Clinical Research Office. A partnership between Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield

Forms and Guidance

 Investigator Site File Contents

 Study File Note

Core Study Documents

 Protocol Writing Guidance

 Protocol Outline Template

Research Governance Documents

 Indemnity Guidance

 Conditions of authorisation (NHS permission letter appendix)

 Project Registration Form

 Host Directorate Approval Form

Financial Management

 Finance Form

Investigator, Facilities and Research Team

 Investigator Responsibilities (for STH sponsored CTIMPs only)

 SOP Training Log

 Delegation of Study Duties Log

Participant Information

 Research Alert Page - IMP

 Research Alert Page non-IMP

 Serious Adverse Event (SAE) Log Form

 Study Enrolment Log (participant recruitment log)

 Subject Screening Log

 Subject Tracking Log

 Tissue Sample Collection Log

 Tissue Sample Tracking Form

 Clinical Trial Participant Tracking Sheet

Project Management

 Serious Adverse Event Report Form

 Diagnostic Cardiology Request Form

 Laboratory Medicine Research Approval Form

 MIMP Approval Form (STH Medical Imaging and Medical Physics)

 Northern General Hospital Pharmacy Questionnaire Approval Form

 Respiratory Physiology Research Approval Form

 Royal Hallamshire Hospital Pharmacy Questionnaire Approval Form

 Weston Park Hospital Pharmacy Questionnaire Approval Form

 Data Protection Notification & Data Mapping Form

 Study Specific SOP Template

 Study Specific SOPs Log

 Internal Study Management Arrangements

 Pregnancy Reporting Form

Pharmacy

 Drug Accountability Log

Monitoring and Auditing

 Protocol non-Compliance form

Research Passports

 STH Guide to the Research Passport System

 Research Passport Application Form

 STH DBS and OH form