Lymphoedema is a chronic, debilitating lymphatic disease that affects nearly 170 million people worldwide. The 6th of March is World Lymphoedema Day. Lymphoedema cannot be cured but it can at times be prevented or managed to reduce the risk of major symptoms such severe pain, swelling, loss of mobility and cellulitis. Let’s join the international lymphoedema community by demanding that lymphoedema as a chronic condition become a priority.
Did you know that UCT recently launched an Institutional Data Repository? It is called ZivaHub: Open Data UCT. The purpose of the repository is to house research data sets that are required to be published (e.g. by funders or journals).
On 5 April, two new regulations on medical devices were adopted by the EU namely EU2017/745 and EU2017/746. These replace the existing Directives for Medical Devices and In-Vitro Medical Devices, respectively i.e. 90/385/EEC and 93/42/EEC, 98/79/EC 2010/227/EU.
The European Medicines Agency (EMA) have issued a guideline on GCP compliance in relation to the trial master file (TMF), and invites comments from stakeholders. The guideline was compiled by the Good Clinical Practice Inspectors Working Group and the deadline for comments is 11 July 2017.
Justin Malherbe, at law firm Norton Rose Fulbright South Africa writes that the long-awaited ‘Regulations relating to Medical Devices and in vitro diagnostic medical devices (IVDs)’ were published by the Minister of Health in the Government Gazette on 9 December 2016. These regulations are now in force.
A number of South African researchers use the REDCap (Research Electronic Data Capture) web application to manage their research data. So much so that the University of Witwatersrand (Wits) invited the REDCap creator, Professor Paul Harris, to South Africa to share his insights. Read the full story here.
UCT eResearch Centre in partnership with UCT Clinical Research Centre (CRC), have managed to organise 3 workshops during the year in order to get input from UCT researchers on their preferred CDMS.- five systems were identified.