Health Condition 1: B338- Other specified viral diseases
Conditions
Interventions
Intervention1: Nil as it is an obeservational study: nil
Control Intervention1: Nil as it is an observational study: Nil
Sponsors
Dr Nithya Gogtay
Eligibility
Inclusion criteria
Inclusion criteria: 1 The regulatory clinical trials archived at Department of Clinical Pharmacology 2 The regulatory clinical trials for which the principal investigator has permitted the access to the study team members
Exclusion criteria
Exclusion criteria: 1 Academic and investigator-initiated studies will be excluded. 2 Study with no protocol deviation will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase of clinical trial Frequency of events [Protocol Deviations and protocol violations] Type of Deviations [Consent related, Investigation product (IP) storage, IP administration, documentation error, sample collection and processing, participant selection] Frequency of events for which corrective action and preventive actions were taken Timepoint: Day 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Word content of the corrective and preventive actions for the protocol deviations, wherever availableTimepoint: Day 0;Frequency of events occurred due to the COVID-19 pandemicTimepoint: Day 0 | — |
Countries
India
Contacts
Public ContactDr Vijaya ChaudhariGunjal
Seth GSMC and KEMH Mumbai
Outcome results
None listed