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Study Management & Closure: Management and monitoring

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Introduction

Risk proportionate management and monitoring strategies should be implemented, informed by the outcome of a formal risk assessment.  Management strategies designed for later phase clinical trials are not always appropriate for small scale studies.  However, it is vital that an appropriate level of delegation is implemented and that communication is maintained between decision makers and the rest of the research team; this may include staff who are not directly employed to work on the study e.g. collaborators.  Independence in decision making should be considered, but may not be deemed necessary where the risks are low.  You should also consider what skills are required in aiding decision-making, for example statistical input may be helpful in some circumstances, but not all.

Any outstanding risks to patient safety or more general risks should be actively monitored.  The intensity and frequency of monitoring, whether it be monitoring of participants' health, monitoring recruitment and consent or monitoring data quality and protocol adherence, will be determined by the risks involved.  The outcomes of monitoring must inform ongoing risk assessment as research progresses.  Re-assessment of risk may identify the need to amend the protocol or to make urgent safety measures.