Clinical Research is very important as it determines the safety and effectiveness of medications and treatment regimens intended for Humans. Clinical Trials may be use for prevention, treatment, analysis or for relieving symptoms of a disease.

Respiratory studies are complex, as respiratory diseases, whether chronic and acute, communicable or non – communicable, impose a major global; burden and affect millions of people. As the leading fully open access journal in the field, Respiratory Research provides an essential resource for pulmonologist, allergists, immunologists and other physicians, researchers, healthcare workers and medical students. Spirometry measurement of the diffusion factor, bronchial provocation tests and force oscillation techniques have found diverse clinical applications in the diagnosis and monitoring of respiratory diseases such as COPD, Interstitial Lung diseases and Asthma.

These areas of research reflect input and feedback from the broad respiratory community and unprecedented opportunities for making rapid and significant progress in pulmonary science. As such, an important objective is to help investigators anticipate a few potential directions for lung research in ways that will best benefit from and contribute to progress in pulmonary science.

Dr Rajesh Swarnakar is a Founder, Director of Getwell Heath and Research Institute and Chief Pulmonologist in respiratory critical care and sleep medicine. He has been working as a Principal Investigator since 2003.

Clinical Research Department is located at 5^th Floor, Getwell Hospital & Research Institute

Staff

·         Dr. Rajesh Swarnakar

Principal Investigator

MBBS, DTCD, DNB (Chest), MNAMS, FCCP (USA)

Director & Chief Pulmonologist

20 years of experience till date

Responsibilities:

v  Principal Investigator will indicate his interest in participating in feasibility of the study by signing and returning the confidentiality statement.Principal Investigator will demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period.

v  Principal Investigator will make available adequate time, personnel’s,                               facilities and resources to efficiently and expeditiously accomplish its responsibilities to conduct study.

v  Principle Investigator attend and participate in investigators meetings and other meetings as needed.

v  Principal Investigator will be thoroughly familiar with protocol and the appropriate use of the investigational products, as described in the protocol, in the current Investigator Brochure, in the product information and in other information source provided by the sponsor.                  

v  Principal Investigator will ensure that any SAE, SUSAR are reported to CRO/Sponsor, DCGI and Ethics Committee in given timelines. Also will ensure that any protocol Deviation will be reported to CRO/Sponsor and Ethics Committee in given Timelines.

·         Dr. Dhiraj Bhatkar

Sub Investigator

MBBS, MD, DNB (Respiratory Medicine), FIP

Interventional Pulmonologist

7 years of experience till date

Responsibilities:

v  Sub Investigator also Attend and participate in Investigators meetings and other meetings as needed.

v  Sub Investigator will be thoroughly familiar with study protocol and with the appropriate use of the investigational product(s), described in the protocol, in the current Investigational Brochure, in the product information and in other information sources.

v  Before initiating the trial, the sub investigator will procure written and dated Approval/favorable opinion for the trail protocol, written Informed Consent Form, Consent form updates and any other written information to be provided to subject from Getwell Institutional Ethics Committee (GIEC)

v  Sub Investigator will be responsible for day to day basis for the conduct of the study, including responsibility for training the study site staff and supervising their work.

v  Sub Investigator will ensure safety and well fare of subjects participating in the trail and also ensure that adequate medical care is provided to subject for any Adverse Event, including clinical significant laboratory values, related to trail. 

·         Dr. Sanket Agrawal

Sub Investigator

MD, DNB, DTCD, MNAMS, FIP

Interventional Pulmonologist

Responsibilities-

v  Sub Investigator also Attend and participate in Investigators meetings and other meetings as needed.

v  Sub Investigator will be thoroughly familiar with study protocol and with the appropriate use of the investigational product(s), described in the protocol, in the current Investigational Brochure, in the product information and in other information sources.

v  Before initiating the trial, the sub investigator will procure written and dated Approval/favorable opinion for the trail protocol, written Informed Consent Form, Consent form updates and any other written information to be provided to subject from Getwell Institutional Ethics Committee (GIEC)

v  Sub Investigator will be responsible for day to day basis for the conduct of the study, including responsibility for training the study site staff and supervising their work.

v  Sub Investigator will ensure safety and well fare of subjects participating in the trail and also ensure that adequate medical care is provided to subject for any Adverse Event, including clinical significant laboratory values, related to trail.

·         Ms. Nita Itule

Clinical Research Coordinator

B.Sc (Microbiology) ,DMLT, PG Diploma in Clinical Research  (AECRT)

              Experience –   years

Responsibilities-

v  Maintaining knowledge and understanding of assigned protocols including all protocol requirements for patient visit schedules, test procedures, laboratory information, and drug accountability.

v  Screens subjects for eligibility using protocol specific inclusion and exclusion criteria , documenting each potential participants eligibility or exclusion. Responsible for completion of all study documentation forms including CRF and other specific documents.

v  Registration of AEs, SAE reporting.

v  Coordinates with Principal Investigator to ensure that clinical research and related activities are performed in accordance GCP, Protocol, Regulatory requirement and site SOP. To Maintain communication with GIEC and take lead in reporting serious adverse events, protocol deviation, safety reports, and other items as directed by ICH guidelines and the GIEC.

v  Interact with CRA to facilitate the monitoring and database cleanup process. Participate in data query resolution process.

v  Maintained updated Investigators file, including regulatory documents at the clinical site. Close- out of the clinical trial. Audit preparation, assisting in final study report.

·         Mr. Prashant Wadve

Spirometry Technician

B.Com ,

14 years of experience till date

Responsibilities:

v  Confers with patient in treatment room to explain test procedure and explains Specified methods of breathing to patients and conduct pulmonary function tests, such as vital capacity and maximum breathing capacity tests, using spirometer or other equipment.

v  Observe and record readings on metering devices of analysis equipments and conveys findings of tests and analysis to PI/Sub Investigators for interpretation.

v  Explains the methods of drug consumption.

v  Calibration of PFT machine.

v  Conduct ECG of the subject according to Protocol and report the ECG to PI/SUB-I. 

·         Mr. Kareena

Spirometry Technician

B.Com,

10 years of experience till date

Responsibilities:

v  Confers with patient in treatment room to explain test procedure and explains Specified methods of breathing to patients and conduct pulmonary function tests, such as vital capacity and maximum breathing capacity tests, using spirometer or other equipment.

v  Observe and record readings on metering devices of analysis equipments and conveys findings of tests and analysis to PI/Sub Investigators for interpretation.

v  Explains the methods of drug consumption.

v  Calibration of PFT machine. 

·         Mrs. Sumanlata Bandewar

Study Nurse

BA , Diploma in Nursing Home

4 years  of experience till date

Responsibilitites:

v  Instruct patients about the procedure and safety details during blood draw.

v  Phlebotomist’s duties include collecting samples of blood and other fluids from patients.

v  The Phlebotomist duties will include correctly labeling the collection containers with pertinent patients information for identification and subsequently must complete and file companion paperwork to trace the route of the sample from collection through lab work through final analysis and diagnosis and finally to proper disposal of the fluids.

v  After Blood collection do all the required activities like centrifugation (if Applicable) and procedure according to the protocol. Store the collected blood in proper storage condition. Proper packaging of the blood and fluid sample for transport.

Site certificates:

·         Certificate of Accreditation for Ethics Committee

·         All site staff are ICH GCP Trained.

·         Target achievement certificate from Boehringer Ingelheim & SIRO to Dr.  Rajesh Swarnakar

Site infrastructure:Equipment available at the study site for Research

Micro Quark PC-based Spiro meter-microQuark is the PC-based spirometer designed by COSMED for lung function screening.

–          It can be used with any PC, either desktop or laptop, by simply installing the application software and connecting the USB cable to the USB port of the computer.

–          Performing spirometry tests is extremely easy and intuitive with microQuark and OMNIA, the new generation software developed by COSMED, which is included in the standard package.

–          Fast, simple and cost effective Spirometry screening is now available to all users.

Ø  Niox Mino FeNo Machine- NIOX VERO® is a non-invasive, simple-to-use, point-of-care system that provides rapid standardized FeNO measurements.

–          With over 38 million NIOX® tests undertaken to date, our system is used by healthcare professionals around the world to help improve asthma care, assisting: diagnosis.

Ø  Simul – GECG machine-   PC based ECG Machine with DSP Technology

–          Full frequency response 0.05 to 150Hz

–          Simultaneous Acquisition

–          Measurements of all 12 leads with Interpretation

–          ECG conversion possible into image format

–          Simultaneous acquisition of 12 Leads

–          Display of running traces of 12 leads split into group of 6 each

–           Facility to send ECG data to Remote care server for expert opinion

–           Dimensions : L 105 x B 65 x H 40 mm Weight : 150 gms

Ø  Drug Storage Cabinet-Constructed of high quality CRCA steel with optional bins and lockable doors, our narcotics cabinet ensures that the narcotics and medications at your hospital are securely locked and meet the standards as per the drug storage requirements.It is 15 to 25 degree cabinet.

Ø  Medico Centrifuge (Remi)- Medico centrifuge max. speed 4000rpm with brushless indcution motor, frequency drive, LED display of speed and time, safety lid lock, imbalance detector dymanic brake supplied with choice of any one swing out / angle rotor.

Ø  Deep Freezer (-20  ͦC , -25ͦC)- Deep freezers are the testing equipment that are used to preserve and store food products, medical equipment, blood samples, medicines and injections, etc. for a long period of time.Weighing machine

Ø  Celfrost (2ͦC to 8ͦC)-Optional Digital Controller With DisplaySuper-freeze FunctionHigh-temperature Alarm1 Year Warranty on Complete Machine.

And other required equipment available at site like-

Ø  Cold Centrifuge (Remi)

Ø  Mercury sphygmomanometer

Ø  Electronic BP Apparatus

Ø  Height Measuring Tape

Ø  Digital Thermometer

Past Trials: Drug Trials

Ethics Committee Details

Getwell Hospital and Research Institute in the Nagpur (Maharashtra) with ICU & IPD Facilities. Since past years significant increase in the number of clinical trials. This gave rise to the need for efficient management of its clinical trials to ensure the protection of human rights as mandated by Indian law (NEW CLINICAL TRIAL GUIDELINE 2019) and Indian GCP Guideline and to satisfy public scrutiny.

GIEC is constituted and also functions as per the guidance “Ethical Guidelines for Biomedical Research on Human Participants” provided by “Indian Council of Medical Research” in 2006, NCT, 2019 Guideline and “International Conference on Harmonization – Good Clinical Practice”  and Indian GCP guidelines. The hospital directors and management of Getwell Hospital constituted the Getwell Institutional  Ethics Committee (GIEC). All research proposals were subjected to ethical review by Getwell Hospital Ethics Committee.

These are essential for investigator initiated research, funded research and multi-centric multinational research. All research proposals were scientifically evaluated and approved by Getwell hospital ethics Committee (GIEC)

Address: Getwell Hospital and Research Institute, 20/1, Dr.Khare Marg,Dhantoli,Nagpur-440012

Mob No:8459102442Email:giec201@gmail.com

NABH Accreditation number: EC-CT-2018-0035.  EC NABH Accreditation Validity: Valid From 27/November/2024 and valid upto26/November/2029

Miss. Sejal Kshirsagar

EC Coordinator

  B. Pharm

Responsibilities-

v  Organizing an effective and efficient tracking procedure for each proposal received.

v  Preparing, Maintaining and Distributing study files.

v  Organizing GIEC Meetings Regularly

v  Preparing the Agenda and Minutes of the Meetings

v  Maintaining GIEC Records and Archives.

v  Communicating with GIEC Members and PIs.

v  Arranging Training for Personnel and GIEC Members

v  Filing study related documents.

v  Dispatching sets of study documents to GIEC Members

v  Providing signature against the receipt/submission of all the study related documents which is submitted by the Principal Investigator and communicate with the Member Secretary and Chairperson of the GIEC.