Quality Management System
The QMS includes a suite of Standard Operating Procedures (SOPs) that describe how certain tasks should be performed, and that encapsulate any standards and/or regulatory requirements that may apply to those tasks.
By adhering to the Quality Management System, the user, as staff or partner engaged, the sponsors as well as any other stake holder will be assured that applicable regulations are adhered to.
While several SOPs were already in operation, the formal QMS was implemented in August 2022.
All EUSTAR members or partners participating in clinical research are required to read and acknowledge electronically the QMS as part as their induction or continuous training.
Ongoing review dates of the QMS should be every 2 years.
EUSTAR Structure/Governace, Routine Activities and Collaborative Projects QMS and respective SOPs are listed in the Private Member Area.
A graphic summary of the QMS structure and relative SOPs is below.
- EUropean Scleroderma Tirals and Research group (EUSTAR) must be acknowledged on every presentation/publication that results from accepted proposals.
- EUSTAR centers providing samples and clinical data should be co-authors on manuscripts and presentations derived from the study (at least one per center) whenever possible. In case of a too high number of authors for the target journal, an adequate acknowledgement must be provided in the paper. Conflicts of interests in this matter will be decided by the Executive Officers If submitting centers do not agree with this procedure, they must clearly state this in the proposal. There are no exceptions from this rule. The sequence of authors is decided by the submitting center, but should in general be based on the numbers of cases/samples contributed to the study.
- The intellectual content of the proposal belongs to the submitting center. Misuse of the proposal for own studies is strictly forbidden.
The caretaker officers positions will be opened to candidature and there being no alternative nominations, election by closed written ballot will take place by one representative of every EUSTAR members eligible to vote.
The caretaker officers will be elected by an overwhelming majority (>50%), supervised by the appropriate World Scleroderma Foundation officer
According to the EUSTAR statute, election is for 3 years with an option to continue for another 3 years. Officers can be re-elected only in a different position.
The following positions are open to election:
- Councellors (4)
The past board will present the names for nomination. Any other colleague or group of colleagues can be nominated for election. This one must be EUSTAR member.
In April, before the elections taking place during the EULAR congress in June, an announcement will be made asking all EUSTAR members for nominations. Nominations must arrive at the EUSTAR secretariat before the end of April. Nominations will be collected and the names will be put forward for election.
Committee members will be chosen by the board (after the elections of officers) and proposed to the general assembly for ratification.
The next new board (chairman, treasurer, secretary) will be elected and will start to work with the help of previous board in order to shape up the EUSTAR programme of the next triennium.
SOP EUSTAR clinical project
- Apply for a EUST AR project on the EUST AR website: http://eustar.org/projects
- The application review is handled by the EUST AR clinica! project coordinator
- The project is assigned a clinica! project number and the clinica! project leader adds it to the project number list.
- The project is send out for external review (1-2 reviewers)
- The clinica! project coordinator is confirming the receipt by email.
- The board and clinical project leader agree to the application after review. In a split vate, the EUSTAR chairman decides.
- The applicant signs the author form, which indicates that the database will only be used for the spe-cific project. The form also included informati on on the authorship rules for EUSTAR projects ( own SOP).
- The applicant sends the signed form back to the clinica! project leader.
- The EUST AR statistician/database manager will be contacted to send the applicant a recent down-load of the database. If any restrictions apply to the datato be provided (full data set or just paits), the data manager gets informed. Specific information: The data will be drawn once a month – usually in the first week of a month – an expoti of the database (Excel file).
- The data manager/statistician will provide the recent EUSTAR Excel file via a Drop box link per email to the applicant with the clinical project leader and the EUST AR secretary in cc.
- Authorship: Please referto the EUSTAR publication SOP. When the EUSTAR database is used, EUSTAR authors need to be included. Please contact the EUST AR board early enough to select co-authors and include them in the result discussion.
- When a project results in a publication, the applicant is sending the paper to provide the clinica! pro-ject leader with the publication information and a pdf.
It has been decided by all members that companies may have access to data presented on the database for special purposes. EUSTAR will be the interface between companies and centres that have filled the database. When a company wants data collected in EUSTAR centres, they have to ask EUSTAR and once approved, they will pay EUSTAR that will use the money to maintain the datased system and improve the quality and content of the database. After cross consultation the following fees were decided:
- Regular updates on demographics from the MEDS for a fixed annual fee (€ 20,000)
- NO details of centres
- Ad hoc project based studies with fee according to amount of work required. All negotiations between EUSTAR board and Company only.
The Companies will have no access to raw data, no influence over statistical analysis and no veto rights on the final publications. Only centres in which patients have given permission for anonymous data use will participate (this is an intrinsic part of the MEDS on-line participation)