Perception of ethics committee members and investigators on implementation of e-EC software for ethics committees

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dc.contributor.authorShetty, Yen_US
dc.contributor.authorMarathe, Pen_US
dc.contributor.authorLad, Men_US
dc.contributor.authorAuti, Pen_US
dc.contributor.authorKatkar, Jen_US
dc.contributor.authorSingh, V.en_US
dc.date.accessioned2025-05-09T08:46:58Z
dc.date.available2025-05-09T08:46:58Z
dc.date.issued2024-09
dc.description.abstractBackground: An e-EC software (Create 4) was introduced since past 4 years at few institutional ethics committees (EC) in India. The software provided facilities for submission, online review and communication between investigator and EC. The study was to assess the perception of different stakeholders: investigators, chairperson, member secretary (MS), EC members, administrative staff regarding their experiences of using software, challenges faced and recommendations for improvisation. Methods: Following approval of the institutional EC, the participants were enrolled after obtaining their written informed consent. The questionnaires specifically designed and validated for each category of investigators, EC members and administrative staff were administered. Strict confidentiality was maintained. The data was analysed using descriptive statistics. Results: A total of 64 stakeholders who participated, there were 34 investigators, 18 EC members, 2 Chairpersons, 4 member secretaries, 6 administrative staff. The e-software was accepted well by majority of the stakeholders. Overall, the software was found to be user-friendly. A few challenges faced were: lack of adequate training for investigators and new EC members, inconvenience faced while downloading study documents one by one and the need to ensure uninterrupted internet access at workplace. The user ECs should ensure that the investigators and EC members are tech-savvy and they receive prior training. It was suggested that there needs to be an autofill option built-in while uploading document/s. Conclusions: E-software was found to be useful by the stakeholders and provided suggestions to optimize its us.en_US
dc.identifier.affiliationsDepartment of Pharmacology and Therapeutics, Seth GSMC and KEM Hospital, Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmacology and Therapeutics, Seth GSMC and KEM Hospital, Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsInstitutional Ethics Committee-II, Seth GSMC and KEM Hospital, Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsInstitutional Ethics Committee-III, Seth GSMC and KEM Hospital, Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsInstitutional Ethics Committee-I, Seth GSMC and KEM Hospital, Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmacology and Therapeutics, Seth GSMC and KEM Hospital, Mumbai, Maharashtra, Indiaen_US
dc.identifier.citationShetty Y, Marathe P, Lad M, Auti P, Katkar J, Singh V.. Perception of ethics committee members and investigators on implementation of e-EC software for ethics committees . International Journal of Clinical Trials. 2024 Sep; 11(3): 176-181en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/243658
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber3en_US
dc.relation.volume11en_US
dc.source.urihttps://doi.org/10.18203/2349-3259.ijct20241999en_US
dc.subjectSoftwareen_US
dc.subjectECen_US
dc.subjectInvestigatorsen_US
dc.subjectE-submissionen_US
dc.subjectPerceptionen_US
dc.subjectMSen_US
dc.titlePerception of ethics committee members and investigators on implementation of e-EC software for ethics committeesen_US
dc.typeJournal Articleen_US
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