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Bulgarian Clinical Investigators Forum (BUCIF)

(draft provosional)
Terms of Reference

Article 1
Designation of BUCIF

The 'Bulgarian Clinical Investigators Forum' is a not-for-profit organisation dedicated to the enhancement of clinical research for public health improvement in Bulgaria through information exchange, discussion, and education.
The organisation has adopted the acronym 'BUCIF'.

Article 2
Emblem of BUCIF

The logo of BUCIF shall be nominated by the Steering Committee and approved by the first General Assembly.

Article 3
Seat of BUCIF

The official location of BUCIF is the office the Chairperson of BUCIF.

Article 4

The Objectives of BUCIF are:
1. To advance clinical research in Bulgaria for the improvement of public health.
2. To exchange knowledge and experience among clinical research investigators.
3. To advocate for, and develop, a clinical trials infrastructure in Bulgaria.
4. To develop cooperation between public and private organisations and individuals involved in clinical trials.
5. In cooperation with the Bulgarian Forum for Members of Ethics Committees (BUMEC), to advocate and develop the protection of the dignity, rights, safety and well-being of research participants.
6. BUCIF will seek affiliation with the European Clinical Research Network (ECRIN) and the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER).
7. To coordinate with other national and international organisations involved with clinical research of research in human subjects.

Article 5

Membership of BUCIF comprises:
1. Ordinary Members who are, or used to be, investigators in clinical trials in Bulgaria.
2. Honorary Members are those invited by the Steering Committee to be an Honorary Member.

Article 6
Membership Responsibilities

The rights and obligations of members are the following:
1. Ordinary members have rights and obligations as follows:
   a) Render support to activities of BUCIF.
   b) To be elected or selected as a Steering Committee member of BUCIF.
   c) Participate in activities that have been set up by BUCIF.
   d) Propose opinions to the Steering Committee.
   e) Request for a special General Assembly of BUCIF to evaluate and change rules and regulations of BUCIF.
2. Honorary members have rights and obligations as follows:
   a) Render support to activities of BUCIF.
   b) To be invited as a consultant of BUCIF.
   c) Participate in activities initiated by BUCIF.
   d) Give advice and consultation to BUCIF.

Article 7
Membership Term and Fee

Membership is for life. It is voluntary and free of charge.

Article 8
Membership Termination

Membership ends by:
1. Death,
2. Resignation,
3. Withdrawal by more than two-thirds majority vote of the whole Steering Committee.

Article 9
Composition and Appointment of the Steering Committee

The Steering Committee comprises the following six officers:
• Chairperson
• Co-Chairperson
• Secretary
• Treasurer
• Ethics Officer
• GCP Officer
• Education Officer

The officers are elected by the General Assembly.

In the event of vacancy of any position before the term expires, the Steering Committee shall appoint a new member to fill the vacancy to serve until the end of the original term.

Article 10
Responsibilities of the Steering Committee

The Steering Committee is authorised to assume the following responsibilities:
1. Undertaking the objectives of BUCIF;
2. Appointing sub-committees or working teams as deemed necessary;
3. Ensuring to arrange a General Assembly meeting at least once a year to report past activities, financial statements, and future plans.

Article 11
Term of Office for the Steering Committee

The term of office for members of the Steering Committee is three years.

Article 12
Termination of Office for a Steering Committee Member

A Steering Committee member’s office can be terminated upon:
1. Death;
2. End of term;
3. Resignation;
4. Disqualification of ordinary membership;
5. Individual or all Steering Committee members can be removed by the vote of more than two-thirds of members present at the General Assembly provided that the proposal for removal has been included on the agenda in advance;
6. At least ten ordinary members must request the proposal for removal to be included in the agenda ten days prior to the meeting of the General Assembly.

Article 13
Responsibilities of the Steering Committee Offices

The Chairperson is responsible for undertaking all duties under the objectives of BUCIF.
The Co-Chairperson is responsible for the Chairperson’s responsibility in his/her absence or when he/she is unable to work; and for duties designated by chairperson.
The Secretary is responsible for
1. Preparing and keeping membership records,
2. Preparing meetings,
3. Recording the minutes of meetings,
4. Coordinating with other organisations,
5. Other duties as designated by the Chairperson.
The Treasurer is responsible for
1. Safeguarding funds of BUCIF;
2. Receiving and making payments according to the receipts and payment requests;
3. Preparation of receivable/payable accounts, and the lists of assets and liabilities of BUCIF.

The Ethics Officer is responsible for ensuring the ethical quality of BUCIF as an organisation and the integration of national and international issues in health research ethics into the activities of BUCIF.

The Good Clinical Practice Officer is responsible for the developing GCP practices and awareness within BUCIF as well as for integrating national and international GCP frameworks into GCP practice in Bulgaria.

The Education Officer is responsible for the development of an education programme for BUCIF and its association with national and international institutions.

Article 14
Steering Committee Meetings

1. The Steering Committee must meet at least twice times a year.
2. The minimum number of Steering Committee members must be at least four to meet the quorum requirement.
3. The Steering Committee attempts to reach its decisions by consensus. When this is not possible, a vote of at least 51% of those present is required for a decision. Members holding a minority view may request to record a dissenting opinion.

Article 15
The General Assembly

1. The Steering Committee must arrange the General Assembly at least once a year.
2. At least one-third of all ordinary members agreement is required to request a special General Assembly. The Steering Committee must arrange the meeting within 45 days upon receiving such a written request.
3. The General Assembly requires at least one-third, or not less than twenty members, to meet the quorum requirement.

Article 16
Finances of BUCIF

1. The Treasurer is responsible for keeping all funds of BUCIF that are under the supervision of the Committee.
2. Funds of BUCIF must be deposited in the bank or savings co-operative in the institute where the Treasurer is working.
3. The Treasurer can keep no more than 1000 Leva petty cash, unless otherwise deemed necessary with approval of the Chairperson, on a case-by-case basis.
4. The Treasurer must prepare an accurate account, including
   a) Receivable and payable accounts of BUCIF.
   b) Assets and liabilities accounts of BUCIF.
5. All payments of BUCIF must be the Treasurer and one other person designated by the Steering Committee.
6. Sources of income of BUCIF are from:
   a) National or international institutions agreed to by the Steering Committee.
   b) Other methods (e.g., activities organised by BUCIF).

Article 17
Dissolving BUCIF

1. BUCIF shall be dissolved through a resolution of the General Assembly attained by not less than two-thirds vote of all members.
2. When dissolved, all assets of BUCIF shall be given to the public organisations according to approval of the Steering Committee.

Article 18
Transitory Provisions

The following were elected to a 'Temporary Steering Committee' for one year at the 'Seminar on the Implementation of the EU Directive on Good Clinical Practice in Bulgaria' organised by the Association for Good Clinical Practice and Research Development in Bulgaria and the European Forum for Good Clinical Practice on 10-11 May 2004 at the National Palace of Culture in Sofia. The Temporary Steering Committee will have responsibility to review the Terms of Reference and carry out a nation-wide consultation prior to the first BUCIF General Assembly in 2005 where the final Terms of Reference will be presented for approval and the first 'Steering Committee' may be elected.

Temporary Steering Committee Members

Ethics Officer
GCP Officer
Education Officer


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