OUTSOURCING A step-by-step guide
Brian J Nugent, senior director of clinical operations and compliance at GRAIL, and Angie Maurer, senior director of training, outsourcing, process and standards at Principia Biopharma, introduce a practical guide on creating a clinical compliance function with leadership support.
(QC) exercises and at others, full clinical compliance departments with a structured clinical quality management system (Clinical QMS). The process and extent of the development of a clinical compliance group may vary widely between organisations, but the basic principles and the components of a Clinical QMS are becoming more routine. Our objective of developing a clinical compliance
O
group is to ensure that clinical operations (ClinOps) have a system of internal processes and internal controls, so that they identify, measure and manage the risks, and regulatory obligations they face. This article is designed to address the common compliance concerns within the industry, including risk and issue management, as well as E6 R2 changes and overall operational quality. It is expected that many of the ideas will be subject to change Many of the activities mentioned in this article will
take a concerted effort to accomplish, which may be expected to involve a cross-functional approach,
ver the past 15 years, we have been developing clinical compliance functions. At times, these were simple quality control
significant planning and an iterative build. External consultants may be required and vendors will have to be identified. It is strongly recommended that any systems that requires validation be outsourced to a vendor, unless there is someone in-house.
Compliance group development steps Our first step in the development of a clinical compliance function is to establish a baseline understanding of our organisation’s compliance needs. We strive to take a holistic view of this while tailoring to the specific business model. We first look at the initial clinical compliance design and the staffing required to support the design, based upon their accountabilities and responsibilities. A gap analysis – existing staffing versus requirements – should be performed to determine initial staffing requirements and to project the potential needs over the following 12-month period. At this time, we also establish the preliminary Clinical QMS structure, as it will not only strongly influence resources but is the fundamental means we create for addressing clinical quality and compliance – see below.
Clinical compliance CQMS
Clinical risk management/ failure analysis
Process support Training and knowledge management
Issue management Clinical systems
Outsourcing in Clinical Trials Handbook | 37 CQMS support Periodic compliance monitoring General compliance support for teams
audit programme/CAPA support/ issue management
Inspection preparation/
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