This blog covers:
- What constitutes an investigation by report
- Investigations as valid adverse events based on defined criteria
- Special conventions for coding investigations as adverse events
Table of Contents
Introduction
If you’re involved in case processing, you’re likely aware that investigation records can sometimes be classified as adverse events or part of the medical history.
This blog, we discuss this topic with a focus on helping beginners understand the nuances, including some important coding conventions for capturing significant investigation findings as adverse events.
Reporting laboratory tests is a hallmark of a well-documented case report. It should include relevant therapeutic measures as well as baseline laboratory data.
Understanding Investigations Data Within ICSR Sources
In ICSR reports, investigations are not limited to routine blood tests or laboratory values. They encompass a broader range of diagnostic procedures, including:
- Physical or anatomical investigations
- Psychiatric evaluations
- Dermatological (skin) assessments
- Investigations involving special senses (e.g., vision, hearing)
It’s important to note that not all investigation results will contain numerical values—yet, they can still be highly relevant. Any type of investigation and its outcome can be considered significant enough to be coded as an adverse event, depending on the context and relevance.
A complete ICSR should include:
- Relevant laboratory findings, along with reference (normal) ranges
- Any supporting or refuting evidence related to the suspected adverse reaction
- Results of tests and procedures that helped diagnose or confirm the reaction/event
- Investigations conducted to rule out non-drug-related causes, such as serologic tests for infectious hepatitis in suspected drug-induced hepatitis
Both positive and negative results are important and should be documented in the ICSR to ensure comprehensive evaluation.
“Laboratory investigations are the silent detectives of medicine—unveiling truths the eyes cannot see and guiding decisions that save lives.”
Investigations Become Adverse Events
All significant investigation values should be captured under the Adverse Events section—even if they are not explicitly reported as adverse events in the source document.
While all investigation results are applicable for database coding, only significant findings—values that are not within the normal range (either elevated or decreased)—should be considered valid adverse events. However, this does not apply to investigations conducted in the past, which are generally part of the medical history unless deemed otherwise.
It is essential to report:
- Relevant laboratory evidence, including normal reference ranges
- Any additional data that supports or refutes the suspected adverse reaction
The section titled “Results of tests and procedures relevant to the investigation of the patient” should be completed thoroughly. Additionally, the relevant data elements should be repeated wherever applicable to ensure consistency and completeness in the ICSR.
All relevant laboratory tests and investigations should be documented in the narrative section of the ICSR.
MedDRA coding conventions
- To code an investigations results wit MedDRA, most of the investigations that probably falls under an SOC as investigations
- Must be coded as reported as investigation result
- Investigation reports must be coded as ainvestigations as SOC, i should not be considered as an condition of patient until it reported diredctly by the investigatr as condition of the patient.
- For example: if the report you found it has abnormal level f blood glucosw either increased or decreaed must be coded as it “blood glucose level increased or decreaesed” instead of condition diabtes mellitus.
When coding investigation results using MedDRA, it’s important to note that most investigation-related terms. Here are key points to follow:
- Investigation results must be coded appropriately as referring investigation, reflecting the specific test outcome.
- These results should be coded under the SOC ‘Investigations’, and not interpreted or classified as a clinical condition unless the investigator has explicitly reported them as such.
Example:
If a report indicates blood glucose levels—whether increased or decreased—it should be coded as “Blood glucose increased” or “Blood glucose decreased”, not as “Diabetes mellitus”, unless diabetes is specifically mentioned as a diagnosis by the reporter.
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Conclusion
This article aims to provide clarity for beginners on how to assess and code adverse events derived from investigation results. Remember, any abnormal value from investigative results may be considered an adverse event, depending on its clinical relevance and context.
If you believe we’ve missed any important points or if there are areas of uncertainty, please feel free to share your feedback—we’d love to hear from you.
If you found this article helpful, we’d appreciate it if you shared it with your colleagues and professional network. Let’s spread awareness and strengthen understanding together!
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