GCP Compliance and Common Warning Letters

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

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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

#1 — Document Management

#2 — Quality Event Management

#3 — Training Management

#4 — Vendor Management

#5 — Audit Management

  • 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.

Originally published at https://www.mastercontrol.com.

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