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Regulation Of The Minister Of Health The Number 66 By 2013

Original Language Title: Peraturan Menteri Kesehatan Nomor 66 Tahun 2013

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vision of the execution Clinic Research Regwives in accordance with their respective tasks and functions.

Section 17
(1) The coaching and supervision as referred to in Article 16 is directed to improve, develop, and advance the quality and amount of Clinic Research.
(2) The coaching and supervision as referred to in paragraph (1) is exercised through:
a.   advocacy and socialization;
B.   Monitoring and evaluation.

Section 18
(1) In conducting coaching, the Minister may provide administrative sanction of a written reprimand to the managing institution of clinical research and/or clinical research researchers who do not perform registri.
(2) In the event of a written reprimand as referred to in paragraph (1) not to be inked, the Minister may make an announcement written on national and international scientific journals and send to the organization/association of Indonesian health research profession To do the coaching of professwork.
(3) The announcement as referred to in paragraph (2) contains a research notice of non-regated clinic.

BAB IV
CLOSING PROVISIONS
Section 19
The rules of this minister are valid 1 (one) year since promulgated.
In order for everyone to know it, order the invitational of the Minister's Regulation with its placement in the News of the Republic of Indonesia.

Set in Jakarta
on October 31, 2013
HEALTH MINISTER
REPUBLIC OF INDONESIA,

HEY, HEY, HEY, HEY.

Promulgated in Jakarta
on November 12, 2013
MINISTER OF LAW AND HUMAN RIGHTS
REPUBLIC OF INDONESIA,

AMIR SYAMSUDIN


nesian health researchers ' profession.
B.   have obtained the Clinical Trial Implementation Agreement (PPUK) of the Drug and Drug Control Board for drug clinic tests, biological products, traditional medicine, cosmetics, food supplements/healthcare that will be marketed in Indonesia; and/or
c. has obtained a material transfer agreement (material transfer agreement) for the delivery of the specimen in accordance with the provisions of the laws applicable to the Research of the Clinics after consideration for the sake of the Program. National interests require the delivery of specimens abroad.
(2) The research ethics commission as referred to in paragraph (1) letter a is a research ethics commission already listed on the National Commission of Health Research Ethics.

The Second Part
Registri Status Stage
Section 8
(1) The clinic research regime is carried out in 3 (three) status stages as follows:
a.   Initial stage;
B.   Recruitment stages; and
C.   Rampung up.
(2) The initial paragraph of the paragraph (1) of the letter (1) is the stage of the completion of all the preparation of the research, as 7 verses (1)
(3) The Rehire of the Cloud Service is defined as the following:
(4) The completion of the completion of the term (1) of the letter c is the stage since the end of the recruitment of research subjects until the completion of the study.

Section 9
In the event the Clinic Research is held for a term of more than 1 (one) year, then the registry is performed in the first year, and further research organizers must convey the clinic's ongoing research status.

Section 10
(1) Each stage of the regWife status contains data and information set out as Set Data in accordance with the degree of implementation of the Clintons Research.
(2) Each Set of Data as referred to in paragraph (1) must be filled, furnished, and signed by the managing chairman of the Research Clinic.
(3) Certain data and information contained in the Data Set, for the benefit of the Rights of the Intellectual Property may be kept secret by the conduct of the clinic research by providing a confidential code according to the rules. Applicable laws.
(4) The details of Set Data and the charge of Set Data as referred to in paragraph (1), paragraph (2) are listed in the Attachment which is an inseparable part of the Regulation of this Minister.

The Third Part
Proof of RegWife
Section 11
(1) Every research clinic that has been regated is given a clinic research registry number as a proof of registri.
(2) Any registry number as referred to in paragraph (1) applies only to 1 (one) clinical research title.

Section 12
The process of the RegWife Research Clinic is not levied on charges.
Section 13
Non-regal clinic research cannot be published in recognized national and international scientific journals recognized by the Ministry of Health.

The Fourth Part
Clinic Research Managing Oblicity
That Has To Have The Number Of RegWife
Section 14
Managing Research Clintons who have had the RegWife's Research Clinic number have the following obligations:
a.   carry out the research of the Clinics as per ethical approval and comply with the provisions of the applicable laws;
B.   Maintain the quality of the research clinic;
c. provide or facilitate the hosting of the External Quality Assessment System (s); and
D.   Perform a renewal of the stage status of the execution of the Research Clinic and the development of information regarding changes

The Fifth Part
Access the Clinic Research RegWife System
Section 15
The information obtained from the Data Set on the Clinic Research Wife System is accessible to the public in accordance with the provisions of the applicable laws.

BAB III
COACHING AND SUPERVISION
Section 16
Minister, Head of the Agency, Head of Provincial Health Service, Head of District Health/City, health care research research organization, head of clinic Research organizers, and related agencies conducting the coaching and superistry against clinical trials.

Section 3
The Settings of the RegWife Research Clinic aims to:
a.   protect the public from unaccountable and transparent research results;
B.   protecting the subjects of the Clinic Research
c. provide Clinic Research information that results can be utilized for health development;
D.   provide number, type, form, and research steps of the Clinic, including its protocols;
e.   enhance the harmony and transparency of information hosting research between government, society, and researchers.

BAB II
ORGANIZING THE CLINIC ' S RESEARCH REGISTRY
The Kesatu section
General
Section 4
(1) An