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CORDIS - Forschungsergebnisse der EU
CORDIS

PReparing for Optimal Phase III/IV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT)

CORDIS bietet Links zu öffentlichen Ergebnissen und Veröffentlichungen von HORIZONT-Projekten.

Links zu Ergebnissen und Veröffentlichungen von RP7-Projekten sowie Links zu einigen Typen spezifischer Ergebnisse wie Datensätzen und Software werden dynamisch von OpenAIRE abgerufen.

Leistungen

Plan for the exploitation and dissemination of results including communication activities (öffnet in neuem Fenster)

Development DEC plan for dissemination, exploitation and communication measures

Draft stewardship plan (öffnet in neuem Fenster)

Draft stewardship plan all WPs

SOPs and Training Plan (öffnet in neuem Fenster)

Development SOPs (sepsis consensus definition, sample collection/analysis), Training Plan

Charters of advisory bodies (öffnet in neuem Fenster)

Terms of Reference (ToR) of Advisory Bodies

Study initiation package WP2 (öffnet in neuem Fenster)

Registration number clinical study, final version study protocol, ethics approval

GBS Surveillance harmonised protocol (öffnet in neuem Fenster)

Development surveillance study harmonized protocol, and CRFs for data collection

Study initiation package WP3 (öffnet in neuem Fenster)

Registration number clinical study, final version study protocol, ethics approval

Management SOPs (öffnet in neuem Fenster)

Development SOPs management structure, workflows and procedures

Statistical analytical plan (öffnet in neuem Fenster)

Development statistical analytical data from site sentinel GBS surveillance

Core outcome measures (AESI/AEFI) (öffnet in neuem Fenster)

Consensus report of core AESI/AEFI of interest for maternal vaccine trials

Social media toolkit & guide (öffnet in neuem Fenster)

Guide to social media platforms for coherent and timely communication

Stakeholder mapping (öffnet in neuem Fenster)

Report of relevant national and international stakeholders

EHR scoping review AEFI/AESI monitoring (öffnet in neuem Fenster)

Review of existing EHR to establish their operations and gaps to inform the proposed PER

A situational analysis report (öffnet in neuem Fenster)

Report factors influencing willingness to participate in maternal vaccine trials

Laboratory manual sample analysis (öffnet in neuem Fenster)

Development laboratory manual for handling, processing and analysis of samples

Dissemination toolkit (öffnet in neuem Fenster)

Professional corporate identity: project logo/style guide, dissemination/marketing materials

Protocol (öffnet in neuem Fenster)

Development of the final study protocol approved by regulators

Project Intranet (öffnet in neuem Fenster)

Development intranet for document storage, file sharing and up-to-date overview project status

Data linkage tools to existing datasets (öffnet in neuem Fenster)

Identifying identifiers for data linkage maternal/infant datasets and developing linkage codes

Study registration (öffnet in neuem Fenster)

Registration on clinicaltrials.gov

Algorithms for data abstraction in EHR (öffnet in neuem Fenster)

Reviewing and adapting data extraction codes

Ethical approvals (öffnet in neuem Fenster)

Ethical review and approvals by relevant regulatory bodies

Project Website (öffnet in neuem Fenster)
Updated Data Management Plan (öffnet in neuem Fenster)

Updated DMP for data entry, cleaning and handling

Data Management Plan (öffnet in neuem Fenster)

Development DMP for data entry, cleaning and handling.

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