IC HG CPR has issued guideline according to which the CRAs are the in charge of the risk based monitoring and of all the people on clinical operation site. These guidelines gives the philosophy of monitoring the sites in a better way that do not require to go on the site and CRA can monitor the sites remotely and will visit the sites for the tasks that cannot be done remotely. For this purpose, there are available positions for in-CRAs and remote monitors. Companies do have some policies in which the CRA can perform both the tasks as he can monitor the site remotely and can also travel.
Attending monitoring calls for the first time take a lot of struggle and time to get used to it. New monitors on study are given full explanatory note as annotated report containing all the protocols and answer to all the queries that can be asked by the study coordinator at the site, patient recruitment guidelines, versions of informed consent are given to the monitor within the explanatory notes and he only has to follow the instructions and answer those calls.
Monitor can ask question about the expired investigational product, protocol deviations that can affect studies and if there is any adverse event at site. The new monitors when they have zero experience ask questions as they are written on the annotated report but after getting experience and getting used to it, they ask delicate questions according to their requirements for the data.
There can be someone other than the study coordinator making monitoring calls to ensure that remote monitor is answer the queries in a well manner and is helping the site with studies. This can be your manager or the director who can sign you off when you are not full filling the requirements and unable to follow the protocols.
In the monitoring community, it’s a philosophy to watch one doing the job then do it yourself for couple of time and then teach the further group of people to perform monitoring tasks. Watching other doing monitoring and monitoring calls can be easy especially for those who already have visited sites in case of some tasks in their past experiences and they will not be nervous for making monitoring calls.
New monitor get confused and nervous when the site ask questions that he should answer from the protocol but he do not know how to review protocols and when he is not able to answer queries.
Study coordinators at site can be very welcoming as they help the monitor with the protocols and make it easier for the monitor to answer queries and they do not complain for any inability to work with the site. But due to huge turnover in clinical industry, such welcoming study coordinators can move to anywhere or can leave the company.
After the monitoring calls, monitors have to write a follow report that can take couple of days to write. In this report, monitor has to mention all the informative conversation that occurs between the sites that can be about patient recruitment, missing training, action items log. These reports are approved by the CTLs and CRAs and are ready to be submitted to the trial master file that goes to the sponsor at the end of the study.