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Among the main novelties in clinical trials are
the following:
Transfer of ethics approval/supervision functions from
the Central Ethics Committee to LECs. The updated
regulation prohibits conducting clinical trials on a site where LEC
is not established.The list of documents to be submitted for LECs
review became shorter: no detailed information on investigational
products, as well as no liability insurance contract and related
documents have to be filed any longer. However, these documents are
obligatory for submission to the State Expert Center. The positive
change is that the Amendments eliminated duplication of the
mentioned documents review by both ethics and regulatory
authorities.
New requirements to contractual framework between study
participants. The Order allows sponsors (CROs) to
establish contractual relations with both medical institution and
investigational team members (first of all with
investigators).
Study subjects personal data protection. The
Informed Consent shall include the study subject's (his/her
legal representative) consent to personal data processing according
to the Law of Ukraine "On Personal Data Protection".
GMP Confirmation regarding Manufacturer of
Investigational Medicinal Products. The Order extends the
list of documents confirming GMP compliance of investigational
products manufacturers: Ukrainian GMP certificate issued by the
local GMP inspectorate (based on either inspection or documental
confirmation for PIC/S countries) may be filed to prove the GMP
compliance.
Filing additional information about
co(sub)-investigators. While filing application and
related documents for approval of a study, CVs of
co(sub)-Investigators (in addition to investigators CVs) shall be
submitted whenever involvement of healthcare professionals with
different specialization is required for the purpose of the
study.
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