None listed
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Sponsors
Sri Ramachandra Institute of Higher Education and Research SRIHER DU
Eligibility
Inclusion criteria
Inclusion criteria: Trial site Selection 1. Clinical trial sites approved under NDCT Rules, 2019 and CDSCO-registered EC 2. Sites that have conducted at least three interventional clinical trials in the past 3 5 years. 3. Availability of a qualified Principal Investigator and trained research staff. 4. Presence of basic GCP-compliant infrastructure, including clinical space, investigational product storage, and trial documentation systems. 5. Willingness to participate and consent to workflow processes, Suggestions and site framework. Stakeholder Selection 1. Principle Investigator Site In-charge/ Employee, 3 to 5 years of Trial Experience, Well versed Site s Policy, Rules and Regulation and Experience in Clinical Trial funded/ Pharma/ academic trial. 2. Senior Clinical Trial Coordinator Above 3 years of Pharma- Phase Trial Experience, Qualifications are Medical, Pharma, life science, Biotechnology, Dentistry, Alternative medicine, Team player, Regulatory Knowledge (NDCT Rules-2019, CTRI Registration, ICH-R3), Audit (Sponsor, DCGI, FDA) etc. SAE Reporting Timeline and Guidelines. 3. Research Pharmacists A Qualified and Registered Pharmacists with 2 years of Trial experience, Aware of Regulatory Requirements for Clinical Trial and IP Management include Handling, Accountability, storage, shipment, Discarding Procedures. 4. Research Nurse A Qualified Nurse, 1 to 2 Years of Trial Experience, Patient Handling, IP administration, sample collection, storage and shipment. 5. Phlebotomists A Qualified Nurse/ Lab Technician, 1 to 2 Years of Trial Experience, Patient Handling, sample collection, storage and Shipment. 6. Project Manager or Site SMO or Head of Clinical Research or Director or Research Consultant Extensive experience (5 10 years) in clinical trial unit selection and oversight, regulatory compliance, and site management across multiple phases and therapeutic areas. 7. Project Manager of CRO 2 to 3 years of experience as a Project Manager in a Contract Research Organization (CRO), overseeing end-to-end clinical trial execution. 8. Pharma Industry Manager of Sponsor Pharmaceutical industry professional with 2 3 years of experience in managerial roles, overseeing trial operations, compliance, and team performance.
Exclusion criteria
Exclusion criteria: Trial Site Selection 1. Sites without prior clinical trial experience. 2. Sites conducting only observational or non-interventional studies. 3. Sites not consenting to the Interaction of operational workflow processes or participation Stakeholder Selection Not Applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study will be helpful to a.Identify current practices and propose strategic solutions including workflow optimization, enhanced training, effective resource management, and technological integration. b.Provide evidence-based recommendations and best practices for the effective operation of Clinical Trial Units c.Identify site-level challenges proactively using real-world data and incorporate multi-centric approaches to enhance trial efficiency. Timepoint: 1 years 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| d. Develop a validated standardized protocol and checklist as a practical resource for researchers, clinicians, and healthcare institutions to facilitate the seamless conduct of clinical trials.Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr R Kavitha
Sri Ramachandra Institute of Higher Education and Research SRIHER DU
Outcome results
None listed