인체적용시험 가이드라인(영어 번역본)I. Glossary
1. An “in vivo investigation” refers to an investigation or research (hereafter referred to as “investigation”) on human bodies conducted to confirm clinical effects and investigate potential negative side effects with the purpose of verifying safety and efficacy of a cosmetic.
2. “Well-being of the trial subjects” refers to the physical and mental wellness of the trial subjects participating in the investigation.
3. “Applicable regulatory requirements” refer to the cosmetics legislations and related notifications pertaining to the execution of an in vivo investigation.
4. A “subject” or a “trial subject” is a participant of the investigation to whom test product (material) or comparator product (material) is applied. However, it excludes mental patients as dictated by Article 3(1) of the Mental Health Act, persons with skin disease in the area where the test material should be anointed or sprayed as determined by a dermatologist, and persons who cannot understand written information.
5. A “protocol” refers to a document including all revisions that describes the purpose, method, range and execution plan for the investigation.
6. An “informed consent” refers to a procedure in which a trial subject is provided all the information related to the institution through an Explanatory Document for a Trial Subject (henceforth referred to as “document for subject”) and confirms that he voluntarily chooses to participate in the investigation (henceforth referred to as “consent”) with a document signed and dated (henceforth referred to as “consent form” prior to determining whether to include the trial subject to the investigation.
7. “Confidentiality” refers to allowing only those who are authorized to directly access the data to have access to personal details of trial subjects and intellectual properties of the sponsor.
8. The “director of an Institution” refers to the person who has the privileges and official responsibilities for the organization and functions of the institution.
9. “Quality assurance” refers to the supervision of an investigation or an institution and other procedures conducted to verify the reliability of the investigation results.
10. A “principal investigator” refers to the person who bears overall responsibility of the operation and execution of an investigation.
11. An “investigator” refers to a principal investigator, a chief investigator or a sub-investigator.
12. A “chief investigator” refers to a person responsible for the delegated matters from a principal investigator of another institution in case an investigation is conducted by multiple institutions. However, a principal investigator cannot delegate responsibilities such as approval of a protocol or its revisions, approval of the final report and matters related to supervision of execution following investigation procedures to a chief investigator.
13. An “institution” refers to the persons, buildings, facilities and operation units required for an investigation.
14. “Standard operating procedures (SOPs)” refer to the documents that describe in detail evaluation procedures, execution method, etc. in order to execute matters for which the protocol or investigation guideline does not offer detailed guidance using standardized methods.
15. A “comprehensive investigation schedule” refers to the overall investigation plan that enables an institution to trace each investigation process and gain information necessary to evaluate workload.
16. A “comparator” refers to the material compared with the test product or material.
17. A “sub-investigator” refers to a person who takes responsibility for matters related to investigation under the delegation and supervision of a principal investigator or determines necessary matters.
18. A “test product” or a “test material” refers to the material (henceforth referred to as “test material”) that is the object of an investigation.
19. A “test location” refers to the location where an investigation is conducted.
20. “Raw data” refers to a record, a document or its copies that records the observations and proceedings of an investigation. Raw data may include photographs, microfilms, microfiche, devices readable by a computer, spoken recordings of observations, printouts from automated devices or other storage devices deemed capable of maintaining information until the end of the investigation.
21. A “sponsor” refers to the person who requests an investigation study to an institution.
22. A “negative side effect” refers to an undesirable and unintended result observed of a trial subject who applied a test material. It may not necessarily have causal relationship with the corresponding cosmetic.
23. A “diluting agent” refers to a material used to mix, disperse and dissolve a test material or a comparator when a material, not a product, is used for an investigation. It is used in order to facilitate the application of the test material or comparator to a trial subject.
24. A “lot number” refers to numbers, characters or symbols designated to enable confirmation of all matters related to the production and maintenance of a test material or a comparator.
25. “Randomization” refers to a procedure that randomly distributes each trial subject to a group to decrease potential bias during an investigation.
26. “Blinding” refers to a procedure that keeps the information about designated treatment away from persons or groups participating in an investigation. The generally used single blinding involves blinding only the trial subjects, and double blinding involves blinding trial subjects, trial conductors, monitors, and if necessary, data analysts, etc.
27. A “subject identification code” refers to unique identification code that a principal investigator assigns to each trial subject. It is used in place of the name of the trial subject when the principal investigator is reporting negative side effects or other data pertaining to the investigation.
28. A “case report form (CRF)” refers to a printed or electronic form that records information about trial subjects as dictated by a protocol in order to be handed to a sponsor.
29. An “investigation start date” refers to the date when a principal investigator signs a protocol.
30. An “investigation end date” refers to the date when a principal investigator signs a final report.”
31. A “lot” refers to a unit amount of a test material or a comparator that is manufactured uniformly using an identical production process. |
