... specific, in as much detail as possible, and include procedures for monitoring the quality of the data, including, for example, how data collectors will be trained and supervised and how information ... be realistic in their estimates of accrual rates in clinical CAM research. Accrual in clinical investigations using CAM products and interventions may be particularly challenging in accrual, ... should include a compelling rationale for its use for this intervention in this study population. Researchers often propose moving directly to a Phase III clinical trial with CAM products and interventions...