Investigators & Site Communique

The Investigator sector seeks to assist investigators in matters related to clinical trials.

A Site Investigator survey will be conducted in 2015 which will aim to collect demographic information as well as to highlight issues of concern to investigators. Updates to the SACRA website will be coordinated so as to ensure that investigators and sites benefit from SACRA membership.

From SACRA Investigator Representatives : Building Sites through engagement

Dear Investigator/Site representative

This email serves as an introduction to the Site Representatives that have been elected to the Executive Committee of SACRA for the 2016-2018 period.

There are 2 representatives, Dr Essack Mitha (Johannesburg), and Dr Mohammed Siddique Tayob (Middelburg).

SACRA has made efforts in the last few years to include Investigators within its structures. This is an opportunity for sites to raise and discuss issues of relevance. We encourage all sites to register with SACRA via the website (www.sacraza.com). And so this will ensure that the correct details are used for all future communications. This link is specifically directed to Investigator and Site staff alone.The investigator sector has been formed specifically for site staff in order to address a longstanding need within the South African research landscape.

Under the unifying umbrella of SACRA, this sector will finally add the site voice to all discussions. It acknowledges the importance of the site in the successful execution of clinical trials within our borders and would like to focus attention on the unique needs, challenges & success stories that exist. This sector will only be as successful as the sites & their staff allow and we request for your involvement. Without this buy in by sites, this initiative will become irrelevant to those shaping policy and shaping our industry.

This sector is for ALL sector site staff (investigators, coordinators, technicians etc)With this in mind our first priority is to involve your sites and to get feedback from you on your concerns/comments & issues. This will build the solid foundation that will guide and prioritise any future discussions & projects. Our aim is to make sites relevant in the broader clinical trial discussion, to share best practices to improve our quality of data produced & ultimately to make South Africa an attractive place for conducting research in the competitive global village.The Investigator sector seeks to assist investigators in matters related to clinical trials.

Updates to the SACRA website will be coordinated so as to ensure that investigators and sites benefit from SACRA membership.

We have also uploaded the results of the Investigator/Site survey conducted in 2016 on the SACRA website under the Investigator and Site section.

If you have any contributions to make, or would like to raise concerns via SACRA, please send an email to emitha@newtowncrc.co.za or ms@bmc.za.netRegardsDr Essack Mitha & Dr Sidiqque Mohammed Tayob

Documents for your perusal:·

Emergency trolley: http://www.mccza.com/documents/7e0456522.41_Emergency_Procedures_Clinical_Trial_Sites_Jun16_v2.pdf·

Principal and Co-Principal Investigators: http://www.mccza.com/documents/3fcbcf2c9.84_Clinical_Trial_Investigators_Nov16_v1.pdf·

Remuneration of trial participants: http://www.nhrec.org.za/docs/Documents/Paymentconsiderations.pdf·

Changes in regulations regarding Dispensing Licences: GG37032 15 Nov 2013 Regulation 18 – addition of wording regarding scope of practice: http://www.mccza.com/documents/cfbd5477Gov_Gazette_37032_15_11_2013_Regulations_Act101.pdf

GG 36929 14 Oct 2013 – Regulation 20 – dispensing license remains valid as long as annual fee is paid: http://archive.opengazettes.org.za/archive/ZA/2013/government-gazette-ZA-vol-580-no-36929-dated-2013-10-14.pdf

Removal of subsections in Regulation 18 determined to be unconstitutional – related to requirements for application (extension of license period to 5 years, replaced by GG36929): http://www.gov.za/sites/www.gov.za/files/33177_389.pdf·

Draft documents out for comment: http://www.mccza.com/Publications/Index/4

  • &#8226 Website – Investigator / Site blog

  • &#8226 Site training and capacity building – various initiatives including working with Department of Health

  • &#8226 Dispensing licence working group

  • &#8226 Site start-up fees

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