7 Key Terms You Need to Know

In the dynamic world of clinical research, ensuring medication safety throughout a drug's lifecycle is paramount. Pharmacovigilance (PV) stands as the guardian of this mission. But navigating this field requires fluency in its specific language. Here's a breakdown of 7 crucial terms every PV professional should understand in 2024, along with valuable resources to empower your journey:

1. Adverse Drug Reaction (ADR): Any unintended effect of a drug, regardless of severity or dosage. All ADRs are documented and evaluated for regulatory purposes.

• Reference: Council for International Organizations of Medical Sciences (CIOMS) I Working Group III: A glossary of terms used in pharmacovigilance. Br J Clin Pharmacol. 1999;47(2):835-7. PubMed: https://pubmed.ncbi.nlm.nih.gov/10434043/

2. Side Effect: An unintended but expected consequence of a drug at the recommended dosage. Side effects differ from ADRs as they are anticipated outcomes of the medication.

• Reference: Good Clinical Practice: E6(R2). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. November 2016. Available online at ICH website: https://www.ich.org/

3. Adverse Drug Event (ADE): Defined by the International Council for Harmonisation (ICH) as any unfavorable medical experience during a patient's medication use. Unlike ADRs, ADEs don't necessarily imply a causal relationship with the drug.

• Reference: International Council for Harmonisation (ICH) Guidance for Industry E6(R2) Good Clinical Practice: ICH Topic E6. Available online at ICH website: https://www.ich.org/

4. Serious Adverse Event (SAE): A severe medical reaction to a drug at any dose, including life-threatening situations, hospitalization, disability, or birth defects. PV professionals assess reported events to determine if they meet SAE criteria.

• Reference: ICH Topic E6(R2) Section 4.8 Definitions and Abbreviations. Available online at ICH website: https://www.ich.org/

5. Unexpected Adverse Drug Reaction (USADR): An ADR not previously documented in the drug's local labeling. If a USADR is also serious or life-threatening, it becomes a Suspected Unexpected Serious Adverse Reaction (SUSAR). These occurrences require prompt reporting to regulatory bodies by PV teams.

• Reference: Regulation (EU) No 1381/2007 of the European Parliament and of the Council of 20 November 2007 on the transparency of medicinal products for human use and amending Directive 2001/83/EC, Council Regulation (EC) No 2587/95 and Directive 2004/27/EC. Europa.eu website: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32007R1381

6. Signal Detection: A cornerstone of pharmacovigilance. PV professionals leverage data analysis tools to identify trends and deviations from expected patterns in drug safety data. Signals may indicate a new, potential drug effect, either beneficial or adverse.

• Reference: World Health Organization (WHO) Guidelines for Standardized MedDRA Coding and Use in Pharmacovigilance. WHO website: Although not directly related to signal detection, this is a relevant WHO resource: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

7. Causality Assessment: The process of determining the likelihood that a drug caused a reported ADE. This assessment helps PV professionals establish the level of association between the medication and the adverse event. Causality assessments can range from:

• Certain: There is clear and convincing evidence that the drug caused the ADE.

• Probable/likely: It is more likely than not that the drug caused the ADE.

• Possible: There is a chance that the drug caused the ADE, but other factors could also be responsible.

• Unlikely: It is improbable that the drug caused the ADE.

• Conditional/unclassified

In addition, if you want to be more qualified in the field of clinical research, you may want to consider getting certified in several key areas. A great starting point is the CCRPS’ online pharmacovigilance course, which helps new professionals improve their qualifications and gain expert insight in the field. This course is curated by real clinical research professionals and is flexible to your schedule.

If you’re aiming to further enhance your career, CCRPS offers a variety of specialized courses tailored to different roles within clinical research. Those interested in coordinating clinical trials might consider the Clinical Research Coordinator course. For those looking to oversee clinical trial conduct, the CRA (Clinical Research Associate) course is ideal.

Aspiring clinical trials assistants who support clinical research sites can benefit from the Clinical Trials Assistant Training. If you are pursuing leadership roles in clinical research projects, the Advanced Clinical Research Project Manager Certification might be the right choice.

For physicians who wish to lead clinical studies, the Advanced Principal Investigator Physician Certification can provide the necessary expertise. Furthermore, individuals interested in ensuring the safety and efficacy of clinical trials may find the Medical Monitor Certification extremely useful.

Finally, to stay compliant with international standards in clinical research, consider our ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) course, which is crucial for anyone involved in global clinical research.

To explore these courses and learn more about how they can enhance your career in clinical research, please visit our website at CCRPS.Org.