GxP Lifeline

GCP Compliance Hack: How to Avoid the Most Common Warning Letter Trigger


Over the past decade, the most common violation of good clinical practice (GCP) guidelines cited in warning letters from the U.S. Food and Drug Administration (FDA) has been the failure to ensure that studies were conducted as per their investigational plans, according to researchers at Eastern Michigan University.(1)

Clinical organizations struggle with protocol adherence and inconsistencies in protocol implementation primarily because of quality deficiencies in their clinical trials, Patricia Santos-Serrao, director of product strategy at MasterControl, stated in a recent European Pharmaceutical Contractor article.(2)

“A study’s protocol is the single most important document in a clinical trial, which makes adherence to the protocol the most critical element of sustained study quality,” Santos-Serrao said.

All issues relating to study protocol adherence and study quality boil down to a problem of not storing data central location, according to Santos-Serrao.

The Disconnected Data Dilemma

It’s common for clinical personnel to work at a variety of different sites. If they are all using different disconnected systems to record and share data, establishing a single source of truth is impractical, if not impossible. There are bound to be inconsistencies across multiple sites and studies if there isn’t a centralized source of accurate, up-to-date data. Maintaining quality standards effectively becomes impossible if data reliability is questionable.

The key to avoiding deviations from the study protocol is ensuring that data can be accessed and maintained within a centralized digital system, Santos-Serrao said. Digitized clinical quality processes reinforce clinical quality management principles across the board. A unifying digital system can connect and synchronize data, which enables clinical professionals to better manage quality events that occur across studies and product lines. A digitally connected system also improves their ability to effectively steer actions that should be taken when deviation issues are identified.

5 GCP-Critical Activities That Benefit From Digitization

Digitization streamlines every process related to GCP compliance, but there are five essential clinical areas that digital connectivity can enhance dramatically.

#1 - Document Management

Maintaining documentation on the standard operating procedures (SOPs) attributable to all of a study’s activities and roles is vital to GCP compliance. Efficiency and communication improve drastically when clinical documentation like SOPs, work instructions and research documents can be stored in and readily accessed from a single centralized repository. Digitally connected documents make it easier to meet and complete goals and objectives in a timely manner. Plus, digitization enhances an organization’s ability to leverage otherwise dormant data that is often trapped in unstructured clinical documents, like PDFs, and requires manual processes to extract.

#2 - Quality Event Management

To meet GCP requirements, an investigational plan must adequately establish processes for managing quality events and formalizing the steps that should be taken in response to various types of events like corrective and preventive actions (CAPA) and deviations. A software system that is specifically designed to centralize clinical data can cohesively integrate all quality events and clinical operations across vendors, study sites and contract research organizations (CROs).

#3 - Training Management

GCP guidelines require all personnel participating in relevant activities to be appropriately and thoroughly trained. In clinical settings, training is geared toward empowering personnel to make informed, knowledge-based actions as they perform relevant tasks. A digital system can facilitate GCP-compliant training programs by aligning training requirements with clinical roles. With a connected digital system, all GCP data and content can be efficiently distributed to all requisite roles and other pertinent individuals.

#4 - Vendor Management

GCP compliance is contingent on the assurance that external parties (i.e., vendors, partners, suppliers, etc.) are capable of meeting predetermined levels of acceptable quality. A digital solution with reporting and analytics capabilities makes vendor qualifications easier. When you can effortlessly access reliable information on vendor audits and histories, you have a better understanding of current and potential partners’ statuses. Digitization offers greater insight into partners as an extension of your organization while also strengthening oversight, accountability and compliance. A digital platform enables organizations to manage partner relationships in real time from a centralized system and maintain a continuous view of their statuses, risks and histories.

#5 - Audit Management

A digital system makes it easier to support audits of clinical programs, studies, vendors, sites and quality events. Digitization simplifies the supervision and documentation of all procedures that are classifiable as audit-related activities, specifically:

  • Performing periodic vendor audits of manufacturing suppliers or clinical vendors like CROs.
  • Performing clinical study site audits.
  • Verifying that required activities have been accomplished.
  • Providing reasonable assurance that the organization is prepared to manage adverse events when they arise.

Sticking to a clinical study’s investigational plan is impractical if everybody involved isn’t on the same page. A centralized system that allows all personnel to depend on the same accurate and up-to-date information is the surest way to harmonize their activities and conduct. A robust clinical management software system is ideal for streamlining GCP-related operations, processes and tasks. As a study progresses, a centralized digital solution reinforces GCP guidelines by ensuring personnel have a common set of tools that facilitate alignment with the study’s investigational plan.


  1. Warning Letters Issued to Sponsors, IRBs and Investigators from 2010 to 2019,” by Deepika Sri Prashanthi Gundrathi, Eastern Michigan University School of Health Sciences, March 13, 2020.
  2. Applying Quality Best Practice Principles to GCP,” Patricia Santos-Serrao, European Pharmaceutical Contractor, Nov. 2018.


James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

Free Resource
MasterControl Clinical Excellence™ Solution Overview

Enjoying this blog? Learn More.

MasterControl Clinical Excellence™

Download Now
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]