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Clinical Data Management
       -An Introduction




       GRATISOL LABS TRAINING
             MATERIAL
Clinical Data Management is
involved in all aspects of
processing the clinical data,
working with a range of
computer         applications,
database systems to support
collection,   cleaning    and
management of subject or
trial data.

                   GRATISOL LABS TRAINING
                         MATERIAL
What is Clinical Data
   Management
Clinical Data Management is
involved in all aspects of
processing the clinical data,
working with a range of
computer applications, database
systems to support collection,
cleaning and management of
subject or trial data.

                  GRATISOL LABS TRAINING
                        MATERIAL
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
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
Key members
The Key members involved in Data
  Management:
Clinical Data Manager
Database Administrator
Database Programmer
Clinical Data Coordinator
Clinical Data Associate
                 GRATISOL LABS TRAINING
                       MATERIAL
Bigger Picture




            GRATISOL LABS TRAINING
                  MATERIAL
Clinical Trail   Overview




                    GRATISOL LABS TRAINING
                          MATERIAL
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
Responsibilities of CDM
Study Setup
CRF design and development (paper/e-CRF)
Database built and testing
Edit Checks preparation and testing


Study Conduct
Data Entry
Discrepancy Management
Data Coding (using MEDRA and WHODD
dictionaries)
Data review (Ongoing QC)
SAE Reconciliation
Data Transfer

 Study Closeout
 SAE Reconciliation
 Quality Control
 Database Lock
 Electronic Archival
 Database Transfer         GRATISOL LABS TRAINING
                                  MATERIAL
CDM Process Overview




               Startup phase                                            Conduct phase       Close out phase




               CRF Design                     Discrepancy
                                             management -                Coding of
                                                Query to                                Database QC
                                                                        medical terms
               Quality check                  investigator


Protocol
                                Data entry
 design
              Database Design

                                                             Database
                                                                                        Database Lock
               Quality check                                 updates




                Edit Checks


               Quality check




                 Database
                 activated




                                     GRATISOL LABS TRAINING
                                           MATERIAL
Study Start Up Process Review


                                       CRF design




 Protocol                              Database
                                        design




                                       Validation/
                                        derivation
                                       Procedures




                                   Activated database
                                    ready to accept
                                    production data




              GRATISOL LABS TRAINING
                    MATERIAL
CRF Design/Review
A representation of the study as outlined in the protocol is made
(including CRF completion guidelines if necessary). Therefore a
final protocol needs to be available before this activity can be
initiated.. CRF design usually takes about three rounds: First draft
(rough without detail but correct content), second draft (as good as
we can get it) and final version. We need input from our sponsor to
correct draft versions and to approve the final version.

Traditional Paper Based Case Report Forms
e-CRF (Electronic Case Report Form)- Study information
directly entered into computer.
e-CRF is prepared by using:
ORACLE CLINICAL
CLINTRIAL
                          GRATISOL LABS TRAINING
                                MATERIAL
Paper CRF                            e-CRF
            GRATISOL LABS TRAINING
                  MATERIAL
How many CRFs do you need?

-Eligibility or Screening
form
-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
Data Base Design
Data from a clinical trial will
be collected and stored in
some kind of computer
system.
A database is simply a
structured set of data.
A collection of rows and
columns.
--Excel Spreadsheet
--Oracle application
                      GRATISOL LABS TRAINING
                            MATERIAL
DBMS:
MS Access XP, MS Excel XP
Oracle Clinical
Clintrial
Phaseforward InForm
medidata Rave
                  GRATISOL LABS TRAINING
                        MATERIAL
CRF Annotation
An annotated CRF is generally defined as a blank CRF
with markings, or annotations, that coordinate each data
point in the form with its corresponding dataset name.
Essentially, an annotated CRF communicates where the
data collected for each question is stored in the database.
CRF Annotation is the first step in translating the CRFs
into a database application.
CDM annotates the CRFs by establishing variable names
for each item to be entered.
Reviewed by CDM and Statistician


                      GRATISOL LABS TRAINING
                            MATERIAL
GRATISOL LABS TRAINING
      MATERIAL
Validation Checklist:
Validation Checklist describes in detail which data shall be
checked and queried if necessary. The programming of the
checks occurs according to this checklist. Before the
programming starts, the sponsor will be asked to give
approval of this Validation Checklist.
Test subjects are entered in the database to test the entry
screens and the programming. The exact number of test
subjects is not standard, but every check has to pass and
fail (negative and positive proof) at least once.
                       GRATISOL LABS TRAINING
                             MATERIAL
Database set up and testing
Database 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
GRATISOL LABS TRAINING
      MATERIAL
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
CRF Tracking
Logistic 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
Discrepancy Management
Discrepancy management is a
process of cleaning subject data in
the Clinical Data Management
System (CDMS), it includes
manual checks and programmed
checks. Trivial discrepancies are
closed as per self evident
correction method or Universal
ruling and discrepancies which
require response from the site are
queried by raising Data
Clarification Forms (DCF).
                  GRATISOL LABS TRAINING
                        MATERIAL
Medical Coding
The medical coding for a study is done
as per the project specific protocol
requirement. The dictionaries used for
a study are:

Adverse Events: MedDRA (Medical
Dictionary for Regulatory Activities)
Medications: WHODD (World Health
Organization – Drug Dictionary)

Manual coding is performed using
Thesaurus Management System (TMS)
which is integrated with our Clinical
Data Management System (CDMS).
                     GRATISOL LABS TRAINING
                           MATERIAL
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
Study Close out Process Review

                       Discrepancy
                       management




 Safety data
                                             Coding terms
reconciliation



                           Query
                         generation




                        Resolution
                       and/or update
                        of database




                         Manual
                       checks/QC/
                       CRF tracking




                       Database lock
                         & freeze


                    GRATISOL LABS TRAINING
                          MATERIAL
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
Database Lock
The 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
Analysis & Reporting Process Review



  Database                        Data
   release                     extraction/
                                Mapping



                                                Statistical
                                                  report
                                                generation




                                               E-publishing




                          Creation of             Published
Submission of
                         Clinical study        tables, figures
   CSR
                         report(CSR)             and listings




                      GRATISOL LABS TRAINING
                            MATERIAL
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
Importance of CDM

CDM 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
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
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
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
Mission of CDM

•   Consistency
•   Accuracy
•   Validity
•   Archiving




                  GRATISOL LABS TRAINING
                        MATERIAL
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
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: www.gratisol.com
    E-mail – training@gratisol.com

           GRATISOL LABS TRAINING
                 MATERIAL

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Clinical Data Management Training @ Gratisol Labs

  • 1. Clinical Data Management -An Introduction GRATISOL LABS TRAINING MATERIAL
  • 2. Clinical Data Management is involved in all aspects of processing the clinical data, working with a range of computer applications, database systems to support collection, cleaning and management of subject or trial data. GRATISOL LABS TRAINING MATERIAL
  • 3. What is Clinical Data Management Clinical Data Management is involved in all aspects of processing the clinical data, working with a range of computer applications, database systems to support collection, cleaning and management of subject or trial data. GRATISOL LABS TRAINING MATERIAL
  • 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. 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. Key members The Key members involved in Data Management: Clinical Data Manager Database Administrator Database Programmer Clinical Data Coordinator Clinical Data Associate GRATISOL LABS TRAINING MATERIAL
  • 7. Bigger Picture GRATISOL LABS TRAINING MATERIAL
  • 8. Clinical Trail Overview GRATISOL LABS TRAINING MATERIAL
  • 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. Responsibilities of CDM Study Setup CRF design and development (paper/e-CRF) Database built and testing Edit Checks preparation and testing Study Conduct Data Entry Discrepancy Management Data Coding (using MEDRA and WHODD dictionaries) 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. CDM Process Overview Startup phase Conduct phase Close out phase CRF Design Discrepancy management - Coding of Query to Database QC medical terms Quality check investigator Protocol Data entry design Database Design Database Database Lock Quality check updates Edit Checks Quality check Database activated GRATISOL LABS TRAINING MATERIAL
  • 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. CRF Design/Review A representation of the study as outlined in the protocol is made (including CRF completion guidelines if necessary). Therefore a final protocol needs to be available before this activity can be initiated.. CRF design usually takes about three rounds: First draft (rough without detail but correct content), second draft (as good as we can get it) and final version. We need input from our sponsor to correct draft versions and to approve the final version. Traditional Paper Based Case Report Forms e-CRF (Electronic Case Report Form)- Study information directly entered into computer. e-CRF is prepared by using: ORACLE CLINICAL CLINTRIAL GRATISOL LABS TRAINING MATERIAL
  • 14. Paper CRF e-CRF GRATISOL LABS TRAINING MATERIAL
  • 15. How many CRFs do you need? -Eligibility or Screening form -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. Data Base Design Data from a clinical trial will be collected and stored in some kind of computer system. A database is simply a structured set of data. A collection of rows and columns. --Excel Spreadsheet --Oracle application GRATISOL LABS TRAINING MATERIAL
  • 17. DBMS: MS Access XP, MS Excel XP Oracle Clinical Clintrial Phaseforward InForm medidata Rave GRATISOL LABS TRAINING MATERIAL
  • 18. CRF Annotation An annotated CRF is generally defined as a blank CRF with markings, or annotations, that coordinate each data point in the form with its corresponding dataset name. Essentially, an annotated CRF communicates where the data collected for each question is stored in the database. CRF Annotation is the first step in translating the CRFs into a database application. CDM annotates the CRFs by establishing variable names for each item to be entered. Reviewed by CDM and Statistician GRATISOL LABS TRAINING MATERIAL
  • 20. Validation Checklist: Validation Checklist describes in detail which data shall be checked and queried if necessary. The programming of the checks occurs according to this checklist. Before the programming starts, the sponsor will be asked to give approval of this Validation Checklist. Test subjects are entered in the database to test the entry screens and the programming. The exact number of test subjects is not standard, but every check has to pass and fail (negative and positive proof) at least once. GRATISOL LABS TRAINING MATERIAL
  • 21. Database set up and testing Database 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. 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. CRF Tracking Logistic 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. Discrepancy Management Discrepancy management is a process of cleaning subject data in the Clinical Data Management System (CDMS), it includes manual checks and programmed checks. Trivial discrepancies are closed as per self evident correction method or Universal ruling and discrepancies which require response from the site are queried by raising Data Clarification Forms (DCF). GRATISOL LABS TRAINING MATERIAL
  • 26. Medical Coding The medical coding for a study is done as per the project specific protocol requirement. The dictionaries used for a study are: Adverse Events: MedDRA (Medical Dictionary for Regulatory Activities) Medications: WHODD (World Health Organization – Drug Dictionary) Manual coding is performed using Thesaurus Management System (TMS) which is integrated with our Clinical Data Management System (CDMS). GRATISOL LABS TRAINING MATERIAL
  • 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. Study Close out Process Review Discrepancy management Safety data Coding terms reconciliation Query generation Resolution and/or update of database Manual checks/QC/ CRF tracking Database lock & freeze GRATISOL LABS TRAINING MATERIAL
  • 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. Database Lock The 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. Analysis & Reporting Process Review Database Data release extraction/ Mapping Statistical report generation E-publishing Creation of Published Submission of Clinical study tables, figures CSR report(CSR) and listings GRATISOL LABS TRAINING MATERIAL
  • 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. Importance of CDM CDM 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. 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. 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. 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. Mission of CDM • Consistency • Accuracy • Validity • Archiving GRATISOL LABS TRAINING MATERIAL
  • 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. 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: www.gratisol.com E-mail – training@gratisol.com GRATISOL LABS TRAINING MATERIAL