Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4

Document information
Reference	EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017
Validity area	EU
Scope(s)	HM
Document name	Recommendations of the expert group - Risk proportionate approaches in clinical trials
Version / Revision	25-Apr-2017
Status	Current
Document type	Official recommendation
Language(s)	EN
Description	Risk proportionate approaches in clinical trials Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Scope	HM
Document part	4.4
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Monitoring activities focused on risk mitigation

Content

4.4. Trial management Monitoring Monitoring activities should focus on preventing or mitigating important and likely sources of error in the conduct, collection, and reporting of critical data and processes necessary for human subject protection and trial integrity. [...] Based on the outcome of the risk identification and evaluation, the sponsor should develop a monitoring plan that describes the monitoring methods, responsibilities, and requirements for the trial to be monitored. The monitoring plan should include a brief description of the study, its objectives, and the critical data and study procedures, with particular attention to data and procedures that are unusual in relation to clinical routine and require training of study site staff. The plan should be communicated to relevant parties (e.g. monitors, project managers, data managers, statisticians etc.) and should provide those involved in monitoring with adequate information to effectively carry out their duties. [...] The type and combination of monitoring activities should be adapted and tailored to suit a particular clinical trial. These include: - on site monitoring activities, - monitoring activities that do not require visits to individual sites such as: telephone contact with the site, web-enabled training (remote monitoring), - centralised monitoring of the trial data (a remote evaluation of accumulating data, performed in a timely manner, supported by appropriately qualified and trained persons (e.g., data managers, biostatisticians), - central medical review of trial data, - centralised monitoring of pre-defined operational metrics critical to quality (e.g. turnaround time of central laboratory results to the investigators). [...] In defining the monitoring strategy based on the trial specific risk assessment performed, the intensity and focus of the monitoring may vary. The level of on-site monitoring activities may range from frequent and or detailed monitoring to lower levels of activity and less frequent on-site visits to targeted visits of certain sites or of a particular activity or in rare circumstances to no on-site visits. [...] In order to ensure that any monitoring that is carried out is sufficiently focused, escalation procedures should be built in to communicate, follow-up and correct identified non-compliance at an early stage.