STEP 1: READ AND ACCEPT THE PRINTO BYLAW Genova, October 1, 2003
I'have read and accept the printo Bylaw
ARTICLE I PURPOSE
The purpose of the Paediatric Rheumatology INternational Trials Organisation (PRINTO) is to foster, facilitate, and conduct high quality research in the field of paediatric rheumatology.
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Centres: The PRINTO is composed of clinical centres that actively engage in the diagnosis and management of children with rheumatic diseases. New centres who wish to become members apply by letter to the Chairman of the PRINTO group. If approved by majority vote of the Advisory Council (4/6), the applicant centre is considered probationary until successful performance is evidenced in at least one PRINTO study. Following this, the centre is considered to be in good standing.
Physicians: Each centre must have a designated Centre Director who is a physician with documented experience in paediatric rheumatology. Centres also may have additional paediatric rheumatologists who participate actively in PRINTO studies, with the approval and supervision of the Centre Director.
Apply for membership
ARTICLE III GOVERNING BODY - THE ADVISORY COUNCIL
Authority: The AC has the authority to: decide membership of the PRINTO, approve grant proposals and study protocols which call for the utilisation of the PRINTO's patient resources, approve the use of PRINTO databases by members of the group and non-members who have use for such data and discipline PRINTO members. The AC also has authority to appoint sub-committees to study certain issues when the need arises.
Members of the AC: The AC has six voting officers. Five Counsellors (one of whom act as Chairman), and the Senior Scientist. All the voting officers must be paediatric rheumatologists and, except for the position of the Senior Scientist, must come from different states.
Election to the AC: The election process will occur prior to July 1 of the terms in office, with the newly elected (or re-elected) member's term commencing the following January
Terms in Office: The officers of the AC have the following terms in office (beginning January 1 after election). For the seek of continuity there should not be a complete change of the AC at any point in time.
Meetings of the AC: The AC will have at least one meeting per year, and may have more if the AC decides that the extra meetings are necessary. Minutes of each meeting will be kept by the Senior Scientist and distributed to the general membership following approval by the AC.
ARTICLE IV ORGANIZATION
International Co-ordinating Centre (ICC): The ICC has the function to: facilitate the logistic and scientific details necessary to design, launch and manage a multi-centred, multi-national, collaborative clinical trial. The ICC could assist the Principal Investigator (PI) in the design of the protocol, statistical analysis and generation of the final report and of the manuscript. Access to the electronic database: each member has direct access to the data of his own centre, and NCC can have direct access to the data of his own country. The complete database will be provided to members and non-members after proper request by letter to the Chairman, and approval by the AC.
National Co-ordinating Centres (NCC): The function of each NCC is to: facilitate the participation of the greatest number of individual PRINTO members, disseminate the information about on-going trials in the local national setting, provide the translation of all the forms to be completed by the parents/patients, or the physician if not familiar with the English language (official language used by the PRINTO group).
ARTICLE V ACTIVATION OF THE PRINTO MEMBERSHIP FOR PURPOSES OF CONDUCTING A STUDY
Any member of the PRINTO in good standing may submit a protocol to the AC for approval. Protocols may be submitted in either one of two forms: a complete protocol, or an idea protocol.
Complete Protocol. If a member of the PRINTO has written a complete protocol for the conduction of a study (either clinical or basic science studies), and needs assistance in recruiting patients or could benefit from the other resources of the PRINTO such as computational assistance, the protocol is submitted to the Chairman for approval to the AC. If approved, the investigator submitting the protocol will serve as PI for that study. The AC can decide to assist the PI in obtaining funding for the study if not already secured.
Idea Protocol. If a member of the group has an idea for a study, but lacks the time or expertise to develop a full protocol, an idea protocol can be submitted by the member to the Chairman for approval to the AC. If approved, the Chairman and the Senior Scientist and other appropriate resources within the group will assist the member in the development of the full protocol. In this case, the AC will designate one person to serve as PI and the member who proposed the idea as co-PI.
ARTICLE VI AUTHORSHIP OF JOURNAL ARTICLES AND OTHER PUBLICATIONS USING PRINTO GENERATED DATA
Secondary Results of a PRINTO Study: Articles reporting results of studies that use data from any PRINTO database will have as the lead author the person most responsible for the design, analysis and reporting of the results. This person may or may not have been the PI of the original study. Other authors will be included as deemed appropriate by the lead author. Following the named Authors the statement "for the Paediatric Rheumatology International Trials Organisation" should be included.
ARTICLE VII LIAISON TO OTHER ORGANIZATIONS AND GROUPS
The AC can appoint official liaisons to other groups as deemed appropriate.
ARTICLE VIII DISCIPLINARY ACTIONS
The AC has the authority to discipline PRINTO members whose conduct during a study has compromised the study's results or successful completion, or endangered a patients well-being.
International and national co-ordinating centres: The ICC and the NCCs may have their role revoked and be placed on probation by majority vote (4/6) of the AC. Adequate causes for a change in status of the ICC or the NCCs include inadequate performance during a study such that the integrity or success of the study is threatened. Good status may be reinstated following correction of the deficiency and majority vote (4/6) of the AC.
Individual centres: Individual centres may have their good standing status revoked and be placed on probation by majority vote (4/6) of the AC. Sufficient causes for a change in status of a centre include the departure of the Centre Director without replacement by a paediatric rheumatologist, or other changes that would compromise the centre's ability to carry on high quality clinical research. Good status rating may be reinstated following correction of the deficiency and majority vote of the AC (4/6).
Individual physicians. Individual physicians may be placed on probation by majority vote (4/6) of the AC. Adequate reason for placing a physician on probation include inadequate performance during a study such that the integrity or success of the study is threatened. A physician on probation may reapply for full membership if desired.
Officer of the AC: Any officer of the AC may be removed from office or AC membership by majority vote (4/6) of the AC.
These bylaws may be amended by a majority vote (4/6) of the AC according to the suggestion of the NCCs.
ARTICLE X TRANSITION RULES
For the first three years of existence (starting on January 1, 1998) of the PRINTO, the Officers will be the Founders of the Organisation:
Counsellors: Boel Andersson Gäre, MD, PhD Jönköping Sweden Wietse Kuis, MD Utrecht The Netherlands Anne Marie Prieur, MD Paris France Patricia Woo, MD London United Kingdom
Senior Scientist: Nicolino Ruperto, MD, MPH Genova Italy
Liaison with the Paediatric Rheumatology Collaborative Study Group (PRCSG) in North America
The AC of the PRINTO will request that the AC of the PRCSG elect one of their members to act as non-voting observer. Additionally, the PRINTO will request that one of our members act in a similar capacity to the PRCSG.
Italy, June 15, 1997
PRINTO ORGANISATION CHART
Centre Directors: Boel Andersson Gäre, MD, PhD Jönköping, Sweden Wietse Kuis, MD, Utrecht, The Netherlands Anne Marie Prieur, MD, Paris, France Patricia Woo, MD, London, United Kingdom
Senior Scientist: Nicolino Ruperto, MD,MPH Genova, Italy
One Observer from the PRCSG
