Quality and Risk Management in Clinical Studies

Patricia Santos Serrao
Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

With all that goes into a clinical trial, from documentation and procedures, to a variety of study support staff, managing risk may often be overlooked or merely addressed in a reactive way. However, in order to increase success in clinical trials, an organization must have an efficient risk management plan and be proactive and not simply reactive. In order to obtain a complete understanding of risk in a clinical trial, a risk assessment must be taken from various perspectives. Also, risk management is more than just assessing the risk; it should include contingency plans for rectifying and preventing risk in order to minimize risk.

An efficient risk management plan must include a risk matrix or measurement to aid in assessing acceptable and unacceptable risk.

An efficient risk management plan must include a risk matrix or measurement to aid in assessing acceptable and unacceptable risk. For example, a risk matrix can be used to measure the risk associated with the use of a specific clinical site using qualification criteria to assess the investigators qualification (i.e., therapeutic area expertise, years in practice), a clinical sites facility / equipment, past clinical monitoring findings, audit history, and support staff qualifications, to name a few. A risk matrix can also be used to evaluate the level of complexity in the procedures of a protocol (i.e., numerous similar tests, complex detailed procedures requiring specific equipment). Often times a clinical protocol is written by a medical writer with limited input from team members, such as a Clinical Research Associate (CRO), who may spend much of his or her time on the field and understand the impact of complex procedures on clinical investigators and error prone procedures.

The following are examples of areas and activities that may impact risk throughout a clinical trial:

  • Internal Procedures
    • Lack of transparency and communication between Medical Affairs and Clinical Operations
    • Unclear roles and responsibilities between Sponsor and CROs for outsourced studies
    • Lack of SOPs that clearly define clinical procedures, roles and responsibilities
  • Documentation & Training
    • Overly complicated protocol procedures with minimal targeted training
    • New study site support staff hired during trial and not properly trained
    • Training on amendments or changes to study not completed in a timely manner
  • General Study Procedures
    • Inadequate investigational product labeling and/or storage
    • Study documentation files incomplete or stored in an area away from study location or with limited access
    • Inconsistent data collection
  • Patient Enrollment & Safety
    • Low patient enrollment
    • Enrollment of patients not meeting qualification requirements
    • High number of safety events

How you incorporate quality procedures into your clinical trials is a large part of risk management and can mean the difference between a positive or negative outcome at trial closeout.

Patricia Santos-Serrao, RAC, is a Life Sciences professional with almost two decades of experience in Regulatory Affairs and Clinical areas of the Pharmaceutical Industry.

Prior to joining MasterControl, Patricia held the position of Manager, Global Regulatory Solutions for QUMAS, a company specializing in quality and compliance management software for Life Sciences, where she helped drive the development, sales, marketing and implementation of solutions for the R&D areas of the Pharmaceutical Industry with a particular focus on submission document management for Regulatory Affairs, and Clinical Trial Master Files (CTMF) for Clinical.

She's worked for several Tier 1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim, both in Regulatory Affairs and Clinical. She's assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling eCTDs, and other submission format filings worldwide. A graduate of Western Connecticut State University and University of Phoenix, Patricia holds a Bachelor's of Science degree in Business Administration. Patricia is a member of Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA). She has also earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Regulatory Affairs Certification Board (RACB). You may reach her at psantosserrao@mastercontrol.com.