2011 February 11 Johannesburg

Exco 2011 introduction Savi Chetty-Tulsee (Chair)Independent Judith Ramuthaga (Vice)Pharma Tebogo Sebata (Treasurer)Pharma Robert Voogt (Secretary CT)Laboratory Diederik van Niekerk (Bloem)Independent Dr Francois BurgerCRO & Investigator Natalie DresseLogistics Nicky SulzerStudy Coordinator Dr Luthando AdamsSMO & Investigator Catherine LundCRO Barbara SematimbaFull time administrator

Updates of 2010 activity Sub-group activities CRA unit standard development Regulatory working group for CTF review Facilitation of the GCP sub-committee of stakeholders (SCT chair of committee) ITG meetings with registrar and development of good relations with MRA

Updates of 2010 activity Regulatory approval timeline tracking Dispensing w/group Collaboration with PIASA for common objectives Marketing of SA Survey on regulatory barriers in SA Journal of Clinical studies Jan11articles

Updates CRA Unit Standards: Still at the CHIETA SGB – no news Regulatory w/group review of CTF: Completed review of CTF1, 2 and 3. Pending progress report. Requested meeting with MRA to discuss proposed changes

Update GCP subcommittee of industry stakeholders Approval by HPCSA to review and accredit GCP providers 2011 – all providers to submit applications to HPCSA accreditor ( CPD2A form + GCP provider application forms) CPD accreditation to serve as educational point allocation as well as confirmation that the GCP provider meets the industry set criteria 9Feb11: Training of HPCSA accreditors on the review of the application process conducted

Update ITG has requested a meeting with the SAHPRA project w/group to get a status update MCC review and approval timeline tracking will recommence Feb11. Collaboration with PIASA will continue Development of a marketing SA package Survey of regulatory barriers report and liaison with stakeholders Dispensing License – legal review (in progress)

Updates Publications Encourage positive publications on SA Education initiatives to increase lay persons’ clinical trial knowledge

Recognition of excellence Site of the Year Clinical Research Associate of the Year Study Site Coordinator of the Year The person nominating the individual needs to check against the criteria in providing a brief summary of their experiences with working with the individual and provide examples of how this person went “over and above the call of duty”. This will help the judges in the decision making process. Any suggestions?? Nominations open on SACRA website Send s to SACRA Coordinator Visit website for criteria!!

Expectations from our membership Increased members across stakeholders Increased membership involvement in activities and projects Increased interaction through use of technology Pride, support and loyalty from within membership

2011 stakeholder focus

Sites & Study Coordinators (1) Increasing site capacity by raising the awareness of clinical research amongst clinical staff. There are many experienced clinicians in South Africa (doctors, nurses, allied health industry members) who potentially have a lot to add to our industry. Information sessions to be hosted by relevant SACRA members in each area where interested parties can gather to hear what is involved in becoming a research site and receiving useful information and contacts.

Sites & Study Coordinators (2) Increasing business skills’ knowledge amongst site staff. Clinical research is first and foremost a business & equipping relevant site staff with simple business skills is important to the efficient management of a site. If the decision this year is to host a conference perhaps SACRA could once again invite Christine Pierre to host a ‘Site business skills’ workshop. If there is to be no conference this year, perhaps SACRA & it’s partners could co-ordinate a site workshop where topics could include business skills, QC, SOP design and other topics suggested by interested attendees.

Service Providers (Natalie Dresse) Export Permit Information: May11 meeting Application document completion Application process FAQ’s IATA Training requirements for investigator sites: Last meeting IATA regulation training Roles & responsibilities in transportation

SMO/Investigators (Dr Luthando Adams, Dr Francois Burger) Review of Investigator fees/ budgets based on submitted costs. Review of Investigator sites payment terms. Capacity Building of sites Foster more early patient research activity in SA Improve cross networking amongst Investigator Collaboration with PIASA/SACRA to develop a marketing package/brochure

CRO’s - Catherine Lund, Dr Francois Burger Marketing and branding of SA Investigator database to be utilised by CROs for clinical trial study related information Bench marking survey on CRA salaries on the lines of expertise and skill set Education initiative (articles in magazines to improve clinical research understanding)

Pharma- Tebogo Sebata Judith Ramuthaga Continue ITG membership Restart MCC tracking Identify structure for corporate membership fees Education initiative (articles in magazines to improve clinical research understanding)

Independents - Savi Chetty-Tulsee, Diederik van Niekerk To impress the importance for continued education perhaps through small group meetings. Maintaining communication network is a challenge. The non involvement gaps identified may include budget constraints. Propose a client & independents survey on what education the independents require.

How often should the SACRA Conference be held How often should the SACRA Conference be held? Bi-Annually (Every 2 Years) % Annually (No change) % Every 18 Months % Number of Voters: 51

Website management,  Yearly memberships carry yearly user name and password  When renewing, it means you need to “re-register yearly !!  Company invoices generated on the home-page-Public menu-Multiple invoice request  Individual invoices generated at the “Become a member”  Or when you log on the your membership has expired, you need to “renew here”.  Choose payment option and please be careful to give correct details  Coupon code is then sent to you & needs to be used within 3 weeks to activate your access and log in into the members

How to activate your account

What’s new (1) The FDA amended the regulations governing the informed consent process for clinical research studies of products regulated by the FDA, at 21 C.F.R. § 50.25(c). This final rule was published on January 4, 2011 and it is effective March 7, The final rule requires that all informed consent documents for “applicable” drug (including biological product) and device clinical trials include a statement to inform individual subjects in the trials that a description of the clinical trial will be made available on the National Institutes of Health/National Library of Medicine (NIH/NLM) website at clinicaltrials.gov. The statement must also indicate clinicaltrials.gov will not include individually identifiable information. Compliance date: The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date.

What’s new (2) FDA Draft Guidance for Industry: Electronic Source Documentation in Clinical Investigations, December

What’s new (3) International Compilation of Human Research Protections 2011 Edition Compiled By: Office for Human Research Protections, U.S. Department of Health and Human Services

What’s new (3) cont. is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations. Many of the listings embed hyperlinks to the source document. These laws, regulations, and guidelines are classified into six categories: General Drugs and Devices Privacy/Data Protection Human Biological Materials Genetic Issues Embryos, Stem Cells, and Cloning