To all our sites, happy 2018!
Wishing all of you a blessed year ahead.
This year will see our 8th Clinical Trial Conference taking place from 12th – 14th September. T
he SACRA team is hard at work finalising the venue and agenda. More information will follow in due course.
The Site Sector of SACRA will be hosting a plenary session during the conference, with topics that will be of interest and relevance to sites.
Currently, our team have identified the following possible topics.
SACRA – providing insight into clinical trials in SA – how can SACRA assist sites.
Site Industry Collaboration
ICH update and how it affects sites, are your site processes compliant?
Transcelerate and its impact on sites
Various site related issues: contracts and budgets – the impact on sites, remote monitoring, audits and inspections.”
How to be well prepared for an audit/inspection.
Clarification on the clinical notes and medical records
Site SOP’s and which site-specific SOP’s are recommended
The MCC transition to SAHPRA and how it could affect sites?
These are still draft topics, and we would need input from YOU on what YOU would like to be presented.
Kindly send suggestions to Dr E Mitha and we will will review them for inclusion in the conference.
If any site is keen to have a site-specific workshop separate from the conference, we are willing to look into this if there is enough interest.
Please send me an e-mail if you are interested, and add your geographic location.
Thank you,
Dr Essack Mitha: emitha@newtowncrc.co.za
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SITE CAPACITY BUILDING:
1. As a continuation of SACRA's Site Capacity Building we will be holding GCP and GCLP refresher training, that will endeavor to address how the new revisions to ICH-E6 affect sites.
This will be on a date to be confirmed in May, 2018.
Johannesburg Sites staff are invited to confirm their participation by emailing: barbara@sacraza.com or nicolette.stott@ppdi.com.
Venue and cost will be confirmed shortly.
2. Durban Capacity Building Workshop is also to be held in May (dates to be confirmed).
The daytime sessions will be IATA accredited classroom training (which is required to be conducted over 2 days).
Registration fee of R2400 covers IATA training plus attendance of the evening session plus SACRA website membership - all for 20% less than the usual IATA training fee.
Reserve your seat as soon as possible by emailing: barbara@sacraza.com (only 20 slots available).
Following the IATA training session, there will be an afternoon/evening session consisting of capacity building related talks, some of which are accredited for Ethics CPD points. . This session is open to all at a fee of R1200 (for those not attending the IATA training).
We would like to hear from the Durban network, indicating to the SACRA Administrator which they would prefer:
* an afternoon (2:30-7:00pm) or evening (4:30-9:00pm) capacity building session?
Hoping to hear from you soon.
Thank you
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SACRA Administrator: barbara@sacraza.com.
Cell: +27 83 6308612