Site organization and management.

The principal investigator is responsible for everything involved in the conduct of a clinical research study. Prior to the initiation of any clinical trial, an investigator must become acquainted with the material requirements, personnel needs, and best practices involved in the conduct of the trial. Commitment to a clinical trial should not be taken lightly because even a simple study may require a major investment of staff, space, and time. Standard operating procedures help to standardize staff training and improve regulatory compliance. Reasons for participation in clinical research may differ between community and academic gastroenterologists, but responsibility for patient care, regulatory requirements, and assumption of accountability are identical. Careful attention to the details of site organization, administrative requirements, and patient recruitment and retention all contribute to the successful performance of clinical research.