🏁 Case Processing: Initials and Follow-ups Explained

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This blog includes:

  1. Key Definitions
  2. Criteria for Classifying Initials and Follow-Ups
  3. How to Identify Initials and Follow-Ups

Table of Contents:

  1. Introduction
  2. Definitions
  3. Criteria of defining reports
  4. Identifying initials and follow-ups
  5. Key Takeaways
  6. Conclusion

Introduction

In adverse event reporting, each case often includes initial reports and multiple follow-ups.

This can lead often confusion, when trying to locate the report you are processing. This guide aims to clarify these terms and help you navigate through the complexities of reporting.

Definitions

Initials

Initial reports are the first submissions filed or registered for a specific adverse event. These reports can arise in two main scenarios:

  1. First-Time Reports: When an adverse event is reported for the first time concerning a particular patient.
  2. Separate Cases: Sometimes, a patient may have existing reports for other adverse events. If a an adverse event have enough to have as a separate case, it will be classified as an individual case, even if it stems from the same source as prior reports.

β€œInitial reports lay the groundwork; follow-ups build the understanding.”

Follow-Ups

Follow-ups are subsequent reports related to an existing initial report for the same patient and in the same case.

Why are Follow-Ups Necessary?

  1. Incomplete Information: Initial adverse event reports often lack comprehensive details.
  2. Supplementary Information: Follow-ups help gather additional data essential for a thorough scientific evaluation.
  3. Understanding Drug Safety: They contribute to a better understanding of drug safety and the implications of the adverse event.
  4. Patient and Reporter Details: Sufficient information about the patient and the reporter is critical at the time of the original report.
  5. Comprehensive Understanding: Follow-ups allow for a deeper understanding of the drug’s effects.
  6. Missing Information: They provide an opportunity to obtain any missing information related to the initial report.

Criteria

For Initial Reports

  1. The report is categorized as a new.
  2. No prior reports exist for the same event concerning the patient.
  3. Reports has to generate a fresh case for the particular adverse event.

For Follow-Up Reports

  1. There must be at least one existing report for the same patient concerning similar events.
  2. Any report generated after the initial submission is classified as a follow-up.
  3. Corrections or merging of cases do not imply as follow-ups.
  4. New reports for the same patient, whether related to similar or additional events, are considered follow-ups.

This guide aims to simplify the process of distinguishing between initial reports and follow-ups, ensuring clarity in adverse event reporting.

Identifying initials and follow-ups

Argus general tab
A yellow highlight appears: Case has been saved successfully .

Every database includes a designated section to identify cases as either initials or follow-ups.

This section differ the cases by the receipt dates of each reports, which can be helpful in locating the relevant sources.

Key Takeaways

Every case begins with an initial report that initiates follow-ups.

An initial report does not always indicate that it is the first case for that specific patient.

Reports are processed based on the date they are received.

Follow-ups indicate that there is at least one existing report for that case.

Existing cases or reports can be identified through linked cases.

Wrap-Up

The above write-up had provided you with a clearer understanding of these distinctions.

However, some key points may still be unclear to certain readers.

Hopefully, you’ve gained new insights from this article. This discussion aims to clarify initial and follow-up reports. If you feel any important details were overlooked, please share your thoughts.

Your recommendations and suggestions are always welcome!

References:
  1. ICH E2D guideline
  2. EMA – Good Pharmacovigilance Practice

Disclaimer: We write this blog based on our experience and extensive knowledge, supported by references. Please note that we are not responsible for the content on the referenced websites. If you come across any misinformation or misguidance or spelling mistakes, kindly inform us promptly.



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Meet Bala, the founder of Drugvigil, a service provider specializing in pharmacovigilance. He’s not only an expert in this field, but also a passionate entrepreneur who enjoys creating new opportunities and helping others grow. Despite starting from scratch, he’s determined to develop his company from the ground up. If you’re interested in his work, be sure to show your support and share his message with others.




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One response to “🏁 Case Processing: Initials and Follow-ups Explained”

  1. […] Difficulty in following up on spontaneous reports with incomplete details. (To learn more in detail..) […]

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