Clinical Data Management Training @ Gratisol Labs


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Clinical Data Management Training in Oracle Clinical @ Gratisol Labs

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Clinical Data Management Training @ Gratisol Labs

  1. 1. Clinical Data Management -An Introduction GRATISOL LABS TRAINING MATERIAL
  2. 2. Clinical Data Management isinvolved in all aspects ofprocessing the clinical data,working with a range ofcomputer applications,database systems to supportcollection, cleaning andmanagement of subject ortrial data. GRATISOL LABS TRAINING MATERIAL
  3. 3. What is Clinical Data ManagementClinical Data Management isinvolved in all aspects ofprocessing the clinical data,working with a range ofcomputer applications, databasesystems to support collection,cleaning and management ofsubject or trial data. GRATISOL LABS TRAINING MATERIAL
  4. 4. Clinical Trial Data Clinical Data Management is the collection, integration and validation of clinical trial data During the clinical trial, the investigators collect data on the patients health for a defined time period. This data is sent to the trial sponsor, who then analyzes the pooled data using statistical analysis. GRATISOL LABS TRAINING MATERIAL
  5. 5. Why CDM Review & approval of new drugs by Regulatory Agencies is dependent upon a trust that clinical trials data presented are of sufficient integrity to ensure confidence in results & conclusions presented by pharma company Important to obtaining that trust is adherence to quality standards & practices Hence companies must assure that all staff involved in the clinical research are trained & qualified to perform data management tasks GRATISOL LABS TRAINING MATERIAL
  6. 6. Key membersThe Key members involved in Data Management:Clinical Data ManagerDatabase AdministratorDatabase ProgrammerClinical Data CoordinatorClinical Data Associate GRATISOL LABS TRAINING MATERIAL
  8. 8. Clinical Trail Overview GRATISOL LABS TRAINING MATERIAL
  9. 9. Multidisciplinary Teams in Clinical Trials 1. Clinical Investigator 11. Regulatory affairs 2. Site coordinator 12. Clinical Data Management 3. Pharmacologist 13. Clinical Safety Surveillance 4. Trialist/Methodologist Associate (SSA) 5. Biostatistician 14. IT 6. Lab Coordinator 15. IT/IS personnel 7. Reference lab 16. Trial pharmacist 8. Project manager 17. Clinical supply 9. Clinical Research 18. Auditor/Compliance Manager/Associate 10. Monitor GRATISOL LABS TRAINING MATERIAL
  10. 10. Responsibilities of CDMStudy SetupCRF design and development (paper/e-CRF)Database built and testingEdit Checks preparation and testingStudy ConductData EntryDiscrepancy ManagementData Coding (using MEDRA and WHODDdictionaries)Data review (Ongoing QC)SAE ReconciliationData Transfer Study Closeout SAE Reconciliation Quality Control Database Lock Electronic Archival Database Transfer GRATISOL LABS TRAINING MATERIAL
  11. 11. CDM Process Overview Startup phase Conduct phase Close out phase CRF Design Discrepancy management - Coding of Query to Database QC medical terms Quality check investigatorProtocol Data entry design Database Design Database Database Lock Quality check updates Edit Checks Quality check Database activated GRATISOL LABS TRAINING MATERIAL
  12. 12. Study Start Up Process Review CRF design Protocol Database design Validation/ derivation Procedures Activated database ready to accept production data GRATISOL LABS TRAINING MATERIAL
  13. 13. CRF Design/ReviewA representation of the study as outlined in the protocol is made(including CRF completion guidelines if necessary). Therefore afinal protocol needs to be available before this activity can beinitiated.. CRF design usually takes about three rounds: First draft(rough without detail but correct content), second draft (as good aswe can get it) and final version. We need input from our sponsor tocorrect draft versions and to approve the final version.Traditional Paper Based Case Report Formse-CRF (Electronic Case Report Form)- Study informationdirectly entered into computer.e-CRF is prepared by using:ORACLE CLINICALCLINTRIAL GRATISOL LABS TRAINING MATERIAL
  15. 15. How many CRFs do you need?-Eligibility or Screeningform-Physical Exam form-Enrollment form-Medical History form-AE form/ SAE form-Concomitant therapy form-Blood test form-Laboratory test form-Follow-up Visit form LABS TRAINING GRATISOL MATERIAL
  16. 16. Data Base DesignData from a clinical trial willbe collected and stored insome kind of computersystem.A database is simply astructured set of data.A collection of rows andcolumns.--Excel Spreadsheet--Oracle application GRATISOL LABS TRAINING MATERIAL
  17. 17. DBMS:MS Access XP, MS Excel XPOracle ClinicalClintrialPhaseforward InFormmedidata Rave GRATISOL LABS TRAINING MATERIAL
  18. 18. CRF AnnotationAn annotated CRF is generally defined as a blank CRFwith markings, or annotations, that coordinate each datapoint in the form with its corresponding dataset name.Essentially, an annotated CRF communicates where thedata collected for each question is stored in the database.CRF Annotation is the first step in translating the CRFsinto a database application.CDM annotates the CRFs by establishing variable namesfor each item to be entered.Reviewed by CDM and Statistician GRATISOL LABS TRAINING MATERIAL
  20. 20. Validation Checklist:Validation Checklist describes in detail which data shall bechecked and queried if necessary. The programming of thechecks occurs according to this checklist. Before theprogramming starts, the sponsor will be asked to giveapproval of this Validation Checklist.Test subjects are entered in the database to test the entryscreens and the programming. The exact number of testsubjects is not standard, but every check has to pass andfail (negative and positive proof) at least once. GRATISOL LABS TRAINING MATERIAL
  21. 21. Database set up and testingDatabase setup and testing are always performed in a secure, non study data environment. Only when a database has been reviewed and fully tested, will it be set in ‘production’, a separate environment where only study data will be entered. Changes in structure or programming will always first be performed and tested in the non study data environment before they are made effective in the ‘production’ database. GRATISOL LABS TRAINING MATERIAL
  23. 23. Study Conduct Process Review Data entry/Activated DB Data loading Discrepancy (CRF and management external data) Safety data Coding terms reconciliation Query generation Resolution and/or update of database Manual checks/QC GRATISOL LABS TRAINING MATERIAL
  24. 24. CRF TrackingLogistic way if it is paper based study.EDC-electronic data capture if it is e- CRF. Data Entry Data entry is a process of entering/transferring data from case report form to Clinical Data Management System (CDMS). Data Entry: 1) Single data Entry 2) Double Data Entry GRATISOL LABS TRAINING MATERIAL
  25. 25. Discrepancy ManagementDiscrepancy management is aprocess of cleaning subject data inthe Clinical Data ManagementSystem (CDMS), it includesmanual checks and programmedchecks. Trivial discrepancies areclosed as per self evidentcorrection method or Universalruling and discrepancies whichrequire response from the site arequeried by raising DataClarification Forms (DCF). GRATISOL LABS TRAINING MATERIAL
  26. 26. Medical CodingThe medical coding for a study is doneas per the project specific protocolrequirement. The dictionaries used fora study are:Adverse Events: MedDRA (MedicalDictionary for Regulatory Activities)Medications: WHODD (World HealthOrganization – Drug Dictionary)Manual coding is performed usingThesaurus Management System (TMS)which is integrated with our ClinicalData Management System (CDMS). GRATISOL LABS TRAINING MATERIAL
  27. 27. SAE Reconciliation• Serious Adverse Event (SAE) data reconciliation is the comparison of key safety data variables between Clinical Data Management System (CDMS) and Master Drug Safety Database (MDSD). Reconciliation is performed to ensure that events residing in both systems are consistent. GRATISOL LABS TRAINING MATERIAL
  28. 28. Study Close out Process Review Discrepancy management Safety data Coding termsreconciliation Query generation Resolution and/or update of database Manual checks/QC/ CRF tracking Database lock & freeze GRATISOL LABS TRAINING MATERIAL
  29. 29. Quality Control• Quality Should be maintained for overall study by performing Quality checks at intervals for all data points (Critical & Non-Critical) prior to database lock.• QC helps to ensure that all the data processed is accurate, clean and Correct. GRATISOL LABS TRAINING MATERIAL
  30. 30. Database LockThe database lock for a study is done to ensure no manipulation of study data during the final analysis. Database lock for a study is done once all data management activities are completed. This includes the database lock checklist which ensures the same. Some of the activities included in database lock checklist are All discrepancies closed, DCFs received and updated, coding complete, SAE Reconciliation process complete etc. GRATISOL LABS TRAINING MATERIAL
  31. 31. Analysis & Reporting Process Review Database Data release extraction/ Mapping Statistical report generation E-publishing Creation of PublishedSubmission of Clinical study tables, figures CSR report(CSR) and listings GRATISOL LABS TRAINING MATERIAL
  32. 32. Objectives of CDM CDM is a vital vehicle in Clinical Trials to ensure:  The Integrity & quality of data being transferred from trial subjects to a database system  That the collected data is complete and accurate so that results are correct  That trial database is complete and accurate, and a true representation of what took place in trial  That trial database is sufficiently clean to support statistical analysis, and its subsequent presentation and interpretation GRATISOL LABS TRAINING MATERIAL
  33. 33. Importance of CDMCDM has evolved from a mere data entry process to a much diverse process today It provides data and database in a usable format in a timely manner It ensures clean data and a ‘ready to lock’ database GRATISOL LABS TRAINING MATERIAL
  34. 34. CDM Professionals CDM Professionals: o Pharmacists o Graduates/Post graduates in Life Sciences, IT, Statistics o Graduates with post graduation diploma in Clinical Research o Licensed Medical Practitioners ICH.E6.5.5.1: Utilize qualified individuals to: o Supervise overall conduct of trial (Project Manager) o To handle and verify the data (Data Manager) o To conduct the statistical analysis (Biostatistician) o To prepare study reports (Medical Writer) GRATISOL LABS TRAINING MATERIAL
  35. 35. DM Role in Clinical Research Data Management Role in Clinical Research:  The data management function provides all data collection and data validation for a clinical trial program  Data management is essential to the overall clinical research function, as its key deliverable is the data to support the submission  Assuring the overall accuracy and integrity of the clinical trial data is the core business of the data management function Continued… GRATISOL LABS TRAINING MATERIAL
  36. 36. DM Role in Clinical Research  Data management starts with the creation of the study protocol  At the study level, data management ends when the database is locked and the Clinical Study Report is final  At the compound level (of the drug), data management ends when the submission package is assembled and complete GRATISOL LABS TRAINING MATERIAL
  37. 37. Mission of CDM• Consistency• Accuracy• Validity• Archiving GRATISOL LABS TRAINING MATERIAL
  38. 38. DATA MANAGEMENT WORKFLOW Receipt of CRFs First Pass Second Pass(CRF Tracking/Filing) Clinical Data Auto Entry Entry Management Coding Batch Validation Data Clarification Form Thesaurus (DCF) DCF Discrepancy Manual Resolutions Management Coding SAE Quality Control Reconciliation Plan Database Lock GRATISOL LABS TRAINING Electronic MATERIAL Archival
  39. 39. For further info & Guidance A Training Divison of Gratisol Labs, Plot No-70, Road No.10, Banjara Hills, Banjara Hills, Hyderabad-500 034 Ph: +91 40 65741017, 64615852 Mobile: +91 8885198390 , 9705790302 Web: E-mail – GRATISOL LABS TRAINING MATERIAL