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Validation of a tool for assessing risks and benefits of proposed clinical research studies by members of ethics committee

Validation of a Tool for Risk Benefit Assessment for Initial Review of Research Proposals by Ethics Committees

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/10/037160
Enrollment
20
Registered
2021-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Indian Society for Clinical Research
Lead Sponsor
Department of Pharmacology and Therapeutics Seth GSMC and KEM Hospital Mumbai
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: - For content validity and cognitive interview testing, the participant should be an â?? EC member (having reviewed a minimum of 5 regulatory clinical trials OR BA/BE studies, and 5 biomedical and health research studies) while serving on a Department of Health Research (DHR) and CDSCO registered EC (Institutional or Independent) for at least 3 years. - For reliability testing, the participant should be an â?? EC member who has been serving on a DHR and CDSCO registered EC (Institutional or Independent) for a minimum of 1 year

Exclusion criteria

Exclusion criteria: Those not willing to participate

Design outcomes

Primary

MeasureTime frame
Validation of the tool by testing its validity and reliabilityTimepoint: One year after obtaining CTRI approval—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDr Padmaja Marathe

Seth GS Medical College and KEM Hospital

pam2671@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026