SOP's, Protocols and Study Materials Shared with The Global Health Network

Resources

Groups across Africa, Asia and Latin America are sharing their approaches in what they are measuring and how - through their SOPs and training resources - to support a faster implementation of research studies during this pandemic. You can read more about this crowdsourcin iniciative and access this material here or click the below direct links to the study profiles:

WHO

Key criteria for the ethical acceptability of COVID-19 human challenge studies
This document aims to pr;ovide guidance to scientists, research ethics committees, funders, policy-makers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining key criteria that would need to be satisfied in order for such studies to be ethically acceptable.

Early Investigation Protocols
These protocols and forms have been designed so that data regarding the epidemiology and clinical characteristics of COVID-19 can be rapidly and systematically collected and shared in a format that facilitates aggregation, tabulation and analysis across different settings globally. The WHO encourage any and all countries and study centres to contribute to this effort regardless of resource availability or patient volume. The ownership of the primary data remains firmly with the individual countries/sites. Selected protocols are listed below:

Database of publications on coronavirus disease (COVID-19)
The WHO is gathering the latest scientific findings and knowledge on coronavirus disease (COVID-19) and compiling it in a database. The database is updated daily from searches of bibliographic databases, hand searches of the table of contents of relevant journals, and the addition of other relevant scientific articles.

  • Coinfections in COVID-19

COVID Co-infections Forum
This forum is to help create a research community around secondary infections and co-infections in COVID-19. These are often important in acute respiratory infections, but there are few details emerging on the topic during the pandemic.

HIV i-Base: COVID-19: HIV and COVID-19 Co-infection

Collection of literature relating to HIV and COVID-19 co-infection

BMJ:Epidemiology for the Uninitiated

Epidemiological information is used to plan and evaluate strategies to prevent illness and as a guide to the management of patients in whom disease has already developed. This short book aims to provide an ABC of the epidemiological approach, its terminology, and its methods.

CDISC: Interim User Guide for COVID-19

The Clinical Data Interchange Standards Consortium (CDISC) has developed this freely available Interim User Guide for studies pertaining to COVID-19. The User Guide provides examples and guidance on implementing CDISC standards for COVID-19 so that users can collect, structure and analyze data more effectively. The User Guide was rapidly developed by a task force of several CDISC member organizations and partners.

Trials and Data

GloPID-R/UKCDR COVID-19 Research Project Tracker
Live database of funded research projects, clinical trials and funding calls across the world, mapped against the COVID-19 research priorities identified in the WHO Coordinated Global Research Roadmap: 2019 Novel Coronavirus.

Veridata EDC
On 26/03/2020, Elsevier launched Veridata EDC, a secure, compliant and user-friendly platform to capture patient data for clinical research. To assist researchers working to develop vaccines and other therapies for COVID-19, Elsevier has pledged to make Veridata EDC available for free. Interested clinical researchers can contact Elsevier customer support via e-mail at covid19@elsevier.com and apply for a demo account. Following the necessary compliance training, you will receive a free 12-month license.

Tools

The ISARIC-WHO Case Record Form (CRF) can be used to collect data on suspected or confirmed cases of COVID-19.

CONSISE has developed several standardized research protocols for influenza, MERS-CoV and Zika Virus. The protocols have been designed to maximize the likelihood that epidemiological, clinical and exposure data and biological samples are systematically collected and shared rapidly in a format that can be easily aggregated, tabulated and analyzed across many different settings globally.

  • NEW: TB, COVID-19, HIV and Malaria Rapid Surveillance Protocol

This protocol, developed by KEMRI, Kenya, has been designed to to determine whether leveraging upon TB active case finding for COVID-19, HIV and malaria surveillance can assist understand the burden of these four diseases. This comprehensive sets of active case-finding activities may achieve population-level reductions in the four diseases when interventions are expanded to other counties than the seven in the study. The data generated from this study could be useful to other counties, countries and to the World Health Organization. You can view the concept protocol, and provide comments and feedback, here.

Training