After the initial submission of data via the on-line registration form, supplemental information can be updated at www.ethicsapp.co.za, particularly recruitment status information.
To ensure that the information available through the data bank is timely and accurate, it is asked that the sponsor/principal investigator reviews, verifies, and updates all active protocol records on a six-monthly basis, at a minimum. With regards to market related products, license holders will be responsible for updates.
The research team must confirm the starting date of the study. It is recommended that information about trials that are unexpectedly closed (e.g. clinical hold) should be updated within 10 days after the closing or sooner if possible.
The sponsor/funder/principal investigator must also inform the SA National Clinical Trials Register of the trial completion date (i.e. date that analysis is concluded for the protocol), again within 10 days, as well as provide a summary of findings within a year of study completion.