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 - Personal summary of SOP and Protocol Training

 Delegation of Study Duties Log

 Research CV Template 

 Clinical Research Registration Form

Participant Information

Adverse Events Case Report Form template

Clinical Trial Participant Tracking Sheet

Concomitant Medications Case Report Form template

 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

Project Management

 Serious Adverse Event Report Form

 Serious Adverse Event Report Form DEVICES ONLY

 Diagnostic Cardiology Request Form

 Laboratory Medicine Research Approval Form (Microsoft Office version)

 Laboratory Medicine Research Approval Form (Apple MAC version)

 MIMP Approval Form (STH Medical Imaging and Medical Physics)

 Respiratory Physiology Research Approval Form

 Sheffield Teaching Hospitals 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


 Drug Accountability Log

Monitoring and Auditing

 Protocol non-Compliance form

Research Passports

 STH Guide to the NHS Research Passport System

 Research Passport Application Form

 STH Pre-Engagement Check Form


Research Informatics

  STH Research Informatics Reference Guide