e-EC is an online platform that facilitates submission of ethics related applications (by researchers) and their review / approval (by Institutional Ethics Committees). It has been designed in accordance with the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017, New Drugs and Clinical Trial Rules 2019 and the FERCI Standard Operating Procedures 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.
Please contact the CDSA team at email@example.com, for further information regarding the software or to request a demonstration.
Please refer to the Clinical Trials Toolkit for India, for information on existing guidelines and regulations for clinical trials in India, and their practical implementation.