Data Entry Operator

As a Data Entry Operator, to handle the source documentation and Data Entry for following Projects-

• MDR-TB Mukt Cohort A & B project.

Preempt project.

RNTCP Nikshay for DRTB BDQ & DLM patients.

Observation Cohort

PHASE-II-DX Cohort, Cohort A AND Cohort B PROJECT

Any upcoming NIH sponsored studies for TB cohorts with the PIs

General Job responsibilities:

Doing data entries in "ACCESS SOFTWARE" & Scanning, redacting, filing & maintaining excel sheet under the project of MDR-TB MUKT COHORT A & B

Doing data entries in " REDCAP SOFTWARE" & Scanning, redacting, filing & maintaining excel sheet under the project of  PREEMPT STUDY & PHASE II.

Doing data entries in "NIKSHAY PORTAL SOFTWARE" & Scanning, redacting, maintaining excel sheet -"PMDT TRACK SHEET" under the project of DRTB BDQ & DLM ELIGIBLE PATIENTS.

Specific Job responsibilities

FOR MDR TB MUKT COHORT A & B (INDEX CASE), OBSERVATION COHORT, PREEMPT STUDY & PHASE-II (DX COHORT, COHORT A & COHORT B)

Check the Email and reports received in inbox of   These reports are then download then the name is being redacted and saved in the appropriate pts. folder as per packages. Some reports comes in digital sign format (CBC,ESR,Culture tb,Gene xpert, DST report, Xray reports) that reports downloaded and then converted into adobe pdf file and saved in appropriate pts. Folder and then redacted and again save in the appropriate pts. folder and delete original adobe pdf report.

These report are then checked with MDR TB SOURCE DOCUMENT CHECK LIST as per packages and patient id, checked the reports and mentioned the date as and when received.

Also download the reports which are recorded on the study TAB or communicated from the clinical team. These reports also redacted and saved in appropriate folder & updated in source document check list as per packages.

Download the xray images from pacs and save in the folder.

Make the in excel sheet. For new enrollment copy pest the and crate new copy excel sheet as per the date. Entere HH no.,Pt.Id for Mukt , Observational, Preempt study, Cohort B id, Consented information, Pt. Name, Contact no.,Birth date.

Sputum Isolate excel sheet updated for new culture report receive. Enter Cohort A & B, PREEMPT patient's id, HH NO., Ex no., ref no. order no., patient id sample, sample type, enrollment date, collection date, days from enrollment, culture status, culture result date, MGIT revival, plating date etc.

Check the CRF'S for completeness and in case of any incompleteness (missing elements), inform to clinical team & get the necessary corrections made. Put the and mention the f/u no. in CRF'S. Measure the Vas for the Medication adherence self-report And write down in appropriate box. Also check the dot cards against the CRF and these dot cards save in the folder.

These CRFS (Initial visit form, psychosocial form, eligibility and f/u clinical form, f/u psychosocial form, MIC'S 1ST & 2nd review CRF's.) are to be scanned, saved in pt. folder and redacted. Also update the same in MDR TB & PHASE II SOURCE DOCUMENT CHECK LIST after scanning and save the CRF's in appropriate PT. ID folder.

These CRF's data are then entered into data base as per the version and redcap. In case of any query, clarify with the study team internally or if not resolved, email them to "Jeff or Pawandeep or Komala" for the query to be resolved of respective project person.

After complete  entering the data into data base, shift the CRF's in to entered redacted Mukt folder Cohort A & B. Also uploaded on One Drive- Mukt-entered redacted- respective cohort a & b folder

F/u with concern person for Pyrosequencing report, MIC report and culture MGIT positive days and hours & lab crfs for preempt study.

After scanning file all the crfs in respective files.

Help or coordinate with TEAM as whenever requires during study audits or routine study requirements.

OBSERVATION COHORT – Resolve any queries regarding recorded data and entries of patients follow ups as and when required.

DRTB BDQ & DLM patients through RNTCP.

Receive all BDQ & DLM CRF'S from clinician.

First check the patient's Nikshay ID in NIKSHAY PORTAL to check current status of the treatment, whether patient availing BDQ & DLM from Hinduja Hospital or other institute or hospital. If doesn't reflect in the nikshay portal current status as P.D HINDUJA HOSPITAL & MRC, then inform to DADAR DTO TEAM for patients transfer in P.D HINDUJA HOSPITAL & MRC.

Whether patient transfer in or not to check the status in NIKSHAY PORTAL on daily basis & Give reminder to DADAR DTO TEAM for transfer in.

Coordinate with Micro lab person & Clinician to check on concerned lab reports (at least one of the three test CBNAAT, LPA & CULTURE TEST positive) whether patients are eligible for BDQ OR DLM regimen, before starting the data entry in Nikshay Portal.

Generate the new Nikshay ID as outcome-(Treatment regimen changed) & this new Nikshay ID updated in CRF as well in PMDT TRACK SHEET.

All patients details entered in Nikshay portal  and in PMDT TRACK SHEET for e.g enrollment details (address, contact no. etc) , lab tests, adherence, bank details, comorbidity, treatment details, contact tracing, outcome.

For any discrepancy and queries arise while entering the data in Nikshay portal Coordinated and clarified with DADAR DTO TEAM & to resolve queries.

Update the DRTB BDQ & DLM patients follow up on every visit – like culture reports, ecg, adherence in Nikshay Portal & in PMDT TRACK SHEET.

Take the authorized signature of DR. Camilla madam on enrollment Crf and all Enrollment, Follow up CRF'S Scanned & saved in appropriate folder.

Update the DROPD VOUCHER EXCEL SHEET for every month.

Roles and Responsibilities

As a Data Entry Operator, to handle the source documentation and Data Entry for following Projects-

• MDR-TB Mukt Cohort A & B project.

Preempt project.

RNTCP Nikshay for DRTB BDQ & DLM patients.

Observation Cohort

PHASE-II-DX Cohort, Cohort A AND Cohort B PROJECT

Any upcoming NIH sponsored studies for TB cohorts with the PIs

General Job responsibilities:

Doing data entries in "ACCESS SOFTWARE" & Scanning, redacting, filing & maintaining excel sheet under the project of MDR-TB MUKT COHORT A & B

Doing data entries in " REDCAP SOFTWARE" & Scanning, redacting, filing & maintaining excel sheet under the project of  PREEMPT STUDY & PHASE II.

Doing data entries in "NIKSHAY PORTAL SOFTWARE" & Scanning, redacting, maintaining excel sheet -"PMDT TRACK SHEET" under the project of DRTB BDQ & DLM ELIGIBLE PATIENTS.

Specific Job responsibilities

FOR MDR TB MUKT COHORT A & B (INDEX CASE), OBSERVATION COHORT, PREEMPT STUDY & PHASE-II (DX COHORT, COHORT A & COHORT B)

Check the Email and reports received in inbox of   These reports are then download then the name is being redacted and saved in the appropriate pts. folder as per packages. Some reports comes in digital sign format (CBC,ESR,Culture tb,Gene xpert, DST report, Xray reports) that reports downloaded and then converted into adobe pdf file and saved in appropriate pts. Folder and then redacted and again save in the appropriate pts. folder and delete original adobe pdf report.

These report are then checked with MDR TB SOURCE DOCUMENT CHECK LIST as per packages and patient id, checked the reports and mentioned the date as and when received.

Also download the reports which are recorded on the study TAB or communicated from the clinical team. These reports also redacted and saved in appropriate folder & updated in source document check list as per packages.

Download the xray images from pacs and save in the folder.

Make the in excel sheet. For new enrollment copy pest the and crate new copy excel sheet as per the date. Entere HH no.,Pt.Id for Mukt , Observational, Preempt study, Cohort B id, Consented information, Pt. Name, Contact no.,Birth date.

Sputum Isolate excel sheet updated for new culture report receive. Enter Cohort A & B, PREEMPT patient's id, HH NO., Ex no., ref no. order no., patient id sample, sample type, enrollment date, collection date, days from enrollment, culture status, culture result date, MGIT revival, plating date etc.

Check the CRF'S for completeness and in case of any incompleteness (missing elements), inform to clinical team & get the necessary corrections made. Put the and mention the f/u no. in CRF'S. Measure the Vas for the Medication adherence self-report And write down in appropriate box. Also check the dot cards against the CRF and these dot cards save in the folder.

These CRFS (Initial visit form, psychosocial form, eligibility and f/u clinical form, f/u psychosocial form, MIC'S 1ST & 2nd review CRF's.) are to be scanned, saved in pt. folder and redacted. Also update the same in MDR TB & PHASE II SOURCE DOCUMENT CHECK LIST after scanning and save the CRF's in appropriate PT. ID folder.

These CRF's data are then entered into data base as per the version and redcap. In case of any query, clarify with the study team internally or if not resolved, email them to "Jeff or Pawandeep or Komala" for the query to be resolved of respective project person.

After complete  entering the data into data base, shift the CRF's in to entered redacted Mukt folder Cohort A & B. Also uploaded on One Drive- Mukt-entered redacted- respective cohort a & b folder

F/u with concern person for Pyrosequencing report, MIC report and culture MGIT positive days and hours & lab crfs for preempt study.

After scanning file all the crfs in respective files.

Help or coordinate with TEAM as whenever requires during study audits or routine study requirements.

OBSERVATION COHORT – Resolve any queries regarding recorded data and entries of patients follow ups as and when required.

DRTB BDQ & DLM patients through RNTCP.

Receive all BDQ & DLM CRF'S from clinician.

First check the patient's Nikshay ID in NIKSHAY PORTAL to check current status of the treatment, whether patient availing BDQ & DLM from Hinduja Hospital or other institute or hospital. If doesn't reflect in the nikshay portal current status as P.D HINDUJA HOSPITAL & MRC, then inform to DADAR DTO TEAM for patients transfer in P.D HINDUJA HOSPITAL & MRC.

Whether patient transfer in or not to check the status in NIKSHAY PORTAL on daily basis & Give reminder to DADAR DTO TEAM for transfer in.

Coordinate with Micro lab person & Clinician to check on concerned lab reports (at least one of the three test CBNAAT, LPA & CULTURE TEST positive) whether patients are eligible for BDQ OR DLM regimen, before starting the data entry in Nikshay Portal.

Generate the new Nikshay ID as outcome-(Treatment regimen changed) & this new Nikshay ID updated in CRF as well in PMDT TRACK SHEET.

All patients details entered in Nikshay portal  and in PMDT TRACK SHEET for e.g enrollment details (address, contact no. etc) , lab tests, adherence, bank details, comorbidity, treatment details, contact tracing, outcome.

For any discrepancy and queries arise while entering the data in Nikshay portal Coordinated and clarified with DADAR DTO TEAM & to resolve queries.

Update the DRTB BDQ & DLM patients follow up on every visit – like culture reports, ecg, adherence in Nikshay Portal & in PMDT TRACK SHEET.

Take the authorized signature of DR. Camilla madam on enrollment Crf and all Enrollment, Follow up CRF'S Scanned & saved in appropriate folder.

Update the DROPD VOUCHER EXCEL SHEET for every month.