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Table 1 Stakeholders involved in the Coverage trial implementation between mid-March and end-June 2020, (n = 213)

From: Implementing an outpatient clinical trial on COVID-19 treatment in an emergency epidemic context: a mixed methods study among operational and research stakeholders within the Coverage trial, Bordeaux (France)

 

Function

Role within the trial

N

Trial investigation and coordination team

Sponsors

Promotion of the trial

Responsible for the proper conduct of the trial in compliance with existing regulations

Financial and administrative oversight of the trial

13

Methodological centre & Trial Coordination Unit

Contribution to trial protocol, information sheet and informed consent form for patients, design of the electronic case report form, coordination of trial implementation

31

Researchers

Design of the trial. Supervision and coordination of trial implementation

25

Operational and clinical team (working from the operational office/base)

Study coordinators

Coordination of trial implementation in the field

6

General practitioners (GP)

Information of eligible patients, consent collection, clinical activity as part of mobile medical teams

14

Non-medical students and professionals

Administrative support and human resources management

7

Health students

Logistical support to mobile medical teams

117