Question: What are the differences between clinical research administration and regulatory affairs? Clinical Research Administration vs. Regulatory Affairs
Updated: November 30, 2022
Answer: Clinical research administration and regulatory affairs are two related jobs that are integral to the rigorous process of bringing pharmaceuticals and medical devices from the discovery phase to market. Clinical research administration involves direct oversight of clinical trials that test the safety and efficacy of new medications, biologics, and devices. Ensuring that those clinical trials adhere to applicable federal and international laws and statutes is the purview of regulatory affairs.
Prior to approval by the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other affiliates of the International Coalition of Medicines Regulatory Authorities (ICMRA), pharmaceuticals and medical devices must undergo formal clinical trials to demonstrate their safety and efficacy. Clinical research administrators work with research scientists and medical professionals to design, implement, and manage these clinical trials. This commonly involves setting up and managing clinical sites (e.g., research hospitals, medical centers, cancer centers…), enrolling test subjects, assigning human and material resources, securing and storing samples and data, documenting results, communicating with the FDA and internal review boards (IRBs), and more.
Regulatory affairs specialists are tasked with advising clinical research professionals and others overseeing clinical trials on adherence to the laws and regulations that govern the testing and approval of pharmaceuticals and medical devices. They serve as intermediaries between the FDA and the organization conducting the clinical trials, ensuring that all aspects of the testing process, from experimental design and sample size to implementation and analysis, comply with federal regulations. Whereas the responsibilities of clinical research administrators generally ends when the clinical trials conclude, regulatory affairs professionals are tasked with post-trials compliance in areas related to packaging, advertising, and marketing.
Thus, clinical research administrators and regulatory affairs specialists are crucial to facilitating the process by which new medical treatments and devices move from the development phase to approval. They each have distinct, yet complementary roles to play in ensuring safety, efficacy, and legality of pharmaceuticals, biologics, and medical devices.
Clinical Research Administration vs. Regulatory Affairs
One way to contrast the roles of clinical research and regulatory affairs professionals is through their relative proximity to actual clinical trials. While both are involved in the process, clinical research administrators typically fulfill their roles by engaging directly with the implementation and management of clinical trials, from setting up sites and enrolling patients to collecting patient samples. In contrast, regulatory affairs operates at a greater distance from the trials, scrutinizing protocols, standard operating procedures (SOPs), and processes to ensure all aspects of a clinical trial align with the most up-to-date regulations.
As a result, the focus of training in clinical trial administration differs from that in regulatory affairs. Understanding the foundational principles, scientific practices, and ethical standards for clinical trials is important in both fields. However, clinical trial administration combines managerial skills with knowledge of experimental design and scientific methodology, which includes familiarity with relevant regulations. Regulatory affairs, in contrast, focuses on the intricacies of the laws that clinical trials are subject to and how those laws are enforced.
There are thus areas of overlap and divergence in the training for these two professions. The table below illustrates some of the differences between clinical research administration and regulatory affairs using the types of courses that are commonly part of graduate curricula in these fields.
| Clinical Research Administration | Regulatory Affairs |
|---|---|
| Clinical Research Methods | Protection of Human Subjects |
| Clinical Trials Planning and Implementation | Food and Drug Law |
| Critical Evaluation of the Medical Literature | Ethical Concerns in Drug Discovery |
| Biostatistics | Quality Control and Safety in Clinical Trials |
| Data Management and Analysis | Post-Market Drug Safety and Marketing |
It is important to note that the management of clinical trials and regulatory compliance are closely linked and have a common purpose — to safely test the efficacy of pharmaceuticals, biologics, and medical devices and pilot them to market. Indeed, training to become a clinical research administrator typically involves learning about regulatory compliance, and training to become a regulatory affairs specialist includes cultivating a clear knowledge of how clinical trials are conducted.
For more information on clinical research and regulatory affairs, check out our Graduate Certificate Programs in Clinical Research Management and Graduate Certificate Programs in Regulatory Affairs and Regulatory Science pages.