South African good clinical practice guidelines. 2nd edition

1 South African GOOD CLINICALPRACTICE GUIDELINESSECOND edition Suggested Citation: Department of Health, 2006. Guidelines for Good Practicein the Conduct of clinical Trials with human Participants in South Africa. Department of Health: Pretoria, South Africa. 2006 Department of HealthGuidelines for Good practice in the Conduct of clinical Trials with human Participants in South Africa1 PREAMBLEThis is the second edition of the Guidelines for Good practice in the Conduct of clinical Trials in HumanParticipants in South Africa following those published in 2000. They have been revised by a workinggroup convened by the Director-General of the Department of Health that principally included represen-tatives from the Department of Health, the Medicines Control Council and the Interim MinisterialCommittee on Ethics in Health Research.

2 The Guidelines are addressed to investigators including ethics review committees, pharmaceutical manufacturers and other sponsors of research, drug regulatory authorities, the general public and allthose who have an interest in clinical trials research in South Africa. By providing a basis both for the scientific and ethical integrity of research involving human subjects andfor generating valid observations and sound documentation of the findings, these Guidelines not onlyserve the interests of the parties actively involved in the research process, but protect the rights and safety of participants, including patients.

3 And ensure that the investigations are directed at theadvancement of public health Guidelines will support the regulatory requirements of the Medicines Control Council and regulations related to Health Research in the National Health Act. It is therefore critical that researchethics committees, researchers, trial participants, principal investigators of trials and sponsors use theseguidelines so as to ensure a standardised and ethical approach to clinical trial activities in South guidelines are also applicable to both academic and contract clinical Guidelines are intended to be applied during all stages of drug development -both prior to and subsequent to product registration and marketing, and they are also applicable, in whole or in part.

4 To biomedical research in general. They should also provide a resource for editors to determine theacceptability of reported research for publication and specifically, on any study that could influence theuse or the terms of registration of a pharmaceutical product. Not least, they provide an educational toolthat should become familiar to everyone engaged in biomedical research and, in particular, to everynewly trained clinician. DR ME TSHABALALA-MSIMANG MINISTER OF HEALTH2 Guidelines for Good practice in the Conduct of clinical Trials with human Participants in South Africa ACKNOWLEDGEMENTST hese national guidelines have been developed to promote good practice in the conduct of clinical trials in South Africa.

5 The revision process of these guidelines started in 2005 through a number of consultations with regulatory authorities, the pharmaceutical industry, Community Advisory Boards andthe Department of smaller team was convened to compile and adjudicate contributions fromrespectable team members relied on their experiences and knowledge, experts' advice, available literature, various country experiences and a variety of internationally accepted standards and guidelines. I herebythank all those who granted us permission to refer to their documents. I would like to express my sinceregratitude to all those who contributed to the drafting and writing of these guidelines; in particular Dr L E Makubalo (Chief Director), Ms P Netshidzivhani (Director) Ms M Ratsaka-Mothokoa and Mr K Hlongwa of the National Department of Health.

6 Thank you to the South African Drug Action Programme/World Health Organisation; Medicines ControlCouncil; Medical Research Council; Universities of KwaZulu-Natal and Witwatersrand; Lawyers forHuman Rights; and the National Department of Health Clusters: Health Information Evaluation & Research and pharmaceutical Policy & Planning. I would like to thank various organisations for givingus special permission to draw from their documents which included the International Conference onHarmonisation (ICH), Council for International Organisations of Medical Sciences (CIOMS), WorldMedical Association and the would further like to sincerely thank all persons and groups that reviewed and made constructive comments and inputs to the this second edition of the guidelines including the National Health LaboratoryServices; the National Institute for Communicable Diseases.

7 The Medicines Control Council of SouthAfrica; the South African pharmaceutical clinical Research Association (SACRA); Quintiles Clindepharm;the Medical University of South Africa; the Universities of Cape Town; Free State and Pretoria; the HIVAIDS Vaccine Ethics Group; the Africa Centre for Population Studies and the site community members;Tshwane University of Technology; Durban University of Technology; Johannesburg University ofTechnology; Indian Ocean Triangle Quintiles; WHO/EURO Programme for Pharmaceuticals; the HealthProfessions Council of South Africa; clinical Quality Concepts; WHO Collaborating Centre for DrugPolicy; the University of Johannesburg, Pfizer Global Pharmaceuticals; GlaskoSmithKline Beecham(Southern African Region) and all other : HEALTHG uidelines for Good practice in the Conduct of clinical Trials with human Participants in South GUIDELINES?

8 Rationale and of Harm and Multi-centre OF THESE GUIDELINES AND LEGISLATION AUTHORITIES ROLES AND RESPONSIBILITIES Medicines Control Council (MCC) African clinical Trial Register (SACTR)/Department of National Health Research Ethics Council (NHREC) Ethics Committees (REC) Principal Investigator (PI) TRIAL APPROVAL IN South OF STUDY REQUIRING ADDITIONAL : Children and Consent Assent Parental/Legal Guardian Women and Foetuses In-Utero as Foetuses Ex Utero, Including Nonviable Foetuses.

9 As with Mental Disabilities or Substance Abuse Related in Dependent Relationships or Comparable Highly Dependent on Medical Intensive Care Neonatal Intensive Care Terminal Care Research224 Guidelines for Good practice in the Conduct of clinical Trials with human Participants in South Africa Research Involving Persons with Impaired Capacity to Research Involving Unconscious Involving Involving Indigenous Medical Care Research Involving Innovative Therapy or Research Involving Vulnerable HIV/AIDS clinical and Epidemiological HIV Related Drug Access to HIV Related Placebo and HIV Preventive Vaccine Patient Management after Withdrawal from a Access to Study Medications Following the Completion of a clinical HIV Confidential HIV Unlinked Anonymous HIV Linked Anonymous HIV Population Based Studies to Prevent HIV HIV Vaccine Involvement of People Living with HIV/AIDS (PWAs) Other Special AND COMMUNITY OF THE PRINCIPAL INVESTIGATOR (PI)

10 AND PARTICIPATING INVESTIGATORS AND RESPONSIBILITIES OF THE INVESTIGATOR/INVESTIGATOR'S QUALIFICATIONS AND CARE OF TRIAL CONSENT OF TRIAL PRODUCT(S) WITH AND OF PRINCIPAL AND/OR DATA SAFETY ISSUES REPORTING OF SERIOUS ADVERSE BREAKING THE TREATMENT PROGRESS REPORTS AND FINAL STUDY REPORTS TRIAL OF THE TO THE MCC FOR OF REVIEW BY RESEARCH ETHICS COMMITTEE South African clinical TRIAL ASSURANCE AND QUALITY CONTROL39 Guidelines for Good practice in the Conduct of clinical Trials with human Participants in South RESEARCH ORGANIZATION (CRO)