Quality assurance of clinical data: internal monitoring: patient and study management at the clinic.

Adquate methods to assure the quality of data collected at the clinic need to be developed. A full understanding of the limitations of physicians as information processors and reasonable performance expectations for physicians during peak information periods will result in concentrated planning for patient visits and will limit the data that must be collected at the clinic. It is mandatory for each clinical research project that protocol treatment take into account the question of variable provider follow-up versus constant provider follow-up. It is also imperative that all clinical research providers receive special training, testing, and follow-up evaluation. The prime responsibility for the overall conduct of clinical research rests with the principal investigator. A monitoring tool that should be more fully used is the informed patient.