The new article clarifies the regulatory requirements related to record-keeping and reporting in the context of clinical trials.
Table of content
The New Zealand Medicines and Medical Devices Safety Authority (MedSafe), a country’s regulating agency in the sphere of healthcare products, has published a guidance document dedicated to various aspects associated with medical devices intended to be marketed and used in the country. In particular, the document addresses the matters related to clinical trials to be conducted in order to assess the actual effectiveness and safety of medical devices before placing them on the market.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers, study sponsors, and other parties involved in order to ensure compliance. At the same time, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Preservation of Records
As explained in the guidance, clinical trial records must be carefully preserved in accordance with the CHMP Good Clinical Practice (GCP) guideline and additional New Zealand-specific requirements. The applicant or sponsor is responsible for ensuring that all study records and data related to New Zealand trial participants are retained, with full compliance with New Zealand’s privacy laws, including the Privacy Act 1993 and Health (Retention of Health Information) Regulations 1996.
Key points include:
- Records may be stored by the principal investigator or another designated person, with the sponsor holding information on the location and the responsible individual.
- Records may be stored overseas if they comply with New Zealand legislation and remain accessible.
- Records must be kept for at least 10 years after the study concludes.
Reporting Adverse Events
In accordance with the applicable regulatory requirements, adverse reactions to unapproved medicines used in clinical trials must be reported to Medsafe. Reporting requirements differ slightly from the CHMP GCP guideline, with only serious adverse events occurring in New Zealand participants requiring expedited reports to Medsafe.
Investigators are required to report adverse events as specified in the trial protocol to the sponsor. Sponsors must maintain reports of all worldwide SUSARs (suspected unexpected serious adverse reactions) but are not required to routinely send these to Medsafe.
These records must be accessible and available to Medsafe upon request. Serious adverse reactions to approved medicines used in clinical trials should be reported to the Centre for Adverse Reactions Monitoring (CARM), following the procedures outlined in New Zealand’s pharmacovigilance guidelines.
Furthermore, sponsors must report all life-threatening SUSARs occurring in New Zealand trial participants to Medsafe within seven days of receiving the investigator’s report. Follow-up reports are only necessary if significant new information arises.
Other SUSARs that are not fatal or life-threatening do not need to be reported to Medsafe but must be maintained in an accessible form.
Notifying Medsafe of Actions Related to an Investigational Medicine
It is also stated that Medsafe must be informed within seven days if an investigational medicine used in a clinical trial is withdrawn from development, the market, or if a study is terminated due to adverse events. This includes temporary halts for safety reasons in overseas studies that are also being conducted in New Zealand.
Study Reporting Requirements
According to the guidance, there are a few categories of reporting set forth under the existing legislation, namely:
- Amendments to the Trial: Any changes to the trial protocol or essential documents, such as investigator brochures, must be notified to Medsafe. Changes to trial sites or investigators require prior approval, and all relevant details must be kept up-to-date on the approval letter.
- Study Progress Reports: Sponsors must submit progress reports to Medsafe every six months, starting six months after the trial’s approval, even if recruitment has not commenced. Reports are required until the New Zealand arm of the trial is completed.
- Final Report: Upon trial completion, a final report must be submitted to Medsafe. Before the End of Trial report is available, a “Notification of Conclusion of the Study” should be submitted. A synopsis of the final report should be sent once the global trial concludes, with the full report kept on record and available upon request.
All reports, amendments, and applications related to clinical trials should be submitted through the online clinical trial application system. In case of technical difficulties, submissions can be made via email to the Clinical Trial Coordinator.
Conclusion
In summary, the relevant section of the present document issued by Medsafe provides comprehensive guidance on the meticulous handling, retention, and reporting of clinical trial records and adverse events, ensuring full compliance with both international standards and New Zealand-specific requirements.
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