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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Clinical trials in Sweden require authorisation from the Medical Products Agency.
An application is primarily assessed by experts at the Medical Products Agency. Generally, such assessment is made within 30 days. The applicant may amend the application in respect of any unclear points identified during the preliminary assessment. If no unclear points are identified, authorisation is granted. If unclear points remain after the amendment is provided, the application may be dismissed. In general, the turnaround time for an application does not exceed 60 days.
How robust are the standard good clinical practices followed in your jurisdiction?
According to the Provisions on Clinical Trials of Medicinal Products for Human Use issued by the Medical Products Agency, the person in charge of clinical trials must have relevant knowledge and training in good clinical practice (GCP). GCP must be applied. The Medical Products Agency has the authority to conduct inspections to ensure compliance with GCP.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
According to the Provisions on Clinical Trials of Medicinal Products for Human Use, the holder of the authorisation must notify the Medical Products Agency and the ethical board that the clinical trial has been finalised. Such notification must be given within 90 days of finalisation of the clinical trial. If the clinical trial is suspended before finalisation, the holder of the authorisation must inform the Medical Products Agency and the ethical board within 15 days, using EU common forms in electronic format. In addition, there are requirements for reporting during clinical testing.
No later than 12 months after the clinical trial has been finalised, a comprehensive report must be submitted to the Medical Products Agency.
What are the informed consent obligations with respect to clinical trial subjects?
According to the Medicinal Products Act, consent must at all times be obtained from a clinical trial subject, the subject’s guardian or a trustee. Such consent may be withdrawn at any time with immediate effect.
What are the insurance requirements for clinical trials?
The sponsor must ensure that all trial subjects are covered by insurance or guaranteed adequate financial protection by other means.
What data protection issues should be considered when conducting clinical trials?
The Personal Data Act applies to the processing of personal data in connection with clinical trials. Clinical trials normally involve the processing of health information, which is regarded as sensitive personal data. The processing of sensitive personal data normally requires express consent from the individuals concerned. However, it may be possible to justify the processing of sensitive personal data without consent if this has been approved by an ethics committee. The individuals concerned shall also be informed regarding the processing of their data. The information to be provided must include:
- the identity of the data controller;
- the purpose of the processing; and
- any other information necessary for the individuals concerned to protect their right to privacy.
The following general data protection requirements should also be considered:
- Personal data must be adequate, relevant and non-excessive in relation to the purpose of the processing.
- Personal data must not be processed for any purpose that is incompatible with that for which the information is collected.
- Adequate security measures for the protection of personal data must be implemented.
- Data processing and data transfer agreements may be necessary.
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