Handbook of SOPs for Good Clinical Practice, Second Edition

Front Cover......Page 1
Table of Contents......Page 12
MON-001.0: Preparation, Issue, and Revision of Standard Operating Procedures (SOPs)......Page 16
MON-002.0: Training Clinical Research Staff......Page 20
MON-003.0: Selecting Investigators and Study Sites......Page 24
MON-004.0: Developing Informed Consent Forms......Page 28
MON-005.0: Conducting Site Evaluation Visits......Page 32
MON-006.0: Conducting Study Initiation Visits......Page 36
MON-007.0: Conducting Periodic Site Visits......Page 42
MON-008.0: Reviewing Case Report Forms at the Study Site......Page 48
MON-009.0: Reviewing Regulatory Documents......Page 54
MON-010.0: Adverse Experiences (AEs), Serious Adverse Experiences (SAEs), and IND Safety Reports......Page 66
MON-011.0: Managing Study-Specific Clinical Supplies......Page 72
MON-012.0: Conducting Study Termination Visits......Page 76
MON-013.0: Telephone Contact Reports......Page 82
SITE-001.0: Preparation, Issue, and Revision of Standard Operating Procedures (SOPs)......Page 84
SITE-002.0: Training Study Site Clinical Research Staff......Page 88
SITE-003.0: Assessing Protocol Feasibility......Page 92
SITE-004.0: Investigator Agreements with Sponsors or Contract Research Organizations......Page 94
SITE-005.0: Organizational Chart for the Study Site......Page 96
SITE-006.0: Interactions with the Institutional Review Board......Page 98
SITE-007.0: Recruiting Study Patients......Page 102
SITE-008.0: Study Initiation and Implementation......Page 106
SITE-009.0: Reviewing and Obtaining Informed Consent......Page 110
SITE-010.0: Adverse Experiences (AEs), Serious Adverse Experiences (SAEs) and IND Safety Reports......Page 116
SITE-011.0: Drug Storage and Accountability......Page 120
SITE-012.0: Managing Biological Samples......Page 124
SITE-013.0: Interactions with the Sponsor or Contract Research Organization (CRO)......Page 126
SITE-014.0: Study Files and Record Retention......Page 132
IRB-001.0: Institutional Review Board Responsibilities......Page 136
IRB-002.0: IRB Membership and Training......Page 140
IRB-003.0: Institutional Review Board Meetings......Page 146
IRB-004.0: IRB Record Keeping......Page 152
IRB-005.0: IRB Review of Research......Page 156
IRB-006.0: IRB Review of Informed Consent......Page 162
IRB-007.0: IRB Review of Advertisements......Page 168
IRB-008.0: IRB Review of Unscheduled Mandatory Reports......Page 172
IRB-009.0: Criteria for Exempt and Expedited Review......Page 176
Ad Review: Advertisement Review Checklist......Page 182
Amendment: Protocol Amendment Form......Page 184
Bio Sample: Bio Sample: Biological Samples Inventory......Page 186
CRF Review: CRF Review Form......Page 188
DCF Form: Data Clarification Form......Page 190
Dispense: Drug Dispensing Log......Page 192
Dispense by Pt: Study Subject Investigational Product Dispensing Record......Page 194
Drug Disposition: Clinical Trial Materials Disposition Form......Page 196
Drug Order: Investigational Drug Shipping Order......Page 198
Drug Receipt: Investigational Product Receipt Form......Page 200
Drug Return: Drug Return Form......Page 202
Enrollment: Screening and Enrollment Log......Page 204
Expedited: Expedited Review Form......Page 206
ICF Review: Subject Information and Consent Form Checklist......Page 208
Init Doc Track: Study Initiation Document Tracking Worksheet......Page 212
Initial Sub: Initial Submission Form......Page 214
IRE3 Member: IRB Membership Roster......Page 222
Minutes Template: IRB Meeting Minutes Template......Page 224
Monitor Log: Monitoring Log......Page 228
Patient Master: Master Subject Log......Page 230
Phone Rpt: Telephone Contact Report......Page 232
Progress Rpt: IRB Progress Report Form......Page 234
Responsibilities: Study Responsibilities Form......Page 236
Review Cklist: Reviewer's Checklist......Page 238
Review Results: IRB Review Results Form......Page 240
SAE: Serious Adverse Experiences......Page 242
Safety Rpt: Safety Information Form......Page 248
Sig Sheet: Study Site Personnel Signature Sheet......Page 250
St Term Ack: IRB Study Termination Acknowledgement......Page 252
St Term Notice: IRB Notification of Study Termination Form......Page 254
Training Plan: Training Plan Form......Page 256
Training Record: Training Record Form......Page 258
Training Request: Staff Training Request Form......Page 262
Training Verification: Staff Training Verification Form......Page 264
Trip Rpt Evaluation: Site Evaluation Visit Trip Report......Page 266
Trip Rpt Init: Study Initiation Visit Trip Report......Page 270
Trip Rpt Interim: Periodic Site Visit Trip Report......Page 274
Trip Rpt Termination: Study Termination Visit Trip Report......Page 278
Index of Forms – In Alphabetical Order By Form Name......Page 284