You already know that working with the DrugCard electronic pharmacovigilance platform for literature monitoring is as easy as 1-2-3. The DrugCard platform team is constantly working on improvements to comply with GVP and GMP requirements fully. At the same time, we make the literature monitoring process as convenient as possible for our clients. Pharmacovigilance specialists work with tons of articles from the scientific and medical literature daily. Therefore, improving the article workflow is always at the head of the table. We have implemented an Article card for even faster and more traceable work with articles. Pharmacovigilance teams can now easily manage their weekly literature reviews using the Article card.
What is an Article card?
The Article card is a special page designed to detail the user’s actions with the article.
The functionality of Article Cards includes:
- Display of information about the found article (name of the source, year of publication, date of finding, keywords used for the search);
- Categorization and approval of categorization of articles;
- Links to full-text materials, including the DrugCard Spotlight function;
- Displaying the history of changes in categories and article statuses (search log entries);
- The ability to add a user note with the date/time of the last change.
User note – that’s the point
Regulators typically expect MAHs to review the scientific literature in three safety areas:
1) Individual case safety reports (ICSR), with an identifiable patient, reporter, suspect drug and adverse event;
2) information for periodic safety reports (PSUR) on the drug’s safety profile; and
3) new safety signals, which provide information on new adverse events.
Users can add notes to the found article after categorizing it. You can specify the details of the information found in the article for colleagues or the reasons for the decision to move the article to this particular category.
For example, the article contains a valid case of an adverse drug reaction. Please type in a short note, and your colleagues will see it. Or for instance, the information from the article will be valuable for the upcoming PSUR. Add a brief description of the information you found.
Full compliance with GVP and GMP
Of course, notes are optional and can be edited by users at any time. At the same time, the date/time and the user who made the last edit are recorded. Also, each article card has a history section. It details information about user actions with the article, and displays who and when categorized or approved the article categorization. The history section shows the records of the Search Log applicable to the article.
We improve the functionality and usability of the platform for our users. And there are many more exciting updates and improvements to the DrugCard platform ahead!
