Halt of audits, conversion of physical visits into phone, other updates – Ukraine MoH State Expert Center provides clarifications regarding clinical trials conduct in Ukraine under the circumstances of military aggression and martial law.
To the attention of clinical trial Sponsors/Sponsor’s representatives, investigators, chiefs of enterprises, institutions and organizations involved in clinical trials conduct.
As a result of military aggression of Russian Federation on the territory of Ukraine and implementation of the Martial Law as per President Order #64/2022 dd 24.02.2022, taking into consideration potential difficulties connected to execution of its authorities stipulated by Procedure on Clinical Trials in Ukraine approved by MoH order 690 dd 23.09.2009 (hereinafter-Procedure), State Expert Center provides to Sponsors the following recommendations:
- Sponsor should critically evaluate the feasibility to initiate new clinical trial, halt activation of new clinical trials, activation of new clinical trial sites or inclusion of new subjects to ongoing studies
- In case it is not possible to continue clinical trial at the approved site, to implement the procedure of patient withdrawal from clinical trial, or should this be possible –transfer such patients to other clinical trial sites since under current circumstances it is difficult to safeguard their rights, safety and health to the full extent.
- It is recommended to take all possible actions regarding uninterrupted provision of patient IMP at site and compliance with study protocol by all parties to ensure patients safety under conditions of Martial Law
- To notify on all protocol deviations which concern patient safety as well as on other aspects of clinical trial in accordance to clauses of Procedure
- It is reasonable that notifications on above mentioned are provided by e-mail (email@example.com), original hard copies may be provided later, once possible and if necessary.
- Additional separate notifications regarding start of military aggression of Russian Federation for all clinical trials should not be submitted by Sponsors to SEC/MoH and Ethics Committees of the Healthcare facility, to avoid redundant communication.
- In case of limitation of patient movement, the following actions should be considered, where possible:
a) Conversion of physical visits into phone or video visits (telemedicine methods), re-scheduling or cancellation of visits if needed.
b) In case it is not possible to obtain initial informed consent (hereinafter IC) of potential subject or updated written IC of study subject due to movement restrictions, study subject may provide consent verbally in the presence of impartial witness. In such cases impartial witness should sign and date the ICF, whereas investigator should document in source medical file how impartial witness has been selected (Article IV point 1.2 of Procedure).
c) Moreover, there can be a situation when patient and person obtaining consent are signing and dating separate ICFs. In any case, all related records regarding such procedure should be stored in investigator site file at clinical trial site. Later, once it becomes possible, signed and dated ICF from patient should be obtained in ordinary manner as soon as possible. Sponsor should evaluate IMP related risks and consider any alternative methods of organizing IMP delivery with complying to storage conditions set by manufacturer. IMP may be delivered to subjects by independent distributor, contracted by Sponsor, in those cases when it is possible as per study protocol and with detailed instructions from Sponsor to subjects available.
d) To consider an option to use site laboratories for patient examination, provided there are necessary contractual agreements and required technical possibility.
- In certain cases, in particular in COVID treatment/prophylaxis clinical trial or at the stage of interim or final data base locks, remote source data verification (SDV) is possible.
- To use recommendations “International ethical guidelines for health-related research involving humans” prepared by Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO), in particular Guideline 20. Research in Disaster and Disease Outbreaks”
- Any action taken in clinical trial should be conformed with Sponsor and agreed, if necessary, in a form of Substantial Amendment to SEC and approved by MoH of Ukraine.
- We additionally inform that conduct of planned clinical trial audits is halted.