Clinical Trial Start-Up Activities

• PI and study team identification and briefing
• Documents processed at CDSA-CCRE office:
• Confidentiality Disclosure Agreement, Site Feasibility Questionnaire, Investigator Undertaking, Study team CVs and FDFs, Essential documents of IEC, Essential documents of JSS Hospital , ICF template finalization, Site Contact details, Checklist for EC submission

Site Selection Visits:

• Ensuring PI and team availability and proposing a suitable date.
• Protocol explanation and discussion with PI and study team
• Site facilities tour

EC submissions and approvals

• Receiving EC dossiers and preparing EC submission letters
• Coordinating with PIs and EC for review meeting presentation
• Processing conditional and final EC approvals

CTA review & finalization

• Finalizing study budget with PI after multiple correspondence with the Sponsor
• Ensuring legal aspects involved
• Finalization with all required signatures and submission to EC and MS.

Site Initiation Visit:

• Coordinating a suitable time and venue for SIV
• Ensuring appropriate study related training completed by the study team for a clear understanding of all study related procedures

Coordinating smooth conduct of study:

• Conduct of internal audits if required for ensuring proper conduct of study

Managing finances:

• Finances of five clinical trials and WHO project and CDSA grant handled from study start till close out

EC correspondence

• All EC correspondences during the study channelized through CDSA-CCRE Office.

EC audits

• Assisting EC for conduct of internal audits for ongoing clinical trials once in 3 months

Close-out activities

• Conducting close out meetings and EC notification for all studies
• Archival of the study documents as per Sponsor requirements in suitable boxes in the newly constructed archival room.

Study designing:

• Protocol development
• ICF review
• MoU format and finalization

EC submission and correspondence

ICMR grant application

SERB, DST-New Delhi applied

Acute febrile illness project under revision

DAHLIA: Exploring Digital and Health Literacy among Older People in Rural India