Health Product Regulatory Authority (HPRA) recommends some specific measures for the COVID-19 emergency.
Meditrial manages several studies in Ireland and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support.
The Authority has alerted the Department of Health which is the responsible body for ethics committees about the possibility of amendments relating to e.g. changes to a trial and/or sites, introduction of alternative site locations, and the possible need to suspend trials.
Priority will be given to any clinical trial applications relating to COVID-19, and/or amendments to existing studies as a result of COVID-19.
Where required, patient recruitment should be temporarily halted, or suspended.
Addition of a new trial site to the clinical trial would require amendment to the study application form and approval from the recognized ethics committee. However, urgent safety measures, where appropriate, can be taken without prior approval.
Any protocol deviations should be clearly documented.
In the current situation centralized monitoring is recommended alternative to the on-site.
The guideline will be continuously updated. For more details, please see the website.
Meditrial can help – Contact us for immediate support
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