The First Time I Went To a Clinical Research Site

 

Clinical experiences like project management and remote monitoring are very helpful for visiting a research site and to understand documents and regulatory binders. These experiences are very beneficial to be a CRA in future.

While shadowing a CRA on a site you have to go to a nearby clinic that is the responsibility of another monitoring team and you have to help providing the information. Study coordinators have all the study binder that include all the IP law, IP accountability logs, monitoring calls, confirmation letters, inter monitoring confirmation letter and huge data related to the studies. Someone who has been working as a remote CRA and in clinical operations can easily understand all these documentations that can be boring and confusing for any non-experienced person. Site visits can be different as site initiation visit, close out visits and qualification visits and all these visits are different from each other.

CRAs do not schedule calls with the study coordinators, study coordinators keep coming to the CRA time by time to ask if he need any documents.

CRA and PIs meeting at the site can be very short but it depends upon the study and trials. Monitors at the site also have to deal with a lot of action item log and with queries and these things can be easily understood when you have experience of being a remote monitor.

Remote monitors can’t:

  • Remote monitor are familiar with all the documents at site but the only thing they lack doing is IP accountability that is to check that the patient has taken correct amount of pills and how many in a month. This is done with every patient that is involved in a study.
  • Source data verification and source data review is something that a remote monitor can’t do because that needs to be at site to check if there is any mistake in entering data by the study coordinators. This data need to be accurate for the study to make it successful. This data is required for the sponsor that should be accurate.

Source data verification:

Source data verification includes looking at the sources that can be documents and measurements related to blood pressure, height, weight and measurements of the patient under study and entering these measurements in electronic data capture. Source data verification needs to be hundred percent for the study and some documents are required to be verified by the CRAs.

Going on site gives you a lot of understanding about the studies, trials and about the research work. This also helps to learn working with CRAs, in-house CRAs, risk based monitoring team, data management team and with clinical trial leads.

 

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