| Deliverable no | Title | Dissemination level |
|---|
|
D1.1
|
Data model and functional database
|
confidential |
|
D1.2
|
Data monitoring, cleaning and export
|
confidential |
|
D1.3
|
Update of data monitoring, cleaning and export
|
confidential |
|
D1.4
|
Prospective analysis of risk factors associated with a lower quality of life in SSc patients
|
public |
|
D1.5
|
Analysis of disease characteristics in juvenile SSc patients
|
public |
| D2.1 |
Comparison of the current status of drug treatment in hand dysfunction by arthritis
|
public |
| D2.2 |
Evaluation of the efficacy and safety of different
treatments in preventing the occurrence of new digital ulcers
|
public |
| D2.3 |
Comparison of the efficacy and safety of different treatments
in healing of manifest ulcers
|
public |
| D2.4 |
Identification of the incidence of potential predictors for the
deterioration of hand dysfunction
|
public |
| D2.5 |
Determination ofthe optimal drug treatment for hand dysfunction
by arthritis and validation of DAS28,DAS28(CRP),
SDAI and CDAI in SSc
|
public |
| D3.1 |
Determination of the prevalence of SHD (CB, VA,
CHF, SD) and its association with drug treatment
|
public |
| D3.2 |
Retrospective evaluation of treatments preventing the
development of SSc-related PH and identification of predictors for development of SSc-related PH including validation of Cochin risk prediction
|
public |
| D3.3 |
Merged D3.2/D3.3
|
public |
| D3.4 |
Determination of the incidence of manifest SHD (CB, VA, CHF, SD) in asymptomatic SSc patients
|
public |
| D3.5 |
Current standard of ILD therapy and confounders recommendations on therapies
|
public |
| D3.6 |
Evaluation of the efficacy and safety of various preventive drugs
on PAH/PH development
|
public |
| D3.7 |
Comparison of the optimal drug treatment regimen for the
prevention of SHD in SSc patients at risk
|
public |
| D3.8 |
Prediction of outcome and response to therapy in ILD patients
|
public |
| D4.1 |
Comparison of outcomes based on the analysis of the currently available data already documented
|
public |
| D4.2 |
Comparison of outcomes using the prospectively collected data of the different OTs
|
confidential |
| D4.3 |
Aggregation of all results for preparation of therapy recommendations
|
public |
| D5.1 |
Written standard operating procedures and working instructions in accordance with ICH-GCP guidelines
|
public |
| D5.2 |
MEDSonline and data management infrastructure in accordance with ICH-GCP guidelines
|
confidential |
| D5.3 |
Incidental finding reporting system
|
confidential |
| D5.4 |
Monitoring and audit reports
|
public |
| D5.5 |
Compilation of initial ethics approvals
|
public |
| D5.6 |
Compilation of updated ethics approvals
|
public |
| D5.7 |
Report of PEC meeting
|
public |
| D5.8 |
Compilation of updated ethics approvals
|
public |
| D5.9 |
Update report of PEC meeting
|
public |
| D5.10 |
Update report of PEC meeting
|
public |
| D5.11 |
Update monitoring and audit reports
|
public |
| D5.12 |
Update monitoring and audit reports
|
public |
| D6.1 |
Implementation of a webpage for internal and external communication
|
confidential |
|
D6.2
|
Abstracts submitted to national and international meetings
|
public |
|
D6.3
|
Set of guidelines (“pre-Delphi”)
|
confidential |
|
D6.4
|
National SSc days for patients
|
public |
|
D6.5
|
Training courses at EUSTAR centers for physicians
|
public |
|
D6.6
|
Advertisement of the project to recruit additional EUSTAR centers
|
public |
|
D7.1
|
Project Management Manual
|
confidential |
