Ethical and Regulatory review

    Necessary approvals of the Trial Protocol, the Patient Information and Informed Consent Form (ICF) must be obtained before enrolment of any patient into the trial. Furthermore, it is the responsibility of the Sponsor to keep the applicable Independent Ethics Committee (IEC) informed of any Suspected Unexpected Serious Adverse Reactions (SUSARs) and any substantial amendments to the protocol during the trial period. The written approval from the IEC, including a trial identification and the date of approval, will be filed at the Sponsor representative and at the trial site(s) together with a list of the IEC members, their titles or occupation, and their institutional affiliations.


Ethical conduct of the trial

   The trial will be performed in accordance with the recommendations guiding physicians in biomedical research involving human patients that were adopted in 1964 by the 18th World Medical Assembly, in Helsinki, Finland, with later revisions.


Patient information and consent

     It is the responsibility of the Investigator to give each patient (or the patient’s legal representative), adequate verbal and written information regarding the objectives and the procedures of the trial as well as any risks or inconvenience involved before including the patient in the trial. The patient (or the patient’s legal representative) should be informed that by signing the ICF he/she authorizes monitor(s), auditor(s), the IEC and the Regulatory Authorities (RA) to have direct access to the patient’s medical records for verification of clinical trial procedures. The patient must be informed about the right to withdraw from the trial at any time. The patient should be allowed sufficient time for consideration of the proposal. It is the responsibility of the Investigator to obtain signed informed consent from all patients before including them in the trial. The ICF must be signed and dated before any trial-specific procedures are performed, including screening procedures. The signed ICFs must be filed by the Investigator for possible future audits and/or inspections. The final version of the Patient Information and ICF is submitted to the Ethics Committee(s) and concerned RA and must not be changed without permission from the Sponsor and the local IEC.


Patient data protection

     The Investigator must file a patient identification list which includes sufficient information to link records, i.e. the Case Report Form (CRF) and clinical records. This list should be preserved for possible future inspections/audits but should not be made available to the Sponsor except for monitoring or auditing purposes.The patients will be informed that the data will be stored and analyzed by computer, that Swedish regulations for the handling of computerized data will be followed and that identification of individual patient data will only be possible for the Investigator. The patients will be informed about the possibility of inspections/audits of relevant parts of the clinical records by representatives of the Sponsor, and/or RA. Authorization to direct access to the patient’s clinical records, as described above, is given by signing the ICF.