PRINTO BYLAWS
Genova,
October 1, 2003
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.
To the top
ARTICLE
II
MEMBERSHIP
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
To the top
ARTICLE
III
GOVERNING
BODY - THE ADVISORY COUNCIL
Functions:
The governing body of the PRINTO is the Advisory
Council (AC). The chief functions of the AC are
to provide leadership and guidance for the PRINTO
in the following areas: identification and facilitation
of research areas most likely to be successful and
clinically or scientifically useful; seeking of funded
support for the groups research efforts; management
and quality assurance of the PRINTO’s membership,
its scientific studies, statistical analyses, databases
generation, and publications.
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
- The officers of the AC are elected in the following
manner: 1. Counsellors: solicited and elected
by majority vote by the National Co-ordinating
Centres (one country one vote).
- Senior Scientist: appointed by the Counsellors.
- Chairman: the AC will elect by majority vote
(4/6) one of the five Counsellors to the position
of Chairman.
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.
- Counsellors: five years.
- Senior Scientist: appointed
for a 10 years term to ensure continuity in the
activity of the group;
- Chairman: five years
(Article III amended on October 1st, 2003 by the
AC)
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.
To the top
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).
To
the top
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.
To
the top
ARTICLE
VI
AUTHORSHIP
OF JOURNAL ARTICLES AND OTHER PUBLICATIONS USING PRINTO
GENERATED DATA
Primary
Results of a PRINTO Study: In most cases,
the lead authorship of a journal article that reports
the primary results of a PRINTO study will be the
PI of that study. Additionally, several other individuals
who played key roles in the study's development, conduction,
or analysis may be included as co-authors. Following
the named authors, the statement "for the Paediatric
Rheumatology International Trials Organisation"
will be included. The cover page of the paper will
list the names of all members of the PRINTO who participated
actively in the study being reported.
The AC will determine prior to beginning a study a
minimum number of patients that must be enrolled in
each centre. If the minimum number of qualified patients
is enrolled at one centre, then a single investigator
will be included from that centre as an author on
the subsequent publication reporting the primary results
of the study. A centre that enrols patients, but does
not meet the minimum number as set forth by the AC,
will be recognised in the cover page of the paper.
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.
To
the top
ARTICLE
VII
LIAISON
TO OTHER ORGANIZATIONS AND GROUPS
The AC can appoint
official liaisons to other groups as deemed appropriate.
To
the top
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.
To
the top
ARTICLE
IX
AMENDMENTS
These bylaws may
be amended by a majority vote (4/6) of the AC according
to the suggestion of the NCCs.
To
the top
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:
To
the top
ARTICLE
XI LIST
OF FOUNDERS
| ADVISORY
COUNCIL |
| Chairman:
Alberto
Martini, MD Genova Italy
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
|
| National
Co-ordinating Centre Directors: |
Boel
Andersson Gäre, MD, PhD Jönköping
Sweden
Zsolt
Balogh, MD Budapest Hungary
Jaime
De Inocencio, MD Madrid Spain
Øystein
Førre, MD Oslo Norway
Hans-Iko
Huppertz, MD Wüerzburg Germany
Wietse
Kuis, MD Utrecht The Netherlands
Alberto
Martini, MD Genova Italy
Jose'
A. Melo-Gomes, MD Lisboa Portugal
Freddy
Karup Pedersen, MD Copenhagen Denmark
Pirkko Pelkonen, MD Helsinki Finland
Anne
Marie Prieu r, MD Paris France
Alexander Shaikov, MD Moscow Russia
Eric
Veys, MD Gent Belgium
Patricia
Woo, MD London United Kingdom |
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
To
the top
PRINTO
ORGANISATION CHART
|
|
|
Voting Officers:
Chairman:
Alberto
Martini, MD, Genova, Italy
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 |
|
|
International
Trials Co-ordinator
Nicolino
Ruperto, MD, MPH Genova Italy |
To
the top |
