Conducting Clinical Trials

Front Matter....Pages i-xii
Front Matter....Pages 1-1
Introduction....Pages 3-17
Front Matter....Pages 19-19
Deciding to Enter the Research Field....Pages 21-28
Physicians....Pages 29-41
Evaluating a Sponsor....Pages 43-50
Budget Planning and Development....Pages 51-66
Staff Selection and Training....Pages 67-76
Other Preparatory Activities....Pages 77-81
Front Matter....Pages 83-83
The Institutional Review Board Process....Pages 85-103
Front Matter....Pages 105-105
Recruitment....Pages 107-125
Front Matter....Pages 127-127
Informed Consent: Decision amid Uncertainty....Pages 129-143
Special Populations....Pages 145-157
The Enrollment/Continuation Decision....Pages 159-181
Compliance of Patients Currently on Study....Pages 183-190
Adverse On-Therapy Experiences....Pages 191-200
The Referral Process....Pages 201-214
Front Matter....Pages 215-215
Principles of Data Management....Pages 217-222
Scheduling and Log Systems....Pages 223-229
The Research Chart....Pages 231-237
Study Checklists....Pages 239-243
The Case Report Form....Pages 245-248
Front Matter....Pages 215-215
Records of Excluded Patients....Pages 249-250
Regulatory Document Files....Pages 251-256
Record Storage and Access....Pages 257-261
Computer Technology in Data Management....Pages 263-267
Front Matter....Pages 269-269
Drug Accountability....Pages 271-278
Front Matter....Pages 279-279
Publications and Presentations....Pages 281-287
Preventing Fraud....Pages 289-306
Quality Assurance....Pages 307-313
FDA Inspections....Pages 315-323
Back Matter....Pages 325-353