The Increasing PV Obligations of Scientific Literature

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3. Creating a scientific literature process

Following a decision on the type of database to be used and the search strategy,  consideration should be given to the details of the literature process such as;

• the screening process,
• implementing quality review checks to ensure that the primary reviewer is identifying the relevant articles,
• storage systems such as repositories,
• methods for the ordering of full articles, and
• the management of translations.

Once a process has been established it should be clearly outlined in an SOP.

4. Carrying out a testing phase

Initial testing should be conducted to check that relevant records are not omitted. Term selection should be relevant to the database used and the subject of the search and/or medicinal product. Recorded confirmation that the search results have been tested will assist in demonstrating that there is a systematic approach to collecting information about suspected adverse reactions from literature sources.

5. Are your staff trained appropriately?

It is expected that the person reviewing the results of a search is trained to identify articles of relevance. A common issue in selecting relevant articles from the results of a search is that often this process is conducted for the purposes of identification of ICSRs only. Whereas the review should also be used for collating articles of safety information, for example, to support PSURs. Having an appropriately trained team will mitigate the risk of missing important information. As literature is the one of the largest sources available for the collection of safety information it is crucial that careful planning is allotted to the development of an adequate process. If you would like to speak to us about issues relating to scientific literature or seek our advice then call us on 00353 52 61 76706, email us: info@acornregulatory.com or complete the form below and we will get back to you. [ninja_form id=1]