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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Clinical trials for pharmaceutical products are regulated by the Regulation on Clinical Trials of Pharmaceuticals and Biological Products, together with several guidelines published by the Pharmaceuticals and Medical Devices Agency regarding specific topics. In order to undertake a clinical trial, ethics committee approval must first be sought, as well as agency authorisation where necessary. The authorised representative of the sponsor in Turkey or a contract research organisation domiciled in Turkey and authorised by the sponsor can apply for ethics committee approval; if the committee discovers that the trial’s benefits are bigger than its possible risks, ethics committee approval is secured. It may later be necessary to apply to the agency with relevant information and documentation, including ethics committee approval, depending on the subject and subjects of the clinical trial. It is also possible to apply to the ethics committee and agency concurrently if preferred.
How robust are the standard good clinical practices followed in your jurisdiction?
Good clinical practice is mainly regulated by the Good Clinical Practice Guideline and various supplementary guidelines published by the Pharmaceuticals and Medical Devices Agency in different specific topics. Considering that the clinical trials may be conducted only at centres determined pursuant to good clinical practice, trial applications are prepared in line with good clinical practice. The main issues (ie, determination of the changes that require ethics committee and agency approval or that have informative values only) are regulated by the Good Clinical Practice Guideline. Good clinical practice is well adhered to in Turkey.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
Pursuant to the relevant legislation, clinical trials which are approved by the Pharmaceuticals and Medical Devices Agency will be registered in a publicly available database on the condition that confidentiality of personal data is protected. In order to perform such a registration obligation, the agency has created a website (http://kap.titck.gov.tr/). The information provided in this publicly available database for clinical trials on pharmaceuticals and medical devices includes the status, number, type and name of the clinical trial, as well as the names of the coordinator physician and coordinator centre. There is no mandatory requirement to publish clinical trial results.
What are the informed consent obligations with respect to clinical trial subjects?
While conducting a clinic trial, the subject’s consent is obtained confirming willingness to participate freely in a particular trial after having been informed of its nature. The trial subject’s consent is documented in written form, with informed consent forms that include informative matters (ie, the nature, purpose, significance, duration, conditions, implications and risks of the study) and indicate the subject’s right to withdraw from the trial at any time, as regulated by the Regulation on Clinical Trials of Pharmaceuticals and Biological Products. However, receiving informed consent forms does not eliminate the subject’s right regarding the retrieval of loss arising from the trial.
What are the insurance requirements for clinical trials?
Insurance procedures within clinical trials are regulated with the Regulation on Clinical Trials of Pharmaceuticals and Biological Products, together with a guideline published by the Pharmaceuticals and Medical Devices Agency. The insurance requirements and guarantees regulated in the said legislations are concerned with the clinical trial subjects participating in the trial and there is no explicit provision or regulation for insurance required for institutions and investigators. Even though a compulsory pecuniary liability insurance exists regarding medical malpractice for doctors, it does not usually include clinical trials.
What data protection issues should be considered when conducting clinical trials?
In addition to the regulations in the recently published Law on the Protection of Personal Data, the clinical trials rules also confer specific importance regarding the protection of the personal information of the trial subjects and provides several restrictions on the data to be accessed by different parties. Accordingly, the sponsors or contract research organisations can access trial data only for monitoring purposes, to the extent allowed by law. Accordingly, these rules specifically govern that neither the case report form nor the adverse event reports will include the identification of the trial subject.
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