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Table 8 Recording and reporting guidelines for notables AE/AR

From: Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: study protocol for a multicenter, open-label randomized controlled clinical trial

 

Individual AE

Aggregated AEs

Who reports

Site Researcher

CTU

How it is reported

AEs eCRF

Safety Report (SR) and

Development Safety Update Reports (DSURs)

Timing

7 days since knowledge

6-monthly (SR)

Yearly (DSURs)

Whom

Central CTU

SR: DSMB - 6 monthly

DSUR: EDCTP, Regulatory authorities, Ethical boards - yearly

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Trials

ISSN: 1745-6215