Rationale/ Background
Good Clinical Practice is a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of research involving human participants. Compliance with GCP assures the public that the rights, safety, and well-being of research participants are protected and respected, and are consistent with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines. Further, these ensure the integrity of clinical research data. The conduct of clinical research is complex and compounded by the need to involve stakeholders with a range of background all of whom must perform their tasks skillfully and efficiently. The course aims to strengthen knowledge and skills, and modify the attitude of researchers and health professionals in developing countries with regard to the management of research and apply Good Clinical Practices.

Topics
• Principles of research ethics and GCP, and its application in research involving human participants
• Processes in product development, informed consent, safety & quality management and preparation of trial documents

Course Level
Intermediate

Outputs expected/ Competencies to be acquired
Application of learning through assessment of their home laboratories using the provided checklist.

Participant’s Profile
This training is designed for professionals who currently manage or work in a clinical setting with at least one (1) year of exposure, and those involved in clinical trials.

Admission Requirements
Fully accomplished and signed Application Form
Full payment two (2) weeks before the training

Course Length
The training will be conducted for two days:
First day: 07:30 a.m. – 05:00 p.m.
Second day: 08:00 a.m. – 05:00 p.m.


For more information, please contact RITM RTC at info.ritmrtc@gmail.com