STATUTES OF THE EORTC MELANOMA GROUP
- Revised Statutes: February 26, 2003 -
1. Background and Aims of the EORTC Melanoma Group
The EORTC Melanoma Group was founded by both clinicians and scientists from various disciplines and fields of research with a common interest in malignant melanoma. The Group is committed to further execute and expand a comprehensive melanoma program through the fully integrated and collaborative approach by its member scientists and clinicians. This collaborative approach should be seen as the foundation of the Group’s strength.
The aims of Melanoma Group of the EORTC are to conduct, develop, coordinate and stimulate research on a clinical basis for the treatment of cutaneous melanoma cancer patients. To this end, the EORTC Melanoma Group is fundamentally based on prospective leading studies in the field of oncology with agents and treatment having potential value in the treatment of patients with melanoma. With an interest in tumour biology and especially the immunologic aspects of the disease, the Group should pursue a scientific approach to treatment development in malignant melanoma.
Moreover, the EORTC Melanoma Group has vocation to perform epidemiologic studies, histopathologic studies defining standards and guidelines, translational researches regarding prognostic factors and various metastatic and immunologic aspects of melanoma, and developed quality assurance programs for immunologic and molecular biologic assays in laboratory networks.
The EORTC Melanoma Group conducts its activities under the EORTC legal entity and is complying will all EORTC policies (available on the EORTC website) and strategies defined by the EORTC Board and approved by the EORTC General Assembly.
The EORTC Melanoma Group is a multidisciplinary Group and members of the Group are institutions or department (with the exception of scientist members and pathologists of the pathology review panel).
Membership is primarily linked to an institution. If the key person moves, the institution must come up with a suitable replacement. If available, this site remains a full member. If the person who moves wishes to remain a member, he may apply for probationary membership.
Depending on the number of patients per year entered into the Group’s trials, institutions can be categorized into:
|Active members:||≥5 patients/year over a period of three years.|
|Ordinary members:||1 - 4 patient(s)/year over a period of three years.|
In addition to patient numbers, the quality of protocol adherence and generated data will be subject to evaluation, and will be included in the evaluation of membership status.
New members receive the status of probationary members for an observational period of two years. During this period, at least 1 patients per year must be entered.
Institutions participating only in specific trials are designated as foreign members.
A specific status is recognized for scientists (epidemiologists, geneticists, molecular biologists, biochemists, pathologists, immunologists, clinicians) involved in the translational research programs in EORTC Melanoma Group clinical trials (scientist members).
Active members are expected to contribute at least 5 evaluable patients per year over a period of three years, provided that sufficient feasible studies are being offered by the Group. Furthermore, compliance with data management and timeliness is required. Active membership is also constituted by participation in the pathology review panel for EORTC Melanoma Group trials.
Ordinary members are expected to contribute every year to clinical trials of the EORTC Melanoma Group but with less than 5 evaluable patients per year over a period of three years, provided that sufficient feasible studies are being offered by the Group. Furthermore, compliance with data management and timeliness is required. When, for two consecutive years, an ordinary member do not contribute to EORTC Melanoma Group clinical trials, (s)he will be withdrawn from the Group membership list.
Any institution/department active in the fields of clinical and experimental oncology, which agrees to comply with the rules of the Group, can apply for probationary membership. Details of how to apply for membership can be found in Appendix I.
Besides the above definition, the Group also has individual scientific members, who are not participating in clinical studies. Scientist Members are scientists (epidemiologists, geneticists, molecular biologists, biochemists, pathologists, immunologists, clinicians, etc) involved in the translational research (TR) programs in EORTC Melanoma Group clinical trials or in projects not linked directly to a specific EORTC Melanoma Group clinical trial (i.e. epidemiology projects).
|These centers are allowed to participate only in pre-specified trials for which they have received the status of “foreign members”.
This can either relate to:
|Centers belonging to another EORTC Group and interested in participating in one particular study of the Melanoma Group|
|Centers from other Groups (e.g. SAKK, NCIC, ECOG) participating in interGroup studies initiated by the EORTC Melanoma Group|
|Centers removed from the probationary members as described in the “Probationary Members” section|
|These centers will receive an invitation to the Group meetings and a copy of all information relating to the study in which they are participating. They will NOT be allowed to attend any meeting restricted to the full or probationary members. Their participation at a sub-committee meeting depends on the explicit acceptance by this sub-committee Chair.|
|Observers are representatives from centers or from pharmaceutical companies, or anybody who has expressed the wish to remain in contact with the EORTC Melanoma Group. They will receive an invitation to the open Group meetings, which they are welcome to participate in. They will NOT be allowed to attend any meeting restricted to the full or probationary members. Their participation at a sub-committee meeting depends on the explicit acceptance by this sub-committee Chair.|
3. Board and Officers of the EORTC Melanoma Group
The Board of the EORTC Melanoma Group comprises a Chairman, a Secretary and a Treasurer.
They are responsible for coordination between all members of the Group and between the Melanoma Group other EORTC Groups and EORTC Data Center.
The Board is the executive body of the Group. All members of the Board are Officers of the EORTC Melanoma Group and are the effective members of the Group.
All Officers of the Melanoma Group of the EORTC must comply with the various EORTC policies (available on the EORTC website). Each Officer will act as a voluntary consultant for the EORTC.
They are responsible for providing a yearly report on the activities of the Group for submission to the EORTC General Assembly.
The Board meets at least twice a year and communicates by phone and e-mails as often as needed.
|The Chairman is elected by the active members of the Group for a term of three years. He can be re-elected once for a second three-year term (with the prior approval of the EORTC Board and a written justification from the Steering Committee of the Group).|
|The Secretary is elected by the active members of the Group for a term of three years. He can be re-elected once for a second three-year term. The secretary is responsible for the organization of the twice-yearly meetings and the distribution of the minutes to the whole Group membership. Minutes of Group’s meeting must be sent to all members and the EORTC Data Center representatives no later than 3 months after each meeting. The official language of the Group is English.|
|The Treasurer is elected by the active members of the Group for a term of three years. He can be re-elected, with possibility for several consecutive “three-year” terms. A yearly financial report must be submitted to the EORTC treasurer together with a grant application for the following year (if applicable).|
Full members (or her/his representative) of the Melanoma Group have the right to vote.
Each active institution/department represents one vote. In addition, pathologists participating in the Group’s pathology review panel have the right to vote.
Full members are Active members and some Scientist members (elected by the Steering committee of the Melanoma Group).
All votes should be performed in the business meeting.
The Steering committee nominates candidates; all full members can propose other candidates.
The elections will take place during the business meeting or by mail ballots.
Elections for individual positions must be secret and should be carried out in such a way as to ensure that the majority of the full members support the elected official decision/officer.
5. Group meeting, Group Subcommittees and Steering Committee
The Group meetings are organized twice-yearly.
A Group meeting consists of an open plenary session, a business meeting and several sub-committee meetings.
- The open plenary sessions are open to all members and observers.
- The business meeting is open to full members only.
During the business meeting, administrative, financial and general problems are discussed. All votes should be performed in the business meeting.
- The sub-committee meetings usually follows the open plenary sessions.
The sub-committees are nominated by the active members during the business meeting.
The EORTC Melanoma Group presents several distinct sub-committees fully integrated in a collaborative approach and all concerned with the management of melanoma. These current sub-committees are:
• Adjuvant Therapy strategies
• Chemotherapy / New Drugs
• Vaccine Development
• New Laboratory Techniques /New Assays
This sub-committee structure is adapted accordingly to the sharply increased activities of the Group and is subject to change according to future developments.
Each sub-committee is headed by one Chair elected by the Steering committee of the Group according to her/his field(s) of expertise for a term of three years. She/He can be re-elected once for a second three-year term.
Each Sub-committee Chair is member of the Steering Committee.
Each Chair acts as Quality Assurance Officer of his/her sub-committee and reviews the performance of the different institutions/members participating in the Group trials and/or sub-committee’s activities.
The Steering Committee of the EORTC Melanoma Group:
The Steering Committee of the EORTC Melanoma Group comprises the 3 members of the Board, all Sub-committees Chairpersons, the Group’s Coordinating Physician of the EORTC Data Center and a few representatives of the Group (selected from institutions with the highest accrual, taking a diversity of specialties into account).
The Steering Committee is advising the Group on new activities (clinical and scientific activities) and is in charge of discussing the future strategy of the Group. The Steering Committee meets at least twice a year, usually just before each Group meeting.
All members of the Steering Committee of the Melanoma Group of the EORTC must comply with the various EORTC policies (available on the EORTC website) and act as a voluntary consultant for the EORTC.
6. Representation of the EORTC Melanoma Group in the General Assembly
The chairman of the Group automatically becomes a full member of the EORTC General Assembly for the duration of his/her mandate.
7. Publication and Authorship
The EORTC Melanoma Group publications:
All Group publications, oral and written, will have “EORTC Melanoma Group” in their title or authorship.
All information generated by the studies is the full property of the Group unless specified otherwise in the contracts with sponsors.
None of this information may be used for publication without written approval of the study coordinator, the Group chair and the sponsor involved. The latter should be notified at least 30 days before intended submission.
Final papers should be drafted by the study coordinator within 6 months of receiving the final study report. If this deadline is not adhered to, the Group board may appoint another first author.
No analysis of single institution data that are part of the full data set of any study performed by the EORTC Melanoma Group may be published by an institute before the full data set has been published by the Group. In addition, publication of institutional data that are part of an EORTC Melanoma Group study require written approval by the Chair of the Group and EORTC DC in order to ensure compliance to general EORTC rules.
If there is disagreement, the Group Board will decide with majority vote. In case of non-compliance of an EORTC-Melanoma Group member institution with these policies the Board will decide on further actions with unanimous agreements and may terminate the membership immediately.
After the first publication, other study participants are free to communicate the results at their respective national meetings, but abstracts for this purpose always need to be approved by the study coordinator and the Melanoma Group Chair.
|1.||The study coordinator (usually the first author).|
The Group chair is a co-author on all EORTC Melanoma Group studies during his/her mandate (usually the last author).
Representative(s) of the member institutions which have contributed most of the cases (to be determined per protocol) (co-authors).
The Statistician and the Coordinating Physician are co-authors as EORTC Data Center representatives. The position of the EORTC statistician and the Coordinating Physician of the Group among the authors are discussed on a per case basis.
Whenever possible, each participating institution will be acknowledged by name and institution.
Manuscripts must be reviewed by all co-authors prior to submission for publication.
All accepted abstracts and publications must be sent to all co-authors, the secretary of the Group and the EORTC Data Center.
When a manuscript has been accepted for publication, the Study coordinator should send a copy of the abstract to the Secretary, with the object to keep informed all Group Members of the final outcome of the work.
Translational Research Side Studies publication:
Reports on TR Scientific Side studies in conjunction with a clinical trial of the Group are encouraged as separate publications.
The coordinator of such a side study is the first author, and usually the study coordinator is last author, with other authors listed according to their input into the side study.
The report has to be approved by the MG chair prior to submission.
The Statistician and the Coordinating Physician are co-authors as EORTC Data Center representatives only if they have participate into the management and/or analysis of this TR Side Study.
The EORTC Melanoma Group has to explicitely be acknowledged in the title of the report.
After the first publication, other study participants are free to communicate the results at their respective national meetings, but abstracts for this purpose always need to be approved by the side study coordinator and the study coordinator.
Scientific publication not related to EORTC Melanoma Group clinical trials:
Reports on scientific projects performed within the framework of the EORTC Melanoma Group can also be reported as EORTC-Melanoma Group projects, regardless of funding by the MG.
The authorship is according to standard authorship rules for scientific publications.
The support of the EORTC Melanoma Group in terms of framework and potential funding has to be appropriately acknowledged in the publication.
All reports need to be approved by the MG chair prior to submission.
8. Relations with pharmaceuticals companies
Financial support from a pharmaceutical company will be negotiated by the chairman, the physician coordinator of the EORTC Data Center and the study coordinator.
All financial contributions will be put in the Group’s fund and allocated after decisions taken by the Group during the business meetings.
Any data transfer to the pharmaceutical industry should be approved by the chair, the physician coordinator of the EORTC Data Center and the study coordinator.
9. Protocol Design and Writing
This Standard Operating Procedure is meant to supplement the standard general rules already present at the Data Center for outline submission and protocol development.
|1.||A proposal for a clinial trial or a TR Side Study can be made by any member of the EORTC Melanoma Group. The proposal should usually be first discussed with the appropriate subcommittee chair, before it is brought forward to the Group steering cie or the business meeting for further discussion.|
|2.||If a decision has been made by the Group board to develop a proposal, a writing cie is formed. Automatic members of this writing cie are the Group chairperson, the DC Coordinating Physician, the member of the Group who proposed the study and the appropriate sub-commitee chair. Also at this point a proposal for the study chair is made.|
|3.||Correspondence regarding further development of the proposal into the Protocol Review Committee (PRC) outline or the full protocol is communicated to all members of the writing cie, usually by email.|
|4.||Further development of the outline/protocol should be done according to the EORTC guidelines. The guidelines are described in the Investigator’s Handbook.|
|5.||Submission of the proposal to PRC needs explicit approval of the MG chairperson.|
Study coordinator is designated by the Group and hold office for the duration of a protocol.
They should actively take part in the study. They are responsible for the smooth running of the protocol, with the help of the Data Center, and for resolving any difficulties which may arise during the study.
They are responsible for the preparation of appropriate publication material, obtaining the agreement of all authors concerned. The role of the study coordinator is fully detailed in Appendix II.
10. Participation in an EORTC Melanoma Group Trial
Any active or probationary member can participate in a Group trial after fulfilling the administrative procedure as described in Appendix III.
Foreign members can participate only in those trials for which they have received the status of “foreign members”.
Participation in certain Clinical and/or TR Side Studies may be restricted by the experience of a given Institution/department in a complex treatment approach and/or study logistics.
11. Clinical Trial Data
Data will not be released from the EORTC Data Center without the permission of the study coordinator, the chair of the Group and the medical advisor/statistician. Data may not be used in oral or written form without the permission of the study coordinator.
The chair and treasurer are responsible for the finances of the Group. Financial issues are discussed during the steering committee and the business meeting.
The treasurer is responsible for presenting an overview of the account of the Group during the business meeting.
The Group’s funds are formed by:
• All financial contributions from pharmaceutical companies for Group trials.
• The EORTC grant (whenever applicable).
• Other sources.
Financial support from the Group is available for the following circumstances:
• Scientific studies related to EORTC Melanoma Group trials.
• Preparation of EORTC Melanoma Group trials.
• Secretarial expenses for the chairman, secretary and treasurer.
• The allocation to member institutions (per evaluable patient).
• Quality control activities or review of data at participating centers by members of the Group.
• Study coordinators’ visits to the DC.
• Travel expenses of non-members who are invited to Group meetings to give presentations.
• Fellows allocated to specific Group projects.
• DC statistician and data managers to attend Group meetings or protocol specific meetings.
13. Clinical and scientific misconduct
If a member of the EORTC Melanoma Group is found to be involved in scientific misconduct or gross violation of the Statutes of the Group, the Board will decide on further actions with unanimous agreements and may terminate the membership immediately.
The decisions of the Board will be presented to the Group at the next meeting for approval.
The chair of the Group will inform the EORTC Quality Control Committee and the EORTC Board.
14. Relations with the EORTC Data Center and with the Central Office
Close collaboration between the Chair, Study Coordinators, and the EORTC Data Center Group- staff and EORTC DC Director) is essential.
All protocols to be submitted to the Protocol Review Committee and to the Translational Research Advisory Committee must be reviewed by the EORTC Data Center staff (coordinating physician, statistician, data manager, and quality of life and health economics specialists when appropriate) prior to their submission.
For sponsored trials, negotiations with pharmaceutical industries should be carried out jointly by the Chair of the Group, the Group coordinating physician, the Data Center Contract Manager and the Director of the Data Center to guarantee financial support for the management of the study, and to assure optimal services to the pharmaceutical industries.
For all trials, sponsored or not, optimal communication between the Chairpersons of the Groups and the Regulatory Affairs Manager of the EORTC is also mandatory to provide adequate insurance coverage for all studies which are conducted with the EORTC label and under EORTC legal responsibility.
All applications for funding by the European Commission or by any other granting agencies (ESF, etc…), on behalf of an EORTC Group, or bearing the name of the EORTC and involving EORTC, should be transmitted prior submission to the EORTC Central Office for appropriate coordination.
15. Modification of the Statutes
Wrote request for modification of these statutes are sent to the Chairm at least two weeks before the General Assembly. Its discussion in the General Assembly is immediately followed be a vote. Majority of votes is necessary for its acceptance.
SUMMARY OF THE PROCEDURE TO BECOME A MEMBER OF
THE EORTC MELANOMA GROUP
A new center may apply either to the chairman, the secretary or the EORTC Data Center (DC) representative. Any application request will be transmitted to the Melanoma Group team at the DC.
The DC will send a standard information package to the applying institution which consists of a questionnaire, an overview of the Group’s ongoing studies and a copy of the statutes. A copy of the letter of application and the reply should be forwarded to the chair, the secretary.
The applicant should return the questionnaire to the DC indicating the studies in which he/she is interested and the number of patients he/she expects to enter in these trials. In addition, the applicant must send a copy of his/her C.V. and the normal laboratory values of his institution.
Upon receipt of the questionnaire and the necessary documents, the DC will forward a copy of the questionnaire to the chairman, the secretary and the chairman of the subcommittee.
All applications received at the DC are discussed by the Board and subcommittee Chairman (by e-mail and if needed during specific meetings), who decide whether the application is accepted, with or without site visit or whether is rejected. A written reply is always addressed to the applicant, with copies to the chairman and the secretary.
Applicants whose request has been accepted will receive an invitation to the meeting. They may be asked to present their center and activities.
On the basis of the information available and the decision of the Board, a site visit might be scheduled at the applicant’s institution before acceptance of the application. The applicant might be asked to provide financial support for the site visit.
THE EORTC MELANOMA GROUP STUDY COORDINATOR (SC)
The general guidelines have already been described in the two chapters dealing with the responsibilities of EORTC study coordinators in the EORTC Investigator’s Handbook.
The study coordinator is responsible for the good conduct of the study. In this respect, he will work closely with the Data Manager (DM), the statistician and the physician coordinator at the DC for the duration of the study.
Together with the chairman and the medical advisor, the SC will negotiate contracts with the pharmaceutical industry for his trial.
The SC will submit the protocol to the Protocol Review Committee according to their guidelines (see Investigator’s Handbook).
Final paper should be drafted by the SC within 6 months of receiving the final study report. If this deadline is not adhered to, the Group will appoint another first author.
During the conduct of the clinical trial, the SC has the following responsibilities:
1. Trial monitoring
From the start of the study onwards, the SC visits the DC to review the accrual and the data on the patients entered, to evaluate eligibility and to discuss the problems of the study with the DC staff. Finances are provided for two visits a year, including travel (ground transportation or economy class flight ticket) and one night’s hotel accommodation, if necessary.
2. Preparation for Group meetings
The SC contacts the DM at least one month before the meeting to discuss the tables to be included in the report for the Group meeting. The DM will send the prepared tables to the SC one week before the meeting. The SC will check the tables and request additional information if necessary. If the SC does not contact the DM, minimum information for the trial will be prepared.
3. Group meetings
The SC will present the data of his study at meetings and discuss the status and the results with the Group.
4. Distribution of information, study forms and protocols
Study forms and protocols, at the start of each new study, are sent from the administrative secretariat to the centers listed in the protocol, together with a letter from the study coordinator. During the trial, protocol and forms can either be sent from the secretariat or the SC. Subsequent amendments to protocols and/or study forms should follow the same route as for the activation of the protocol.
PARTICIPATING IN AN EORTC MELANOMA GROUP TRIAL
The investigator must contact the EORTC Data Manager of the trial:
Data Manager of trial “trial-No”
EORTC Data Center
Ave. E. Mounier 83 /11
Tel: +32 2 774 16 04
Fax: +32 2 772 35 45
The data manager will reply by a letter, requesting the following information:
■ Curriculum vitae (if not yet available)
■ Normal laboratory values (if not yet available)
■ Ethics Committee approval for this specific protocol
■ Commitment Statement (which includes disclosure of potential conflict of interest)
The data manager will put an institution on the list of authorized participants only upon receipt of the required information. This will enable the institution to enter patients into the trial. The procedure on how to enter patients into a trial is described in each trial protocol.