Remote means from far away at different location. So, remote monitoring means to monitor site, the study coordinators and their data remotely.
According to IC-HG-CPR regulations, clinical industry has opened up door to remote monitoring and risked based monitoring. Remote monitoring works in conjunction to the traditional monitoring as they have a person who works as a remote monitor who is monitoring the site and study coordinators at site remotely that a CRA does face-to-face interaction. There are things that a remote monitor is unable to perform and can be done only at site are IP accountability and source data verification.
IP accountability is to check if the IP is stored correctly, numbers of pills are administered in the system as the study coordinator says that the IP and investigational product is matching matches up. First thing is IP accountability.
Source data verification:
Verifying the forms that the patient, study coordinator is filling and the collected medical records should be checked that what is entered in electronic data capture (EDC) system.
Documents can be collected remotely unless the CRA want wet ink.
A new study coordinator has to submit his financial disclosure form, documentations, CV, license and ICH GCP confirmations to the CRA that is to be mentioned in trial master file. CRA don’t need to be on site when all the documents are collected.
• Remote monitors can perform task as reviewing data on EDC system and can issue queries on EDC system, data collection, conducting monthly monitoring calls and to check all the emails regarding to the study.
Taking monitoring calls with the site gives you more structure and interaction with the site but emails are used preferably and people should be well-versed in order to show professionalism in email communication.
In monitoring data, it is to make sure that the data is accurate and is coming on time that is necessary because sponsors analyze data on time to avoid any problem in future.