The aim of this clinical trial protocol is to provide guidance for TB vaccine clinical trial design and to establish a repository of clinical trial protocols for TB vaccine trials. The protocol is coherent with the defined stages and gates (www.tbvacpathway.com) and aligned with other similar ongoing activities such as the EDCTP Knowledge Hub. It is a general protocol that includes sub-templates with specific considerations for TB vaccine trials with different targets and types of vaccines.
A regulatory plan defines the regulatory strategy applicable to the TB vaccine candidate. It outlines the path to follow to obtain regulatory approval. The standard template for a regulatory plan includes directions on how to draft a regulatory plan and provides considerations and information about the approval process of a TB vaccine. It includes guidance and advice on a more strategic level for different stages of the development path that could be taken into account by developers. The template is coherent with the defined stages and gates (www.tbvacpathway.com) and aligned with other similar ongoing activities, for example, the EDCTP Knowledge Hub.
The core purpose of a data management plan is to present all key activities conducted by the data management team and the contribution of other relevant functional groups that support the data management processing activities. The data management plan guidance documents include recommendations whereas the template offers practical support for developing a data management plan.
Available repositories: the EDCTP Knowledge Hub has been developed to provide support to researchers that include a data management portal and a data sharing toolkit with an extensive collection of resources linked to data management.