About the Center
About the Center
In accordance with the Korean Good Clinical Practice (KGCP) and international Good Clinical Practice (ICH-GCP) guidelines, the Future Life Science Research / Clinical Trial Center at St. Peter's Hospital will demonstrate the safety and efficacy of pharmaceuticals, health functional foods, medical devices and other products scientifically and ethically through human application trials.
The paradigm of national healthcare policy is shifting from treating disease to preventing it. As geriatric conditions increase with population ageing, and as adult diseases — that is, lifestyle diseases — such as hypertension, diabetes, hyperlipidemia, arteriosclerosis, obesity, fatty liver, degenerative arthritis and malignant tumors caused by excessive stress and poor exercise and eating habits become more common, demand for health functional foods for self-management is rising sharply.
In step with this trend, the Future Life Science Research / Clinical Trial Center at St. Peter's Hospital focuses on human application trials of health functional foods and medical devices, seeking to contribute to public health by playing a central role in demonstrating their safety and efficacy.
Director, Future Biomedical Research / Clinical Trial Center, St. Peter's Hospital Lee, Jung Yong
History
History
Directions
Directions
2633, Nambusunhwan-ro, Gangnam-gu, Seoul St. Peter's Hospital New Building, B2
Tel 1544-7522
Subway (Line 3 or Sinbundang Line) Yangjae Station Exit 4, walk straight 300m
Clinical Trial Center
Clinical trials include research on human-derived materials that uses specimens, personal health information, or records obtained from the human body, as well as tests or studies that confirm the safety and efficacy of drugs, medical devices, health functional foods and similar products after they are applied to the human body.
Future Biomedical Research / Clinical Trial Center organization chart
Clinical trial process flow
How to take part in a clinical trial
1. Participant recruitment notice
The investigator or sponsor places recruitment advertisements, by approved methods, using the participant consent form, information sheet, and recruitment notice approved by the Institutional Review Board, through mass media such as the Future Life Science Research / Clinical Trial Center website, hospital notice boards, the internet, and newspapers.
2. Application to join the trial
You can apply to take part on the website or by phone, or visit the Future Life Research / Clinical Trial Center in person.
3. Written informed consent
Before taking part in a clinical trial, you are given full information, decide voluntarily to participate, and then complete a written consent form. The investigator explains to you directly and in detail the purpose and methods of the trial, the expected efficacy and effects, the possible risks and anticipated adverse reactions, the fact that you may withdraw your consent at any time of your own free will, the fact that compensation and treatment will be provided should harm occur, and other matters necessary for protecting participants' rights.
4. Pre-study tests (screening)
This is the process of confirming eligibility for the clinical trial and usually takes about 2 hours. For accurate results, excessive exercise and alcohol should be avoided from 3 days before the screening test.
5. Trial participation
If you are found eligible for the clinical trial, you will take part in the trial itself. In accordance with the study protocol, the investigational product or health functional food is administered once or repeatedly, and blood or urine may be collected several times to evaluate the safety and efficacy of the investigational product; in some cases you will also receive admission instructions.
6. End of trial participation
Participation ends when the study period set out in the protocol is complete. If an adverse reaction occurs in a participant, participation may be discontinued at the investigator's discretion or at the participant's request, and appropriate compensation may be provided by the sponsor.
IRB
The Institutional Review Board (IRB) of St. Peter's Hospitalreviews all research involving human subjects and human-derived materials under the relevant laws, ensuring it is conducted in line with domestic and
international good clinical practice standards (KGCP), thereby
protecting the safety, rights and dignity of every participant in clinical research,
promoting their welfare and enhancing the reliability of human application studies.
Inquiries: 02-6200-3513 Contact: Do, Ji Ye djy3013@gmail.com
IRB Review Guide
※ Apply at least 2 weeks before the review date
| Full review | Expedited review |
|---|---|
| Last Thursday of each month | Every Tuesday |
Review procedure
Review fee
For study review fees, please pay the review fee together with the application form as shown below. Before paying the review fee, please complete the invoice issuance request form and send it to the coordinator's email.
(Do, Ji Ye djy3013@gmail.com 02-6200-3513)
| IRB Review Fees | ||
|---|---|---|
| Initial review | Sponsor-initiated trial (SIT) | KRW 770,000 (VAT included) |
| Investigator-initiated trial (IIT) | No funding: KRW 55,000 (VAT included) Funding under KRW 10 million: KRW 330,000 (VAT included) Funding of KRW 10 million or more: KRW 550,000 (VAT included) |
|
| Human-derived material research | KRW 55,000 (VAT included) | |
| Amendment review | All reviews | |
| Continuing review | All reviews | KRW 275,000 (VAT included) |
| St. Peter's Hospital: 1005-904-679401 (Woori Bank) | ||
Lee, Jung Yong Center Director
Doctor of Medicine / Anatomic Pathology specialist
St. Peter's Hospital Future Biomedical Research / Clinical Research Center
- Graduated from the Catholic University of Korea College of Medicine
- Visiting Research Professor, Lab of Pathology, NCI, USA
- Director, Microdissection Genomics Research
- Director, BK21 Biomedical Science Project Group
- Outside Director, Samsung Life Public Welfare Foundation
- General Director, Korean Society of Pathologists
- Full member, National Academy of Medicine of Korea
- Member, American Association for Cancer Research
- Former President, Society of Molecular Cancer
- Former President, Molecular Pathology Study Group
