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)

Main step

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 overlap with I-CARE main objectives (independant project or in collaboration with Executive Committee to work in main objectives)
Methodologic commitee : C. Baumann (I-CARE methodologist), H. Rousseau (I-CARE statistician)
K. Kirchgesner (coding group referent), Executive Committee.
- To validate project methodology (endpoint, statistical analysis plan, design)
- To ensure compliance with I-CARE database

* To be voted

Red : Overlap width I-CARE main objective

	SUBSTUDY ASSESSMENT
I-CARE STUDY GROUP	EX COM	METHODOLOGY	SCI COM
DATA IBD 2020 Scientific officer: Glen Doherty	Pending
PREGNANCY Scientific officer: Mette Julsgaard	Pending
PREVALENCE OF COMBO THERAPY WITH IS IN IBD PATIENTS RECEIVING BIOLOGICS Scientific officer: Uri Kupilov	On Hold
CARDIO VASCULAR RISK Scientific officer: Eran Zittan	+	Comments	+
OLDCARE Scientific officer: Mathurin Fumery	On Hold
RESPONSE SHIFT (PRO) Scientific officer: Cedric Baumann	+	+
SURGERY IN PERIANAL CD Scientific officer: Catherine Reenaers	+	+	+
PRIMARY SCLEROSING CHOLANGITIS IN THE I-CARE COHORT Scientific officer: Pauline Rivière David Laharie	+	+	+
EFFICACY OF A BIOLOGICAL-BASED COMBO THERAPY WITH A BIOLOGICAL MONOTHERAPY IN INDUCING AND MAINTAINING CLINICAL REMISSION Scientific officer: Julien Kirchgesner Mathieu Uzzan	On Hold
COVID 19 SUBSTUDY Scientific officer: Aurelien Amiot Johan Burish	+	+	+
NON I-CARE INVESTIGATORS (NIIISS)
PREDICTIVE MODEL Scientific officer: Parambir Dulai	Pending*
SAPHIRE (Pas de Protocol reçu) Scientific officer: Jean-Fred Colombel	Pending*
VTE RISK Scientific officer: Véronique Regnault	Pending*
MORTALITY RATES AND CAUSES IN IBD patients (new substudy) Scientific officer: Koldo Garcia Etxebarria	Pending*

Substudy Area