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Julian Brooks
Julian Brooks

A Practical Guide to Writing CIOMS V Narrative Templates for Adverse Events Reporting


What is a CIOMS V narrative template?




If you are involved in pharmacovigilance, you may have heard of the term CIOMS V narrative template. But what does it mean and how can you use it? In this article, we will explain what a CIOMS V narrative template is, why it is important to use it, how to use it, what are some challenges and limitations of using it, and how to overcome them.




Cioms V Narrative Template



A CIOMS V narrative template is a standardized format for reporting adverse events (AEs) or suspected adverse drug reactions (ADRs) that occur during clinical trials or post-marketing surveillance of drugs or vaccines. It was developed by the Council for International Organizations of Medical Sciences (CIOMS) Working Group V on Current Challenges in Pharmacovigilance in 2001.


The purpose of using a CIOMS V narrative template is to provide a clear, concise, and consistent description of the case that includes all the relevant information for assessing causality, severity, frequency, and preventability of the AE or ADR. It also helps to facilitate communication and comparison among different stakeholders involved in pharmacovigilance, such as sponsors, investigators, regulators, health professionals, patients, and consumers.


Why is it important to use a CIOMS V narrative template?




Using a CIOMS V narrative template has several benefits for pharmacovigilance. Some of them are:



  • It ensures that all the essential data elements are captured and reported in a logical and coherent manner.



  • It reduces ambiguity and confusion that may arise from using different formats or terminologies.



  • It enhances the readability and comprehensibility of the narratives for different audiences.



How to use a CIOMS V narrative template?




To use a CIOMS V narrative template, you need to follow some general principles, understand the key components, and look at some examples.


General principles




Here are some guidelines for writing clear, concise, and consistent narratives using the CIOMS V template:



  • Use plain and simple language that can be understood by a non-expert reader.



  • Avoid jargon, abbreviations, acronyms, and symbols that may not be familiar to the reader.



  • Use standard medical terminology and coding systems (such as MedDRA) for describing the AE or ADR.



  • Use chronological order and logical sequence for presenting the information.



  • Use active voice and third person perspective for writing the narrative.



  • Use past tense for describing events that have already occurred and present tense for describing current status or ongoing events.



  • Use punctuation, capitalization, and spacing appropriately to improve readability.



  • Check spelling, grammar, and accuracy of the information before submitting the narrative.



Key components




A CIOMS V narrative template consists of four main elements:



  • A brief summary of the case that includes the patient identification, the drug(s) involved, the AE or ADR, and the outcome.



A detailed description of the case that includes the following information:


  • Patient characteristics: such as age, gender, weight, height, race, ethnicity, medical history, concomitant diseases, allergies, etc.



  • Drug exposure: such as name, dose, route, frequency, duration, indication, start and stop dates, batch number, etc. of the suspected drug(s) and any concomitant drug(s).



  • AE or ADR description: such as onset date, duration, severity, seriousness, outcome, treatment, recurrence, dechallenge and rechallenge results, etc. of the AE or ADR.



  • Laboratory tests and other investigations: such as results of blood tests, urine tests, imaging studies, biopsies, etc. that are relevant to the AE or ADR.



  • Causality assessment: such as the method and criteria used for assessing the causal relationship between the drug(s) and the AE or ADR.




  • A company comment that provides a clinical evaluation of the case and highlights any important or unusual features.



  • A list of references that support the information provided in the narrative.



Examples




Here are some examples of narratives using the CIOMS V template:



Example 1Example 2


nitroglycerin, and streptokinase. He recovered and was discharged after 5 days. The investigator considered the AMI to be possibly related to Drug X. The company comment stated that this was the first report of AMI associated with Drug X and that further investigation was warranted.A 65-year-old female with a history of rheumatoid arthritis and osteoporosis experienced a fracture of the left femur after taking Drug Y 5 mg once daily for 6 months for osteoporosis. She was admitted to the hospital and underwent surgery to repair the fracture. She also received calcium and vitamin D supplements. She recovered and was discharged after 10 days. The investigator considered the fracture to be unlikely related to Drug Y. The company comment stated that this was a known complication of osteoporosis and that there was no evidence of increased risk of fracture with Drug Y.


What are some challenges and limitations of using a CIOMS V narrative template?




Although using a CIOMS V narrative template has many advantages, it also has some challenges and limitations that need to be considered. Some of them are:



  • It may not capture all the nuances and complexities of a case that may be relevant for causality assessment or signal detection.



  • It may not accommodate all the variations and specificities of different types of AEs or ADRs, such as those related to vaccines, biologics, herbal products, etc.



  • It may not reflect all the updates and changes that may occur in a case over time, such as new information, corrections, amendments, etc.



  • It may not be compatible with all the electronic systems and databases that are used for storing and transmitting narratives.



  • It may not be feasible or practical to use it for all cases, especially those that are very simple or very complex.



How to overcome these challenges and limitations?




Best practices




To overcome these challenges and limitations, some best practices can be followed when using a CIOMS V narrative template:



  • Use professional judgment and common sense to adapt the template to the specific needs and circumstances of each case.



  • Use additional or alternative formats or tools when appropriate, such as tabular summaries, graphical displays, causality algorithms, etc.



  • Use consistent and transparent methods for updating and revising narratives as new information becomes available.



  • Use standard data exchange formats and terminologies (such as ICH E2B) for ensuring interoperability and compatibility among different systems and databases.



  • Use a risk-based approach for prioritizing and selecting cases that require a narrative using the CIOMS V template.



Resources




To help you use a CIOMS V narrative template effectively, you can refer to some resources that provide more information and guidance on this topic. Some of them are:



  • The original report of CIOMS Working Group V on Current Challenges in Pharmacovigilance: Pragmatic Approaches, which contains detailed explanations and examples of the CIOMS V template.



  • The CIOMS website, which contains other publications and resources related to pharmacovigilance and drug safety.



  • The ICH website, which contains guidelines and standards for clinical safety data management and reporting.



  • The WHO website, which contains guidance and tools for pharmacovigilance systems and activities.



Conclusion




and limitations that need to be overcome by using professional judgment, common sense, and additional or alternative formats or tools. There are also some resources that can provide more information and guidance on how to use a CIOMS V narrative template effectively.


FAQs




Here are some frequently asked questions and answers about the CIOMS V narrative template:



  • What is the difference between a CIOMS V narrative template and an ICH E2B format?



  • An ICH E2B format is a standard data exchange format for transmitting individual case safety reports (ICSRs) electronically among different stakeholders involved in pharmacovigilance. It contains a set of data elements that are structured and coded according to predefined rules and terminologies. A CIOMS V narrative template is a standardized format for writing the narrative section of an ICSR, which is a free-text description of the case that summarizes and complements the data elements. Both formats are complementary and compatible, and can be used together for reporting adverse events or suspected adverse drug reactions.



  • How long should a CIOMS V narrative be?



  • There is no fixed rule or limit for the length of a CIOMS V narrative, but it should be as concise as possible while providing all the relevant information for the case. A general recommendation is to keep the narrative within one page or less, unless there are exceptional circumstances that require more details.



  • How can I learn more about pharmacovigilance and drug safety?



  • There are many sources of information and education on pharmacovigilance and drug safety, such as books, journals, websites, courses, workshops, conferences, etc. Some examples are:



  • The International Society of Pharmacovigilance (ISoP), which is a professional association that promotes pharmacovigilance and drug safety worldwide.



  • The Uppsala Monitoring Centre (UMC), which is a WHO collaborating centre that provides scientific leadership and operational support for pharmacovigilance and drug safety.



  • The Drug Safety Research Unit (DSRU), which is an independent academic unit that conducts research and education on pharmacovigilance and drug safety.



I hope you found this article helpful and informative. If you have any questions or feedback, please feel free to contact me. Thank you for reading.



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