NeuAge Institute (NAI)

Maximizing MedDRA Knowledge: 3 Essential Tips for Clinical Research Training Graduates

Clinical research training graduates in a lab

Graduates of the Drug Development, Clinical Research, Drug Safety, and Pharmacovigilance Certificate Program at the NeuAge Institute (NAI) typically boast the full suite of skills and knowledge required to be impactful and successful in their chosen career path. However, if you’re considering embarking on a career in clinical research, gaining an in-depth knowledge of vital tools and techniques in the field is essential.

The Medical Dictionary for Regulatory Activities (MedDRA) is one of the most pivotal tools for medical coding, and it’s one tool you’re bound to encounter at some point in your career. Understanding and effectively utilizing MedDRA can significantly enhance your proficiency as a clinical researcher. In this blog post, we will introduce you to MedDRA and share three essential tips to maximize your knowledge of this invaluable software.

Understanding MedDRA During Clinical Research Training

MedDRA is an internationally recognized and clinically validated medical terminology tool that holds immense importance for regulatory authorities and the regulated biopharmaceutical industry. Its primary purpose is to facilitate the exchange of clinical information through standardization. This robust terminology is utilized throughout the entire regulatory process, from pre-marketing to post-marketing, providing critical support for various activities.

One of the key functions of MedDRA is to enable the coding, retrieval, and analysis of clinical information related to human medical products. Whether it’s pharmaceuticals, biologics, vaccines, or drug-device combinations, MedDRA ensures that data is consistently captured and reported standardized. This uniform approach streamlines the evaluation and monitoring of products while also facilitating effective communication between stakeholders.

Furthermore, MedDRA plays a pivotal role in supporting product evaluation and oversight. Regulatory authorities rely on this comprehensive terminology to assess the safety and efficacy of medical products throughout their lifecycle. MedDRA enabled the systematic categorization and classification of adverse events and other clinical data, allowing for reliable analysis and informed decision-making.

MedDRA is an invaluable tool for standardizing clinical information exchange and promoting consistency in regulatory activities. As a recently graduated clinical research training student, here are a few tips that can help you achieve full knowledge and use of this tool:

1. Familiarize Yourself With Coding Conventions

MedDRA serves as a standardized medical terminology and coding system, facilitating the classification of adverse events and other medical data during clinical trials. Becoming well-versed in its coding conventions is vital to make the most of MedDRA. This includes understanding the structure of MedDRA’s five hierarchical levels: System Organ Class (SOC), High-Level Group Term (HLGT), High-Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT). Each level provides increasingly specific details, allowing for precise medical coding. Our clinical research courses shed more light on this arrangement.

Clinical research training graduates studying MedDRA coding conventions
Gain full knowledge of MedDRA coding conventions after clinical research training.

In addition, get familiar with MedDRA’s extensive hierarchy and the relationship between terms. This understanding will enable you to accurately assign the most appropriate code for each adverse event, ensuring consistent and reliable data analysis. Regularly consult the MedDRA terminology and coding guidelines to stay updated on any revisions or additions.

2. Start Data Retrieval With Research Questions

Before diving into data retrieval using MedDRA, it’s crucial to establish clear research questions. You can streamline data retrieval by identifying your research objectives and questions upfront and avoiding sifting through irrelevant information.

Clinical research training graduates identifying research questions
Identify your research questions before diving into data retrieval after clinical research training.

Consider the specific adverse events or medical conditions you are investigating and formulate research questions accordingly. For example, if your study focuses on a particular drug’s side effects, ask targeted questions such as “What are the most common adverse events associated with Drug X?” or “Is there a statistically significant relationship between Drug X and adverse event Y?” Starting with precise research questions will enable you to retrieve relevant data efficiently, saving time and effort.

3. Refrain From Making Structural Changes to Meddra

While using MedDRA, it’s essential to remember that it is developed and maintained by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Making structural changes to MedDRA can compromise its integrity and interoperability, leading to consistency and potential errors in data analysis.

Avoid modifying or altering the MedDRA hierarchy, coding conventions, or terminologies to suit individual preferences or research needs. Instead, focus on utilizing MedDRA as intended, ensuring the accuracy and comparability of data across different studies and regions. Consult MedDRA experts or the MedDRA Maintenance and Support Services Organization (MSSO) for guidance if you encounter any challenges or have specific requirements.

Are you interested in pharmacovigilance training?

Contact NAI to learn how to get started.

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