Clinical Data management is one of the vital part of clinical research. Clinical research is research on drugs,devices ,medicines that has to be adminstered for various diseases and illness,to check the efficacy and safety in human voluteers or patients. It helps in determining dose and dosages of a particular drug or treatment regimen.CR also helps in label expansion of investigational drug. Furthermore it helps in checking any adverse event in post marketed drug which increases the potability of drug among population of various geographical regions.There are various guidelines and regulatory bodies from several parts of world . Each country has its own regulatory body both at state and central level,eg.CDSCO for India,TGA for Australia,USFDA for USA,MCC for South Africa ,UNCST for Uganda,EMEA for European Union,MHRA for UK.Thus CDM plays important role in maintaining accuracy,consistencies,validity reliabilty of available data.It also in decreasing redundancy of duplicate and inconsistent data.It is required to resolve issues pertaining to inaccuracy , signal detection in pharmacovigilance. CDM is completed in three steps set up,conduct ,close out.Database used i n cdm are DBMS ,MS -Access,OC-RDC.Data managers,operators,programmers,developers are include in the process.CDMS Clinical data management system ,clinical system validation.

1. CLINICAL DATA MANAGEMENT
PRESENTED BY
SMRATEE S MALODE
M.SC BIOTECHNOLOGY,CHEMISTRY

3. CONTENTS
 Introduction
 Set up of Cdms
 Conduct
 Medical Coding
 Close out
 Guidelines to publish Clinical Data
 Key Role Players
 Summary
 Conclusion

4. CDM
 It is the process that is required by the sponsor
and regulatory bodies to establish the results to
ensure safety,efficacy,well being of trial subjects
and humans during drug discovery and
development process.
 It ensures integrity,quality,consistency,accuracy,
 completeness of huge quantity of data collected
during clinical trials.
 CDM process starts with creation of study
protocol ,designing of CRFs, Edit check
specifictions,UAT .

5. CONTINUED…
 Key role players are data managers,medical
coders,data entry operators,data reviewers
etc.
 It is required in-site,in-house,ware –house of
data collection in pharamaceutical
companies,sponsors to report to regulatory
bodies.

6. Set Up Of Cdm
 CDMS is a tool used in clinical research to
manage the data of a clinical trial.Data collected
at investigator’s site is stored in Clinical Data
Management System.
 Several databases used are OC-
RDC,RAVE,INFORM.
 Data Management Plan(DMP) is living
document throughout the lifecycle of a study to
address any updates or changes made during
conduct of study.

7. CONTINUED…
 DMP is the first plan developed seprately for
each trial study and early stage during set up of
CDM.It ensures timely,accurately,cost-effective
data deliverables.
 Case report form(CRF) is printed
,optical,electronic document designed to record
all of the protocol required information to be
reported to sponsor on each trial subject.It is of
two types Paper CRF and electronic CRF. It
should be Clear,Concise, Consistent with the
Protocol.

8. CONTINUED…
 Edit Check Specifications :
 Edit checks consisting of manual and computer
checks need to be per- formed on the data to
ensure the database is accurate and
consistent. The definition stage consists of
producing an Edit Check Specifications
(ECS) document and the implementation stage
involves the programming and testing of the
checks.
 User Acceptance Testing.

10.  User Acceptance Testing (UAT), is an element of
validation and is performed once the database has been
developed. This is performed before the CDMS is used to
capture/process any live data. It is performed by a user of
the database or CDMS (data entry operators, data
managers, medical department, statistician and principal
investigator), and should follow a predefined protocol
detailing each step and expected result with clearly
defined pass and fail values. The UAT report provides
objective evidence for the validation process. Once UAT
has been successfully completed and documented and
any remedial actions implemented and retested, the test
database is moved into production mode to capture live
trial data

11. CONDUCT OF CDM…
 It starts with Data Entry:
 Single Data entry:Entered by single person
 Double Data entry:Entered by double person
at two different sites.
 Data review and data validation is done after
data entry.
 Three types of data is :Time dependent
 Non time dependent,cumulative data.

12. CONTINUED…
 Query writing :
 It involves discrepancy management.Invalid
query,incomplete query,duplicate query,language
error,insufficient explanation.
 Data Clarification Form(DCF):A data clarification
form (DCF) or data query form is a questionnaire
specifically used in clinical research. The DCF is the
primary data clarification tool from the trial sponsor
or contract research organization (CRO) towards the
investigator to clarify discrepancies and ask the
investigator for clarification. The DCF is part of the
data validation process in a clinical trial.

13. MEDICAL CODING
 Coding becomes essential part of CDM
because different data can be collected as
part of multicentre trial and different
investigators,countries.
 It takes place during query management and
data validation, to maintain
uniformity,validity,accuracy,
 Med DRA and WHO-ART dictionaries are
used.

14. CONTINUED…
 The concomitant medications, medical
history adverse event, serious adverse event
data are generally coded using medical
dictionaries.

15. CLOSE OUT

16. CONTINUED…
 Trial close-out is the act of ensuring that all
activities related to the clinical trial are
appropriately reconciled, recorded and
reported at the end of the trial. End of trial
declaration should be in accordance to the
protocol, relevant SOPs, and applicable
regulatory and GCP guidelines.

17. GUIDELINELINES TO PUBLISH CLINICAL DATA
 CONSORT: Consolidated Standard of
Reporting Trials.
 TREND: Technology Recreation Education
Nature and Discovery.
 STROBE:Strengthing the reporting of
Observational studies in epidemiology.
 STARD:Standards for reporting of diagnostic
accuracy studies.

18. KEY ROLE PLAYERS IN CDM
 Data Managers
 Data Entry operators
 Data reviewrs
 Investigators
 Monitors
 Statistician
 Database Programming
 Database Adminstrator

19. SUMMARY
 CDM is process started from clinical data
collection from site,subjects,data checks
,validation ,entry
,Storage,archiving,Database handling and
lock.Medical coding in CDM is to maintain
accuracy,consistency. All phases of clinical
trial involves data management.
 Different regulatory bodies publish clinical
data
 For drug development.

20. CONCLUSION
 CDM is vehicle to ensure safety,efficacy,well-
being ,integrity,confidentiality of trial subjects
during clinical data and patients after drug
marketing.Non clinical data is collected to
ensure pre clinical studies and adminstration
of drug for clinical trials or phases.