Co-Monitoring and Coaching

Satisfying work and feedback are essential factors for continuing self-motivation and efforts to improve.
In times when many R & D departments have to cope with a reduced group of own experienced staff it is difficult to dedicate sufficient capacities to the training of young colleagues in their starting period.
Also, it is not always possible to follow up on the development of junior CRAs closely over an adequate period of time.

CRAs in the period of gaining first experience often claim to miss the supervision by colleagues and the necessary advice which would help them to feel comfortable in their daily work and especially in exceptional situations.

In my experience co-monitoring visits contribute to improvements in several ways.
The quality of the work by both the staff of the trial site and the CRA can be assessed and improved by means of site- and person-specific evaluation criteria (in addition to the standard GCP criteria) and a well-defined corrective action plan.
The diverse aspects of the performance of the CRA such as soft skills, time management, etc. can be evaluated in detail and combined with ad hoc training and proposals for further training modules.

 

I offer co-monitoring services with the target to help, to train and to motivate the CRA, to improve processes and to help to fulfill GCP requirements.

A co-monitoring should last for 1.5 or 2 days on site.

As preparation, the monitoring visit reports and visit follow up letters will be reviewed in detail and site specific logs or checklists might be requested to get an impression of certain practical aspects.

During the visit, findings with regard to GCP requirements and sponsor or CRO standard operation procedures will be discussed with the investigator and CRA to identify the thoughts or conditions that have led to findings.

 

In the follow up process a corrective action plan incl. allocation of action to a specific person and the timelines for resolution of findings will be prepared and followed until all items have been resolved and adequately documented. The proposed follow up actions and timelines will take into account the available capacities and priorities as defined by the client.

During the whole process from preparation of the visit until closure of the follow up items log the CRA should be in direct contact with the co-monitor and actively involved in all steps. The CRA will gain experience in preparing a clinical trial site for a co-monitoring visit and has to explain the intention and benefit to the site staff. This practical experience will be useful for later audits and inspections announced the CRA’s sites.

Discussions about possible ways to resolve issues will be used for further training and exchange of experience.