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Roles and Responsibilities of On site and Off Site Data Managers

Roles and Responsibilities of On site and Off Site Data Managers. December 11, 2005 Sheraton Park Tower Chennai, INDIA Lolita Lantican (INCTR Senior Data Manager ). A need for accurate recording and processing of patient data is fundamental to any Clinical Research/Trial !!. THEN.

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Roles and Responsibilities of On site and Off Site Data Managers

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  1. Roles and Responsibilities of On site and Off Site Data Managers December 11, 2005 Sheraton Park Tower Chennai, INDIA Lolita Lantican (INCTR Senior Data Manager)

  2. A need for accurate recording and processing of patient data is fundamental to any Clinical Research/Trial !! THEN If data stored is incorrect Conclusion of Analysis will be incorrect GOAL: Accurate Recording of Patient Data Data Management team

  3. 1. Overview of DM Team Sponsor/CRO Study Site Project Manager Data Entry Clerk Off Site data manager Investigators/Clinicians On Site Data Manager Data Monitor/CRA

  4. 2. Data Collection Flow On Site (HOSPITAL) Off site (INCTR/Sponsor) • Investigator,s See patient and record data on source doc • Data managers, • Complete the CRF’s • Verifies data capture on CRF’s • Submits CRF’s to sponsor (1) DEC’senter data in DB Data managersverify data consistencies/errors Data managers prepare and send electronic queries to site (7) (5) (6) (2) (3) (4) (8) Data manager/Study monitor Verifies queries with source documents (9) Submits Data managerupdates central database (10)

  5. 3. Major Tasks of On site Data Manager 3.1 Gathers information from source documents to crf’s 3.2 Submits data to sponsor/data center 3.3 Resolve queries 3.4 Manages source documents and Maintains trial documents/forms

  6. 3. Major Tasks of On site Data Manager 3.1. Data collection Data Transcription: From source document To Case report Forms (CRF’s)* *(Data entry/collection guidelines is provided by the sponsor) Accuracy Correctness Completeness

  7. 3. Major Tasks of On site Data Manager 3.2. CRF submission: Verify data for completeness & Accuracy Paper form RDES Remote Data Entry System

  8. Characteristics of RDES • Database can be accessed through internet (web based application) or • Database is installed at the site(A stand alone windows application) • No need to submit paper CRF’s to INCTR/sponsor. Database is submitted to sponsor or On line submission.

  9. Characteristics of RDES • On site Data entry • Data Errors or discrepancies are checked through data extraction techniques

  10. Example RDES: Web based Application

  11. Example RDES: Stand Alone Windows Application System • Executable file: • File: mdb access file • Set up:

  12. 3. Major Tasks of On site Data Manager3.3Query Resolution What is Query ? Requests for data clarification, missing data, data discrepancies that are sent to the PI and On site data managers for verification with source documents (generated by the on-site or off-site data manager)

  13. Query Resolution 2 Ways to Correct Data Errors Electronic Queries Manual Correction Log • Site Correction Verification Query • Data discrepancies identified on-site,and reported to off-site data manager • Electronic Query • Off site Queries generated automatically by off-site data managers

  14. Example: Query Resolution Manual Query Log Electronic Query Form

  15. 3. Major Tasks of On site DM 3.4 Recordkeeping (GCP requirements Related To Recordkeeping) An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigations on each individual (patient).

  16. 4. Major Tasks of OFF site Data Manager 4.1 Ensures data timeliness 4.2 Generates Queries 4.3 Maintains and updates the Central Database 4.4 Develops guidelines or manuals related to data management 4.5 Designs database structures and data validation plans

  17. 4.1 Ensures Data Timeliness (Using CRF tracking System) .

  18. 4.2 Generates Queries .

  19. 4.3 Maintains Central Database .

  20. 4.3 Updates data (CRF and Database) .

  21. 4.4 Develops Guidelines/Manuals related to data management .

  22. Example: Guidelines/manuals related to data management EXAMPLE

  23. 4.5 Designs data validation plans

  24. . On ON GOING TRAINING PLUS OFF Site team On Site team

  25. « The sponsor should utilize Appropriately qualified individuals to supervise the Overall conduct of the trial, to handle the data, to verify the data, ….. » Excerpt from: ICH Topic E6:Guideline for Good Clinical Practice

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