice (GCP) should be followed. The number and extent of audits will vary from study to study, depending upon specific requirements.

At the completion of the study, the final evaluation of data for both efficacy and safety is undertaken by an adjudication committee. This committee ensures the accuracy, completeness and legibility of the data. Finally, the results and conclusion of the study are summarized in a final report which must be reviewed and signed by the investigators. Publication of the data in a peer-reviewed medical journal follows.