The second article provides additional details regarding the responsibilities of the parties involved in clinical trials and the most important aspects associated thereto.
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Turkey has published a new regulation on clinical trials intended to set forth rules and requirements about clinical studies carried out to collect additional data which is necessary to assess the safety and effectiveness of medical devices when used in the clinical environment. The document prescribes, inter alia, the spheres of responsibilities of sponsors of a clinical trial, as well as of other parties involved.
Responsibilities of a Sponsor
First of all, it is important to mention that for the regulation, a sponsor of a clinical trial stands for an entity that has initiated the study and, consequently, remains to be the main responsible party. According to the regulation, a sponsor should be responsible for all operations with the medical device including storing, delivery to the examination site, deployment, technical maintenance, repair, calibration, collection of unused products, and their return upon completion of the study. All the above mentioned actions should be duly documented, and all the records should be kept by a sponsor. At the same time, receiving a medical device, its storing and operations with remaining devices are falling within the scope of responsibility of a chief investigator of the appropriate examination site.
In the case of medical devices that do not have a CE marking, additional permission from the authority should be obtained to import such devices in the country.
Should the clinic study be temporarily suspended due to safety reasons, all medical devices intended for investigational use should be immediately withdrawn by a sponsor, and the latter should duly inform the authority about this within 15 days via the electronic system. The report to be submitted should contain information about the medical device seized, as well as about other measures taken.
Insufficient Changes and Notifications
The regulation also prescribes the way a sponsor should notify the authority about the insufficient changes to a clinical trial, as well as notification rules to be followed in such cases. For instance, a chief investigator is allowed to include in the group the investigators from other institutions, provided the authority will be notified accordingly.
The reports should be submitted to the authority on an annual basis. However, the ethics committee or the authority are entitled to request the report to be provided within the shorter term, should be reasonably necessary, or in case of short-term trials.
The sponsor remains to be solely responsible for submitting all the notifications promptly.
Delegating and Sharing Responsibilities
Under the applicable legislation, a sponsor is also allowed to assign some of its responsibilities to a specific examination institution, provided there is a written agreement in place, and all the actions are taken by scientific principles and good clinical practice. At the same time, such an assignment does not reveal a sponsor from being responsible for the matters assigned, including administrative and criminal liability. The sponsor and the contracted institution would be jointly responsible for the results of actions taken by the agreement. Written agreements between sponsors and subcontractors should be submitted to both the ethics committee and the authority when applying for permission for the trial. In case the contracting entity is based outside Turkey, an authorized representative should be duly appointed.
Extraordinary Safety Measures
The regulation also pays special attention to the measures that should be taken to ensure the safety of study participants. Should such measures be applied, a sponsor shall duly notify the authority no later than seven days from the date these measures were implemented. It is important to mention that such measures should be taken without undue delay.
Liability
According to the regulation, a sponsor should bear financial liability concerning the study. However, in certain cases, a legal representative of a contracted examination entity or investigation group could be found liable as well.
A study participant should not be asked to pay for any product subject to assessment and used in a clinical trial, any materials necessary to use these products, or any other procedures undertaken in the course of a clinical study.
Information about all clinical trials should be entered into a generally accessible database, provided that the personal data of market participants is kept confidential.
Additional Aspects
The present regulation also contains a “Miscellaneous” section which addresses various matters related to clinical trials and the responsibilities of the parties involved. In particular, the regulation outlines the responsibilities of advisory boards and ethics committees, as well as of institutions involved in the investigation process.
As prescribed by the regulation, the applications for clinical trials or applications for significant changes should be submitted to an ethics committee first, and then to the regulating authority. At the same time, some other applications should be submitted to the authority and an ethics committee simultaneously. Such applications include:
- Notification on termination, temporary suspension, or early termination of clinical trials;
- Notification on an adverse event;
- Notification on the seizure of a medical device subject to review from the institution engaged in an investigation;
- Notification on insignificant changes to the clinical trial;
- Notification on events subject to reporting;
- Notification on extraordinary safety measures implemented by a sponsor as described hereinabove.
The regulation also emphasizes the importance of ensuring compliance with the applicable regulatory requirements in terms of studies conducted in the country or abroad, investigators, examination sites, sponsors, their authorized representatives, and scientific institutions engaged as contractors, sites where the manufacturing facilities or laboratories are based. All the parties involved could be inspected by the authorized bodies to verify compliance with these requirements.
Apart from this, the regulation provides references to the applicable legislation which sets forth the basics from criminal liability for the parties involved and describes the way they should be applied.
In summary, the present regulation describes in detail the requirements to be applied concerning clinical trials carried out to assess the safety and performance of medical devices when they are used for their intended purposes in the intended use environment (clinical settings). The document specifies the obligations and responsibilities of all the parties involved in clinical studies including study sponsors and third parties that could be engaged to perform certain functions.
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