操作和程序手册（MOP）编制指南.pdfVIP

National Center for Complementary and Integrative Health Guidelines for Developing a Manual of Operations and Procedures (MOP) TABLE OFCONTENTS Page WEB LINKS错误 ！未定义书签。 1. INTRODUCTION4 2. OVERVIEW4 3. MOPCONTENTSANDORGANIZATION5 3.1 Study Protocol6 3.2 Study Organizationand Responsibilities6 3.2.1 Roster6 3.2.2 Coordinating Center6 3.2.3 Study Sites7 3.2.4 Pharmacy Activities7 3.2.5 Steering Committees7 3.2.6 OtherStudy Committees8 3.2.7 NCCIH8 3.3 Training Plan8 3.4 Communications Plan8 3.5 Study Intervention9 3.6 Recruitment Plan9 3.7 Participant Retention9 3.8 Study Flow10 3.9 Screening and Eligibility Criteria10 3.9.1 Screening Log 12 3.9.2 Eligibility Criteria12 3.10 Informed Consent and HIPAA12 3.10.1 HIPAA Authorization12 3.11 Randomization 13 3.12 Blinding and Unblinding (Masking and Unmasking)13 3.13 Study Measurements and Procedures14 3.13.1 Timeline andVisit Schedule14 3.13.2 Scope/Schema14 3.13.3 FinalStudy/Early Discontinuation Evaluations 14 3.14 Concomitant Medication15 3.15 Safety Reporting15 3.16 Study