chapter MON-001.0: Preparation, Issue, and Revision of Standard Operating Procedures (SOPs) -- chapter MON-002.0: Training Clinical Research Staff -- chapter MON-003.0: Selecting Investigators and Study Sites -- chapter MON-004.0: Developing Informed Consent Forms -- chapter MON-005.0: Conducting Site Evaluation Visits -- chapter MON-006.0: Conducting Study Initiation Visits -- chapter MON-007.0: Conducting Periodic Site Visits -- chapter MON-008.0: Reviewing Case Report Forms at the Study Site -- chapter MON-009.0: Reviewing Regulatory Documents -- chapter MON-010.0: Adverse Experiences (AEs), Serious Adverse Experiences (SAEs), and IND Safety Reports -- chapter MON-011.0: Managing Study-Specific Clinical Supplies -- chapter MON-012.0: Conducting Study Termination Visits -- chapter MON-013.0: Telephone Contact Reports -- chapter SITE-001.0: Preparation, Issue, and Revision of Standard Operating Procedures (SOPs) -- chapter SITE-002.0: Training Study Site Clinical Research Staff -- chapter SITE-003.0: Assessing Protocol Feasibility -- chapter SITE-004.0: Investigator Agreements with Sponsors or Contract Research Organizations -- chapter SITE-005.0: Organizational Chart for the Study Site -- chapter SITE-006.0: Interactions with the Institutional Review Board -- chapter SITE-007.0: Recruiting Study Patients -- chapter SITE-008.0: Study Initiation and Implementation -- chapter SITE-009.0: Reviewing and Obtaining Informed Consent -- chapter SITE-010.0: Adverse Experiences (AEs), Serious Adverse Experiences (SAEs) and IND Safety Reports -- chapter SITE-011.0: Drug Storage and Accountability -- chapter SITE-012.0: Managing Biological Samples -- chapter SITE-013.0: Interactions with the Sponsor or Contract Research Organization (CRO) -- chapter SITE-014.0: Study Files and Record Retention -- chapter IRB-001.0: Institutional Review Board Responsibilities -- chapter IRB-002.0: IRB Membership and Training -- chapter IRB-003.0: Institutional Review Board Meetings -- chapter IRB-004.0: IRB Record Keeping -- chapter IRB-005.0: IRB Review of Research -- chapter IRB-006.0: IRB Review of Informed Consent -- chapter IRB-007.0: IRB Review of Advertisements -- chapter IRB-008.0: IRB Review of Unscheduled Mandatory Reports -- chapter IRB-009.0: Criteria for Exempt and Expedited Review -- chapter Ad Review: Advertisement Review Checklist -- chapter Amendment: Protocol Amendment Form -- chapter Bio Sample: Bio Sample: Biological Samples Inventory -- chapter CRF Review: CRF Review Form -- chapter DCF Form: Data Clarification Form -- chapter Dispense: Drug Dispensing Log -- chapter Dispense by Pt: Study Subject Investigational Product Dispensing Record -- chapter Drug Disposition: Clinical Trial Materials Disposition Form -- chapter Drug Order: Investigational Drug Shipping Order -- chapter Drug Receipt: Investigational Product Receipt Form -- chapter Drug Return: Drug Return Form -- chapter Enrollment: Screening and Enrollment Log -- chapter Expedited: Expedited Review Form -- chapter ICF Review: Subject Information and Consent Form Checklist -- chapter Init Doc Track: Study Initiation Document Tracking Worksheet -- chapter Initial Sub: Initial Submission Form -- chapter IRE3 Member: IRB Membership Roster -- chapter Minutes Template: IRB Meeting Minutes Template -- chapter Monitor Log: Monitoring Log -- chapter Patient Master: Master Subject Log -- chapter Phone Rpt: Telephone Contact Report -- chapter Progress Rpt: IRB Progress Report Form -- chapter Responsibilities: Study Responsibilities Form -- chapter Review Cklist: Reviewer's Checklist -- chapter Review Results: IRB Review Results Form -- chapter SAE: Serious Adverse Experiences -- chapter Safety Rpt: Safety Information Form -- chapter Sig Sheet: Study Site Personnel Signature Sheet -- chapter St Term Ack: IRB Study Termination Acknowledgement -- chapter St Term Notice: IRB Notification of Study Termination Form -- chapter Training Plan: Training Plan Form -- chapter Training Record: Training Record Form -- chapter Training Request: Staff Training Request Form -- chapter Training Verification: Staff Training Verification Form -- chapter Trip Rpt Evaluation: Site Evaluation Visit Trip Report -- chapter Trip Rpt Init: Study Initiation Visit Trip Report -- chapter Trip Rpt Interim: Periodic Site Visit Trip Report -- chapter Trip Rpt Termination: Study Termination Visit Trip Report.