Introduction: The Randomized Controlled Trial (RCT) has long been recognized as the gold standard approach to testing the efficacy of medicines. More recently the method is being used to ...
ORRCA (www.orrca.org.uk) is a free, online, searchable database of research around recruitment to Clinical Trials. It aims to help users identify promising recruitment interventions and inform the ...
Clinical research nurses are busy people! The Global Health Network Training Centre is therefore designed to offer snappy, practical 'how to' training courses that can be completed within 60-90 minutes ...
Sr Cordelia Leisegang and Sr Brenda Wright from the University of Cape Town's Collaborating Centre for Optimising Antimalarial Therapy (CCOAT) were involved in developing (and starring in!) a video ...
Though recipients of medicines, input from patients has historically been limited within healthcare systems, and by extension health research. This has resulted in their experiences, views, and decisions regarding medicine ...
A systematic meta-narrative review of the qualitative literature Abstract: Objectives Locally led health research in low and middle income countries (LMICs) is critical for overcoming global health challenges. Yet, despite ...
New in 2018 is an African Chapter for the International Society for Pharmacoepidemiology. The Chapter mission to develop, sustain and advance Pharmacoepidemiology research in the African region, through intra- and intercontinental scientific collaborative work. Read more
The TMRP aims to support researchers and trialists to improve trials in many ways. From funding projects, organising conferences and training, and developing guidance. Regular webinars are held which are often available as recordings after the event Read more
The 3rd edition of the World Conference on Pharmacometrics will be held at the southern tip of the continent of Africa on 6-9 April 2020 in Cape Town, South Africa. Late abstract submission until 31st Jan 2020 Read more
Pre-conference workshops 9th Sept. Early registration closes on 30 April 2020: R4000 / Standard Registration: R4500 closes 4 September 2020 Read more
This guideline describes the process to be followed when the inspected companies compile and submit the inspection response to the inspectorate following a GMP /GWP/GCP inspection. It is not intended as an exclusive approach leaflet and should not be taken ... Read more
The objective of this document is to articulate the Authority’s understanding of capacity building and transformation; for all stakeholders involved in clinical research to embrace transformation and capacity building to increase formalised training of young graduates, encourage healthcare and scientific ... Read more
The purpose of the Workload Table is to inform SAHPRA of the capacity of all potential investigators to safely and effectively conduct the planned study Read more
Methodological research into the design, conduct, analysis and reporting of trials is essential to optimise the process. UK specialists have established a set of top priorities in aid of this research which may not be reflected in the needs of ... Read more
This book is a collection of fictionalized case studies of everyday ethical dilemmas and challenges often encountered in the process of conducting global health research in Africa where the effects of global, political and economic inequality are particularly evident. Our ... Read more
SACRA meetings 2018
- Johannesburg: 16th November
- Cape Town: 23rd November
SACRA's 8th Clinical Trials Conference: 13th & 14th Sept, Bytes Conference Centre, Midrand, Gauteng
African Evidence Summitt, 25-28 September 2018, CSIR International Convention Centre, PretoriaGo to page
The South African regulatory landscape for clinical trials is in a state of flux at the moment as the Board for the New South African Health Products Regulatory Authority (SAHPRA) has been announced. We will endeavour to keep you up to date as to how the transition from the Medicines Control Council will evolve and offer links to other relevant reources.Go to page
Essential training for anyone involved in handling biological specimens for clinical trials - including laboratory and clinical staff. It describes the clinical standards expected in the analysis of samples from clinical trials and provides a framework for organisations regarding facilities, systems and procedures to ensure the reliability, quality and integrity of the work and results to satisfy GCP expectations
Updated ICH eLearning after the revision in 2016 which involved an integrated Addendum to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency were also updated
GCLP: Method and System Validation is the fifth module of the Good Clinical Laboratory Practice (GCLP) course. The course is designed for all those wanting to gain an in-depth understanding of the principles of GCLP, how each principle is applied in a clinical laboratory and the impact implementation of these principles has on the laboratory and the clinical trial.