Health Condition 1: 4- Measurement and Monitoring
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Bhaktivedanta Hospital and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients experiencing an SAE during participation in a clinical trial - Phase II, III, or IV 2. Only those regulatory clinical trials being undertaken at Bhaktivedanta Hospital and Research Institute under the responsibility of the Principal Investigator and or the Co-investigators will be considered for inclusion in this study 3. SAE data will be drawn only from those regulatory clinical trials for which the concerned investigator has voluntarily signed the Investigator Undertaking Annexure 6 consenting to share anonymized, numerical, and aggregated SAE-related causality information for this study 4. Immediate relatives spouse or parent or child of patients with SAE-related death 5. Age equal or more than 18 years 6. Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Participants with severe cognitive impairment preventing meaningful participation 2. Participants not available for follow up 3. Any clinical trial for which the treating investigator has not signed the Investigator Undertaking will be excluded from the data pool of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in understanding over time among patients and their relatives regarding: 1.Serious Adverse Events 2. Medical management 3.Compensation processes under NDCT Rules 2019 Timepoint: Baseline, 3 months, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate agreement in causality assessment of SAEs among- 1.Investigators 2.Ethics Committees 3.Sponsors 4.Regulatory authorities - DCGI 5.To assess the association between educational status and level of understanding 6.To evaluate longitudinal changes in patient satisfaction with medical management and compensation processes 7.To identify gaps in communication and suggest improvements in clinical trial practices Timepoint: Baseline, 3 months, 6 months and 12 months | — |
Countries
India
Contacts
Public ContactDr Nirmal Raut
Bhaktivedanta Hospital and Research Institute
Outcome results
None listed