Israel Ministry of Health facilitates clinical trials and allows study products delivery to patient homes during the coronavirus outbreak
Following the outbreak of the COVID-19, the Israeli government issued new guidelines to faciliate clinical research. Meditrial has translated the guidelines issues by the Medical Technologies and Infrastructure Administration for Sponsors, Investigators, Helsinki Committees and Hospital Directors. These guidelines are constantly changing as the situation in Israel evolves every day.
Meditrial manages studies in Israel. Our team is on the field with rapid access to investigators, hospitals, and authorities, to ensure that patients are receiving necessary help. Please feel free to contact us for advice and support.
Below are the Israeli Ministry of Health guidelines conducting and monitoring of clinical trials:
- Monitoring visits are not recommended in most of the hospitals and should be minimized to the minimum required; remote activities are preferred
- Study data continue to be entered into the eCRF and the queries answered
- Study drugs can be delivered directly to patient’s home, as well as investigational products may be delivered directly from the importer to the patient’s home with the condition that the investigational product provided is taken or used by the patient independently
- If a hospital/ department cannot carry out the study due to concern for coronavirus infection and the investigational product cannot be supplied to the patient’s home, the patients will be able to receive treatment at a different medical center or home in coordination with the Sponsor and the hospital director
- Protocol deviations due to the coronavirus outbreak are not considered as a violation
- Changes to the study protocol resulting from dealing with the coronavirus (such as virtual visit, digital activity, administrative or logistical changes) will be sent to the institutional committees as “notifications” without the need for approval.
Meditrial can help, Contact us now for free advice
Meditrial has developed rapid workflows to conduct a risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
