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Ideal amount of information in an informed consent form

Optimal amount of information in an informed consent form - OPTSTUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/01/048999
Enrollment
152
Registered
2023-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site

Interventions

Intervention1: Not Applicable: Not Applicable Control Intervention1: Not Applicable: Not Applicable

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older 2. Patients enrolled in interventional clinical trials ongoing at TMH, Mumbai

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Assessment of the level of satisfaction with the information provided in an Informed Consent Form for a clinical trial among patients who are already enrolled in a clinical trialTimepoint: Baseline—

Secondary

MeasureTime frame
Assessment of the level of subject satisfaction regarding various sections of the Informed Consent FormTimepoint: Baseline;correlation between level of satisfaction with the information provided and various factors Sex ,intent of therapy, type of primary tumor,education levelTimepoint: Baseline;Determination of the desired length of an Informed Consent Form in number of pagesTimepoint: Baseline—

Countries

India

Contacts

Public ContactDr Vanita Noronha

Tata Memorial Hospital

vanita.noronha@gmail.com9769328047

Outcome results

None listed

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