Sonia Mansoldo Dainesi, MD, PhD, MBA

Size: px
Start display at page:

Download "Sonia Mansoldo Dainesi, MD, PhD, MBA"

Transcription

1 Sonia Mansoldo Dainesi, MD, PhD, MBA Post-trial access to trial drugs: Legal, ethical and practical issues Brocher Founda-on, Geneva Dec th, 2011

2 Poten-al conflicts of interest São Paulo University / Medical School (HCFMUSP) Specialization: Endocrinology PhD: Public Health Pharma companies: Rhodia Farma Sandoz Aventis Boehringer Ingelheim (currently Medical Director) Former president of SBMF (Braz Soc of Pharmaceutical Medicine) University ( ): Clinical Research Support Center (HCFMUSP) Brazilian Network of Clinical Research (Ministry of Health)

3 Background Local legislation E- Survey on post- trial access in Brazil Final considerations

4 Background Continuous growing of Brazil participation in international clinical trials (as well as other developing countries) BR: Strong history in ethics, mainly in biomedical research National Ethics Commission on Research (CONEP) as second ethics approval of protocols, after the EC/IRB approval Thiers F et al. Trends in the globalization of clinical trials. Nature Reviews. Drug Discovery 2008; 7:13-4. CONEP:

5 Legisla-on Resolutions from National Council of Health (CNS, Conselho Nacional de Saude) Res. 196/1996 Res. 251/1997 Res. 404/2008 Current options Res. ANVISA 26/1999: Expanded Access (EAP) Study Extension Donation Program

6 Res. CNS 196/96 (general principleson biomedical research) III.3m: Assure that, whenever possible, the research in communities is translated into benefits whose effects continue to be present after the research is concluded III.3n: Research involving human beings shall comply with the following: guarantee the benefits of the research to the people and communities where research is carried out.

7 Res. CNS 196/96 III.3p: Research involving human subjects must ensure to research subjects the benefits resulting from the research project, be it in terms of social return, access to procedures, products or research agents.

8 Res. CNS 251/97 (new drugs) IV.1m: access to the medicine being tested must be assured by the sponsor or by the institution, researcher, or promoter in the event its superiority to the conventional treatment is proven.

9 Res. CNS 404/08 (DoH modificagons not accepted)...all research participants should be assured the access to the best methods identified by the study... DoH

10 OpGons currently available in Brazil 1) ResoluGon 26 (1999) - ANVISA: Expanded Access (EAP) hvp://www.anvisa.gov.br/legis/resol/26_99rdc.htm 2) Study extension (Follow- up study) hvp://www.anvisa.gov.br/medicamentos/pesquisa/extensao.htm hvp://conselho.saude.gov.br/biblioteca/livros/manual_ceps.pdf 3) DonaGon program hvp://www.anvisa.gov.br/medicamentos/pesquisa/doacao_medicamento.htm Or other clinical trial.

11 Law 6360 RDC 26/1999: Expanded Access Follow- up study Donation of study medication New product Not approved in the country Severe and life- threatening conditions Lack of therapeutic satisfactory options Protocol, CRF, Informed Consent Patients who benefit from treatment: optional continuity of treatment will be provided EC approval (and CONEP) together with the mother protocol Defined before the study initiation ANVISA recommends: Final report of the trial Medical report with the reasons for the donation Sponsor declaration: provide medication and continuous safety assessment

12 Since Multicenter International Clinical Trials If access to study medication after trial is not clearly stated in the protocols and informed consents, the trial is not approved by CONEP.

13

14 I. Identify the main issues on the continuity of study medication after trial end; II. Analyse the perspective of main players in clinical research on the topic.

15 Survey, with questionnaires sent through the internet ( ) Participants : 1. Clinical investigators (HIV/AIDS and DM) Identified through sponsors and 2. Members of ECs (Ethics Committees) As available at CONEP site (Feb 2009) 3. Sponsors Pharma companies and CROs established in Brazil 4. Research participants (patients) Questionnaires (paper & pen) through the clinical investigators

16 Mat & Met a) Non- probabilistic approach (convenience sample) b) Questionnaires Based in literature and adapted to current scenario (i) (ii) Three models: Clinical investigators Sponsors and EC members (iii) Research participants

17 Mat & Met c) Pilot assessment of questionnaires 2 lawyers with experience in clinical trials 2 members of ECs 2 clinical investigators 4 sponsors 1 assistant (lay people in research) Four domains: (i) Participants characteristics (ii) Informed consent (iii) Motivation (iv) Post-trial supply of study medication

18 Mat & Met Informed consent Questionnaire 3 weeks Mailing lists

19 Mat & Met EC (IRB) approval (Apr 2009; Aug 2009)

20 Sta-s-cal Analysis Data base Data base construction EpiData version 3.0 (2003) Validation Double entry, with validation Analysis Analysis: descriptive and non- inferential Absolute and relative frequency Significance level: 5% * Likert scale: Kruskal- Wallis test and, if necessary, non- parametric multiple comparisons * Non- Likert: Association (chi- square test or likelihood ratio test) * Verification inside each question: Friedman test, followed by non- parametric comparisons if necessary.

21 First Domain: Participants characteristiscs

22 Response Rate Questionnaires sent Questionnaires received Response Rate ECs ,7% Clinical investigators ,o% Sponsors ,3% Research participants NA (60-67% of responses arrived after first message)

23 Age and sex distribu-on Number of respondents Age (mean; range) ECs Sponsors Clinical Investigators Research participants (28-74) 40 (29-65) 53 (24-72) 49 (30-81) Sex Male (%) 54 (44,6%) 9 (37,5%) 37 (63,8%) 28 (51,9%) Female (%) 67 (55,4%) 15 (62,5%) 21 (36,2%) 26 (48,1%)

24 DistribuiGon by sex Research participants Clinical investigators Sponsors EC members Male Female

25 Distribu-on according to the schooling Fundamental (4 years) High school (8 years) EC Sponsors Clinical Investigators Research Participants (47,2%) 2 (1,7%) (28,3%) University 5 (3,4%) 5 (20,8%) 1 (1,7%) 12 (22,6%) Especialization 15 (12,7%) 6 (25%) 6 (10,3%) 0 Master 39 (33,1%) 5 (20,8%) 13 (22,4%) 1 (1,9%) PhD 54 (45,8%) 6 (25%) 30 (51,7%) 0 Other 3 (2,5%) 2 (8,3 %) 8 (13,8%) 0 Total 118 (100%) 24 (100%) 58 (100%) 53 (100%)

26 Distribu-on of par-cipants according to the region in Brazil EC Sponsors Others: 57% Southeast: 43% Others: 21% Sponsors and Research Participants: 80% Southeast EC and Clinical Investigators: 43% Southeast Clinical investigators Southeast: 43% Others: 19% Southeast: 79% Research participants Others: 57% Southeast: 81%

27 Second Domain: Attitudes regarding to Informed Consent process

28 How well informed are the research pargcipants? Less informed item (all groups together)

29 Which is the importance of each informa-on in the Informed Consent? Importance of Research Participants group gives to each aspect in the IC EC Clin Invest Sponsors Res Partic Importance of each group interviewed gives to the potential risks in the IC Research objective Potential benefits Potential risks Study design was the less important info for all groups

30 Third Domain: Decision factors and motivation for patients and investigators

31 Patients motivation Main mo-va-on for par-cipa-ng in a clinical trial (all groups together) Altruism- related motivation is the last one in the all groups together analysis but it is one of the most important reasons for patients decision. (90.4% % % % % % respectively)

32 Investigators motivation Which is the main mo-va-on for inves-gators decide to par-cipate in clinical trials? Provide the most innovative option for the patients, through the clinical trial Be updated with new medicines and medical procedures Social motivation Receive training and capacitation in clinical research Have an additional income Obligation in the institution where he/ she works Very important Moderately important Neutral Somewhat important Not important (all groups together)

33 Would you par-cipate again in a clinical trial? Would you recommend to others? 98% of research participants would accept participate in another clinical trial 98% of research participants would recommend to others the participation 98% Participariam Yes e recomendariam Não No

34 Fourth Domain: Opinions and impressions on the continuity of provision of study medication after trial

35 To whom? Who should receive the medica-on aser trial, if a benefit is proven? If proven more effec3ve than available op3ons, who should receive the study medica3on a?er trial end? EC MEMBERS (N=119) CLINICAL INVESTIGATORS (N=58) SPONSORS (N=24) RESEARCH PARTICIPANTS (N=53) Research pargcipants 26% 43% 33% 7% ParGcipants who benefit from the study medicagon and don t have other treatment opgon 23% 40% 50% 19% All people with the same disease in the country 35% 9% 0% 60% No one 7% 9% 8% 7% Some other group 8% 0% 8% 6%

36 To whom? Who should receive the medica-on aser trial, if a benefit is proven? 43 and 40% Clinical investigators 35% EC members 60% Research participants 50% Sponsors None All study participants Participants who benefit All with the disease Other group

37 How? How should the drug be furnished? How should be furnished the study medica3on a?er trial to the group iden3fied in the previous ques3on? EC MEMBERS (N=107) CLINICAL INVESTIGATORS (N=52) SPONSORS (N=22) RESEARCH PARTICIPANTS (N=44) Free of charge 55% 77% 64% 93% At a price established by government 20% 8% 0% 4% At the fabricagon cost 12% 4% 9% 0% At a price defined by the drug company 0% 2% 4% 2% Other 13% 10% 23% 0%

38 By whom? Who should be in charge of furnishing the drug aser trial? Who should be in charge of furnishing the drug a?er trial, before the regulatory approval in the country? EC MEMBERS (N=109) CLINICAL INVESTIGATORS (N=53) SPONSORS (N=22) RESEARCH PARTICIPANTS (NA) Sponsor (drug company) 64% 94% 68% NA Research insgtugon 8% 2% 4% NA Government 17% 4% 14% NA Other 10% 0% 14% NA (NA: not applicable, as this question was not applied to research participants)

39 How long? For how long.. For how long should the medica3on be furnished to the subjects? EC MEMBERS (N=124) CLINICAL INVESTIGATORS (N=58) SPONSORS (N=24) RESEARCH PARTICIPANTS (N=54) For the period defined in protocol and informed consent 17% 28% 4% 7% While the subjects benefit from the treatment 49% 38% 18% 29% While the researcher/physician believes appropriate 24% 24% 59% 31% Up to having the medicine available in the country or in the public system 41% 51% 73% 31% For all life 8% 2% 0% 51% Other 7% 7% 4% 2% (In this question, more than one alternative could be chosen.)

40 For how long? For a period defined in the protocol and/or in the IC While the participant keeps the benefit While the investigator judges as adequate Up to be available in the country and/or public sector For all life Other Clinical Investigators Ethics Committees Research Participants Sponsors

41 Benefit x Risks Thinking in the benefit but also in the safety of pa-ents (risks of an inves-ga-onal drug are not irrelevant), which would be the best op-on for the con-nuity of the treatment? Clin Invest (n=52) EC (n=116) Sponsors (n=22) All together Study medication 57.7% 28.3% % Treatment already available 28.8% 55.7% 81.8% 51.1% Other 13.5% 16% 18.2% 15.6%

42 Access? What do you understand by access? Clin Invest EC Sponsors (n=55) (n=115) (n=24) All together Furnished by the sponsor Made available after regulatory approval 67.3% 78.3% 25% 68.6% 25.5% 16.5% 54.2% 23.7% Other 7.3% 5.2% 20.8% 7.7% Furnished by the sponsor Made available after regulatory approval Clin Invest EC Sponsor Other

43 Beneficial? Is clinical trial conduc-on in Brazil beneficial or not?

44 Differences Differences between DM and HIV clinical inves-gators 38 investigators DM and 20 HIV/AIDS. (Only questions where significant difference was observed) The info regarding to how to obtain the study medication after trial The medicine should be kept while benefit exists Is better furnished by the HIV investigators than DM investigators. Is more mentioned by HIV investigators than DM investigators. Understanding access HIV investigators: furnished by the sponsor DM investigators: be available in the country after regulatory approval

45 Differences Differences between DM and HIV research par-cipants 14 patients DM and 40 HIV/AIDS. (Only questions where significant difference was observed) Free supply after trial? HIV patients: 100% free; DM patients: 78% free Study medication should be given while considered adequate by the investigator Is beneficial to have clinical trials in Brazil? More important for DM patients than HIV patients HIV patients: more beneficial (100% very beneficial) than DM patients (78% very beneficial)

46 - Selection method of patients - Only two diseases included Pioneer study: Conclusion - a chronic disease, besides HIV/AIDS, Limitations: - sponsors included, - developing country. - Population restrict to web users - Population restrict to Brazil - Small sample of patients - Assessment of what they think but not what they do. The solution is not simple nor unique Each research should have its evaluation as Each disease has its peculiarities and Each population, its needs. Thank you!

Tópico: Epidemiologia no planejamento e gestão de serviços de saúde CO-AUTHOR ASSESSMENT AS AN INDICATOR OF NATIONAL AND INTERNATIONAL COOPERATION & Moisés Goldbaum Sonia Mansoldo Dainesi, MD, MBA PhD

More information

NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997

NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997 NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997 Plenary of the National Health Council in its 15 th Special Meeting, held on 5 August 1997, in the exercise of its competencies, as set forth

More information

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2012) Sweden

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2012) Sweden The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe Sweden Question 1: What laws or regulations apply to an application for conducting a clinical trial in Sweden?

More information

Quality Management in Clinical Trials

Quality Management in Clinical Trials CLINICAL CASE STUDY SERIES Quality Management in Clinical Trials Clinical trials are conducted to collect the data necessary to provide information for academia, industry, and regulators to make decisions

More information

Provider Communica/on Interven/on at a Federally Qualified Health Center- based Farmers' Market: Implica/ons for Implementa/on Science

Provider Communica/on Interven/on at a Federally Qualified Health Center- based Farmers' Market: Implica/ons for Implementa/on Science Provider Communica/on Interven/on at a Federally Qualified Health Center- based Farmers' Market: Implica/ons for Implementa/on Science Daniela B. Friedman, MSc, PhD Associate Professor, Department of Health

More information

International Clinical Trials: Global Compliance Norms The Declaration of Helsinki

International Clinical Trials: Global Compliance Norms The Declaration of Helsinki International Clinical Trials: Global Compliance Norms The Declaration of Helsinki John R. Williams, Ph.D. University of Ottawa, Canada II International Pharmaceutical Regulatory and Compliance Congress

More information

The use of alcohol and drugs and HIV treatment compliance in Brazil

The use of alcohol and drugs and HIV treatment compliance in Brazil The use of alcohol and drugs and HIV treatment compliance in Brazil André Malbergier, MD, PhD Hospital das Clínicas Medical School University of São Paulo Brasil The Casa da AIDS offers specialized integral

More information

Kennedy Krieger Institute. Policy and Procedure for Research Involving Nursing Resources. April 2011

Kennedy Krieger Institute. Policy and Procedure for Research Involving Nursing Resources. April 2011 Kennedy Krieger Institute Policy and Procedure for Research Involving Nursing Resources April 2011 Policy: Human research projects conducted within the Kennedy Krieger Institute (KKI) that require the

More information

THE IMPACT OF USING BLOOD SUGAR HOME MONITORING DEVICE TO CONTROL BLOOD SUGAR LEVEL IN DIABETIC PATIENTS

THE IMPACT OF USING BLOOD SUGAR HOME MONITORING DEVICE TO CONTROL BLOOD SUGAR LEVEL IN DIABETIC PATIENTS THE IMPACT OF USING BLOOD SUGAR HOME MONITORING DEVICE TO CONTROL BLOOD SUGAR LEVEL IN DIABETIC PATIENTS Alshammari S., *Al-Jameel N., Al-Johani H, Al-Qahtani A., Al-Hakbani A., Khan A. and Alfaraj S.

More information

Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research

Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research 1. Objective: The objective of this SOP is to contribute to the effective functioning

More information

Study Participant Experiences

Study Participant Experiences 2013 Perceptions & Insights Study Report on Study Participant Experiences Regulatory agencies, ethical review committees, investigative sites, contract research organizations, and clinical research sponsors

More information

Medicine is an ever-changing field. Have we been taught about bioethics???

Medicine is an ever-changing field. Have we been taught about bioethics??? Medicine is an ever-changing field Undergraduate medical education focuses on clinical skills - diagnosis and treatment of diseases Bioethics too is an ever-changing field Have we been taught about bioethics???

More information

I. INTRODUCTION DEFINITIONS AND GENERAL PRINCIPLE

I. INTRODUCTION DEFINITIONS AND GENERAL PRINCIPLE Final: Approved by Partners Professional and Institutional Conduct Committee 8/11/04 Policy on Transfers to Third Parties Of Tissues, Other Specimens, and Data Obtained by Partners-Affiliated Providers

More information

Patient Inclusion in the Clinical Trial Process at Novartis Working to Make it Reality

Patient Inclusion in the Clinical Trial Process at Novartis Working to Make it Reality Patient Inclusion in the Clinical Trial Process at Novartis Working to Make it Reality Therese Johnsen, Clinical Trial Intelligence Manager 8 June 2015, London Transparent, Patient Focused Drug Development

More information

Biotech Concerto #2. Swiss Clinical Trial Environment

Biotech Concerto #2. Swiss Clinical Trial Environment Biotech Concerto #2 Swiss Clinical Trial Environment December 2008 Index Federal Law on Therapeutic Products National Ethics Commission Supervisory Authority: Swissmedic Swiss Ethics Committees Documents

More information

Claim of Exemption Form Page 1 of 6

Claim of Exemption Form Page 1 of 6 Claim of Exemption Form Page 1 of 6 Principal Investigator: Phone: Project or Protocol Title: Contact Person: Address: Phone: Fax: E-mail: Copy of Principal Investigator s CV attached SPONSOR / FUNDING

More information

Overview of CDISC Implementation at PMDA. Yuki Ando Senior Scientist for Biostatistics Pharmaceuticals and Medical Devices Agency (PMDA)

Overview of CDISC Implementation at PMDA. Yuki Ando Senior Scientist for Biostatistics Pharmaceuticals and Medical Devices Agency (PMDA) Overview of CDISC Implementation at PMDA Yuki Ando Senior Scientist for Biostatistics Pharmaceuticals and Medical Devices Agency (PMDA) CDISC 2012 Outline Introduction Update of PMDA activity CDISC implementation

More information

and Regulatory Aspects

and Regulatory Aspects Good Clinical Practice and Regulatory Aspects Nora Espiritu MD, MPh, PhD (c) Former Executive Director of Research and Technology Transfer. Peruvian National Institute t of Health. Member of the Ethics

More information

Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009

Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009 Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009 The innovative pharmaceutical industry 2 is committed to the transparency

More information

History and Principles of Good Clinical Practice

History and Principles of Good Clinical Practice History and Principles of Good Clinical Practice Cristina E. Torres, Ph.D. Social Science Professor, UPM-NIH FERCAP Coordinator ICH: International Conference on Harmonization GCP: Good Clinical Practices

More information

RN NCLEX Pass Rates TBD. National 3 year mean (2012-2014) Program Completion Rates. Semester Admitted and enrolled in first nursing class

RN NCLEX Pass Rates TBD. National 3 year mean (2012-2014) Program Completion Rates. Semester Admitted and enrolled in first nursing class RN NCLEX Pass Rates Southeast Technical Institute RN Program NCLEX Pass Rates Compared to State and National NCLEX Pass Rates 2012 2013 2014 Southeast Technical Institute RN Program 92.5% 80% Annual Pass

More information

CenterWatch. volunteering. clinical trial. for a. www.centerwatch.com

CenterWatch. volunteering. clinical trial. for a. www.centerwatch.com volunteering for a clinical trial www.centerwatch.com :: about this pamphlet This pamphlet provides an overview of the clinical trials process and answers frequently asked questions that many potential

More information

João Silva de Mendonça, MD, PhD Infectious Diseases Service Hospital do Servidor Público Estadual São Paulo - Brazil

João Silva de Mendonça, MD, PhD Infectious Diseases Service Hospital do Servidor Público Estadual São Paulo - Brazil Brazilian Ministry of Health, Brazilian Society of Hepatology PAHO, Viral Hepatitis Prevention Board PART III SESSION 9 Prevention and control of Viral Hepatitis in Brazil HEPATITIS IN SPECIAL RISK GROUPS/

More information

Public Policy Statement: Clinical Trial Ethics

Public Policy Statement: Clinical Trial Ethics Public Policy Statement: Clinical Trial Ethics Purpose As a global healthcare company, Merck's role is first and foremost to discover, develop and provide innovative products and services that save and

More information

Community-based Advocacy in the Criminal Justice System PRESENTED BY: KELLY DIXON, J.D. & EMILY TOFTE NESTAVAL, MSW ROCKY MOUNTAIN VICTIM LAW CENTER

Community-based Advocacy in the Criminal Justice System PRESENTED BY: KELLY DIXON, J.D. & EMILY TOFTE NESTAVAL, MSW ROCKY MOUNTAIN VICTIM LAW CENTER Community-based Advocacy in the Criminal Justice System PRESENTED BY: KELLY DIXON, J.D. & EMILY TOFTE NESTAVAL, MSW ROCKY MOUNTAIN VICTIM LAW CENTER Mission: Transforming the criminal jus5ce system to

More information

Questionnaire: Use of placebo-medication for treating depression. 1. Explanation about the Placebo Treatment for Depression

Questionnaire: Use of placebo-medication for treating depression. 1. Explanation about the Placebo Treatment for Depression Questionnaire: Use of placebo-medication for treating depression We are conducting a research study aimed at examining the position of the subjects towards different treatment options for depression. In

More information

TAKING PART IN CANCER TREATMENT RESEARCH STUDIES

TAKING PART IN CANCER TREATMENT RESEARCH STUDIES For more infomation about Cancer Clinical Trials at Upstate Cancer Center please call Upstate Connect 1.800.464.8668 TAKING PART IN CANCER TREATMENT RESEARCH STUDIES Information provided by: National Cancer

More information

Excessive alcohol consumption increases the likelihood of accidental injury. This

Excessive alcohol consumption increases the likelihood of accidental injury. This Abstract Excessive alcohol consumption increases the likelihood of accidental injury. This pilot study reports on the prevalence of hazardous drinkers presenting to a Minor Injuries Unit. The proportion

More information

Research on Research: Learning about Phase 1 Trials

Research on Research: Learning about Phase 1 Trials CLINICAL CASE STUDY SERIES Research on Research: Learning about Phase 1 Trials Phases of clinical trial investigation are described in some detail in the Code of Federal Regulations. Phase 1 is described

More information

Job Profile Clinical Research Associate I/II (CRA)

Job Profile Clinical Research Associate I/II (CRA) PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed

More information

Information about research

Information about research Information about research Welcome to Papworth Hospital a focus on research As a specialist centre we pride ourselves on the quality of care that we provide for our patients. Knowledge in health care

More information

Study Management SM STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting

Study Management SM STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting M-306.00 SOP for Adverse Event Reporting Study Management SM 306.00 STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature

More information

Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP.

Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP. Role of IRB/IEC in GCP Benjamin Kuo, MD, Dr.PH, CIP. Institutional Review Board (IRB) An independent body constituted of medical, scientific and non scientific members Responsible for ensuring protection

More information

National Poll: Clinical Research

National Poll: Clinical Research National Poll: Clinical Research June 2013 Results of a New Public Opinion Poll National Poll on Clinical Research The National Poll on Clinical Research was conducted online in May 2013 by Zogby Analytics

More information

Substance Abuse Services (Outpatient)

Substance Abuse Services (Outpatient) RYAN WHITE PART B PEER REVIEW 2009-2010 Virginia Department of Health Division of Disease Prevention HIV Care Services Chart Review Substance Abuse Services (Outpatient) ID# 1. Is there referral in the

More information

GUIDANCE ON THE USER TESTING OF PATIENT INFORMATION LEAFLETS

GUIDANCE ON THE USER TESTING OF PATIENT INFORMATION LEAFLETS GUIDANCE ON THE USER TESTING OF PATIENT INFORMATION LEAFLETS 1 Introduction From 1 July 2005 new legal provisions exist in the UK for patient information particularly in relation to involving patients

More information

Paris, 15 June 2013 Response to a public consultation

Paris, 15 June 2013 Response to a public consultation Paris, 15 June 2013 Response to a public consultation Revision of the World Medical Association Helsinki Declaration: - transparency of clinical trial results must be enhanced (articles 23, 24 & 26) -

More information

Impact of Breast Cancer Genetic Testing on Insurance Issues

Impact of Breast Cancer Genetic Testing on Insurance Issues Impact of Breast Cancer Genetic Testing on Insurance Issues Prepared by the Health Research Unit September 1999 Introduction The discoveries of BRCA1 and BRCA2, two cancer-susceptibility genes, raise serious

More information

Office of Clinical Research (OCR)

Office of Clinical Research (OCR) Office of Clinical Research (OCR) Your Partner in the Clinical Research Process h3p://bsdocr.bsd.uchicago.edu Phone: 834-1238 Susan L. Cohn, MD Dean for Clinical Research Professor of Pediatrics OCR Created

More information

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com Education: Masters of Science, Healthcare Administration, Capital City University,

More information

National Cancer Institute

National Cancer Institute National Cancer Institute Taking Part in Cancer Treatment Research Studies U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Taking Part in Cancer Treatment Research Studies If

More information

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18 th WMA General Assembly Helsinki, Finland, June 1964 and amended by

More information

Ethical Review in the New Clinical Trials Regulation: What are the Challenges?

Ethical Review in the New Clinical Trials Regulation: What are the Challenges? Ethical Review in the New Clinical Trials Regulation: What are the Challenges? Eugenijus Gefenas, MD., PhD Vilnius University, Lithuanian Bioethics Committee Lithuania E. Gefenas, Kiev 2015 1 Structure

More information

Managing & Validating Research Data

Managing & Validating Research Data Research Management Standard Operating Procedure ISOP-H02 VERSION / REVISION: 2.0 EFFECTIVE DATE: 01 03 12 REVIEW DATE: 01 03 14 AUTHOR(S): CONTROLLER(S): APPROVED BY: Information Officer; NBT Clinical

More information

Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs

Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) U.S. Department of Health and Human Services Food and Drug

More information

To IRB, or Not to IRB? That Is the Question!

To IRB, or Not to IRB? That Is the Question! To IRB, or Not to IRB? That Is the Question! A presentation by Mary Sapp, Ph.D. Assistant Vice President, Planning & Institutional Research University of Miami and Thomas K. Martin, Ph.D. Associate Vice

More information

NOW!! Registry and BioBank Services for! Your Organization/Company/Clinic/Project!

NOW!! Registry and BioBank Services for! Your Organization/Company/Clinic/Project! NOW!! Registry and BioBank Services for! Your Organization/Company/Clinic/Project! What Does Genetic Alliance Registry and BioBank Offer?! Flexible, customizable, registry and biobank options One-on-one

More information

Classifying Adverse Events From Clinical Trials

Classifying Adverse Events From Clinical Trials Classifying Adverse Events From Clinical Trials Bernard LaSalle, Richard Bradshaw University of Utah, Biomedical Informatics, Salt Lake City, UT USA bernie.lasalle@hsc.utah.edu Abstract The use of adverse

More information

Emergence of Compassionate Use programmes

Emergence of Compassionate Use programmes Emergence of Compassionate Use programmes Rosanna Melchior, PharmD, MS IDRAC, Thomson Scientific Overview What is compassionate use (CU) Overview of CU in Europe Authorities and Sponsors Roles and Responsibilities

More information

Job Profile Clinical Research Associate III (CRA)

Job Profile Clinical Research Associate III (CRA) PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed

More information

PHARMACY GRADUATING STUDENT SURVEY PUBLIC SCHOOL SUMMARY REPORT - 2011

PHARMACY GRADUATING STUDENT SURVEY PUBLIC SCHOOL SUMMARY REPORT - 2011 PHARMACY GRADUATING STUDENT SURVEY PUBLIC SCHOOL SUMMARY REPORT - 2011 Total number of schools: 57 Total number of responses: 4,449 Part A. Demographic Information 1. Gender Response Response Percent Total

More information

CLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES

CLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES 1. Clinical Study Team Principal Investigator Co Principal Investigator (Co PI) Research Coordinator Study Monitor Data manage Sponsor Post Doctoral Scholar

More information

Pediatric Trials Network. Danny Benjamin MD PhD Professor of Pediatrics Duke University www.dcri.org/about-us/conflict-of-interest

Pediatric Trials Network. Danny Benjamin MD PhD Professor of Pediatrics Duke University www.dcri.org/about-us/conflict-of-interest Pediatric Trials Network Danny Benjamin MD PhD Professor of Pediatrics Duke University www.dcri.org/about-us/conflict-of-interest Pediatric Drug Development 1998: essentially no trials Mandate (Pediatric

More information

CERTIFICATE IN CLINICAL TRIAL MANAGEMENT

CERTIFICATE IN CLINICAL TRIAL MANAGEMENT Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034-2713 Phone: 267.468.8560 Fax: 267.468.8565 CERTIFICATE IN CLINICAL TRIAL MANAGEMENT Designed for Pharmaceutical

More information

Clinical Trials at PMH

Clinical Trials at PMH Clinical Trials at PMH What You Need To Know UHN Patient Education Improving Health Through Education A Guide for Patients, Their Families and Friends in the PMH Cancer Program This information is to be

More information

RESEARCH INVOLVING HUMAN SUBJECTS

RESEARCH INVOLVING HUMAN SUBJECTS RESEARCH INVOLVING HUMAN SUBJECTS GUIDELINES FOR IRBS EXECUTIVE SUMMARY Principle 1. There is general agreement internationally that human biomedical research involving risk of harm to human subjects should

More information

Regulatory Considerations for Conducting Clinical Trials In India

Regulatory Considerations for Conducting Clinical Trials In India Regulatory Considerations for Conducting Clinical Trials In India By Mukesh Kumar, PhD & Surinder Kher, MD In the last few years, there has been increasing interest in the pharmaceutical industry in outsourcing

More information

RD SOP17 Research data management and security

RD SOP17 Research data management and security RD SOP17 Research data management and security Version Number: V2 Name of originator/author: Dr Andy Mee, R&I Manager Name of responsible committee: R&I Committee Name of executive lead: Medical Director

More information

Pa#ent Involvement in Clinical Research In Rela#onship with Biobanking BBMRI 15 December 2009

Pa#ent Involvement in Clinical Research In Rela#onship with Biobanking BBMRI 15 December 2009 Pa#ent Involvement in Clinical Research In Rela#onship with Biobanking BBMRI 15 December 2009 Cor Oosterwijk Project Coordinator Pa;entPartner Dutch Gene;c Alliance VSOP European Gene;c Alliances Network

More information

Institutional Review Board (IRB) / Independent Ethics Committee (IEC) Registration Application

Institutional Review Board (IRB) / Independent Ethics Committee (IEC) Registration Application Institutional Review Board (IRB) / Independent Ethics Committee (IEC) Registration Application Step-by-Step Instructions for (IRB) or (IEC) registration Note: - Only institutions or organizations that

More information

Clinical trials regulation

Clinical trials regulation Clinical trials regulation The Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use and Repealing Directive 2001/20/EC an update

More information

New Trends In the Brazilian Healthcare Market. Rafael Vasconcellos,MD UHG

New Trends In the Brazilian Healthcare Market. Rafael Vasconcellos,MD UHG New Trends In the Brazilian Healthcare Market Rafael Vasconcellos,MD UHG Summary Overview Brazilian Healthcare Market Numbers Public System Private System Interaction Between Public X Private Innovations

More information

Investigator Responsibilities

Investigator Responsibilities Investigator Responsibilities Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 010 Version number: 1 Effective date: 01 June 2010 Review due: May 2011

More information

PROCEDURE FOR PREPARING GCP INSPECTIONS REQUESTED BY THE EMEA. GCP Inspectors Working Group

PROCEDURE FOR PREPARING GCP INSPECTIONS REQUESTED BY THE EMEA. GCP Inspectors Working Group European Medicines Agency Inspections London, 20 September 2007 EMEA/INS/GCP/197228/2005 Procedure no.: INS/GCP/2 PROCEDURE FOR PREPARING GCP INSPECTIONS REQUESTED BY THE EMEA GCP Inspectors Working Group

More information

Clinical Research in Mauritius

Clinical Research in Mauritius BOARD OF INVESTMENT Clinical Research in Mauritius This document provides an informative summary of the procedure to apply for a clinical research protocol in Mauritius. Contents INTRODUCTION... 2 I. APPLICATION

More information

Clinical Trial Operations

Clinical Trial Operations Contract Research and Consulting Organisation Consulting Clinical Trial Operations Training Your partner for CLINically remarkable results We are a leading Polish company specializing in clinical research

More information

ON-GOING ACCESS TO TREATMENT FOLLOWING THE COMPLETION OF INDUSTRY SPONSORED CLINICAL TRIALS OR FUNDING

ON-GOING ACCESS TO TREATMENT FOLLOWING THE COMPLETION OF INDUSTRY SPONSORED CLINICAL TRIALS OR FUNDING Healthcare Policy ON-GOING ACCESS TO TREATMENT FOLLOWING THE COMPLETION OF INDUSTRY SPONSORED CLINICAL TRIALS OR FUNDING Policy reference number: G1013 Version 1 Agreed by the HSSD on 24 th April 2013

More information

The College of Family Physicians of Canada. Position Statement Prescribing Rights for Health Professionals

The College of Family Physicians of Canada. Position Statement Prescribing Rights for Health Professionals The College of Family Physicians of Canada Position Statement Prescribing Rights for Health Professionals Introduction The College of Family Physicians of Canada (CFPC) supports models of practice that

More information

Guidance for Industry

Guidance for Industry Guidance for Industry IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer U.S. Department of Health and Human Services Food and Drug Administration Center

More information

25 % RR in premature mortality due to CV diseases Cancer Diabetes COPD Better educated, higher income population which requires modern health care,

25 % RR in premature mortality due to CV diseases Cancer Diabetes COPD Better educated, higher income population which requires modern health care, Education and training of medicines development, regulation and clinical research in Low and Middle Income Countries (LMICs) S. Kerpel-Fronius & B. Rosenkranz Sándor Kerpel-Fronius, M.D., D.Sc. Semmelweis

More information

willing to have a follow-up discussion regarding your answers from this survey? Answer Response % Yes 343 67% No 167 33% Total 510 100% Text Response

willing to have a follow-up discussion regarding your answers from this survey? Answer Response % Yes 343 67% No 167 33% Total 510 100% Text Response In fall 2011, University Communications worked under the direction of President s Executive Group (PEG) and President s Council to audit the processes for and effectiveness of distributing and obtaining

More information

Nurse Researcher or Clinical Research Nurse: Understanding the Difference

Nurse Researcher or Clinical Research Nurse: Understanding the Difference Nurse Researcher or Clinical Research Nurse: Understanding the Difference Claudia D. Smith, PhD, RN, NE-BC Director, Nursing Research St. Luke s Medical Center An Alternate Title for the Presentation:

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DATA MONITORING COMMITTEES

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DATA MONITORING COMMITTEES European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 27 July 2005 Doc. Ref. EMEA/CHMP/EWP/5872/03 Corr COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE

More information

How to Run Clinical Trials in Private Practice

How to Run Clinical Trials in Private Practice How to Run Clinical Trials in Private Practice Thomas M. Siler, MD Midwest Chest Consultants, PC Saint Charles, MO DISCLOSURE Dr. Siler has received research grants from GlaxoSmithKline, Forest, Boehringer

More information

Needs, Providing Solutions

Needs, Providing Solutions Identifying Needs, Providing Solutions 1 I n d u s t r y The growth of medical research and the countless innovations coming from the pharmaceutical, biotechnology and medical device industry, has improved

More information

School of Pharmacy TEMPLE UNIVERSITY

School of Pharmacy TEMPLE UNIVERSITY School of Pharmacy TEMPLE UNIVERSITY Regulatory Affairs and Quality Assurance Graduate Program Te mple Unive rsity School of Pharmacy Re gulatory Affairs and Quality Assurance Graduate Program 4 25 Comme

More information

Accountable Care Organizations: Implications for CHCs Serving AA&NHOPIs

Accountable Care Organizations: Implications for CHCs Serving AA&NHOPIs Accountable Care Organizations: Implications for CHCs Serving AA&NHOPIs Practice Transformation Webinar Series Webinar 4 April 29, 2015 Moderator: Nina Agbayani, Director of Programs About AAPCHO National

More information

Market Research as an agent of change in pharmerging Asia

Market Research as an agent of change in pharmerging Asia Market Research as an agent of change in pharmerging Asia Agenda The challenge The solution The case study Conclusion Agenda The challenge The solution The case study Conclusion The challenge Huge expectation

More information

PHARMACY AND POISONS ORDINANCE (Cap. 138) APPLICATION FOR A CLINICAL TRIAL/MEDICINAL TEST CERTIFICATE

PHARMACY AND POISONS ORDINANCE (Cap. 138) APPLICATION FOR A CLINICAL TRIAL/MEDICINAL TEST CERTIFICATE PHARMACY AND POISONS ORDINANCE (Cap. 138) APPLICATION FOR A CLINICAL TRIAL/MEDICINAL TEST CERTIFICATE PART A: TRIAL INFORMATION A1. Title of Clinical Trial (as stated in proposed Protocol) Protocol No.

More information

NEW YORK STATE EXTERNAL APPEAL

NEW YORK STATE EXTERNAL APPEAL NEW YORK STATE EXTERNAL APPEAL You have the right to appeal to the Department of Financial Services (DFS) when your insurer or HMO denies health care services as not medically necessary, experimental/investigational

More information

Chemicals and Life Sciences Industry Practice. Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom

Chemicals and Life Sciences Industry Practice. Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom Chemicals and Life Sciences Industry Practice Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom i Insurance and compensation in the event of injury in Phase

More information

Research Study Protocol Template

Research Study Protocol Template Research Study Protocol Template (For clinical trials) Instructions This protocol template is a tool to facilitate the development of a research study protocol specifically designed for the investigator

More information

The Evolving Role of Nurses in Early Phase Research

The Evolving Role of Nurses in Early Phase Research U.S. Department of Health and Human Services The Evolving Role of Nurses in Early Phase Research Clare Hastings, RN, PhD, FAAN Chief Nurse Officer, Clinical Center April 27, 2012 Discover America s Research

More information

GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE

GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE ICH E6 GCP: Consolidated Guideline: Investigator 1/7 Institutional Review Board Services ICH HARMONIZED TRIPARTITE GUIDELINE E6: GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE 4. INVESTIGATOR 4.1 Investigator's

More information

Use of Observa,onal Data to Make Causal Inferences About Treatment Decisions in Mul,ple Sclerosis. Brian Healy, PhD

Use of Observa,onal Data to Make Causal Inferences About Treatment Decisions in Mul,ple Sclerosis. Brian Healy, PhD Use of Observa,onal Data to Make Causal Inferences About Treatment Decisions in Mul,ple Sclerosis Brian Healy, PhD Disclosures n I receive research support from Merck Serono and Novar,s Outline n Background

More information

Sheffield Kidney Institute. Planning a Clinical Trial

Sheffield Kidney Institute. Planning a Clinical Trial Planning a Clinical Trial Clinical Trials Testing a new drug Ethical Issues Liability and Indemnity Trial Design Trial Protocol Statistical analysis Clinical Trials Phase I: Phase II: Phase III: Phase

More information

Industry Experience in Clinical Trials Management. Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels

Industry Experience in Clinical Trials Management. Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels Industry Experience in Clinical Trials Management Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels Stakeholders in clinical research Critical activities to ensure patient

More information

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare

More information

Building the Foundation for Clinical Research Nursing

Building the Foundation for Clinical Research Nursing National Institutes of Health Clinical Center Nursing and Patient Care Services Building the Foundation for Clinical Research Nursing DOMAIN OF PRACTICE FOR THE SPECIALTY OF CLINICAL RESEARCH NURSING 9/4/2009

More information

Influence, Information Overload, and Information Technology in HealthCare.

Influence, Information Overload, and Information Technology in HealthCare. Influence, Information Overload, and Information Technology in HealthCare. Inspiration: a clinical trial of an IT based decision support technology The IT system constructed a digital electronic medical

More information

Please find below some views on the issues raised by the EMA Senior Medical Officer's Reflections on the legal basis for EMA/CHMP opinions.

Please find below some views on the issues raised by the EMA Senior Medical Officer's Reflections on the legal basis for EMA/CHMP opinions. Jacques Ropers Afssaps Pierre Demolis Afssaps (French CHMP Member) Philippe Lechat Afssaps (French Alternate CHMP Member) Dear Colleagues, Please find below some views on the issues raised by the EMA Senior

More information

Oversight of Clinical Trials in Europe - Member State perspective. Gunnar Danielsson Senior Expert Pharmaceutical Inspector

Oversight of Clinical Trials in Europe - Member State perspective. Gunnar Danielsson Senior Expert Pharmaceutical Inspector Oversight of Clinical Trials in Europe - Member State perspective Gunnar Danielsson Senior Expert Pharmaceutical Inspector Oversight of Clinical Trials Oversight of clinical trials occur on many different

More information

Determining who the investigators are and who the principal investigator is:

Determining who the investigators are and who the principal investigator is: Responsibilities of the IRBs of the Health System and University for Research Conducted by Investigators from a Combination of the Following Institutions: the Health System, University, and Medical School

More information

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH Martin Valania, Executive Director, Corporate QA and Compliance Introduction Pharmaceutical companies recognize the benefits of carefully managing

More information

Outcome of Drug Counseling of Outpatients in Chronic Obstructive Pulmonary Disease Clinic at Thawangpha Hospital

Outcome of Drug Counseling of Outpatients in Chronic Obstructive Pulmonary Disease Clinic at Thawangpha Hospital Mahidol University Journal of Pharmaceutical Sciences 008; 35(14): 81. Original Article Outcome of Drug Counseling of Outpatients in Chronic Obstructive Pulmonary Disease Clinic at Thawangpha Hospital

More information

ADR PREFERENCE AND USAGE. In Collaboration with General Practice Solo and Small Firm Division of the American Bar Association

ADR PREFERENCE AND USAGE. In Collaboration with General Practice Solo and Small Firm Division of the American Bar Association ADR PREFERENCE AND USAGE In Collaboration with General Practice Solo and Small Firm Division of the American Bar Association CONTENTS GP SOLO ADR Survey Overview 1 Executive Summary of Key Findings 2 Detailed

More information

Insurance and compensation in the event of injury in Phase I clinical trials

Insurance and compensation in the event of injury in Phase I clinical trials Insurance and compensation in the event of injury in Phase I clinical trials Guidance developed by the Association for the British Pharmaceutical Industry, the BioIndustry Association and the Clinical

More information

Pa"ent Reported Outcomes Useful for Whom? Industry s Perspec/ve. Pri/ Jhingran, Ph.D. GlaxoSmithKline

Paent Reported Outcomes Useful for Whom? Industry s Perspec/ve. Pri/ Jhingran, Ph.D. GlaxoSmithKline Pa"ent Reported Outcomes Useful for Whom? Industry s Perspec/ve Pri/ Jhingran, Ph.D. GlaxoSmithKline AGENDA Why PROs? Applica0ons of PROs in Drug Development US Healthcare Reform Enhanced Value of PROs

More information

TEMPLATE DATA MANAGEMENT PLAN

TEMPLATE DATA MANAGEMENT PLAN TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager

More information

Official Gazette no. 213 of 14.9.2009 MINISTRY OF LABOUR, HEALTH AND SOCIAL POLICIES

Official Gazette no. 213 of 14.9.2009 MINISTRY OF LABOUR, HEALTH AND SOCIAL POLICIES The English version of this Decree was prepared in order to help comprehension by non- Italian mother tongue users, but it is NOT an official document. Please, refer to the Italian version for the only

More information