These are few of the questions raised by Webinar audience regarding Literature automation module (LAM) of Sarjen’s PvNet and their appropriate responses
1) Can we integrate the cases into different safety databases?
Yes, it is possible in LAM to integrate cases (ICSRs) into different safety databases
2) Is there a limit to amount of data that the system can hold since many articles can be quite large?
The system is time-tested and can hold numerous data on a daily basis as few hundreds of article are generated per molecule, per client and keep on adding to the database of LAM
3) What literature databases can be searched using LAM? Is it only PubMed?
LAM can be made compatible to different databases and is not only restricted to literature search in PubMed
4) If you execute a weekly PubMed search, how do you specify the date criteria?
PubMed has options for settings in which we can specify the search interval as weekly along with an option for selection of day i.e., from which day we want the database to begin weekly search
5) How many users in an organization can use LAM simultaneously?
There is no limit for number of Users for LAM. Any number of Users can work on LAM and the system operates with optimal speed
6) When we click “Create case”, does the case reference number automatically update in LAM?
As per the webinar presentation (please see the Webinar Videos page on Website for more information and screen shots), on clicking ‘Create Case’ button, the literature ICSR safety report id is created in the Sarjen’s PvNET database and the safety report id will be displayed in LAM, specifically in audit trail of literature article for which case has been created.
7) If any literature information is updated, is it accessible to other users?*
As LAM is 21CFR Part 11 compliant, it maintains audit trail for each User activity. Hence, all details till last User (with date, time and remarks, if any) will be viewed in audit trail to other Users working on same set of literature articles
8) Is LAM fully compliant with 21 CFR 11 and EU Annexure 11?
LAM is fully compliant to 21CFR Part 11 and EU Annexure 11
9) Will it (database) automatically capture data from article?
Mandatory information and some other important details for case creation will be entered in LAM by the primary reviewer after reviewing the literature and on creating a case, all these basic details will be auto-directed in case processing
10) What format is sent to the safety system? is it pdf or are there elements that are provided in e2b format?
At first, the respective data fields show literature data/information as entered in LAM. The format in safety system/database is created after entering requisite details of case as in approved literature. The case (created from literature source) can be submitted to Regulatory as E2B XMLs, in CIOMS or MedWatch formats.
* NOTE: Question reframed for better interpretation
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