Monitoring and recording clinical trials.
A procedure based on the use of on-site monitoring has been developed for managing clinical testing programs. The procedure involves orientation meetings, forms specifically designed for good record-keeping, staff instruction, the establishment of normal laboratory values and criteria for patient selection, and prescribed monitoring functions. This procedure has proved successful in improving the performance of the physician-investigator, maintaining investigator interest, and enhancing the value of program results.
D005069:Evaluation Studies as Topic; D005568:Forms and Records Control; D011996:Records; D012106:Research; D012107:Research Design