Protocol Deviations and Exceptions 102 Sample Clauses

Protocol Deviations and Exceptions 102. 11.2 Information to Study Personnel 102 11.3 Study Monitoring 102 11.4 Audit and Inspection 103 11.5 Data Quality Assurance 103 12 ETHICS 104 12.1 Compliance with Good Clinical Practice and Ethical Considerations 104 12.2 Informed Consent 104 12.3 Health Authorities and Independent Ethics Committees/Institutional Review Boards 105 12.4 Confidentiality Regarding Study Subjects 105 13 DATA HANDLING AND RECORD KEEPING 106 13.1 Data Recording of Study Data 106 13.2 Data Management 106 13.3 Record Archiving and Retention 107 14 FINANCING AND INSURANCE 108 14.1 Contractual and Financial Details 108 14.2 Insurance, Indemnity and Compensation 108 15 REPORTING AND PUBLICATIONS OF RESULTS 109 15.1 Publication Policy 109 15.2 Clinical Study Report 109 16 REFERENCES 110 17 LIST OF APPENDICES 112 17.1 Electronic Bladder Diary 113 17.2 Subject and Caregiver Training 113 17.3 Screening Bladder Diary Review 114
Sample 1
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