Guidance

Research and Innovation have reviewed all published documents to ensure they are up to date.

Please check frequently to ensure you are using the correct version of a document.

Standard Operating Procedures (SOPs)

When old SOPs are invalid they are deleted when superseded. Gaps in numbering for the series of SOPs here are due to older SOPs being merged or deleted in the review process.

SOP-QMS-001 Preparation Review and Approval of SOPs 

SOP-QMS-002 Document Version Control

SOP-QMS-003 Quality Assurance Programme

SOP-QMS-004 Audit and Inspection

SOP-QMS-005 Vendor Management  

SOP-QMS-006 Computer Systems Validation

SOP-QMS-007 Training and Development

SOP-QMS-008 Corrective and Preventative Action

SOP-RES-001 Sponsorship

SOP-RES-002 Risk Assessment

SOP-RES-003 Grant Application

SOP-RES-004 Contracts Management and Indemnity

SOP-RES-005 Intellectual Property

SOP-RES-006 Local Access, Arrange and Confirm Process

SOP-RES-007 Study Protocols and Documents

SOP-RES-008 Case Report Forms

SOP-RES-009 HRA and MHRA Application Process

SOP-RES-010 Site Initiation

SOP-RES-011 Site Green Light

SOP-RES-012 Study Management

SOP-RES-013 Monitoring

SOP-RES-014 Maintaining Study Files

SOP-RES-015 Informed Consent

SOP-RES-016 Medical Records and Source Data

SOP-RES-017 Non-Compliance and Serious Breach Reporting

SOP-RES-018 Research Fraud and Misconduct

SOP-RES-019 Adverse Event Reporting in CTIMPs

SOP-RES-020 Annual Progress and Safety Reports

SOP-RES-021 Out of Hours Medical Cover

SOP-RES-022 Urgent Safety Measures

SOP-RES-023 Managing the Code-Break and Unblinding

SOP-RES-024 Amendments to Active Research Studies

SOP-RES-025 End of Study Notifcation and Premature Discontinuation of Study

SOP-RES-026 Site Close-Out

SOP-RES-027 End of Study Report

SOP-RES-028 Archiving and Destruction of Records

SOP-RES-029 Conducting Phase I Clinical Studies

SOP-RES-030 Study Data Management Statistics and the Randomisation Schedule

SOP-RES-031 Study Oversight Committees

SOP-RES-033 Adverse Event Reporting for Medical Device Trials SOP NUH Sponsor

Templates and forms

All templates and forms are linked to a Standard Operating Procedure (SOP). 

Some of the linked forms are also included as a PDF version. If you are having problems using any of the forms and would prefer to have them as PDFs then please contact us.

TAFQ00701 Standard Operating Procedures Signature Log 

TAFR00201 Risk Assessment Tool

TAFR00301 NUH Intention to Apply Form

TAFR00701 Document Version Control Log

TAFR00702 CTIMP Protocol Template  

TAFR00703 Clinical Investigation Plan (CMD)

TAFR00704 Protocol (Non-CTIMP)

TAFR00705 Participant Information Sheet

TAFR00706 Informed Consent Form

TAFR00802 Concomitant Medication Log

TAFR00901 Research Application Checklist

TAFR01202 Delegation Log

TAFR01403 Investigator Site File Index (CTIMP) Version Two

TAFR01404 Pharmacy Site File Index

TAFR01405 Note to File   

TAFR01406 Investigator Site File Index (Non-CTIMP)

TAFR01407 Investigator Site File Index (Medical Devices) Version Two

TAFR01408 Trial Master File Index (Medical Devices)

TAFR01501 Screening Log

TAFR01502 Enrolment Log

TAFR01503 Consent Delegation Tool

TAFR01601 Screening Investigation Form

TAFR01602 Physical Examination Form

TAFR01603 Clinic Treatment Form   

TAFR01604 Follow-Up Form

TAFR01605 Medical Records Cover Labels     

TAFR01701 Deviation Report

TAFR01702 Deviation Log

TAFR01901 Adverse Events Record

TAFR01902 Serious Adverse Events Log Version Three

TAFR01903 Serious Adverse Event Report (CTIMP) Version Four

TAFR01904 Serious Adverse Event Follow-Up Report (CTIMP) Version Three

TAFR01905 Pregnancy Report               

TAFR01908 Serious Adverse Event Reporting Form (CMD) Version Two

TAFR01909 Serious Adverse Event Follow Up Report (CMDs)

TAFR01910 SAE Reporting Form (other clinical trials)

TAFR02001 Development Safety Update Report Template Version Two

TAFR02101Out of Hours Medical Cover and Unblinding Test Record

TAFR02301 Production of Code-Break Envelopes Record

TAFR02302 Receipt of Code-Break Envelopes

TAFR02303 Distribution of Code-Break Envelopes Record

TAFR02304 Code-Break Record

TAFR02404 Amendment Summary Log

TAFR02701 End of Study Report

TAFR02801 Archiving Request Form - Version Three

TAFR02805 Destruction of Records Form