Monitoring Visits

What is Clinical Trial Monitoring?

Monitoring is defined as the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, regulatory requirements and GCP principles.

Clinical Trial Monitoring are conducted by CRAs, Quality Assurance teams and Trial Managers.

Clinical trial monitoring is an important aspect of clinical trial conduct. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) E6(R2) [1] gives a definition of the purpose of clinical trial monitoring

“5.18.1 Purpose

The purposes of trial monitoring are to verify that:

(a) The rights and well-being of human subjects are protected.

(b) The reported trial data are accurate, complete, and verifiable from source documents.

(c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).”

There are four types of Monitoring Visits:

• Site Selection Visit
• Site Initiation Visit
• Interim (Routine) Visits
• Study Closeout Visit

As mentioned above, the focus of these visits is to evaluate the way the study is conducted and to perform Source Data/Documentation Verification.

During Monitoring Visits, the major reviews performed by CRA is SDV and SDR.

Source Data Verification (SDV): Monitor reviews Source Data against EDC. If any mismatches they raise Queries.

Source Data Review (SDR): Reviews Source data and checks if its compliant with Protocol and ICH-GCP.  (This is the activity for which SRAs are highly paid)

Monitoring Visit Process

The steps involved in a monitoring visit is explained below

Next: Study Close-Out Visit