Standard Operating Procedures

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  1. Standard operating procedures for NUH Trust R&D
    • SOP 1: QA Assurance Program
    • SOP 2: Paper TMF Management
    • SOP 3: Urgent Safety Measures
    • SOP 4: Investigator Led Study Set Up (Non Portfolio)
    • SOP 5: Research and Data Protection Act
    • SOP 6: Regulatory Inspection
    • SOP 7: Document Version Control
    • SOP 8: SSA Exemption
    • SOP 9: Unblinding Procedures for NUH Sponsored IMP Clinical Trials
    • SOP 10: Creating Study Related Information for Clinical Study Staff
    • SOP 11: Adverse Events Monitoring, Reporting and Recording for Investigators
    • SOP 12: Protocol Violation
    • SOP 13: Peer Review
    • SOP 14: Clinical Trial Agreement
    • SOP 15: Study Set Up Procedures for Commercially Sponsored Trials
    • SOP 17: Intellectual Property
    • SOP 18: Sponsorship
    • SOP 19: Training and Completion Maintenance of Training Records for NUH Sponsored Studies
    • SOP 21: Study Registration
    • SOP 22: Use of NUH Generic Case Report Form Instructions for NUH Sponsored Studies
    • SOP 23: Archiving of Essential Documents
    • SOP 24: Fraud and Misconduct
    • SOP 25: IRAS SSI Application Forms
    • SOP 26: IT Server Preventative Maintenance
    • SOP 27: Protocol Amendments
    • SOP 28: Informed Consent
    • SOP 30: Sponsor Monitoring of NUH Sponsored IMP Studies
    • SOP 31: Maintaining Confidentiality for Commercially Sponsored Clinical Research
    • SOP 32: CRF Maintenance for Externally Sponsored Studies
    • SOP 33: Recording Procedure of Research Information in Patient Records
    • SOP 34: Research Indemnity
    • SOP 35: Investigator Site File
    • SOP 37: Patient Visit Guidance
    • SOP 38: Use of Human Tissue in Research
    • SOP 39: Delegation of Study Duties
    • SOP 40: How to Write SOPs
    • SOP 41: R&D Database Audit and Maintenance
    • SOP 42: Adverse Event Management in R&D
    • SOP 43: End of Trial Declaration for Studies