In order to improve the work when conducting clinical trials in healthcare institutions, it is necessary to facilitate the work of study staff, especially study nurses and technicians who play a significant role in the work of teams and make a significant contribution. Due to the large volume of work they have in standard practice and clinical studies, and also due to their weak/insufficient knowledge of the English language – we recommend that the sponsor/CRO translate the documents listed below into Serbian. This documentation should not be submitted initially to the Agency and the EO, nor later through any amendments or administrative notifications. All of the above will greatly facilitate and accelerate the work of study nurses.

  1. Protocol (tabular presentation of study procedures, SoA eng.): in addition to the synopsis translated into Serbian, it is also necessary to translate a tabular presentation of the schedule of procedures/activities per study visit.
  2. Pharmacy Manual: due to the possibility of delegating procedures related to the study drug to study nurses (receiving drug shipments, reconciliation, dispensing and administering the drug, maintaining temperature logs), provide the center with a Pharmacy Manual in Serbian. This would be a great advantage if the drug needs to be prepared before administration (in the case when the drug is not a tablet).
  3. Laboratory Manual: it is not necessary to translate the entire lab manual, but below are the parts of the manual that we believe would be useful to translate into Serbian. This could be in the form of some kind of Leaflet.
  4. Overview of the Requisition Form and instructions for completing it
  5. Tabular presentation of all types of samples that are collected. Important information can include which requisition form is used: a list of visits at which the sample is collected; which tube is used (e.g., a stopper of this and that color); instructions for processing the sample (is it necessary to incubate, centrifuge, rotate, …); conditions for storing the sample before sending; conditions for sending the samples.

The above documentation mentions the Pharmacy Manual and Laboratory Manual, which are not part of the submitted study approval packages. However, it is recommended that the CRO advise/influence the sponsor, or the appropriate vendor, to translate this documentation into Serbian in order to prevent frequent protocol deviations caused by insufficient reference to technical terms in English by study nurses/technicians.