A Nurse’s Guide to Good Clinical Practice Guidelines

Clinical research is the core of advancing patient care. For nurses involved in research or those considering clinical trial roles, understanding good clinical practice (GCP) is essential. 

GCP ensures the safety of research participants, the ethical conduct of studies, and the reliability of the data generated. Whether you’re working as a clinical research nurse, study coordinator, or simply looking to expand your knowledge, GCP is a foundational element of high-quality research practice. 

What is good clinical practice? 

Developed by the International Council for Harmonisation (ICH), GCP is an internationally recognized framework of ethical and scientific quality standards designed to ensure the integrity of clinical trials, and the protection of the rights, safety, and well-being of human subjects involved.  

GCP is endorsed by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and it applies to all phases of clinical research — from early-stage trials to post-marketing surveillance. 

GCP principles every nurse should know 

As a nurse involved in research, you may be responsible for tasks ranging from informed consent to data collection. Here are the key principles of GCP to keep in mind: 

• Ethical conduct: Trials must align with ethical guidelines, including the Declaration of Helsinki, and be approved by an institutional review board (IRB). 
• Informed consent: Participants must voluntarily consent to participate, understanding all risks and benefits involved. 
• Protocol adherence: Research must be conducted according to the approved protocol, with deviations reported and documented. 
• Qualified personnel: Investigators and staff must be appropriately trained and qualified for their roles. 
• Accurate documentation: Complete and timely documentation is essential for monitoring, auditing, and regulatory review. 
• Participant safety: Monitoring adverse events and ensuring participants' welfare are top priorities throughout the study. 

GCP training: A must for clinical research nurses 

If you're participating in clinical trials or aspiring to work in research nursing, GCP training isn’t just recommended — it’s required. Many institutions and sponsors mandate certification before allowing clinical staff to engage in research activities. 

Training typically covers: 

• The history and development of GCP 
• Responsibilities of clinical investigators and research teams 
• Managing informed consent 
• Reporting and handling adverse events 
• Regulatory requirements and compliance 
• Maintaining study records, data integrity, and data quality 

Several reputable programs offer GCP certification, including the CITI Program, National Institutes of Health (NIH), and TransCelerate-accredited online modules. Many healthcare organizations may also offer in-house training to ensure compliance. 

Clinical trials and GCP in action 

Clinical trials rely on adherence to GCP to ensure quality and trustworthiness. Before any trial can begin, a protocol must be developed and then reviewed by an IRB. As a nurse working in a clinical trial, you might recruit participants, collect data, administer investigational treatments, or educate patients about the study process. 

Throughout the trial, it’s also crucial to: 

• Monitor for side effects or adverse events. 
• Accurately document procedures and outcomes. 
• Maintain open communication with the principal investigator and study team. 
• Stay current with ongoing protocol updates or amendments. 

GCP compliance helps prevent errors, ensures ethical standards are met, and protects both the participants and the study’s validity. 

GCP and IRBs 

IRBs are central to the GCP framework. These independent committees review and approve research protocols to ensure participant safety and ethical integrity. 

Before any study-related procedures begin, IRB approval must be obtained. If you're a nurse involved in the study, you may also be asked to: 

• Attend IRB meetings or training sessions. 
• Submit required documentation or reports. 
• Help monitor compliance and address any ethical concerns. 

Maintaining a strong working relationship with your IRB is key to staying aligned with regulatory expectations and GCP standards. 

Why GCP matters for nurses 

Nurses bring a unique perspective to clinical research. With their direct patient care experience and clinical judgment, they ensure ethical conduct and participant safety. GCP empowers nurses to contribute meaningfully to research, advocate for patients, and uphold the highest standards of care. 

Whether you're supporting a study team or leading a clinical trial as a nurse investigator, GCP helps you navigate the complex world of research with confidence and clarity.