Elements of a data management and analysis plan include an annotated case report form with instructions on how to complete and code the form, a data entry manual, and a flowchart that describes the location and custodian of the data. A list of data variables, an analysis grid, and samples of the tables and graphics used for data presentation should also be available. Additionally, an explicit statement of data quality requirements should be developed to provide a standard for auditing purposes. The data management and analysis plan should also address the editing and auditing procedures that will be used, the methods used to calculate derived variables, and the methods used to validate software used in the study, as well as data security, system backups, and archival procedures.
Appearance is important for a form on paper and is even more important for a computer screen used for the electronic capture of data. The data capture instrument should allow data to be collected in parallel with the performance of the clinical routine, check-off boxes should be used if possible, and narratives should be avoided. Units of measure should be specified. Above all, the data capture instrument needs to be kept as simple as possible.
Overriding issues in good clinical testing site selection are access to target patient populations and determination of whether the site has the qualifications and expertise to meet the protocol requirements. Particularly important is the quality of the support personnel responsible for completing the case report form. One often overlooked question is determination of whether the site under consideration has concurrent studies, and how those studies may affect the quality and capacity of the site to conduct the proposed study. Training of personnel at the site begins with the investigator's brochure and continues with a review of a schedule of protocol activities and instructions for completing the case report form. Investigator and study coordinator meetings are recommended, particularly when they bring together personnel from different sites who are working on the same protocol.
Monitoring is required before, during, and after the study. At study initiation, monitoring involves protocol review, drug storage and accountability, and construction of the study file. After the first patient has been processed and the