Skip to main content

Table 2 Components of the EDCTP Knowledge Hub: protocol development toolkit

From: The European & Developing Countries Clinical Trials Partnership (EDCTP) Knowledge Hub: developing an open platform for facilitating high-quality clinical research

Protocol development steps—a step-by-step guide on developing a high-quality health research protocol which provides practical advice and examples on how to develop a protocol, including elements such as writing skills and working collaboratively on the development of a protocol.
Concept Protocol Crowd Review Tool—this short process helps research teams take the first steps in designing a new study by helping them consider what is being asked and what impact the data would have. Here, comments can be sought from the wider research community on the research question being asked, what existing data could be accessed, what outcomes should be measured and how to consider any safety or ethical issues that their study might encounter. This wider community includes the many international partners, collaborators and registered members who contribute to TGHN, representing a full range of research disciplines and roles in global health research [13]. This step is really helpful to initiate the process and guide writing a funding application or guide an institutional review process.
Study Walk-through Toolkit—describes a method to translate a study from a protocol into a successful study. Ideally, this should involve the whole study team to jointly work through every step to identify where training or operating procedures are needed to ensure every time this specific process is safe, accurate and ethical.
Protocol builder—users from LMICs have an opportunity to obtain free access to the SPIRIT Electronic Protocol Tool & Resource (SEPTRE), an innovative, web-based software solution that makes it easier to create, manage and register high-quality protocols for clinical research.
Resources—this section addresses the difficulty a researcher may experience in locating resources using Internet-based searches alone. All of the relevant, open-access, resources retrieved by the specialist software during scoping have been collated to create an extensive collection of nearly 300 resources linked to protocol development which can be searched and filtered depending on their type.