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Templates

Click on the heading below to find the relevant template documents;

SOP_002  Sponsorship

SOP_003  Developing and Designing Your Trial

SOP_004  Writing Protocol to GCP

SOP_005  Gaining and Maintaining Authorisations

SOP_007  Training

SOP_008  Investigator Oversight

SOP_009  Research Safety Reporting 

SOP_012  Study Data

SOP_014  Essential Documents

SOP_015  Archiving

SOP_018  Managing breaches

Support Department Pro-formas

  

SOP_002 Sponsorship

01 - Request for UHB to be Research Sponsor

03 - Scientific Review Form

04 - Risk Assessment Template

05 - UHB Sponsor Study Set Up & Mgmt Plan

06 - CTIMP Amendment Assessment Form for Sponsor

08 - UHB Sponsored Studies - Site Initiation Checklist

SOP_003 Developing and Designing Your Trial

01 - Research proposal draft template

02 - Pre-award checklist

03 - Post-award checklist

SOP_004 Writing Protocol to GCP

01 - UH Bristol standard wording for IMP Protocols

02 - UH Bristol standard wording for non IMP Protocols

SOP_005 Gaining and Maintaining Authorisations

01 - File note for discussions between sponsor and research

SOP_007 Training

01 - Training Log - use this to record evidence of SOP training, either for individual or for department

02 - Personal CPD Folder Template

03 - CPD - NMC revalidation

04 - Short CV template

SOP_008 Investigator Oversight

01 - Statement of Chief Investigator Responsibilities

SOP_009 Research Safety Reporting

Safety reporting - reporting adverse events (If UH Bristol is the Sponsor then use of these forms is mandatory) 

ST - DEVELOPMENT_SAFETY_UPDATE_REPORT__v10.0 10.07.17

ST- Adverse Events template v9.1 17.07.17

ST- Instructions for completion SAEs v9.1 17.07.17

ST- R&I review of SAEs v9.1 17.07.17

ST- SAE SUSAR follow up report v9.1 17.07.17

ST- SAE SUSAR initial report v9.1 17.07.17

ST- SAE SUSAR sponsor report form v9.1 17.07.17

SOP_012 Study Data

01 - Template Data Management Plan

02 - CRF design Key elements to consider

03 - Source data Key elements to include

SOP_014 Essential Documents

01 - CTIMP Trial Master File Contents

02 - Investigator Site File Contents

SOP_015 Archiving

ST - R&I Project Archiving Record Form

ST - Guidance on retention period for study documentation

ST - Label Template

ST - New Intake Returns form

ST - Retrieval Request Form

SOP_018 Managing Breaches

01 - Potential breaches reporting log 

02 - CAPA - Corrective and Preventative Action 

03 - Breaches Log

Support Department Pro-formas

Pro-forma for PACs request form-data transfer SOP Template

Pro-forma for Adult Echocardiography (Radiology)

Pro-forma for Cardiac Physiology Adult

Pro-forma for Cardiac Physiology Paediatric 

Pro-forma for CRIC MRI

Pro-forma for General Services

Pro-formas for Lab Medicine:

 - Aspirate

 - Blood sciences

 - Flow cytometry

Pro-forma for Cellular Pathology (NBT)

Pro-forma for MEMO

Pro-forma for Microbiology (PHE)

Pro-forma for Radiotherapy and Imaging

 - Guidance document on completing radiation proforma

Pharmacy - process for gaining support authorisation

  - List of Pharmacy SOPs