Validation of a tool for assessing risks and benefits of proposed clinical research studies by members of ethics committee
Not Applicable
- Registration Number
- CTRI/2021/10/037160
- Lead Sponsor
- Indian Society for Clinical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Those not willing to participate
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validation of the tool by testing its validity and reliabilityTimepoint: One year after obtaining CTRI approval
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI