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Singapore Clinical Research Institute (SCRI)

SCRI CGH Monitoring Workshop

30 June 2023

Category

Workshops and Training

A hands-on monitoring workshop equipped research staff with the knowledge and practical skills to conduct clinical trial monitoring activities, ensure regulatory compliance, and support the delivery of high-quality research data.

A trainer stands presenting a Quality Reviewer Workshop slide to two seated attendees in a conference room.

Research Office staff enrich their professional skills at SCRI-CGH Monitoring Workshop

SCRI Academy collaborated with Changi General Hospital (CGH) to conduct a monitoring workshop on 20, 22 and 30 June 2023 for four staff from the CGH Research Office (RO).

These staff have an average of five years’ experience in coordinating clinical trials and/or conducting clinical research projects, and the training in project management skills and a broad range of study designs complemented their fundamental competencies in supporting investigator-initiated clinical trials.

Monitoring is an important component in running clinical trials as this role ensures that studies are in compliance with the approved protocol, regulatory and Institutional Review Board (IRB) requirements and Good Clinical Practice (GCP).

The Monitor drives the production of quality research data for clinicians. Some of their responsibilities include source document verification, protocol and GCP compliance checks, safety, operations and essential document review, and conducting reviews for investigational products and lab samples.

They also facilitate communication with project stakeholders including sponsor/ sponsor-investigator and trial sites. These steps are crucial in ensuring the clinical studies continue to run according to plans and they can help find solutions for challenges that occur along the way.

The workshop curriculum was developed by SCRI Academy in collaboration with the SingHealth Office of Research Integrity, Compliance and Ethics (RICE). Topics covered include the following:

• Roles and responsibilities of the Monitor

• Types of visits conducted by Monitors and their purposes

• Design of study logs and templates

• Understanding the monitoring plan

• How to be well-prepared for a monitoring visit

• How to conduct monitoring and follow up tasks after the visit

The sessions were engaging with scenario discussions and role-play on conducting a site initiation visit, as well as how to conduct effective discussions with the site Principal Investigator and the study’s Clinical Research Coordinator (CRC) during a monitoring visit.

The role-play sessions helped prepare the participants for the real-life scenarios they may face when conducting monitoring visits. The participants were also given hands-on practice on how to review the investigator site file, and went through a real case study to help them better understand the monitor’s role in verifying compliance and completeness of source documentation.

The workshop concluded with participants submitting their findings in a written report. The trainers also provided tips on clear report writing and how to develop practical corrective and preventive actions for the findings.

SCRI Academy is glad to partner Changi General Hospital on this collaboration, and we look forward to further opportunities to enhance Singapore’s clinical research ecosystem.