The new article provides additional details regarding the new regulation on clinical trials for medical devices published recently in Turkey. In particular, the article addresses the matters related to the reports associated with clinical trials and also outlines the responsibilities of the parties involved.
Table of Contents
Turkey has recently published a new regulation that sets forth the requirements in the sphere of clinical trials performed concerning medical devices. The document prescribes the way clinical trials should be carried out to ensure the accuracy and reliability of the results, and the safety of all the participants thereto. The rules set forth by the regulation should be followed by medical device manufacturers, the parties responsible for clinical trials (study sponsors), and all the parties involved.
The new rules address, inter alia, the matters related to the documents and records related to quality control, such as test reports. According to the regulation, upon completion of a clinical trial, the appropriate report should be drafted by the sponsor. Moreover, the sponsor should duly maintain and keep the records related to the most important aspects of the trial including the following ones:
- Reports of quality conformity and quality control tests;
- Records of radioactive sources used in quality control and quality conformity tests;
- Reports of maintenance and repair activities;
- Records of monitoring and measuring devices.
The aforementioned records should be kept for five years in original and at least ten years in electronic scanned copies. The sponsor should be able to provide these records to the authority upon request.
Duties and Obligations
The regulation also outlines the responsibilities of all the parties involved in clinical trials, including study sponsors and conformity assessment bodies.
Concerning the responsibilities of conformity assessment bodies, the regulation states the following:
- All the tests covered by the authorization certificate should fall within the scope of respective regulations and be conducted by the applicable requirements;
- A conformity assessment body should have the necessary premises, equipment, and personnel to be able to conduct tests within the scope of its designation;
- All medical devices with measuring functions should be subject to special calibration;
- All personnel involved in operations related to radiation-emitting devices should be duly equipped with the necessary protective equipment and personal dosimeters, and also undergo the respective training;
- The procedures for quality assessment should be based on the applicable regulations, and also on the provisions of the respective international standards;
- A conformity assessment body should be able to provide all the records related to its activities, once requested by the regulating authority;
- When conducting operations with radioactive products, the appropriate regulations should be followed.
The regulation also outlines the responsibilities of a healthcare professional participating in a clinical trial. According to the document they include, inter alia, the following ones:
- Acting within the scope of the work certificate and by the applicable regulations;
- Preparing the reports describing the activities undertaken in the course of conformity assessment;
- Undertaking necessary training;
- Following special requirements when conducting operations with radioactive products.
The regulation, responsibilities, and obligations of healthcare institutions involved in clinical trials include, inter alia, the following ones:
- Ensuring that all the tests are performed by healthcare professionals having a valid certificate, and by the respective instructions;
- Ensuring the involvement of the conformity assessment body as prescribed by the applicable regulations;
- Following calibration procedures that are necessary to ensure the accuracy of the results provided by devices and equipment with measuring functions;
- Developing and implementing the internal audit plan based on the applicable regulatory requirements, with the audits to be performed once per year;
- Ensuring that all the necessary records and documents related to the trial are duly kept within the timelines prescribed by the applicable legislation;
- Ensuring the accuracy, confidentiality, and security of the data generated in the course of clinical trials.
Audit and Sanctions
The scope of the regulation also covers the aspects related to audits to be conducted to verify compliance with the regulatory requirements related to clinical trials, and also the administrative sanctions that could be imposed in case of non-compliances identified.
According to the regulation, the activity of a conformity assessment body should be subject to audits to be conducted on an annual basis. The latter should duly keep all the records and documents related to its activities as prescribed by the present regulation, and provide them to the authority for review upon request. It is important to mention that in case of an incident, the appropriate documentation should be provided to the authority no later than 10 business days from the date the incident occurred.
The regulation also outlines the scope of situations when the certificate of authorization of a conformity assessment body could be suspended by the regulating authority. This could take place if:
- Notification requirements are not properly followed;
- Records are not duly kept;
- A quality assessment conducted in a way that is not compliant with the respective regulations;
- Calibration of the devices and equipment with measuring functions hasn’t been completed in time.
The suspension based on the aforementioned reasons could last from 15 to 90 days. At the same time, should it be identified that the conformity assessment body does not have a specialist necessary to perform the appropriate testing for more than 15 business days, such a person should be duly appointed no later than 180 days. The same correction period applies to the issues related to the minimum hardware, software, and accessories required for quality conformity tests.
It is explicitly stated that a conformity assessment body is not allowed to conduct the respective activities during the suspension period. Should it fail to eliminate the issues creating grounds for suspension, the suspension should be continued for the same period. Should a conformity assessment body fail to remedy the aforementioned deficiencies within the said period, or the issue took place again within a year, the authorization certificate should be suspended for thirty days.
Apart from the restrictions to be imposed concerning an assessment body, the regulation also describes the actions that could be taken concerning a healthcare professional failing to perform the duties set forth by the applicable legislation.
In summary, the present regulation outlines the responsibilities of all the parties involved in clinical trials related to medical devices. Provisions of the regulation also prescribe the actions to be taken in case of such parties failing to obey the said requirements.
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