Terms Glossary

I

INVESTIGATING CENTER:

The institute responsible with organizing and practically conducting a study.

INFORMED CONSENT:

Form by which a subject voluntarily confirms his (unconstrained) written permission to participate to a certain study, after he received the relevant information regarding all the aspects of the study (important and sufficient) in order that the subject to decide his inclusion into that study.

INCLUSION CRITERIA:

Set of requirements necessary for the selection of subjects, required by the study protocol.

INVESTIGATOR:

Medic (dermatologist and/or ophthalmologist, and/or dentist, and/or gynecologist) who is responsible for conducting the clinical study and for the synthesis of recorded data in a report. *
* definition is specific to the investigating center, according to the procedures

IDENTIFICATION TICKET:

A document handled to the subjects in the first day of each study, which contains the following information: study’s number, batch and the subject’s reference within the study. Subjects are identified at the reception desk with the help of this document, valid only during the study period.

M

MEDICAL EXAMINATION:

Medical evaluation summary of the subject by which the doctor performs a brief history of the personal/familial physiological and pathological antecedents, as well as the frequency of using cosmetics, thus assessing the adequacy of the health of the subject to the inclusion criteria in different types of studies.

O

OPEN TEST:

Test for checking the skin’s compatibility after open applications, in controlled and very close to normal conditions of use.

P

PASSED FOR PAYMENT TICKET:

Document issued by the responsible technician from the Technical Compartment proving that the subject has participated in all the study, respected the constraint and can receive the allowance; therefore the allowance can be cashed only on the basis of this ticket.

PAUSE:

The rest period, the period of unavailability to participate in other studies; its duration will be communicated by the recruitment compartment.

PANEL:

Group of subjects selected according to the inclusion and non-inclusion criteria corresponding to test study, as they are described in the study protocol.

PERSONAL DATA:

Confidential information regarding the subject’s identity: name, surname, contact data, medical data, psychological data, etc.

PSYCHOLOGICAL EXAMINATION:

Psychological evaluation summary of the subject which aims to establish the degree of risk for inclusion in the database, the ability to understand the information and to comply with the instructions provided in writing or verbally by the investigating center staff; this is performed by a psychologist.

PROTOCOL STUDY:

This document describes the principle objectives, methodology, conditions for the realization of the study, the instruments, the analysis of the statistics of the results, together with any amendments; the study of protocols is validated by an internal or independent Committee of Ethics, in order to ensure the protection of the rights of subjects.

R

RANDOMIZATION:

The process of distribution of the study subjects in groups for treatment or control by using a hazard element which will reduce the possibility of influencing the study’s results by an systematic error.

RECRUITMENT:

Inclusion of the subjects in the database in order to select them for different types of studies.

S

SAMPLE:

The quantity of product being tested; the samples are being weighed before and after use and they will be used only for the ongoing study.

STUDY CALENDAR:

The individual schedule of the subjects’ visit to our center, provided at the beginning of the study.

STUDY REFERENCE:

A unique code assigned to a study. It consists in the year and the chronological number.

STUDY PROTOCOL:

Document describing the principle, the objectives, the methodology, the conditions for achieving the study, the instruments, the statistic results analysis, as appropriate, together with all the eventual amendments; the study protocol is validated by an internal or independent ethics committee, in order to ensure the protection of the subjects’ rights.

SPONSOR:

A person, a company, an institution or organization which assumes the responsibility of starting the management and/or the financing of a clinical study.

STUDY CALENDAR:

The individual schedule of the subjects’ visit to our center, provided at the beginning of the study.

SUBJECT IDENTIFICATION CODE:

The modality of encoding the subjects’ identity in order to protect their personal data.

STUDY PROTOCOL:

Document describing the principle, the objectives, the methodology, the conditions for achieving the study, the instruments, the statistic results analysis, as appropriate, together with all the eventual amendments; the study protocol is validated by an internal or independent ethics committee, in order to ensure the protection of the subjects’ rights.

STUDY WITHDRAWAL :

Study interruption by a subject; the study withdrawal must be announced to the investigating center; if the withdrawal occurs from objective reasons, independents from the subject’s will, the subject will receive a financial compensation proportional with the study participation; if the withdrawal occurs from subjective reasons, the subject implicitly renounce at the financial compensation.

T

TECHNICAL COMPARTMENT:

The compartment that handles the technical execution of the studies.

TEST OPEN:

Test de verificarea a compatibilitatii cutanate, dupa aplicari deschise, in conditii experimentale controlate foarte apropiate de conditiile normale de utilizare

U

USE:

Verifying the acceptability and/or the assessment of the cosmetic qualities and/or efficacy of a cosmetic product after repeated applications in very close to normal conditions of use.