ANRS 12 175 Quality indicators and GCP compliance in the ANRS clinical trials in France and in the South

1. ANRS 12 175 Quality indicators and GCP compliance in the ANRS clinical trials in France and in the South

2. After the 2nd World War, following the trials performed by the Nazi 1946: The Nuremberg Code Standards to protect humans involved in research (�what is unethical isn�t scientific��) Assure the public that physicians will treat the participants in a respectfull and appropiate way�.. A section of the verdict from that, � - Nuremberg Code : specified standards to which physicians must conform when carrying out experiments on humans in order to assure the public that investigators will treat research participants in a way that is respectful, appropriate, and does not expose them to unwarranted dangers - These protections are usually concentrated at the "front end" of the research process through ethical review process conducted by Research Ethics Committees - There is increasing concern about what happens to research participants after the initial ethics review is over and the study has actually begunA section of the verdict from that, � - Nuremberg Code : specified standards to which physicians must conform when carrying out experiments on humans in order to assure the public that investigators will treat research participants in a way that is respectful, appropriate, and does not expose them to unwarranted dangers - These protections are usually concentrated at the "front end" of the research process through ethical review process conducted by Research Ethics Committees - There is increasing concern about what happens to research participants after the initial ethics review is over and the study has actually begun

3. 1975 : Declaration of Helsinki (amend�e++) 1979: USA, the Belmont Report -> externally imposed protections 1980-90 : USA, Canada and many European countries -> laws regulating research on human

4. International guidelines 1997, Good Clinical Practice (GCP) of the International Conference on Harmonization (ICH),): EU, Japan, USA and WHO 2002, International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences (CIOMS) 

6. There is a permanent concern about what happens to research participants through out all stages of a clinical trial

8. ��Any research funded by the ANRS should comply with international guidelines on ethics, Good Clinical Practices ��� (Ethics Charter, �I, 1.1)

10. Particularit�s organisationnelles[partenariat �quipe Nord/Sud : �quipes de recherche r�parties dans 2 ou plusieurs pays] Particularit�s culturelles et conjoncturelle [culture orale, d�cision partag�e�] Particularit�s structurelles [la recherche apporte le soin : libert� de choix ?]

11. Explain creation of data base extraction of Data and feed back reportsExplain creation of data base extraction of Data and feed back reports

12. Ethical Committee approval The document is: Accessible obtained before starting the trial indicating the members who were present Refers to the trial (N�, title�)

13. Patient�s enrollment freedom: sufficient time between pre-inclusion and definitive enrollment Pre-inclusion tables in the data base Delay between date of pre-inclusion and date of enrollment Minimum number of non enrolled patients

14. ANRS SITES (N=8)

15. 28 phases II et III clinical trials since 10 years in DC 16 are ongoing Topics: PTME, HAART in adult and children, prevention (circumcision++) co-infections (HSV2, TB�)

16. A la phase actuelle 6 sites ANRS participe � ce programme de recueilA la phase actuelle 6 sites ANRS participe � ce programme de recueil