Protocol development is an essential first step in turning any research question into a study. Exisiting protocol development tools can be adapted to allow rapid, effective protocol development during the COVID-19 Pandemic. 
This Protocol Development Toolkit, developed by The European & Developing Countries Clinical Trials Partnership (EDCTP), aims to support researchers in the protocol development process, by providing the tools and guidance to produce a high-quality health research Protocol.

Protocol Development Toolkit

This Toolkit includes the following resources: 

  • Protocol Development Steps 
    Provide guidance on all elements of Protocol development in addition to practical advice such as how to navigate regulations and guidelines, the importance of community engagement and tips on collaborative writing. 
  • The 'Study Walk-through'
    A method to help translate your protocol into an accurate and successful study. This toolkit describes the study walkthrough approach, why it might be of benefit to your study and how you can use successfully implement the method using practical examples and 'How to' guidance.
  • Resources
    A collection of resources linked to protocol development which can be searched and filtered depending on their type. 

Concept Protocol: A Mixed-Methods Platform Trial for Assessing Public Health Interventions During the COVID-19 Pandemic 

This protocol is being developed by an open community of health researchers. The aim is to develop a mixed methods platform trial protocol that any research team can take and adapt and use this to evaluate their public health measures.

We welcome contributions, ideas and comments. This open platform protocol will be desgined so that can be taken and adapted in any setting. Further versions can be designed from the core platform and be finalised appropriately depending on the intervention and assessment tools.

You can view the full concept protocol in the Concept Protocol Review Tool, available here.

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