Study monitoring: A how-to guide on navigating today’s international regulations

Study monitoring assures the rights, safety and welfare of study subjects as well as ensuring the highest quality data for regulatory submissions.

By Claire Jones (Née White) - Clinical Project Manager, ARC Regulatory

Study monitoring is a requirement under FDA and IVDR regulation of any IVD irrespective of the stage of clinical development. It assures the rights, safety, and welfare of study subjects, as well as ensures the highest quality data for regulatory submissions.

A clinical monitor or CRA (Clinical Research Associate) is a professional who is employed by a sponsor or by a CRO (contract research organisation) acting on a sponsor’s behalf, who monitors the progress of investigator sites participating in a study.

The monitor confirms that procedures are performed at the site in accordance with the approved protocol. Monitoring will also identify any problems and recommend solutions.

Clinical monitoring can be conducted in several ways:

1. Single testing site: Onsite, the CRA reviews source documentation and other essential documentation as outlined in the sponsors monitoring plan. In depth reviews take place to help ensure the correct protocols, instructions, samples and test kits are being used, stored and destroyed.
2. Centralised testing site: This type of site includes institutions such as hospitals, CROs, or central clinical testing facilities. Clinical, drug, device, and hospital testing also often takes place here. The CRA reviews source documentation and other essential documentation as outlined in the sponsor’s device monitoring plan. Often, centralised testing sites are selected for device studies being used in the context of a companion diagnostic development.
3. Remote monitoring: A full or hybrid approach to onsite monitoring. CRAs are given access to source data via electronic platforms such as eTMF (Trial Master file) or eDC (Data Capture) which can facilitate remote review as the source documentation is electronic rather than paper.

When monitoring, the CRA may identify common pain points, including:

• Typographical errors
• Missing documentation
• Incomplete documents
• Incorrect storage of investigational product
• Deviation from protocol
• QMS non-Compliance

Undoubtedly, successful monitoring can be achieved by taking a collaborative approach and the benefits are numerous. Here are the top reasons why monitoring matters:

• Understanding relevant regulatory requirements (USA, Europe and MENA)
• Compliance to regulations
• Data integrity
• Establishing good relationships with test sites and supporting staff
• Consistent review of essential documentation
• Effective team communication
• Study progress
• Real time tracking
• Harmonisation across sites
• Operational efficiencies

The above has given you a snapshot of what matters when looking to successfully monitor a clinical study, the common pain points, and the kind of monitoring activities that will ensure smooth regulatory submissions and audits, readying your company for an optimistic future.

By actively engaging with a clinical research organisation like ARC Regulatory to conduct your study monitoring, you can feel confident knowing you have experts at your side when tackling the nuances of international regulations.

Learn more at arc-regulatory.com

Interested to know more?

To learn about how stakeholders are redefining healthcare in the GCC and MENA region, read the full PrecisionMed International May 2023 magazine online?here.

Published in PrecisionMed International Magazine (MENA Edition)