Protocol Development

Key to symbols

: Standard
process
: Good
practice
: Legal
requirement
: Sub
map

This Route Map supports a risk-based approach to protocol development and will be relevant for all experimental medicine studies. You should identify early if any statutory requirements apply.  

Click on Route Map stations to access information

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[Standard process] Research question
[Good practice] Consult statistician
[Standard process] Develop protocol
[Legal requirement]
Statutory regulations [Submap]
1. These stations are processes that can be done in parallel
  
  [Legal requirement] Ionising radiation
  
  [Legal requirement] Adults unable to give consent
  
  [Legal requirement] Children
  
  [Legal requirement] Personal data
  
  [Legal requirement] Collecting or using human tissue
  
  [Legal requirement] Investigating safety and or efficacy of a medicine
  
  [Legal requirement] Gene therapy, xenotransplantation or stem cell therapy
  
  [Legal requirement] Human fertilisation and embryology
  
  [Legal requirement] Trials of medical devices
[Good practice] Benefits and risks
These stations are processes that can be done in parallel
- [Good practice] Benefits
- [Good practice]
  Identifying risks to safety [Submap]
  These stations are processes that can be done in parallel
  
  [Good practice] Hazards of interventions
  
  [Good practice] Quality of interventional agent
  
  [Good practice] Non GMP agents
  
  [Good practice] Hazards of assessments methods
  
  [Legal requirement] Hazards to researchers (Health & Safety)
  
  [Good practice] Hazards to wider community
- [Good practice] Minimising safety risks
- [Good practice]
  Identifying general risks [Submap]
  These stations are processes that can be done in parallel
  
  [Good practice] Quality of science
  
  [Legal requirement] Consent and participants' rights
  
  [Good practice] Participant recruitment
  
  [Good practice] Data validity and intergrity
  
  [Good practice] Staffing and resources
- [Good practice] Minimising general risks
[Good practice]
Consult others [Submap]
1. These stations are processes that can be done in parallel
  
  [Good practice] Sponsor
  
  [Good practice] Research & Development office
  
  [Good practice] Collaborators & support departments