UID:
almahu_9949858806502882
Format:
1 online resource (56 pages)
Edition:
1st ed.
ISBN:
9789240027398
Note:
Intro -- Fig 1: Probability of observing at least one event assuming a given event probability, by varying sample sizes up to 60,000. The horizontal dotted lined correspond to a 95% probability of observing at least one event. -- Fig 2: Data collection and timing (a) for all study participants, and (b) additional data collection for participants in the reactogenicity subset -- illustrated for two doses of COVID‑19 vaccines 28 days apart (timing between doses may differ) -- Table 1: Study sites with principal investigators and contact details -- Table 2: Sample size required to rule out events with the indicated frequency if no event is observed with 95% confidence -- Table 3: Sample size needed to rule out a relative risk if no event is observed within the risk window with 95% confidence. -- Table 4: Sample size needed to rule out different levels of relative risk if no event is observed within the risk window with 95% confidence. Additional results correspond to different values of background rates. -- Table 5: Sample size required to estimate reactogenicity prevalence with the indicated level of precision with 95% confidence interval using Clopper-Pearson exact calculation for the proportion. -- 1. Contents -- 2. List of tables -- 3. List of figures -- 4. Protocol sign-off -- 5. Documentation of protocol amendments -- 6. Study team and responsibilities -- 6.1 Study team -- 6.2 Responsibilities -- 7. Abbreviations -- 8. Synopsis -- 9. Background and rationale -- 10. Objectives -- 11. Methods -- 11.1 Study design -- 11.2 Study population -- 11.2.1 Inclusion criteria -- 11.2.2 Exclusion criteria -- 11.2.3 Withdrawal from the study -- 11.3 Study sites -- 11.4 Study period -- 11.4.1 Start of study and duration of follow-up -- 11.4.2 Study completion and end of study -- 11.5 Sample sizes -- 11.5.1 Sample size for overall cohort.
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11.5.2 Sample size for reactogenicity subset -- 11.6 Study variables -- 11.6.1 Exposure of interest -- 11.6.2 Study outcomes -- 11.6.2.1 Serious adverse events -- 11.6.2.2 Adverse events of special interest resulting in hospitalization -- 11.6.2.3 Reactogenicity -- 11.6.2.4 Severe COVID‑19 disease -- 11.7 Study flow: data sources and data collection -- 11.7.1 Vaccination and enrolment -- 11.7.2 Vaccination during the follow-up period -- 11.7.3 Follow-up -- 11.7.4 Identification of AESIs and SAEs -- 11.7.5 Pregnancy -- 11.7.6 Data collection at withdrawal/lost to follow-up -- 11.8 Data analysis -- 11.8.1 Descriptive analysis of demographics and baseline characteristics -- 11.8.2 Statistical analyses -- 12. Data management -- 12.1 Data security -- 12.2 Data transfer -- 12.3 Source documents -- 12.4 Data retention and archiving -- 13. Quality assurance, monitoring and reporting -- 13.1 Monitoring -- 13.2 Interim analyses and reporting -- 13.3 Final analyses and reporting -- 14. Study management -- 14.1 National pharmacovigilance centre/AEFI committee/national immunization programme manager/dedicated scientific committee -- 14.2 Changes to the protocol -- 14.3 Management and reporting of adverse events/adverse reactions -- 15. Ethical considerations -- 15.1 Guiding principles -- 15.2 Respecting participants' autonomy -- 15.3 Participant confidentiality -- 15.4 Independent ethics committee/institutional review board -- 16. Limitations -- 17. References -- 18. Appendices -- Appendix 1 -- Data dictionary -- Appendix 2 -- Adverse events of special interest -- Appendix 3 -- Relationships between study tables -- Appendix 4 -- Adult informed consent form -- Participant information sheet.
Additional Edition:
Print version: Protocol Template to Be Used As Template for Observational Study Protocols for Cohort Event Monitoring (CEM) for Safety Signal Detection after Vaccination with COVID-19 Vaccines Geneva : World Health Organization,c2021
Language:
English
Keywords:
Electronic books.
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Electronic books.
URL:
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