Clinical Development Services Agency

CReATE

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e-EC (electronic Ethics Committee), is an online platform that facilitates the submission of ethics related application (by researchers) and their review and/or approval (by Institutional Ethics Committee). It has been designed in accordance with the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017, the Good Clinical Practice Guidelines 2001, the New Drugs and Clinical Trial Rules 2019 and the FERCI Standard Operating Procedures (SOPs) for Ethics Committees. It includes a minimal dataset for each project and an online document management system. Institutions can either use their own ethics forms which are then uploaded as PDFs or the Common Forms for Ethics Committee Review developed by the Indian Council of Medical Research (ICMR). If the latter are used, then the data is stored in a searchable database and can be used to facilitate future submissions. All data is securely stored and only available to the relevant ethics committees of the individual organisations.

e-EC has been co-created by CDSA, FERCI, PATH & MRC CTU at UCL. Please contact the team at writetoeec@gmail.com, for further information regarding the software , subscription details, or to request a demonstration.

The team will constantly upgrade e-EC to aid researchers and ethics committee members for online submission and management of data.

CReATE Team

                        

Prof. Usha Menon
Professor – Gynaecological Cancer , UCL London.

Dr. Neha Chawla
Senior Research Officer

Dr. Nitya Wadhwa
Faculty In-charge, CDSA
Associate Professor, THSTI