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