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Table 3 Key activities of the clinical monitor

From: Use of probiotics to reduce infections and death and prevent colonization with extended-spectrum beta-lactamase (ESBL)-producing bacteria among newborn infants in Tanzania (ProRIDE Trial): study protocol for a randomized controlled clinical trial

Site visits When Key activities
Monitoring visit during enrolment One visit, 4 weeks since the start of enrolment. - Inspection of all ICH GCP certificates in place
- Verification of informed consent forms
- Eligibility check
- eCRF completion
- Equipment, consumables, study material
- Review laboratory sample management
Monitoring visit follow-up—first One visit 6 months since the start of enrolment. - Specimen collection procedure
- Eligibility check
- eCRF completion
- Eligibility of source documents
- Source data verification
- Review AE/SAE reporting
Monitoring visit follow-up—second One visit 12 months since the start of enrolment. - Specimen collection procedure
- Eligibility check
- eCRF completion
- Eligibility of source documents
- Source data verification
- Review AE/SAE reporting
Close-up visit monitoring One visit 18 months since the start of enrolment (end of study) - Last query resolution
- Storage and archiving of documentation
- Review, update, and finalization of IF
  1. Abbreviations: AE/SAE adverse events/serious adverse events, eCRF electronic case report forms, ICH GCP International Conference on Harmonization Good Clinical Practice, IF investigator file