Clinical CAPA: CAPA Isn't Just for Manufacturing Anymore

Patricia Santos Serrao

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

Most of us in the pharmaceutical and biopharmaceutical industry are very familiar with the terms corrective action & preventative action (CAPA) and commonly associate it exclusively with quality and manufacturing. However, CAPA can be applied to many different business areas within an organization, including clinical research. A CAPA consists of a collection of tasks and actions executed to ensure and sustain quality and compliance in day-to-day processes. In clinical research, noncompliance can be extremely costly, both directly and indirectly.

"The complexity of clinical trial execution is further magnified when one factors in the number of parties involved in a trial at any given moment."

According to PhRma, a leading pharmaceutical research firm, the pharmaceutical industry spent $67.4 billion in research and development in 2011, a large part of which was spent on clinical research. Often the simplest of oversights can render an entire study or even an entire study site's data useless. For example, a protocol that does not adequately detail patient recruitment criteria may result in the withdrawal of patients who received a drug they shouldn't have, putting the patients' health at risk. Additionally, if such deviations are not found early on, or are missed during the monitoring process and taken to completion, the study may be found to be inadmissible, costing a company tens of thousands of dollars and lost time as it scrambles to enlist additional sites or conduct a new trial in order to obtain necessary data for approval. Deviations and high-risk noncompliance in clinical trials can result in high numbers of patient dropouts or withdrawals, the disqualification of sites, clinical holds, and even a refusal to file by the regulatory agency. Identifying deviations and taking corrective actions in early stages of a clinical trial reduces cost, decreases time to market, and reduces risk to patients.

The complexity of clinical trial execution is further magnified when one factors in the number of parties involved in a trial at any given moment. A sponsor is responsible for ensuring that each of the individuals taking part in the clinical trial is adequately trained and understands how to execute his or her role. Principal investigators often rely heavily on support staff to assist with clinical trials. Therefore, it is important that all individuals be trained on procedures, from patient enrollment, to documentation and patient eligibility. It is also important to keep in mind that training is not a onetime event. Roles and staff members change throughout a clinical trial, and therefore that training is an ongoing process. Another factor of complexity may come for companies that engage a clinical research organization (CRO) to assist with clinical studies. A sponsor and CRO must communicate with each other throughout the trial and ensure that all parties within both organizations understand the distribution of accountability and responsibility, as well as which procedures will be followed, those of the sponsor or of the CRO.

One way for clinical research to minimize risk and increase compliance is by implementing processes that encourage transparency across various of clinical operation. Sound clinical trial management projects should also include:

  • TMF Document Management (including Document Exchange and Collaboration)
  • TMF Project Management (Managed Execution of Documents, Tasks and Processes)
  • GCP Process Management (Trial Monitoring, Site Initiation, Site Closeout, etc.)
  • Site Management (Investigator Documentation, Audit History, Site Eligibility Information)
  • GCP Training (CRO, Monitor and Investigators)
  • GCP Audit and Risk Management

More importantly it is critical that all areas of clinical trial management be integrated in order to increase transparency and decrease the risk of noncompliance.

If you would like information on how MasterControl can help with clinical CAPA and other clinical needs, please contact your local representative.

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