statutes of the eortc brain tumour group

Revision october 2007

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1. Aims of the group

The primary aims of the Brain Tumor Group (BTG) are to conduct, develop, coordinate and stimulate research on primary and secondary brain tumours. To fulfill these aims, the BTG will promote and conduct prospective clinical studies, and whenever possible carry out associated translational research.

2. Membership

The EORTC Brain Tumor Group (BTG) is a multi-disciplinary group within the European Organisation for Research and Treatment of Cancer (EORTC). Individuals from EORTC member institutions may apply for EORTC BTG membership. There is no limit to the number of individuals allowed as BTG members from the same centre, but a primary contact person should be designated for each centre and the existence of a valid e-mail address is mandatory (all regular communications will be done by e-mail).
The BTG recognizes the following membership categories, depending on the participation in previous trials and the number of patients per year entered into BTG trials or on the scientific contribution to the work of the group:

• active: to quality for the active membership it is required to either include  > 4 evaluable patients/year/centre * or to provide major scientific contribution to the clinical studies of the BTG (translational research, pathology review, imaging protocols etc). Members in this latter category are designated by the Steering Committee.
• probationary: new members receive the status of probationary member for an observational period of 2 years. During this period, at least 4 evaluable patients per year per centre have to be entered in BTG trials, with timely and adequate submission of case report forms.

* The numbers of patients required for active membership may be adapted by the BTG Steering Committee based on availability of active trials in a given year.

Requirements, duties and rights of BTG members:
Members are expected to participate regularly in the bi-annual meetings of the group. In case of non-participation, they may be excused for a maximum of 2 consecutive meetings.
Only active and probationary members are allowed to enroll patients in BTG trials.  Patient accrual is restricted to those members fulfilling quality assurance conditions and complying with regulatory requirements.
Members need to provide a valid e-mail contact address, and are required to reply in a timely manner to e-mail requests.
All group members are responsible for their own expenses when attending bi-annual group meetings.
Active members:
Active members must adhere to quality assurance review procedures, which may include formal site visits. For active membership, a recruitment of at least 4 evaluable patients per year for two consecutive years is required. An evaluable patient implies fulfilling all the administrative responsibilities with adequate and timely follow-up as judged by the EORTC Data Centre.
Active members have the right to vote in elections of the officers of the group.
Probationary members:
Any individual who has expressed the wish to join the BTG and who agrees to comply with the rules of the group may apply for probationary membership. A new probationary member is admitted to the group for 2 years. Based on the accrual during these 2 years, they may become active members. Probationary members, after undergoing initial quality assurance clearance may activate BTG protocols and actively enroll patients. The probationary membership-status can be prolonged or discontinued after that period based on review by the BTG Steering Committee.

Membership Procedure:
Those wishing to join the EORTC Brain Tumour Group must apply directly to the EORTC (membership@eortc.be) after which they will be provided with the procedure to be followed and the necessary forms for completion.
The EORTC Membership secretariat will evaluate the applicant’s activity in other EORTC groups, will evaluate the EORTC membership status of other groups within the center, may request additional information and documentation as appropriate (e.g. CVs normal laboratory values and accreditation, etc.), verify that the ROG Facility Questionnaire has been submitted (in the case of the applicant’s wish to enter studies with radiation therapy or request its submission) and will request preliminary approval by the BTG officers.  All applications will be regularly reviewed by the Steering Committee, at least at the half-yearly meetings, for final approval.  If the application is accepted, the applicant becomes a probationary member and may initiate participation in trials.
Applicants from an “EORTC Core Institution” (NOCI) or an EORTC Affiliated Institution are automatically accepted as probationary members.

3. Elections

The election of the chair will be held every three years.  Active members of the group have the right to vote in the election of group officers; if there is more than one member from a single institution that institution has one vote.  Candidates for election may be proposed by all active member institutions.  Voting will take place at the general assembly or by e-ballot.  In case there is no general consensus or clear two-third majority in favour of a proposed candidate, a written election may be organized.
Only active members can become officers. The secretary and treasurer are co-opted while the chairman is elected by the active members.
Prior to the elections the membership list is updated according to section 2.

4. Group Officers

The chairman He/she chairs the steering committee meeting and the plenary business meeting. He/she represents the group at the EORTC General Assembly/Chairmen’s Meeting.

The vice chairman replaces the chairman in case of absence.

The chair-elect will work alongside the sitting Chair until the end of his/her term of office and will be a member of the Executive.

The past chairman is responsible for assistance to the chairman and may represent the chairman at the EORTC General Assembly/Chairmen’s Meeting and other EORTC meetings. He/she remains a member of the steering committee meeting and the plenary meeting to assure continuity of ongoing and closed projects and studies.

The secretary He/she is responsible for the organization of the twice yearly meetings and the distribution of the minutes to the whole group membership. He/she may represent the chairman at the EORTC General Assembly/Chairmen’s Meeting and other EORTC meetings.
The secretary and chairman are responsible for coordination between all members of the group and between the BTG and other cooperative groups within and outside the EORTC. They are responsible for providing a yearly report on the activities of the group for the EORTC Central Office.

The treasurer He/she is responsible for the group finances. The treasurer is responsible for presenting a report on the group’s financial situation during the plenary meeting

Term of Office
The chairman, vice chairman and secretary are elected for a term of three years. In principle a re-election for a second term is only possible in the case of the secretary. The chairman is elected for one term only, and re-election is only possible in exceptional circumstances and with approval of the EORTC Executive Committee. All others are elected or co-opted.
A new Chair will be elected 18 months before the end of the term of office of the sitting Chair, becoming the Chair-elect.  At the end of the sitting Chair’s term of office, the Chair-elect takes the chair and the sitting Chair becomes the Past Chair. The term of the chair and the other group officers coincide with the term of the general EORTC Board elections.

5. Group Meetings

The group meetings are organized twice yearly. A group meeting consists of a steering committee meeting, a plenary meeting and various subcommittee meetings, as appropriate. An agenda for the group meetings will be prepared and posted on the group’s website at least 2 weeks prior to the meeting and all members will be notified by e-mail of this. Any active member can request (in writing) additional topics to be added to the agenda.

All active and probationary members and  EORTC Data Centre representatives are admitted to the BTG plenary meeting. Visitors (i.e. non-EORTC), representatives of the pharmaceutical industry and members of other EORTC groups or other cooperative groups may be granted permission to participate by the chairman or secretary of the group. Parts of the meeting may be declared as a closed session limited to active and probationary members only.

In a year in which an EGAM (EORTC Groups Annual Meeting) is organized, the BTG meeting is incorporated in this event.

Additional meetings can be organized to address specific strategic or scientific issues.

6. Committees

a.  Steering Committee: The EORTC BTG has a steering committee which consists of the past and present chairman, the secretary, the vice chairman, the treasurer and the chairs of the following subcommittees: Quality Assurance (QA), Pathology (PA), Translational Research (TR). Further, all coordinators/study chairs of active trials are automatically also included in the Steering Committee. The EORTC Data Centre is represented by the Coordinating Physician, the Statistician, and the Data Manager(s). Further, the chair of the Brain Tumour Working Party of the Radiation Oncology Group is part of the Steering Committee. The Steering Committee includes a designated young scientist (<40 years). On an ad hoc basis, representatives of other partner groups (i.e. the NCI-C, TROG, RTOG, other EORTC groups) may be asked to join the Steering Committee.

The Steering Committee will meet prior to the BTG plenary meeting. At the Steering Committee meeting future strategies and practical matters will be discussed. The plenary meeting is prepared during the Steering Committee meeting. All decisions proposed in the Steering Committee require approval of by the active members during the plenary meeting.

The participation of Officers and Chairs of the Subcommittees in the semi-annual meetings is considered mandatory. In case of non-attendance due to conflicting engagements, officers should excuse themselves in advance, while subcommittee chairs should seek replacement by another member of the subcommittee. Members of the subcommittees are co-opted by the Steering Committee.

b. The Quality Assurance (QA) Subcommittee: reviews the performance of the different centres participating in the group trials. The members of this committee should reflect the different fields of specialty involved in the treatment of brain tumors (at least a radiotherapist and a medical oncologist). They meet at least once a year. They review the memberships and the compliance with regulations. They will set up a system of quality assurance for the group trials.

c. The Pathology (PA) Subcommittee gives guidelines for pathology review within trials, and assists in the development of translational research.

d. TheTranslational Research (TR) Subcommittee will advice the BTG / EORTC Protocol Review Committee regarding proposals for TR.

e. A Nominating Committee is an ad hoc committee which is convened at the time of election of group officers to receive the names of candidates for the positions to be filled.

7. Publications and authorship

All publications of group studies, oral and written, will have “EORTC Brain Tumor Group” in their title and must be approved by the chairman or the secretary, the involved statistician and the study coordinator. Authorship includes:

• the study coordinator (usually the first author)
• representative(s) of the centres which have contributed 10% or more of the cases included in the publication are always co-authors
• members who have included less than 10% of patients will be included as co-authors at the discretion of the study coordinator, based on the contributions to the trial (e.g. design, associated research, promotion).
• at most two representatives of the EORTC Data Centre
• Authorship may have to be shortened in cases of limitations in the number of authors imposed by the journal, which may overrule the above described regulations.
• All other investigators and sponsor representatives must be acknowledged.

All manuscripts and abstracts must be sent for review by all co-authors prior to submission for publication; the co-authors must send their opinions within 3 weeks. All accepted abstracts and publications must be sent to all co-authors, to the secretary of the group and to the Data Centre.

8. The development and writing of a new protocol

New protocols
New protocols or their outline should be presented and discussed in the plenary meeting. In cases where rapid protocol development is indicated, the outline can be approved by the Group officers, allowing submission to the EORTC Executive Committee for further feasibility review before Protocol Review Committee (PRC) review and full protocol development. All trial proposals are developed according to EORTC regulations, and require approval of the EORTC Executive Committee.

Further development of the protocol requires the involvement of the Data Centre Staff and require approval of the PRC.  It is mandatory that the TR subcommittee approves and is involved early on in the development process.  A representative of the TR and PA  subcommittees should be part of the protocol writing committee.

The formulation of a budget and negotiations with a potential sponsor will be undertaken by the Principle investigator in collaboration with the Group Chair, Secretary and Treasurer, together with representatives of the EORTC Data Centre.

Translational research (TR)
Translational research and correlative studies are a particular focus of the EORTC BTG. The BTG strives for integration of ancillary studies within most clinical protocols. The study coordinator and the Translational Research Committee coordinate, in close collaboration with the Pathology Committee, all translational research, with advice from the EORTC TRAC (TR Advisory Committee) where appropriate.

TR projects must be approved by the principal investigator (PI) of the study which is involved in the project, the TR Subcommittee and the chairman and the secretary of the BTG. If translational research has not been foreseen in the initial protocol, or when stipulated by the protocol, review and approval by the EORTC Protocol Review Committee may be required.
 
All new initiatives within the BTG should be submitted to the TR Subcommittee for review, comment and consideration of biological studies prior to full development of the protocol.

Principle investigators (PI)
PIs are appointed by the group and hold office for the duration of a protocol. The person bringing forward the protocol idea, developing the outline and mobilizing appropriate funding is usually the study coordinator. He/she should actively take part in the study. With help of the Data Centre they are responsible for the good running of the protocol, and for resolving any difficulties which may arise during the study. They are encouraged to have personal contact with local investigators in order to assure a smooth and problem-free accrual.  They are responsible for the preparation of appropriate publication material, and for obtaining agreement of all concerned authors. Principle investigators should be involved in budgeting of a new study, i.e. to include in Data Centre calculations any amounts which will be needed, i.e. for QA or TR so that these are not overlooked.

9. Quality assurance (QA)

The Quality Assurance Subcommittee develops quality assurance criteria for protocol treatments. The chairman of this subcommittee is chosen by the Steering Committee and represents subcommittee in the Steering Committee. All active and probationary members of the BTG are expected to comply with the minimum requirements for participation in BTG studies.  For joint studies with the Radiation Oncology Group, they also need to comply with the ROG-specific quality assurance requirements.

10. Clinical Trial Data

Data will not be released from the Data Centre without the permission of the study coordinator and the chairman of the group. Data of the complete trial may not be used in oral or written form without the permission of the principle investigator. Trial results of individual centres may not be presented in oral or written form before the results of the entire study are published. The first presentation of results of a BTG study will take place at the BTG plenary meeting.  Exceptions to this rule (in the case of advance preparation of abstracts for international meetings) will be decided by the chairman and the secretary of the group.

Any data transfer to a pharmaceutical industry or to other (academic) investigators must be approved by the chairman, the study coordinator and the Director of the Data Centre.

11. Finances

The chairman, secretary and the treasurer are responsible for the finances of the group.
The group has several sources of income:

• Sponsor funding by pharmaceutical companies for trials of the group.
• Grants arising from project applications to funding bodies, e.g. EU Framework Program, national cancer leagues
• Other sources (eg. donations from charitable organizations)

All funds are handled centrally by the EORTC Accountant, expenses require review and authorization by the BTG Treasurer. The chair of the group will authorize expenses of the treasurer.

The group will pay expenses per trial and per randomized eligible patient, based on an approved budget, for which often earmarked income and been secured (eligibility to be evaluated by the Data Centre/PI).  Other expenses require formal approval by the Steering Committee and/or the Group Plenary session.  The following expenses are usually considered by the BTG:

• secretarial expenses for the chairman, secretary and treasurer
• reimbursement of costs of centres in particular trials (per evaluable patient), usually paid at the end of the trial.  Interim payments can be performed based on evaluable patients on written request of a centre
• reimbursement of expenses in connection with quality control activities or review of data at participating centres by members of the group
• reimbursement of the cost of study coordinators’ visits to the Data Centre and other activities related to the study conduct (e.g. representation at other groups’ meetings)
• reimbursement of travel expenses of group members who are requested to represent the BTG at other meetings
• reimbursement of travel expenses of non-members who are invited to group meetings
• reimbursement of expenses of Fellows allocated to specific projects of the group
• cost of publication (e.g. per page costs in certain journals, colour printing of illustrations)

In addition, the group may want to support unfunded or insufficiently funded studies with a grant to the EORTC Data Centre, or to investigators performing ancillary and translational research; decisions on this matter to be taken by the Steering Committee.

Payments up to € 5.000 can be authorized by the group chair or the group secretary, payments between € 5.000 and € 25.000 require authorisation by both the group chair and the group secretary, payments in excess of € 25.000 require authorization by the group chair and at least two of the other three group officers (Secretary, Vice Chair, Treasurer).

12. Revision of statutes

The statutes may be revised at any time by the group officers.  Although changes can come into effect immediately, they require the approval by the active members of the group at the next following general assembly.

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