Substudies Submission
- Information requested for a submission of an I-CARE substudy :
- Substudy Protocol
- Methodologic plan
- Local referent methodologist
- Complete file to be sent by Email to : mcoisnon@getaid.org (in cc : icare@getaid.org)
I-CARE substudy project assessement
Main step
-
Substudy submission
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Executive Committee assessment
-
Methodology assessment
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Form with minor/major comments
-
Presentation and SCI COM vote during international congress
Why?
To ensure the high quality of I-CARE substudy projects.
Who and what?
- Executive Committee : L.Peyrin-Biroulet, F. Baert, L. Beaugerie, JF. Rahier
- To evaluate faisability with I-CARE database (with or without supplementary data).
- To check the absence of overlap with I-CARE 4 main studies and previously approved substudies (independant project or in collaboration with Executive Committee to work in the main objectives)
- Methodologic commitee : C. Baumann (I-CARE methodologist), H. Rousseau (I-CARE statistician)
J. Kirchgesner (Coding group referent) and Executive Committee members.- To validate project methodology (endpoint, statistical analysis plan, design)
- To ensure compliance with I-CARE database.
Substudies received
| SUBSTUDY ASSESSMENT | |||
| I-CARE STUDY GROUP | EX COM | METHODOLOGY | SCI COM |
|
DATA IBD 2020
Scientific officer:
|
Pending | ||
|
PREGNANCY
Scientific officer:
|
Pending | ||
|
PREVALENCE OF COMBO THERAPY WITH IS IN IBD PATIENTS RECEIVING BIOLOGICS
Scientific officer:
|
On Hold | ||
|
CARDIO VASCULAR RISK
Scientific officer:
|
+ | Comments | + |
|
OLDCARE
Scientific officer:
|
On Hold | ||
|
RESPONSE SHIFT (PRO)
Scientific officer:
|
+ | + | |
|
SURGERY IN PERIANAL CD
Scientific officer:
|
+ | + | + |
|
PRIMARY SCLEROSING CHOLANGITIS IN THE I-CARE COHORT
Scientific officer:
|
+ | + | + |
|
EFFICACY OF A BIOLOGICAL-BASED COMBO THERAPY WITH A BIOLOGICAL MONOTHERAPY IN INDUCING AND MAINTAINING CLINICAL REMISSION
Scientific officer:
|
On Hold | ||
|
COVID 19 SUBSTUDY
Scientific officer:
|
+ | + | + |
| NON I-CARE INVESTIGATORS (NIIISS) | |||
|
PREDICTIVE MODEL
Scientific officer:
|
Pending* | ||
|
SAPHIRE (Pas de Protocol reçu)
Scientific officer:
|
Pending* | ||
|
VTE RISK
Scientific officer:
|
Pending* | ||
|
MORTALITY RATES AND CAUSES IN IBD patients (new substudy)
Scientific officer:
|
Pending* | ||
* To be voted
Red : Overlap width I-CARE main objective