This blog covers:
- Case booking procedure
- Detailed step-by-step explanation of the process involved in the case booking.
Table of Contents:
- What is Book-in of cases?
- Locate the source document
- Search for duplicates
- Key Takeaways
- Book-in and registration
- Things to consider before proceeding to data entry
- Conclusion
What is a Book-in of cases?
After collecting and validating cases in the pharmacovigilance process, the next step is to organise and prioritise the cases through a process known as “triage”.
Book-in is followed by triage, which is a process of pulling validated cases into a clinical database, ensuring that all relevant information is collected and properly stored, readily available for further steps of the process.
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.
“Initiating the book-in process is essential for managing inflows efficiently. While allowing the flow to proceed, it’s crucial to ensure that these flows do not overlap, as this can lead to complications.”
Search for source document
Prior to initiating the book-in process for a case in pharmacovigilance, it is important to ensure that the necessary source document(s) are available and review them to confirm that minimal 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
Minimum requirement to determine the book-in:
- Suspected drug/ Product name (Learn more…)
- Adverse event (Learn more…)
- Country of incidence (Learn more…)
- Brief patient information (Having at least one piece of information is beneficial in preventing duplicates)
Age or DOB
Initials
Patient ID
Gender - MRD/IRD – Manufacture Receipt Date/ Initial Receipt Date
- CRD/SRD – Central Receipt Date/ Safety Receipt Date
- A valid reporter
If any above crucial information is missing, an inquiry should be launched upon booking the case.
The image that is provided below is for your reference and it is sourced from the Argus Safety database.
Search for duplicates
It is the crucial step, Each & Every case booked in after the proper search of duplicates.
What are the duplicates?
Duplicates refer to instances where a record already exists in a database, even if it appears as a new case due to inadequate follow-up of previous records.
Due to greater awareness, stringent regulations, and multiple reporting sources, the phenomenon of duplicate reports is common. Every safety management software has a facility to identify and delete duplicates.
How to find duplicates?
To begin, input the product name, event, and country of incidence, then click search. This will gather all relevant cases of data based on the information provided.
For example, 50 cases may appear. From there, filter down to the least amount by adjusting the relevant data available in the source document.
As there are many possibilities, new information may have added or some information may be missing from the previous report, or it may be a new event.
Additionally, it may also be a new drug administration or a new event with a pre-existing patient.
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.
How to Handle Duplicate Entries?
Managing duplicates is not necessarily a complex task, but it does add to the workload of the booking team or booking personnel.
- Upon confirming the case as a duplicate, begin merging all the information.
- Provide a justification for closing the case as a duplicate, referencing the duplicate case numbers.
- Keep the initially booked case and discard the duplicate.
- Send an email to the relevant authority informing them of the impending case closure.
- Direct the case for deletion.
Book-in and registration
After completing the duplicate search, proceed with the book-in process.
Two ways of proceeding book-in 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.
In certain critical cases, it may be necessary to merge them by sending an inquiry and taking into account the medical professional’s advice, in order to ensure compliance with the submitting timeline.
Things to consider before proceeding to data entry
- Ensure that the correct MRD/IRD and CRD/SRD entered.
- Confirm that the appropriate source document attached.
- Make sure to note in the information section any inquiries that have sent.
- Include the date of the most recent book-in in where the source document attached.
- Ensure that the suspected drug and event is matching with the source.
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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.
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