Global Vaccine Safety Multi-Country Collaboration project: safety in pregnancy

Objective:

To provide the quality assurance, data management and data analysis for a multi-country study aiming to assess the applicability of case definitions for early childhood conditions in low and middle income countries. 

Main Tasks:

1. Finalize the study protocol, study procedures, data collection and management tools.
2. Quality assurance for sites selection, training, study implementation and conduct, including:
   1. Assess sites eligibility (using a pre-established site assessment questionnaire and simulation exercise)
   2. Training of each study sites : prepare training material for on-site training (at least one workshop per participating countries) and remote training
   3. Support remotely study sites in study conduct, including case identification, case validation and exposure assessment.
3. Develop support tools including:
   1. an electronic Case Report Form with logical checks
   2. remote instruction videos/tool
4. Follow-up on IT-related issues for all sites.
5. Monitor study progress as per agreed timelines
6. Analysis, including:
   1. creation of a statistical analysis plan
   2. quality control of submitted data and site-specific queries
   3. SAS scripting (double coded)
   4. preparation of results tables and other exhibits.
7. Preparation of a detailed study report and scientific publication
8. Presentation of study results to study sites and the WHO Global Advisory Committee on Vaccine Safety.

Refer to attached documents for additional information.