Protocol Deviations and Exceptions 109 Sample Clauses

Protocol Deviations and Exceptions 109. 11.2 Information to Study Personnel 109 11.3 Study Monitoring 110 11.4 Audit and Inspection 110 11.5 Data Quality Assurance 110 12 ETHICS 111 12.1 Compliance with Good Clinical Practice and Ethical Considerations 111 12.2 Informed Consent 111 12.3 Health Authorities and Independent Ethics Committees/Institutional Review Boards 112 12.4 Confidentiality Regarding Study Subjects 112 13 DATA HANDLING AND RECORD KEEPING 113 13.1 Data Recording of Study Data 113 13.2 Data Management 113 13.3 Record Archiving and Retention 114 14 FINANCING AND INSURANCE 115 14.1 Contractual and Financial Details 115 14.2 Insurance, Indemnity and Compensation 115 15 REPORTING AND PUBLICATIONS OF RESULTS 116 15.1 Publication Policy 116 15.2 Clinical Study Report 116 16 REFERENCES 117 17 LIST OF APPENDICES 119 17.1 Electronic Bladder Diary 120 17.2 Subject and Caregiver Training 120 17.3 Screening Bladder Diary Review 121 17.3.1 Assessment of 24 Hour Voided Volume at Screening 121