Good Clinical Practices: The Pillars of Protocol Compliance and Patient Safety

11/12/2025

Written by: Erin Zielinski, MS, CCRP Director of Research Operations, Department of Obstetrics, Gynecology and Women’s Health, University of Minnesota Medical School

In the world of clinical research, Good Clinical Practices (GCP) form the foundation of ethical and scientific standards. GCP ensures that clinical trials are conducted with the utmost respect for human rights, that data generated are credible, and that participants’ safety and well-being are prioritized. Adhering to GCP covers many research activities; here we will explore the importance as it relates to as adverse event (AE) reporting and collection data regarding of concomitant medications

As clinical trials become more complex, the importance of strict adherence to protocol compliance and proactive strategies to ensure patient safety continues to grow. One of the most overlooked, yet critical, features of this process is how study teams handle concomitant medication and AE reporting.

At the heart of every clinical trial is the participant. Ensuring their safety means more than monitoring vital signs, administering the correct dose of a study drug, or following study procedures in specified windows. It includes understanding the full clinical picture of the participant, including how concomitant medications and adverse events (AEs) are identified and documented.

A common downside in clinical trials is relying solely on electronic medical records (EMRs) or medical chart reviews to collect information on concomitant medications. While EMRs are valuable, they often fail to capture over the counter (OTC) medications, herbal supplements, or medications prescribed by outside providers.

This is why in-person review of medications with the patient is not just recommended — it’s essential.

Why it matters:

• Patients may not consider vitamins or herbal remedies as “medications,” yet these can significantly impact the safety profile or efficacy of the investigational product and sometimes have serious, even fatal interactions.
• Medications obtained from other providers or pharmacies may not be documented in the primary medical record.
• Changes in dosage or frequency often go unrecorded unless confirmed with the patient directly.

At each study visit, coordinators should connect with the patients for a verbal medication reconciliation with the participant. Asking open-ended questions like, “Have you taken any new medications or supplements since your last visit?” helps capture more accurate data than chart review alone. If the trial requires a patient diary, this is also a good tool to review with the patient their symptoms and/or events since their last visit.

Similarly, relying solely on chart review to document adverse events can lead to underreporting or misclassification. Many adverse events go undocumented in the medical record, especially if they are mild, transient, or not medically attended.

Why it matters:

• Participants often don’t report symptoms unless specifically asked.
• Medical records may reflect only events the patient sought care for — omitting headaches, fatigue, GI upset, or other common side effects, especially if they are not treated or had these symptoms prior to enrolling in the trial.
• Accurate AE reporting is crucial for evaluating the safety profile of the investigational product.

A structured conversation during each visit that includes a non-leading, symptom-based review helps elicit relevant AEs. Coordinators should ask, “Have you had any new or different symptoms since your last visit, even if they seemed minor or unrelated?”

Study coordinators play a pivotal role in safeguarding data integrity and participant safety. They are the front-line professionals responsible for:

• Educating participants on the importance of disclosing all medications and symptoms.
• Maintaining meticulous records that align with source documents and study protocol.
• Collaborating with investigators to evaluate the clinical significance of reported AEs and medication use.

Their diligence in conducting face-to-face, or even over the phone reviews, with patients cannot be overstated. This proactive approach often reveals critical safety information that might otherwise be missed.

In conclusion, GCP is not simply a regulatory requirement — it’s a foundation to ensure that clinical research is conducted with integrity, responsibility, and respect for human life. Protocol compliance and patient safety go hand in hand, and both depend on accurate, timely, and thorough data collection.

By prioritizing direct patient interaction — especially when reviewing medications and adverse events — study coordinators reinforce the quality and reliability of the trial, while honoring the ethical duty to protect participants. In the ever-changing landscape of clinical trials, this hands-on, patient-centered approach remains one of the most effective tools in upholding the highest standards of clinical research.