101: Effective Case Book-in Pharmacovigilance: A Step-by-Step Guide 🎟️

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This blog covers:

  1. Case booking procedure
  2. Detailed step-by-step explanation of the process involved in the case booking.

What is a Book-in of cases?

After collection and validating cases in the pharmacovigilance process, the next step is to organize and prioritize the cases through a process known as “triage”.

Book-in is a process followed by triage, which is a process of pulling the cases into a clinical database. To make ready the case for processing with all relevant details.

Notification: While perusing this blog, we also provide a complimentary checklist to enhance your ICSR case processing. Feel free to access it while navigating through the content.

Search for source document

A source document is essential for all cases, as cases will only be booked when the necessary sources are available. These documents should be reviewed to ensure that minimal valid information is present.

A valid case in pharmacovigilance is not only determined by the presence of an adverse event, but also by the availability of sufficient and accurate information that meets established criteria

πŸ“’ Recommendations: As you navigate through this content, take the opportunity to clarify any uncertainties between what are valid cases and invalid cases processing in pharmacovigilance.

Minimum requirement to determine the book-in:

  1. Suspected drug/ Product name (Learn more…)
  2. Adverse event (Learn more…)
  3. Country of incidence (Learn more…)
  4. Brief patient information (Having at least one piece of information is beneficial in preventing duplicates)
    Age or DOB
    Initials
    Patient ID
    Gender
  5. MRD/IRD – Manufacture Receipt Date/ Initial Receipt Date
  6. CRD/SRD – Central Receipt Date/ Safety Receipt Date
  7. A valid reporter

If any above crucial information is missing, an inquiry should be launched on booking the case.

The image that is provided below is for your reference and it is sourced from the Argus Safety database.

πŸ“’ Recommendations: I highly recommend reading an article closely related to this topic, which focuses on significance of receipt dates i.e, initial and safety receipt dates and discussions about sources.

Search for duplicates

Every safety database includes an option to search for exiting cases, accessible to anyone involved in the case processing workflow.

It is advisable for all case processors to conduct a duplicate search for every case, regardless of whether they are part of the book-in team.

The duplicate search function allows users to scan the entire database, enabling cross-verification of cases being processed.

Numerous fields can assist in identifying cases that may involve the same patient or duplicate reports.

For instance, effective searches can be conducted using key characteristics of a case, such as gender, age or date of birth, reaction, clinical trial protocol, country, and reference number.

This helps determine if the same report has already been recorded in the database. This step is vital for the further processing of the case, as a duplicate might provide follow-up information that could change the seriousness of the report.

Conducting a thorough duplicate search is a crucial step, ensuring that every case is booked in only after proper verification.

πŸ“’ Recommendations: I recommend reviewing our article for a detailed overview of the sources, impacts, and challenges involved by duplicates and secondly describing about identifying duplicates effectively.

Key Takeaways:

  • Searching for duplicates effectively can do by inputting the most relevant details one by one at a time.
  • Don’t overwhelm the system with all data at once. To find duplicates, filter and narrow down cases to zero before booking a new one.
  • To identify whether the same report has been databases previously or not.
  • Improper search can lead to more duplicate reports within the database.
  • Missed out duplicates could send misleading information to signal detection systems.

Book-in and registration

After thoroughly searching for duplicates, if none are identified or available, proceed with booking a new case.

Once the case processor has completed duplicate search for a case in database, there are two ways of processing a case. They are as follows:

  • Upon positive duplicate search, i.e., when the processor finds a case in the database, the processor can add a follow-up to the existing case and process the information
  • Upon negative duplicate search, i.e., when the processor does not find any case in the database, the case processor will create a new case to process the information.

If duplicates are found, thoroughly review the case and consider a follow-up.

In some instances, there may be one or more duplicates related to the current follow-up. You can merge all the information in to single master case. Before proceeding this action review completely and confirm it.

Things to consider before proceeding to data entry

  1. Ensure that the correct MRD/IRD and CRD/SRD entered.
  2. Confirm that the appropriate source document attached.
  3. Make sure to note in the information section any inquiries that have sent.
  4. Include the date of the most recent book-in in where the source document attached.
  5. Ensure that the suspected drug and event is matching with the source.

Download our freebie

Version: 1.0

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Conclusion

This step-by-step guide should provide clarity on the book-in process, ensuring we haven’t overlooked any crucial steps.

If you’re still unsure as a beginner, this guidance will be invaluable when you actually engage in the process.

Simply studying is not that beneficial, until you do practical implementation is key to understanding fully.

Feel free to comment your thoughts.

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.



Bala Avatar

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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Comments

4 responses to “101: Effective Case Book-in Pharmacovigilance: A Step-by-Step Guide 🎟️”

  1. […] triage and book-in the case into the database, the next step involves coding events and drugs. This process forms a crucial part of complete data […]

  2. […] πŸŽ‡ Recommendation: Where we detail discuss about part of case processing, i recommend checking our sophisticated category of articles where we discuss all about ICSR management and in particular about case book-in. […]

  3. […] Improper search and handling of duplicate cases (Learn more…) […]

  4. […] I recommend two of our existing articles that closely relate to this topic. First, there’s a step-by-step guide on the booking process in case management. Secondly, check out our comprehensive guide on linking cases within case […]

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