Co Monitoring In Clinical Research

Co Monitoring In Clinical Research. Research monitoring encompasses four categories of activity annual reviews of continuing research monitoring of informed consent monitoring of adherence to approved protocols and monitoring of the integrity of data The authors describe characteristics of research projects that may call for monitoring procedures in each category.

Comonitoring is not mentioned in ICH E6 (R2) and the FDA guidance “Oversight of Clinical Investigations A RiskBased Approach to Monitoring” has a short section on page 16 on comonitoring (last bullet point) https//wwwfdagov/media/116754/download >> When conducting comonitoring a “comonitor” accompanies the CRA to the monitoring visit.

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PDF file–Obligate sponsors to oversee their clinical trials •21 CFR 31250 and 81240 Sponsors are responsible for ensuring proper monitoring of the investigation.

Medical Monitoring in Clinical Trials Atlantic Research

Communication is a key tool for clinical researchers yet problems due to inactive communication are common It is important to monitor possible ineffective communication in order to develop effective solutions to proactively prevent the negative consequences of ineffective communication.

Clinical Monitoring and Site Management – George Clinical

PDF fileComonitors are often responsible for managing the resolution of problems identified in the report Their report includes a corrective action plan The plan may include training followup by the CRA assignment of issues to other personnel and another comonitoring visit The comonitor then followsup on the results.