SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
2.4 Restriction on Using Online Tools to Support Clinical Trials No restriction exists on using online tools to support clinical trials. However, it is gener- ally required that clinical trials are to be con- ducted by doctors or hospitals with in-person interviews, and written informed consents from clinical trial subjects. Recruitment of clinical trial subjects can be conducted online. When a crisis alert level of serious magnitude or higher is declared, and if deemed necessary to protect patients, medical personnel, and medi- cal institutions from the risk of infection, the pro- tocols allowing provisional “untact” medical care (a term coined by a research team in Korea for non-face-to-face contact) under Article 49–3 of the Infectious Disease Control and Prevention Act may be implemented. This may apply to clinical trials, where the treatment for and moni- toring of patients during clinical tests may be converted to untact treatment and monitoring. 2.5 Use of Data Resulting From Clinical Trials The data from clinical trials is considered as personal and sensitive data and the institutions conducting clinical trials are subject to the Per- sonal Information Protection Act (PIPA) for the collection, use, provision, etc, of such personal and sensitive information. In addition, informa- tion with respect to the participant’s identity or sponsor’s intellectual property, etc, shall not be disclosed to third parties unless there is explicit permission granted to access that information. Further, in order to protect the clinical trial sub- jects’ identity, unique identity numbers need to be assigned to subjects instead of their name. When obtaining consent on the clinical trial from its subjects, the medical institution conducting the clinical trial must explain that the records
of subjects’ personal information will be kept confidential, stipulate the same in writing, and make it clear that such personal information shall be maintained confidential even if results of the clinical trial become publicly available. It further needs to inform that the records relating to clinical trial including the subjects’ medical record can be accessed by the sponsor’s moni- toring agent or inspector through an institutional review board (IRB) of the medical institution, and that the MFDS may also access and review such information and relevant materials. 2.6 Databases Containing Personal or Sensitive Data In addition to the requirements described in 2.5 Use of Data Resulting From Clinical Trials , according to clinical trial management stand- ards, such database needs to have a security system which prevents unauthorised persons from accessing the information, and matters as prescribed by the chief of MFDS for proper man- agement of electronic records must be complied with. The sponsor also has to use identifier code for clinical trial subjects. 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices Under Article 2 of the PAA, “drugs” are defined as those other than quasi-drugs, among the articles listed in the Korean Pharmacopoeia, or articles, other than appliances, machinery or equipment, used for the purposes of diagnosis, treatment, alleviation, care or prevention of dis- eases of human beings or animals, or used for the purpose of exerting pharmacological effects
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