______
|TABLE OF CONTENTS
Modification History
1.Name
2.Purpose
3.Scope
4.Objectives
5.Membership and Structure
a.CDISC SAUG COMMITTEE
b.CDISC SAUG COMMITTEE CO-LEADS
6.Meetings
a.CDISC SAUG COMMITTEE MEETINGS
b.CDISC SAUG GENERAL MEETINGS
7.Dues
8.Policies
9.Amendments
10.Dissolution
Appendix 1: Elections
Appendix 2: CDISC SAUG Committee Members
Modification History
Version / Date / Author / Changes1.0 / 22-Mar-2012 / Dianne Weatherall / N/A – first version
2.0 / 30-Jul-2013 / Dianne Weatherall / Updated committee members
1.Name
The name of the CDISC User Network shall be the CDISC South African User Group (SAUG).
2.Purpose
The CDISC SAUG is an independent community of CDISC users, committed to the open exchange of information and sharing of experiences of CDISC models, to enable and promotediscussion and knowledge transfer in relation to CDISC standards amongst the South Africanregion.The CDISC SAUG is made up of volunteers from companies within or serving thePharmaceutical and Life Sciences industries.Other interested parties are welcome to participate as well.
3.Scope
This document covers the governance on the CDISC SAUG and is not intended to be usedor to imply any governance outside this group.
4.Objectives
The objectives of the CDISC SAUG are to:
- develop and maintain a communication framework for connecting members by co-ordinating face to face and/or telephonic meetings where participants can share knowledge and cooperatively address issues surrounding the implementation of CDISC standards
- perform a coordinating and supportive role across all members by monitoring feedback from members on a regular basis to determine common topicswhere discussion would be beneficial
- elevate the level of familiarity of CDISC among participants and within participating organizations through presentations and discussion
- maintain a shared, electronic environment called the web portal (a common area for the storing and sharing ofrelevant electronic documents related to the CDISC SAUG)
- act as a liaison to the national CDISC organization
- provide a cooperative voice for the South African pharmaceutical and biotechnology companies for discussion of standards and related regulations
5.Membership and Structure
There is no requirement for any CDISC SAUG member to be a CDISC member.
The membership of CDISC SAUG will be comprised of:
- Two CDISC SAUG committee co-leads, elected from the CDISC SAUGcommittee members to lead the group. Thetenure for this post (unless re-elected) is 12 months. There should be a period of overlap of at leastsix months between new and old co-leads.
- Committee members (maximum of 10), elected from the CDISC SAUG members. Thetenure for this post is 12 months.
- General members, maintained in the CDISC SAUG membership list.
Electionto the above roles is defined inAppendix 1: Elections.A quorum is defined as a simple majority of total members involved in the election process.
a.CDISC SAUG COMMITTEE
The CDISC SAUGcommittee shall manage the business of the CDISC SAUG.
The responsibilities of the CDISC SAUGcommittee are to:
- Plan and run general meetings.
- Communicate with membership.
- Communicate with CDISC and other organizations.
- Maintain the charter.
- Form and/or participate on subcommittees.
- Handle any other business of the CDISC SAUG as required.
The CDISC SAUG committee may set up permanent or ad hoc committees as necessary to carry out the objectives of the Network. The CDISC SAUG committee will seek participation on these committees from the general CDISC SAUG membership. A CDISC SAUG committee member will lead each committee.
The CDISC SAUG committee and other committees shall generally make decisions regarding the CDISC SAUG business based on consensus. In the event that a committee chooses to take a vote on a matter, all present at the meeting shall have the right to one vote and decisions will be made by a simple majority.
b.CDISC SAUG COMMITTEE CO-LEADS
The CDISC SAUGcommittee will elect 2co-leads who will serve a term of approximately 12 months. Candidates for the CDISC SAUGcommittee lead should have an active record of service in the CDISC SAUG and should usually have served on the CDISC SAUGcommittee.
6.Meetings
a.CDISC SAUG COMMITTEE MEETINGS
CDISC SAUG committee meetings (teleconferences or face to face) shall be held in January, February, April, May, July and August of each year, or as deemed necessary by the CDISC SAUG committee. Members shall be notified of the time and place of the meeting with 7 day minimum notice. Other committees shall meet as deemed necessary.
b.CDISC SAUG GENERAL MEETINGS
CDISC SAUG general meetings shall be held approximately 2 times a year in March and September, or as deemed necessary by the CDISC SAUG committee, at a place and time determined by the CDISC SAUG committee or its designee. Members shall be notified of the time and place of the Meeting with 28 day minimum notice.All general meetings of the CDISC SAUG shall be open to all via a registration process.
7.Dues
The CDISC SAUG shall not charge dues for membership. Voluntary contributions such as providing meeting facilities, teleconference services, or refreshments are welcome.
8.Policies
In maintaining its position within the CDISC community, the CDISC SAUG will adhere to certain policies:
- CDISC SAUG will remain an open organization, allowing new users to join at any time.
- CDISC SAUG will collaborate with CDISC’s Training team for formal training.
- CDISC SAUG will be CDISC-aligned and will be registered with CDISC.
- CDISC SAUG will follow CDISC ethics Policy & Code of conduct.
- CDISC SAUG will be represented in CGUN.
The CDISC SAUG will investigate partnerships with other organisations to address the issues of collectingfees for face to face meetings and paying for venues who need up-front payment.
Requirements for these partnerships include:
- Ability to identify alternative venues.
- More professional meeting organisation.
- Extending the numbers and variety of attendees at face to face meetings.
9.Amendments
Amendments to the charter may be proposed by any member of the CDISC SAUG. The amendment must be agreed upon by at least ten participants and constitutea 66% affirmative vote of those present and voting at a general meeting.
Notice of proposed changes to the charter must be announced by the CDISC SAUGcommittee to the general membership at least 28 days prior to each vote.
The amended charter will be effective immediately upon approval, unless otherwise requested in the proposed change or recommended by the CDISC SAUGcommittee.
10.Dissolution
Dissolution of the CDISC SAUG will occur by a meeting of the CDISC SAUG committee.
Appendix 1: Elections
NOTIFICATION:
The CDISC SAUG co-leads will announce elections at least 28 days in advance via e-mail tothe CDISC SAUGmembership as defined by the CDISC SAUG membership e-mailing list. Theannouncement will identify all of the committee positions up for election.
FREQUENCY
The positions all of the CDISC SAUGcommittee members, including co-leads, will be up forelection after 12 months of serving in their position.
VACANTPOSITIONS
In the event that a committee position is vacant, whether by creation of a new role or byresignation of a committee member from an existing role, an election to fill the positionwill be held within two regular CDISC SAUGcommittee meetings. The tenure of the positionwill be 12 months, afterwhich the position will be up for re-election. In theevent that less than four months, but more than one month, exists between the time whenthe position becomes vacant and the next 12 month anniversary election, that position,when filled, will not require re-election on the impending 12 month anniversary election.The elected person will serve through to the following 12 month anniversary electionwhen the position will again be offered up for election. In the event that one month orless exists between the position being vacated and the next election then no additionalelection will be required before the 12 month anniversary election.A log must be maintained of the names and dates that members joined the committee(please refer to Appendix 1a).
NOMINATIONS
CDISC SAUG Committee members
Following the announcement of a vacant committee position, a CDISC SAUGmember maynominate themselves or another CDISC SAUGmember by notifying the CDISC SAUG co-leads viae-mail. Nominations should occur at least three weeks prior to the election. Nomineescan withdraw their name at any time before the election by notifying the CDISC SAUG co-leadsvia e-mail.
CDISC SAUG co-leads
Following the announcement of a vacant co-lead(s) position, aCDISC SAUG committeemember may nominate themselves or another CDISC SAUG committee member by notifying theCDISC SAUG co-leads via e-mail. Nominations should occur at least two weeks prior to theCDISC SAUG election. Nominees canwithdraw their name at any time before the election by notifyingthe CDISC SAUG co-leads.
ELECTION VOTING
Elections for the co-lead(s) position(s) will be held during a CDISC SAUG Committee Meeting.Each member of the CDISC SAUG committee will have one vote. Committee members who arenot present may cast their vote up to three weeks in advance, via e-mail, to the CDISC SAUG co-leads.The decision to extend the time period for voting, via e-mail, to members who arenot present will be that of the CDISC SAUG co-leads, but must be done before the electionmeeting begins.
Elections for CDISC SAUG committeemembers will be held via e-mail. Each member of theCDISC SAUG will have one vote and they will have three weeks to cast their vote. Each memberwill be invited to cast their vote. The voting period will be closed after the three weeks.Anyone that casts their vote after the voting period will not be included in the voting.CDISC SAUG co-leads will send reminders to members to cast their vote. Election decision willbe made on a majority (as it is assumed that not all members will cast a vote).
ELIGIBILITY
All members of the CDISC SAUGcommittee are eligible to be nominated to the position ofCDISC SAUG co-leads. All members of the SAUG are eligible to be nominated tobecome a CDISC SAUGcommittee member.
LACK OF MAJORITY VOTE
In the event that one individual does not capture more than 50% of the votes cast, thenvoting will be repeated with only the top two candidates being on the ballot.
TIE VOTES
In the event of a tie, the CDISC SAUG co-leads will be eligible to cast a tie-breaking vote, whichis in addition to their regular vote. In the event of a three-way tie, the CDISC SAUG co-leadswill be eligible to cast two votes to allow the voting to move forward.
SINGLE NOMINEES
In the event that only a single person has been nominated in the required timeframe, thenthe vote will not be considered necessary and the person will be considered elected.
Appendix 2: CDISC SAUG Committee Members
CURRENT:
NAME / ROLE / START DATE / RE-ELECTEDDianne Weatherall / CDISC SAUG co-lead / 31-Jan-2012 / 01-May-2013
Dianne Weatherall / CDISC SAUG committee member / 31-Jan-2012 / 01-May-2013
Wouter van Wyk / CDISC SAUG co-lead / 01-May-2013
Wouter van Wyk / CDISC SAUG committee member / 31-Jan-2012 / 01-May-2013
Marielle Knott / CDISC SAUG committee member / 31-Jan-2012 / 01-May-2013
Riekert Henning / CDISC SAUG committee member / 31-Jan-2012 / 01-May-2013
Liza Faber / CDISC SAUG committee member / 31-Jan-2012 / 01-May-2013
Jaco van Blerk / CDISC SAUG committee member / 01-May-2013
RETIRED:
NAME / ROLE / START DATE / RE-ELECTED / RETIREDRichard Roodman / CDISC SAUG committee member / 31-Jan-2013 / 30-Apr-2013
Laurent Marais / CDISC SAUG committee member / 31-Jan-2013 / 30-Apr-2013
Marielle Knott / CDISC SAUG co-lead / 31-Jan-2013 / 30-Apr-2013
______
Document: / CDISC SAUG CHARTER_V2.0_Draft1.docx / Version Number: / 1.0Author: / Dianne Weatherall / Version Date: / 30-Jul-2013
Page: / 1 of 11