5. How can the oversight and monitoring strategies be adapted?
The adaptation of aspects of the conduct of the trial based on a trial categorisation to Type A/B/C and trial specific risk assessment is a broad approach that impacts on all areas of the trial conduct, but beneath this, the activities outlined as the monitoring strategy could include a further flexible or adaptive approach. This ensures that the monitoring tasks undertaken are also risk-based and reflect accumulating information about the compliance of the investigator site(s) or from data/information from outside the trial (e.g. new legislation).
The document(s) comprising the monitoring strategy (e.g. protocol, SOPs, data management plan, medical monitoring plan, safety plan, monitoring plan etc.) are recommended to have been based on the vulnerabilities identified in the risk assessment, but are also recommended to contain further risk-based flexibility within. For example,
- the intensity of monitoring/oversight and/or visits is high initially and then decreases when compliance is acceptable,
- high intensity (visits, contact etc) for unknown/new sites with little trial experience compared with sites used many times by the sponsor,
- triggering an on-site visit, if central monitoring reveals concerns at a particular site (e.g. a serious breach has occurred).
There should always be a process and resources made available to escalate the monitoring activities when necessary. Such decisions could be delegated to the monitor to decide the appropriate level and frequency of monitoring based on guidance in the monitoring strategy together with the outcome of monitoring activities and actively overseen by the project manager/chief investigator/trial steering group. The monitoring strategy is recommended to define how adaptations will be decided and the rationale for the change should be documented. In some cases, the monitoring strategy documents may need to be amended if the planned adaptation is beyond the scope of flexibility built into the original strategy.
Version 1: 22 February 2013