Buy a high-quality English version of the latest Guidelines for Korean Good Clinical Practice (KGCP) in an easy-to-read, two-column format.
1. Save money.
The Korean government publishes good English translations of many official documents. To date, they have not done so for the Guidelines for Korean Good Clinical Practice. Hiring a high-quality, custom translation of this document would cost many thousands of dollars. Because I resell this translation to multiple buyers, I can give you an extremely competitive price for the work.
2. Get a high-quality product.
You’re not buying a cut-rate job; this translation is based on many years of experience in the field, including my work on countless clinical trial documents. Rest assured that the translation will meet your needs. (Scroll down to review the first page of the translation!)
3. Receive the translation today.
Hiring someone else to translate this document would take at least a week, probably longer. However, my translation is ready now, and I can send it to you today.
4. Stay up to date.
If the Korean Ministry of Food and Drug Safety publishes an amended version of the Guidelines for Korean Good Clinical Practice within two years, I will send you the updated translation for free.
The purchase price licenses you to unlimited use of the translation within your company.
Check with me as well if you need translation of another Korean public document. I’ll quote for an exclusive work-for-hire translation or possibly also a heavily discounted price for licensed use.
Framework for clinical studies in Korea
The ethical, legal, and institutional framework for clinical studies in Korea is based on three major documents.
1 The first document is the Pharmaceutical Affairs Act (약사법).
An official English translation of this law can be downloaded at no charge from the Korea Legislation Research Institute website.
2 The second document is the Rules on the Safety of Pharmaceutical Products, Etc. (의약품 등의 안전에 관한 규칙; also abbreviated as Pharmaceutical Product Safety Rules (의약품안전규칙)).
It is not easy to find the official English translation of this document, but it does exist. I would be glad to email it to you at no charge. Contact me if you want a copy.
3 The third document is the Guidelines for Korean Good Clinical Practice (KGCP, 의약품 임상시험 관리기준).
The Ministry of Food and Drug Safety has not made an English translation of this text available, but you can get it from me here today.
Format of my English translation of the Guidelines for Korean Good Clinical Practice
I personally translated this English version of the Guidelines for Korean Good Clinical Practice, doing so in an easy-to-read, two-column format. This makes the translation particularly convenient to use in a bilingual setting for discussion and cross-referencing.
Here is the first page:
Content of the Guidelines for Korean Good Clinical Practice
I will provide you with a complete translation of the 45-page Guidelines for Korean Good Clinical Practice, which includes the following articles:
Article 1 – Purpose (목적)
Article 2 – Definitions of terms (용어의 정의)
Article 3 – Basic principles of clinical studies (임상시험의 기본원칙)
Article 4 – Scope of application (적용범위)
Article 5 – Clinical study contracting and institutions (임상시험의 계약 및 임상시험실시기관)
Article 6 – Independent review board (임상시험심사위원회)
Article 7 – Investigators (시험자)
Article 8 – Clinical study sponsor (임상시험 의뢰자)
Article 8-2 – Supporting organizations (지원기관)
Article 9 – Storage and viewing of supporting documents, etc. (기본문서의 보관 및 열람 등)
Article 10 – Surveys, etc. (실태조사)