Substudy Area

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

  • Executive Committee assessment

  • Methodology assessment

  • 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?

  1. 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)
  2. 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

Substudies received

  SUBSTUDY ASSESSMENT
I-CARE STUDY GROUP EX COM METHODOLOGY SCI COM

DATA IBD 2020

Scientific officer: Ireland flag Glen Doherty

Pending    

PREGNANCY

Scientific officer: Denmark flag Mette Julsgaard

Pending    
PREVALENCE OF COMBO THERAPY WITH IS IN IBD PATIENTS RECEIVING BIOLOGICS

Scientific officer: Israël flag Uri Kupilov

On Hold    

CARDIO VASCULAR RISK

Scientific officer: Israël flag Eran Zittan

+ Comments +

OLDCARE

Scientific officer: France flag Mathurin Fumery

On Hold    

RESPONSE SHIFT (PRO)

Scientific officer: France flag Cedric Baumann

+ +  

SURGERY IN PERIANAL CD

Scientific officer: Belgium flag Catherine Reenaers

+ + +

PRIMARY SCLEROSING CHOLANGITIS IN THE I-CARE COHORT

Scientific officer: France flag Pauline Rivière
France flag David Laharie

+ + +

EFFICACY OF A BIOLOGICAL-BASED COMBO THERAPY WITH A BIOLOGICAL MONOTHERAPY IN INDUCING AND MAINTAINING CLINICAL REMISSION

Scientific officer: France flag Julien Kirchgesner
France flag Mathieu Uzzan

On Hold    

COVID 19 SUBSTUDY

Scientific officer: France flag Aurelien Amiot
Denmark flag Johan Burish

+ + +
NON I-CARE INVESTIGATORS (NIIISS)      

PREDICTIVE MODEL

Scientific officer: USA flag Parambir Dulai

Pending*    

SAPHIRE (Pas de Protocol reçu)

Scientific officer: USA flag Jean-Fred Colombel

Pending*    

VTE RISK

Scientific officer: France flag Véronique Regnault

Pending*    

MORTALITY RATES AND CAUSES IN IBD patients (new substudy)

Scientific officer: Spain flag Koldo Garcia Etxebarria

Pending*    

* To be voted

Red : Overlap width I-CARE main objective

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