The EORTC Gynaecological Cancer Group (EORTC-GCG)

Art. 1: Membership and application for membership

Anybody active in the field of clinical and/or experimental gynecological oncology, who agrees to comply with the rules, can apply for Probational Membership. Members of the EORTC groups and EORTC committees are associate members of the organization.

A new associate member will be on probation for a period of 3 years. During this Probational Memberships period at least 10 fully evaluable patients have to be entered in one or more protocols in 3 years. Evaluation will be done on a yearly basis.  In case of active participation during these 3 years Active Membership can be obtained if 10 fully evaluable patients are entered after 3 years.  Those who did not enter the required number of evaluable patients within 3 years will leave the group at that time. 

The same criteria for active participation used for Probational Membership will be applied for Active Membership. Only in exceptional cases prolongation of Probational and Active Membership will be possible.
A full member who changes hospital retains his/her Active Membership after renewed application for an initial period of 3 years. Therefore, active members are those who are able to enter at least 10 patients into EORTC GCG clinical trials in a maximum period of three years.

The status of Active Membership will temporary be withdrawn from investigators who have a large proportion of inevaluable cases, from those who regularly submit incomplete data or ineligible patients or from those who do not send in their forms in time regularly.
These Institutions with DTL (data timeliness) problems will not be activated until problems are solved.

The EORTC GCG recognizes Corresponding members, who are individuals who will   be informed about the activities of the group, but who are not active members. The status of corresponding members can be obtained by 1 or 2 individuals appointed by other national or international groups, doing research on gynecological cancers. Corresponding members can also be specialized individuals who bring a substantial contribution to the activities of the EORTC GCG without recruiting patients into clinical trials (basic scientists, pathologists, radiologists, pharmacists, etc).  
Corresponding Members can attend the General Assembly and Tumor-site Committees but have no voting right.

In some circumstances, other type of membership may be considered. Foreign membership may be taken into consideration for “temporary” affiliation of an institution with the EORTC GCG in the context of a specific clinical trial provided that the EORTC general rules allowing foreign membership have been followed. This special foreign membership can also apply for those highly specialized individuals who may be involved and contribute to a specific research proposal.  

Art. 2: Structure and rules of the group

The structure of the GCG includes the chairman, the secretary, the treasurer, the GCG Executive Board, the Tumor-Site Committees (for cervix- vagina -vulva; ovary-fallopian tube; endometrium-trophoblastic disease), the Translational Research Subcommittee, the Quality Assurance Subcommittee, three Advisory/Subspecialty Subcommittees (Chemotherapy, Surgery and Radiotherapy),  the representatives of the EORTC  HQ and the associate Active, Probational,   and Corresponding members.

The chairman of the group is being elected by the Active Members for a period of 3 years, only in exceptional circumstances he/she can be reelected for another term but this may require the approval of the EORTC HQ executive board.  The secretary and the treasurer are elected for 3 years. He/she can be reelected for another term.  The chairman, the secretary and the treasurer, are elected among the Active Members and preferentially are not replaced at the same time.

A Vice Chairman may be elected who will work with the Chairman and be a member  the  Executive  board. The Vice Chairman will be an Active member and selected by the Active  members.

The EORTC GCG Executive board consists of the chairman, the immediate past chairman for  upto 3 years,  the secretary, the treasurer, the chairman of the Protocol-Committee, the EORTC clinical research physician, CRP, the statistician and the project manager of the group, the 3 chairpersons of Tumor-site Committees, the TR chairperson, a young oncologist and an ad hoc person nominated by the group chairman.  Its major task is to optimize and maintain the functioning of the group.

The chairperson is in charge of planning the EORTC GCG meetings along with other officers. He/she is responsible for organizing teleconferences and EORTC GCG executive board meetings between the EORTC GCG General Assembly/ Business meetings. The Executive Committee meets at least twice a year.  The EORTC GCG Executive Board can make quick decisions for the group but these decisions have to be confirmed by the Active Members during the regular Business Meeting. 

The Tumor-site Committees are composed of 7 participants, the chairperson and 6 members, of which 3 of the 6 members have to be Active Members.  The chairman has to be an Active Member and is nominated at the Business Meeting.  The Tumor-site Committees nominate a Vice-Chairman.  Active and Probational Members make their choice with preference for the tumor-site committee given according to the number of patients accrued during the previous 2 years.  The chairman stays chairman for 2 years and can be re-elected once.  The proposals of new protocols have to be sent at least 4 weeks before the meeting to the Protocol Committee of the EORTC-GCG.
The Chairperson of the Tumor-site Committee must advise the coordinators and follow the progress of the protocol development closely.  

The Subspeciality Committees are composed of those members belonging to the respective subspecialties.  There is one Chairman nominated at the Business meeting, appointed for 2 years and can be re-elected once.  The Subspecialty oriented Committees will be asked to give advice on new protocols. 

The EORTC-GCG Protocol Committee (PC) consists of at least 15 voting members.  The same rules for duration and chairmanship exist as for the Tumor-site Committees. However, taking into consideration the complexity of this task and the required experience that it is needed for chairing the PC, the PC chairman can be reelected as long as the group considers this is necessary. The membership consists of 1 PC chairman and 1 vice-chairman (Active Member to be elected at the Business Meeting), the 3 chairpersons of the Tumor-site Committees, the EORTC-GCG chairman, 5 members with the highest accrual of patients during the past 2 years (Active Members only), 1 statistician, 1 chair translational research/pathologist-Basic Research, 1 responsible for Quality Control.  Additional voting members are the EORTC-GCG Secretary, the chairpersons of the Subspecialty oriented Committees, the clinical research physician, the project manager and the Treasurer.
The PRC reviews and critizes the new protocol proposals which has been received at least 4 weeks before the PC meeting and has been circulated to the members. At hoc proposals presented during the meeting will not be discussed. The PC will appoint the study coordinator of the accepted protocols.

The Tumor-site Committees, Subspecialty oriented Committees and the Protocol Committee will not function as separate entities but all the work done is part of the EORTC-GCG. A written report of each meeting of the Tumor-site Committees, Subspecialty oriented Committees and Protocol Committee will be sent to the chairman and secretary of the EORTC-GCG.

Art. 3: Voting power

All active centers (represented by one member) have voting power.

Art. 4: Meetings

At least 2 official EORTC GCG meetings are being held per year.  These include a Business Meeting (only one representative of each active center may vote), Committee Meetings (all Active Members, Corresponding Members, Probational Members and invited guests) and a General Assembly which is open to all members and others who show interest in the group.  Subcommittees will meet two times per year.  The chairperson of these subcommittees will report on activities during each Committee Meeting of the EORTC GCG

Art. 5: Minutes of the meetings

Minutes of the meetings will be sent to the EORTC HQ within 2 months after each meeting.  A summary of the minutes will be sent to the General Director of the EORTC and the Scientific Director of the EORTC after each official GCG meeting for publication in the EORTC Newsletter/EORTC website.

Art. 6: Finances

All financial matters will be decided by the Active Members of the group.

Art. 7: Rules for publications and protocols

A. Full papers:

1. There can be only one coordinator.  Depending on the protocol 1 co-coordinator can be appointed. Young oncologist should be encouraged to be co-coordinators or coordinators of new EORTC GCG projects. If possible together with a more experienced coordinator.
2. Trials will be published exclusively at trial maturity. When endpoints (primary and secondary) are mature, cleared and analyzed, unless authorized by IDMC (formal process). 
3. The authorship for centers should be according to the number of evaluable patients entered.  At least the 3 largest recruiting centers should be author (see also A-10)
4.  Whenever possible the clinical research physician and statistician should be co-authors if they were actively involved in the production of the study.
5.  Whenever possible the chairman of the EORTC-GCG at the time of opening the study, will be author.
6. Other persons who were actively involved in the writing or preparation of the manuscript may be author.
7. For intergroup-studies the number of coordinators per group should be one.  The largest center that accrued most patients per group should be author.
8. Mailing of full papers should always be done before submitting, to the chairman, the secretary, the EORTC HQ, the centers that qualify for authorship and to all contributing centers.
9. One institution can not have a coordinator of more than 2 ongoing studies or not yet published studies.  Closed studies should be published within 1 year after the final analysis by the Data Center.  If the coordinator does not produce the manuscript within 1 year after the final analysis by the EORTC HQ, the investigator of the largest recruiting center will be asked to prepare the manuscript.
10. If possible according to the rules of the journal the manuscript will be submitted by the whole EORTC-GCG.  All contributing centers, coordinators, data-manager, clinical research physician, statistician and chairman will be listed as co-authors and owners of the data.  If this is not possible, according to the rules of journal, all contributing centers who do not qualify for authorship will be acknowledged for their active cooperation.
11. All publications have to be approved by the EORTC HQ (Statistician-Clinical Research Physician), the authors  and the EORTC GCG Chairman
12. Quality of life results: not to be published before trial primary endpoints to allow interpretation at the light of main study question.
13. Ancillary studies (prognostic, predictive models, surrogate markers) may not to be published before trial primary endpoints. Translational research studies maybe published before trial primary endpoints provided they do not affect study primary endpoints and the data are mature.

B. Abstracts

1. Abstracts should be faxed at least one week before submission to the chairman, secretary and all centers that qualify for authorship. 
2. Otherwise the same rules for authorship apply as for full papers. 

C. General Assembly

At the first General Assembly after the submission of an abstract or full paper all members of the group should get a copy.

D. Ownership of the data

After publication of the first manuscript the data and the manuscript remain property of the group and can only be used after approval by the study coordinator and the group chairman.  Also in the case of intergroup studies the consent of each group will be required.

Brussels, 2 March 2011.

Appendix. Standard Operating Procedures (SOP)

Chairman’s responsibilities

The chairperson should develop and prepare (together with the EORTC GCG Executive Board) scientific plans and has to attend the meetings with the SAC (Scientific Audit Committee) in Brussels. The chair needs to have a clear understanding of the EORTC functioning. The chair should attend the meetings with the EORTC HQ Executive Board in which new projects are presented. 
The chair represents the EORTC GCG group at international meetings such as GCIG, ENGOT, NCIC, etc. New applications have to be endorsed by the EORTC Membership Committee in Brussels and the EORTC GCG chairman. The chairman will communicate new applications to the EORTC GCG executive board members and will ask them for their opinion.      

Secretary’s responsibilities

The secretary is responsible for making the minutes of the EORTC-GCG meetings (to be approved by the chairman before distribution) assist with the planning of both, the EORTC GCG General Assembly and the EORTC GCG Executive board meetings, prepare reports and circulate it to the members. The secretary has to keep the membership data base up to date; liaising with the membership committee secretariat of the EORTC HQ and assist the chairman with the correspondence regarding membership issues. The secretary replaces the Chairman as representative of the EORTC-GCG at international meetings, if the Chairman cannot attend.

Study coordinator’s responsibilities

The coordinator of the protocol is responsible for taking on the leadership in the
development, conduct and publication of an EORTC Clinical Trial on behalf of
the EORTC GCG. Study coordinators are also responsible for communicating with the responsible chairpersons of the corresponding Tumor-site Committees and the Chairman and the Secretary of the EORTC-GCG.  In addition, they are responsible for sending the protocol to the CRP for review by the EORTC Executive Committee, the protocol Review Committee (PRC) of the EORTC Headquarters.
The coordinator assumes their role early on in the submission of a project proposal to the EORTC Headquarters Early Project Optimization Department (EPOD). The Study Coordinator will seek endorsement from the Group Steering Committee and EORTC Headquarters for any additional/ subsequent studies planned on the data/ biological materials collected in the EORTC Clinical Trial to which they were assigned.

The Study Coordinator needs to be aware of EORTC Policies, and to ensure that the
EORTC clinical trial that they are coordinating is designed, conducted and published according to these policies.
The Study Coordinator also needs to participate in ‘their’ EORTC Clinical Trial as an active EORTC Investigator, which in the case of an EORTC Clinical Trial, also involves their active accrual of patients.
In case a senior and a young investigators are appointed, the senior investigator will have priority in the decision-making process during the study conduct and maximum responsibility with reference to the points 1 to 11. The senior investigator will also have priority as co-author of abstracts, reports and presentations to international meetings.    
The most relevant responsibilities of EORTC study coordinators are: 
1. To discuss the project not only with EORTC investigators, but also with other eventual partners such as other EORTC groups, other non-EORTC groups, potential industrial sponsors and with the clinical research physician and the EORTC HQ team to ensure that the study is feasible.
2. To present the project proposal to the EORTC HQ Executive Committee for strategic assessment in close collaboration with the clinical research physician and the EORTC statistician.
3. Further development of the project for presentation to the EORTC Protocol Review Committee (PRC) and the EORTC advisory committees (the translational research advisory committee, TRAC, and the New Drug advisory committee, NDAC).
4. Develop the study outline into a full EORTC protocol according to EORTC methodology.
5. Review and approve the final version of the complete EORTC protocol prior to resubmission to the PRC.
6. Review the contents of the case report forms (CRFs) proposed by the EORTC HQ team.
7. Answer all medical questions from EORTC investigators and from the EORTC HQ team, in a timely fashion.
8. Review at regular times the case report forms of the entered patients at the Data Center in Brussels and review the serious adverse events reports forwarded by the EORTC HQ Pharmacovigilance unit on a timely basis.
9. Draft a manuscript within six months of receipt of the final statistical report; circulate the draft manuscript to all the co-authors and to the EORTC HQ team.
10. Review and approve all subsequent publications that make use of their EORTC clinical trial data in accordance with the publication section of the EORTC protocol.
11. The study coordinator should include a substantial number of patients into the study and will provide a prolonged support to the study to qualify and maintain the position of study coordinator.