• JSS Hospital, MG Road, Mysuru - 570004
  • cdsa.jssu@gmail.com
  • +91 821 23555 Ext 5390

About Us

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Introduction

Welcome To Center for Clinical Research Excellence

Centre for Clinical Research Excellence (CCRE), at JSS University was approved as a collegium of Clinical Development Services Agency (CDSA) - A DBT, Ministry Centre for Clinical Research Excellence (CCRE), at JSS University was approved as a collegium of Clinical Development Services Agency (CDSA) - A DBT, Ministry of Science and Technology, Government of India initiative to facilitate the development of healthcare products for public health system in 2015 (http://www.cdsaindia.in).The department started its operations in clinical research training in 2016, and we are now fully set up and started with our clinical trials related operations.

The department received the BIRAC project entitled "Capacity building of Infrastructure and human resource for conducting COVID Vaccine clinical trials and Immunogenicity studies as per GCP guidelines" from Department of Biotechnology, under Mission COVID Suraksha, New Delhi on 19.04.2021.

Centers of Excellence

The Centers of Excellence (COE) is a network of institutions initiated by CDSA, Department of Biotechnology, Government of India; which includes clinical research sites that are geographically distributed across India and have the capacity to conduct local and global clinical studies of utmost standards. CDSA fosters partnerships and is a member of CoE. This partnership with leading clinical research and academic institutions collectively works towards enhancing the national capacity & capability to trigger innovative and breakthrough technology development and accelerate the translation of effective research in public and private sectors. Apart from CDSA, the current COE members include the following:

Centre for Chronic Disease Control (CCDC), New Delhi

Centre for Health Research and Development (CHRD) - Society for Applied Studies (SAS), New Delhi.

Christian Medical College and Hospital, Vellore

Jagadguru Sri Shivarathreeswara (JSS) University, Mysore

KEM Hospital Research Centre (KEMHRC) Pune

COE program aims to provide an opportunity for individual COE to build capacity and capability in the area of clinical research. This program is for clinical researchers, investigators and other personnel from India in becoming capable of conducting clinical and epidemiological research. COE program is based on training needs assessment also identifying the gaps & need for achieving clinical research excellence in the country. The program is organized by COE for collaboration in education, training and capacity building and collaboration in research, innovation, and is coordinated by CDSA on behalf of the COE. This program includes short-term training and workshops referred to as COE program in the fields of epidemiology, public health research, clinical research methods, research data management & analysis, good clinical practice and ethics in research involving human subjects. The courses are either independently conducted by COE members or are jointly by one or more members of COE along with the CDSA.

OBJECTIVES of CDSA Sponsored Centre for Clinical Research Excellence (CCRE)

Coordinating center for conducting of high quality and ethical clinical research/ Trials as per GCP guidelines

Conduct GCP and other clinical research associated trainings for clinicians and hospital staff.

Under the leadership and gracious Patronage and blessings of His Holiness Jagadguru Sri Shivarathri Deshikendra Mahaswamiji , the Chancellor of JSS University and Pro Chancellor , Dr.B.Suresh, a noted multifaceted leader in India.

ORGANOGRAM

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Committee Members

In order to Monitor the activities at CDSA-CCRE office at JSS, a committee is formed with the following

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Dr.H.Basavana Gowdappa

Chairman, (Coordinating for CoE for the CDSA)
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Dr. B. Manjunath

Registrar, JSS AHER and Member
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Dr Prashanth M Vishwanath

Director Research (Academic), JSS AHER and Member
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Dr. Pramod T M Kumar

Prinpal JSS college of Pharmacy, Mysore and Member
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Dr. Prathibha Pereira

Head, CDSA-CCRE
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Dr. M. D. Ravi

Chairman, CDSA-CCRE
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Dr.Vinaya Rani G

Clinical Research Investigator, Center for Clinical Research Excellence (CCRE)
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Ms.Shwetha Shree M S

Clinical Research Assistant, Center for Clinical Research Excellence (CCRE)
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Dr Rovin M Theempalangad

Clinical Research Assistant, Center for Clinical Research Excellence (CCRE).

OBJECTIVES of BIRAC

Objective:1 Capacity Building

  • On-site availability of equipment for trial conduct and development of functional laboratory for bio-specimen collection, processing and cold chain facility for storage of vaccines and bio-samples.
  • Recruitment of manpower and completion of training of newly appointed staff (under this grant): GCP/ BLS/ DGCT 2019 (Good Clinical Practice / Basic Life Support, New Drugs and Clinical Trials Rules, 2019)

Objective:2 Volunteer Data Base Development

  • Outreach activities for engaging with community to increase volunteer awareness for vaccine clinical trials and encourage participation for a possible trial of COVID vaccine
  • Relevant local administrative [Government, Medical Colleges, Institutional Head and Committees] and regulatory [Institutional Ethics Committee] approvals in place
  • Relevant local administrative [Government, Medical Colleges, Institutional Head and Committees] and regulatory [Institutional Ethics Committee] approvals in place

Objective:3 To make the site ready for Clinical Trial conduct

  • Gap analysis and development of critical SOPs for COVID-19 vaccine trials
  • Development of clinical trial centre: Clinical examination room, consenting rooms, sample collection facility, trial pharmacy, participant observation room/s, data management and record keeping facility
  • Develop SOPs for managing and reporting Adverse Events following Immunization and management of medical emergency
  • Referral and Inpatient Management for trial participants in case of SAEs
  • Facility for audio-visual consenting
  • Site assessment by industry / third party for readiness to take up clinical trial through audit visits from vaccine manufacturers and subsequent signing of service agreements

Under the leadership and gracious Patronage and blessings of His Holiness Jagadguru Sri Shivarathri Deshikendra Mahaswamiji , the Chancellor of JSS University and Pro Chancellor , Dr.B.Suresh, a noted multifaceted leader in India.

Committee Members of BIRAC

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Dr.H.Basavana Gowdappa

Principal Investigator
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Dr. Prathibha Pereira

Co-Investigator
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Dr. M. D. Ravi

Co-Investigator
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Dr. Subhashchandra

Co-Investigator
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Dr. Shilpa Avarebeel

Co-Investigator
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Dr. Praveen Kulkarni

Co-Investigator
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Dr.Vinaya Rani G

Project Manager
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Ms.Shwetha Shree M S

Study Co-ordinator
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Dr Rovin M Theempalangad

Pharmacist

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