Healthcare and Life Sciences Legal Update - July 2018
Ministry of Health Regulations –
Reporting and Monitoring Safety Information during Clinical Trials Procedure
On June 14, 2018, the Department for Clinical Trials within the Israeli Ministry of Health (“MOH“) issued Procedure 164/01 (the “Procedure“). The Procedure will enter into effect on January 1, 2019 and will replace Chapter 13 in the Clinical Trials Procedure of the Pharmaceutical and Enforcement Department within the MOH. The Procedure specifies guidelines for documentation, monitoring and reporting of Serious Adverse Events (“SAE“) occurring during the trials, and relates to other safety matters.
The requirements specified in the Procedure are supplementary to all existing requirements within the trial protocol or pursuant to international guidelines regarding safety updates. The Procedure applies to tested products, which are either not registered in the State of Israel, are registered in Israel and are being tested for uses other than those registered (off-label), or are tested in order to acquire additional information regarding the labeled use (post marketing trials).
The following major matters are covered by the Procedure:
Principal Investigator’s Obligations:
The Principal Investigator (“PI”) is required to record all Adverse Events that occurred to any of the participants in the trial. The PI is required to evaluate the seriousness of the event and assess the connection between the Adverse Event and the trial product.
The PI is further required to report to the Sponsor and to the Institutional Ethics Committee (“Ethics Committee“) in cases of SAEs (including SAEs which are not death or life-threatening events).
The PI must include within the report a summary of all safety-related changes and findings. Furthermore, the summary should include the impact on the information that is given to the trial participants (whether already recruited or to be recruited in the future). In cases where due to the new findings, the consent forms need to be updated, the new information that will be included in the updated consent form, shall be included in the reports.
The Procedure requires the Sponsor to follow international guidelines for a continuous evaluation of the trial product safety, and to ensure proper documentation of all safety events. Furthermore, the Sponsor is required to assess the seriousness of the relevant event, the connection between the event and the trial product, and to examine whether the event was anticipated (in accordance with its severity and frequency) given the existing information. The Sponsor’s evaluation must be carried out independently from the PI conclusions. The Sponsor is required to record the PI and the Sponsor’s own conclusions in cases of disagreement between the PI and the Sponsor.
The Procedure further regulates the Sponsor’s reporting obligations to the PI and the MOH in cases SAEs (including SAEs which are not death or life-threatening events) and other with respect to other safety related matters.
The Ethics Committee’s obligations:
The Ethics Committee is required to examine and evaluate all received safety reports, in order to decide on the continuation of the trial and the manner of updating the trial participants. The Ethics Committee is required to examine the effect on the safety of the participants and the possible effect on the informed consent process.
In cases of disagreement between the PI and the Sponsor regarding the classification of a SAE as a Suspected Unexpected Serious Adverse Reaction, the Ethics Committee may receive additional information from the Sponsor and shall then decide on the continuation of the trial. In the event that a trial status changes, the Ethics Committee is required to notify the MOH.
In addition, the Procedure regulates the Ethics Committee’s reporting obligations to the PI or the MOH in cases of death, other SAEs and other required reports received by the PI.
For additional information please contact your GKH attorney or one of the following Adv. Hili Cohen, partner and head of life sciences department (Hili@gkh-law.com) or Adv. Tami Fishman, partner (Tamif@gkh-law.com)
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