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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