The Severance Hospital in Sinchon, Seoul, and Yongin Severance Hospital in Gyeonggi Province received administrative punishment for failing to keep the patient consent protocol.
Asan Medical Center also received the government’s warning due to a delayed report on the unexpectedly significant drug adverse event during a trial.
The Ministry of Food and Drug Safety on Tuesday gave a respective warning on the two clinical trial directors, each at Severance Hospital in Sinchon and Yongin Severance Hospital.
According to the Article 34 of the Pharmaceutical Affairs Act, clinical research head must explain to a test subject about details of the study and procedures for an indemnity for any harm that may be inflicted on the patient during the trial. The study head must also obtain the patient consent under the clinical trial management protocol.
A clinical study director must provide participating patients with all information related to the study, before their participation, and obtain a voluntary consent including signature and the signing date. A person in charge of documents should keep the consent form.
The ministry’s investigation revealed that the two hospitals did not abide by the rules.
The government ordered Yongin Severance Hospital to suspend the trial for three months and replace the clinical research director, with an administrative warning. The study director at Severance Hospital in Sinchon also received a warning.
Asan Medical Center’s clinical trial director received a government warning for belatedly reporting a significant drug adverse event.
During a study on Lixiana (ingredient: edoxaban) at the hospital, a patient discontinued the treatment due to the significant, unexpected adverse event. However, the hospital delayed the report of the case.
If an unexpected and significant drug adverse event occurs during a trial, the study director should promptly report it to the food and drug safety ministry. If the patient stops the treatment, the director should also explain the reason with the report.
Meanwhile, Asan Medical Center said it conducted a clinical trial on Lixiana (ingredient: edoxanban) and reported unexpected adverse events to the Ministry of Food and Drug Safety. The patient is enrolled in the control group, not the Lixiana group, and now continues to participate in the clinical trial.
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