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.

Given that the new version of the GCP guideline (ICH GCP R3) comes into force on 23.07.2025. members of study teams participating in clinical trials should complete training on the new version of the guideline in the period until the end of 2025. This notification is based on the fact that there are no substantial differences between version R2 and version R3. ICH GCP R3 elaborates on certain parts of the guideline and clarifies them in a detailed and pragmatic way.

In relation to possible cyberattacks, the Agency draws special attention to the following:

If such situations develop, we expect affected sponsors, based on the information received (e.g. from CROs, investigators) and their own subsequent investigations, to assess whether the security breach falls within the sponsor’s legal responsibility to report a serious non-compliance, as prescribed in the Regulation on Clinical Trials of Medicinal Products in Human Medicine (Article 26, item 23, Serious breach) and, if confirmed, to report it immediately. The breach report must be updated regularly if new significant information is received.

If the attack concerns systems for which the investigator is responsible (e.g., an electronic health care system, a part of an eTMF to which the investigator has access, etc.), the investigator is expected to immediately notify the relevant sponsors to ensure that the affected sponsors can comply with the above-mentioned obligation to report a serious non-compliance.

Compliance with the obligation may be subject to future inspection.

According to applicable local regulations as well as the Good Clinical Practice (ICH GCP R2 and R3) there is no obstacle for the sponsor/CRO to use the services of a Site Management Organization (SMO) as service provider. The roles and relationships between the service provider and the investigator/institution/sponsor have been clarified in ICH GCP R3, which has further facilitated the work in clinical studies for this type of activity (points 2.3. and 3.6 of the guideline). The conditions for using SMO services in the Republic of Serbia are defined by the sponsor/CRO, institution and investigator (contracts, training, oversight, etc.), all in accordance with the relevant points of ICH GCP R2/R3, which has been adopted and is part of local regulations.

The instructions provided in the document with the title above in the subsection of the Agency’s website – Good Clinical Practice,GCP – (Clinical trials subject to US regulations) have the following specifications:

• cut off date – 30.04.2025. (date from which the change in the local procedure is considered)
• The transition period for adaptation intended for the CRO/sponsor is 2 months
• The date of the procedure change refers to the date of signing the FDA 1572, and not to the date of study approval
• Signed and used FDA 1572 for clinical trials after 30.06.2025. will be considered a finding (FDA 1572 dated after 30.06.2025.)
• From 30.06.2025., the change applies to both new studies and existing ones where updates to previously signed FDA 1572 are necessary