Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: Audio-video ICF application: Audio-video ICF application for 2 years
Control Intervention1: written ICF: written ICF for 2 years
Sponsors
National Biopharma Mission, Biotechnology Industry Research Assistance Council (BIRAC)
Eligibility
Inclusion criteria
Inclusion criteria: Adults (18+) who are potential research participants, who have the capacity to provide informed consent, and who are not impaired by any cognitive disabilities that would hinder comprehension.
Exclusion criteria
Exclusion criteria: Individuals with auditory or visual impairments that make it difficult to use the audio-visual tool or read the written document. Participants who have prior participation in clinical tria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome 1) To develop and pilot test an audio-visual tool providing information about the research study for ongoing research studies with varying degree of complexity or risk to the participants. 2) To evaluate incremental benefit of audio-visual tool in combination with written Informed Consent Document on comprehension of the research participants. Timepoint: 1-2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome- 1) To assess the additional time commitment of the research participants with the use of the audio-visual tool. 2) To evaluate cost-effectiveness of the audio-visual toolTimepoint: 3rd year | — |
Countries
India
Contacts
Public ContactMrs Abhidnya V Desai
Tata Memorial Hospital Mumbai India
Outcome results
None listed