None listed
Conditions
Interventions
Intervention1: QuinteT Recruitment Intervention: This involves qualitatively analyzing the informed consent process of other trials and optimize the consent process thereby enabling better recruitment
Sponsors
Seth GSMC KEM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Randomised Controlled Trials: Ongoing RCTs in the Department of Clinical Pharmacology that are open to recruitment will be purposively selected for this study, based on whether they a) have sufficient recruitment period remaining and b) regularly screen patients. 2. Patients: Adults over 18 years of age, who go through the informed consent process in the selected RCTs will be approached for consent to the OrION-I study. 3. Recruiters: The healthcare professionals and/or other researchers involved in the process of obtaining informed consent from patients will be approached for consent to the OrION-I study.
Exclusion criteria
Exclusion criteria: 1. RCTs where the sponsor denies permission for the RCT to be included in OrION-I. 2. The potential patient participants or the recruiters in the selected RCTs who decline consent for this study (or where patient is unable to provide consent).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interviewees feedback on the consent process and suggestions to improve the informed consent appointmentTimepoint: Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Partenrship and networking activities between Bristol University and Seth GSMC & KEM hospital for a larger multicentric studyTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Jeffrey Pradeep Raj
Seth GSMC & KEM Hospital
Outcome results
None listed