RCORE CLINICAL TRIAL REGULATORY FELLOWSHIP PROGRAMME
OBJECTIVES OF PROGRAM
Build capacity and enhance skills of regulators in the area of effective clinical trial regulation through hands-on training and exchange programs to help improve their output.
Increase regulatory workforce to facilitate quality review of clinical trials conducted in Africa.
Provide a platform for regulators and researchers to continually share ideas, knowledge and experiences over the years in the aim of improving their activities
Build capacity and enhance skills of researchers in the area of conduct of clinical trials through hands-on training to help improve their output
30-DAY INTENSIVE FELLOWSHIP COURSE COURSE CONTENT
'To achieve the above objectives, the FDA has designed an intensive fellowship course covering the following areas;
I. Clinical Trials Authorization
Clinical Trials in Practice This module investigates the key steps in the logistical and implementation of clinical trials. It clarifies and operationalizes the primary and secondary objectives of clinical trials and implications of design choices for implementation of a trial. The module will also examine the governance , data collection and recruitment methods. Quality assurance and control, data processing and management issues will be explored as well. Regulatory Issues, Good Clinical & Laboratory Practice The module seeks to develop participants understanding of the main features relating to regulatory legislation and associated approvals and permissions required to conduct high quality clinical trials. Key issues relating to the legislation of Good Clinical Practice (GCP), understanding GCP, implementing GCP, including risk assessment and trial monitoring will be discussed. Good Laboratory Practice (GLP) in trial settings, Quality control and assurance systems shall also be explored. The focus will be on trials of drug products but trials in variety of other areas and in different locations will be taught. Ethics of Clinical Research in developing countries The course aims to discuss the critical ethical issues related to conducting clinical trials in the developing world. The course will cover a historical overview of research ethics in the developing world, medical and human ethics, risk-benefit assessments, vulnerable populations as research subjects, informed consent process and documentation, privacy and confidentiality of research subjects and data, responsible conduct of scientific research, the role and functions of Institutional Review Boards, Data and Safety Monitoring Boards, international research and the Declaration of Helsinki Protocol Development The aim of this module is to be able to learn to develop the trial protocol and the steps to be taken for preparing the protocol for a trial: This entails how to develop the data collection forms, understand the required logistical and budgetary issues in the preparation of the protocol, and procedures different funding bodies use to award grants.
I. Clinical Trials Authorization
Clinical Trials in Practice
This module investigates the key steps in the logistical and implementation of clinical trials. It clarifies and operationalizes the primary and secondary objectives of clinical trials and implications of design choices for implementation of a trial. The module will also examine the governance , data collection and recruitment methods. Quality assurance and control, data processing and management issues will be explored as well.
Regulatory Issues, Good Clinical & Laboratory Practice
The module seeks to develop participants understanding of the main features relating to regulatory legislation and associated approvals and permissions required to conduct high quality clinical trials. Key issues relating to the legislation of Good Clinical Practice (GCP), understanding GCP, implementing GCP, including risk assessment and trial monitoring will be discussed. Good Laboratory Practice (GLP) in trial settings, Quality control and assurance systems shall also be explored. The focus will be on trials of drug products but trials in variety of other areas and in different locations will be taught.
Ethics of Clinical Research in developing countries
The course aims to discuss the critical ethical issues related to conducting clinical trials in the developing world. The course will cover a historical overview of research ethics in the developing world, medical and human ethics, risk-benefit assessments, vulnerable populations as research subjects, informed consent process and documentation, privacy and confidentiality of research subjects and data, responsible conduct of scientific research, the role and functions of Institutional Review Boards, Data and Safety Monitoring Boards, international research and the Declaration of Helsinki
I. Clinical Trials Authorization
I. Clinical Trials Authorization
Ethics of Clinical Research in developing countries The course aims to discuss the critical ethical issues related to conducting clinical trials in the developing world. The course will cover a historical overview of research ethics in the developing world, medical and human ethics, risk-benefit assessments, vulnerable populations as research subjects, informed consent process and documentation, privacy and confidentiality of research subjects and data, responsible conduct of scientific research, the role and functions of Institutional Review Boards, Data and Safety Monitoring Boards, international research and the Declaration of Helsinki
Protocol Development
The aim of this module is to be able to learn to develop the trial protocol and the steps to be taken for preparing the protocol for a trial: This entails how to develop the data collection forms, understand the required logistical and budgetary issues in the preparation of the protocol, and procedures different funding bodies use to award grants.
I. Clinical Trials Authorization
Clinical Trials in Practice This module investigates the key steps in the logistical and implementation of clinical trials. It clarifies and operationalizes the primary and secondary objectives of clinical trials and implications of design choices for implementation of a trial. The module will also examine the governance , data collection and recruitment methods. Quality assurance and control, data processing and management issues will be explored as well. Regulatory Issues, Good Clinical & Laboratory Practice The module seeks to develop participants understanding of the main features relating to regulatory legislation and associated approvals and permissions required to conduct high quality clinical trials. Key issues relating to the legislation of Good Clinical Practice (GCP), understanding GCP, implementing GCP, including risk assessment and trial monitoring will be discussed. Good Laboratory Practice (GLP) in trial settings, Quality control and assurance systems shall also be explored. The focus will be on trials of drug products but trials in variety of other areas and in different locations will be taught. Ethics of Clinical Research in developing countries The course aims to discuss the critical ethical issues related to conducting clinical trials in the developing world. The course will cover a historical overview of research ethics in the developing world, medical and human ethics, risk-benefit assessments, vulnerable populations as research subjects, informed consent process and documentation, privacy and confidentiality of research subjects and data, responsible conduct of scientific research, the role and functions of Institutional Review Boards, Data and Safety Monitoring Boards, international research and the Declaration of Helsinki Protocol Development The aim of this module is to be able to learn to develop the trial protocol and the steps to be taken for preparing the protocol for a trial: This entails how to develop the data collection forms, understand the required logistical and budgetary issues in the preparation of the protocol, and procedures different funding bodies use to award grants.