Clinical data monitoring during COVID-19 pandemic: an experience from a regulatory trial in India

Authors

  • Divya Pillai Clinical Development Services Agency (CDSA), THSTI Building, NCR Biotech Science Cluster, 3rd Milestone, Faridabad, Haryana, India
  • Monika Bahl Clinical Development Services Agency (CDSA), THSTI Building, NCR Biotech Science Cluster, 3rd Milestone, Faridabad, Haryana, India
  • Padmapriyadarsini C National Institute for Research in Tuberculosis (NIRT), Chetpet, Chennai, India
  • Ranjan Kumar Clinical Development Services Agency (CDSA), THSTI Building, NCR Biotech Science Cluster, 3rd Milestone, Faridabad, Haryana, India
  • Supriya Semwal Clinical Development Services Agency (CDSA), THSTI Building, NCR Biotech Science Cluster, 3rd Milestone, Faridabad, Haryana, India
  • Shirali Raina Labroo Clinical Development Services Agency (CDSA), THSTI Building, NCR Biotech Science Cluster, 3rd Milestone, Faridabad, Haryana, India
  • Jeyadeepa B. National Institute for Research in Tuberculosis (NIRT), Chetpet, Chennai, India

DOI:

https://doi.org/10.18203/2349-3259.ijct20211465

Keywords:

Clinical data monitoring, Source data verification, COVID–19, Pandemic, Remote or central monitoring

Abstract

The essence of any clinical or healthcare related discovery is its methodologically sound clinical research and clinical data monitoring. This eventually helps the clinicians to understand the best possible clinical management pathways or patient management at all the levels of healthcare system. The pandemic has had an impact on clinical trial data monitoring as well. New or mixed approaches to routine monitoring have been introduced to ensure the quality of the overall research in these challenging times and are being tested for efficacy, cost-effectiveness while keeping ethical considerations as the main priority. This write up intends to highlight a few steps taken to ensure data integrity and participants’ safety and rights.

Author Biographies

Divya Pillai, Clinical Development Services Agency (CDSA), THSTI Building, NCR Biotech Science Cluster, 3rd Milestone, Faridabad, Haryana, India

Department of Clinical Portfolio Management

Project Manager

Monika Bahl, Clinical Development Services Agency (CDSA), THSTI Building, NCR Biotech Science Cluster, 3rd Milestone, Faridabad, Haryana, India

Department of Clinical Portfolio Management

Consultant

Padmapriyadarsini C, National Institute for Research in Tuberculosis (NIRT), Chetpet, Chennai, India

Director - NIRT

Ranjan Kumar, Clinical Development Services Agency (CDSA), THSTI Building, NCR Biotech Science Cluster, 3rd Milestone, Faridabad, Haryana, India

Department of Clinical Portfolio Management

Quality Manager

Supriya Semwal, Clinical Development Services Agency (CDSA), THSTI Building, NCR Biotech Science Cluster, 3rd Milestone, Faridabad, Haryana, India

Department of Clinical Portfolio Management

Study Monitor

Shirali Raina Labroo, Clinical Development Services Agency (CDSA), THSTI Building, NCR Biotech Science Cluster, 3rd Milestone, Faridabad, Haryana, India

Department of Clinical Portfolio Management

Director

Jeyadeepa B., National Institute for Research in Tuberculosis (NIRT), Chetpet, Chennai, India

Medical Study Coordinator

Department of Clinical Research, NIRT

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Published

2021-04-22

Issue

Section

Short Communication