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Topic Subject 1 Glossary 2 Principles of ICH GCPs 3 Institutional review boards 4 Investigator 5 Sponsor 6 Clinical trial protocols 7 Investigator brochure 8 Essential documents for conduct of clinical trials CFR title and part Subject 21 CFR 312 Requirements for investigational new drug 21 CFR 50 Protection of human subjects 21 CFR 56 Institutional review boards 21 CFR 46 Health Insurance Portability and Accountability Act 21 CFR 812 Investigational devices Component Subject 1 General background information on what type of imaging SOP covers 2 Required imaging personnel to perform tasks and their minimum level of training 3 Definitions for any imaging-specific terms 4 Required equipment (e.g., minimum PET camera specifications) 5 Specific equipment settings to use for different imaging requirements 6 When, how, and what quality control is done to ensure optimal results 7 Image interpretation and reporting criteria 8 Information technology support required for data acquisition, transfer, and storage of study images Topic Subject 1 Receipt, administration, disposal, and storage of radioactive materials 2 ALARA (as low as reasonably achievable) protocols 3 Employee safety/exposure to radioactive agents 4 Managing radioactive spills 5 Safety training (cardiopulmonary resuscitation, fire extinguisher location and use) 6 Emergency safety SOPs, such as crash cart locations and emergency response team numbers
