Preparing Clinical Research Protocols is available from the General Clinical Research Center . Objectives, methods, study management. Objectives and Rationale 3. Device Information on chemical formulation of the drug and mechanism of action or approved PDR package insert. For studies involving devices provide manufacturer's detailed information on the device.
Subjects Provide plan for minin-iizing such risks.
Data Analysis and Biostatistical Evaluation. Subject Recruitment Methods Provide information on strategies for recruiting patients and retaining women and members of minority groups. Data Handling and Confidentiality 11. This program is designed to support ancillary costs of research services, tests and procedures associated with clinical research studies. Investigators should provide a budget justification for any costs which are not self explanatory.