CDM is defined as the process of collection, cleaning, and management of subject data in compliance with regulatory standards.
A database must be accurate, secure, reliable and ready for analysis.
CDMS is the tool for clinical data management.
RESPONSIBILITES OF CDM
STUDY SET UP (15%) - this includes all the activities that are done before at the starting of the study.
STUDY CONDUCT (60%)- this starts once a subject enrollment begins or with first patient‘s first visit.
STUDY CLOSEOUT (25%) -the data is final and ready for statistical analysis.
CASE REPORT FORM
Types of CRF
PAPER CRF
e-CRF
Data entry is a process of entering or transferring data from case report form ( paper or image ) to clinical data management system (electronic storage ).
optical mark reading (OMR)
Data entry may be entirely manual or partly computerized using optical character recognition (OCR).
The three basic types of data entry system:
(a) Local data entry system - data entry is done on site
(b) Central data entry system - data entry is done at data management centre from the received CRFs;
(c) Web based data entry system - data entry is done through web (secure link) using internet connection.
DATA CLEANING
MANAGING ADR DATA
ADR data are collected from clinical trials and marketed products.
All ADR are reported to clinical data management system or safety system.
During clinical trials-ADR information is also received through CRF or EDC.
These information are stored in clinical data management database.
DATABASE LOCK PROCESS
Data manager – data is accurate and complete
Clinical project manager – site activities are complete
Medical monitor - data is medically accurate
Biostatistician - data is ready for evaluation and analysis.
Data manager asks for the database to be locked .
Done through the company’s IT department.
Once locked, no data can be changed.
Signed process for locking the database is placed in Trial Master File (TMF)
Data base closure (database lock): The database closure for the study is done to ensure no manipulation of study data during final analysis.
DATABASE LOCK/FREEZE is a TWO step process:-
The first step is often referred as SOFTLOCK or DATABASE FREEZE- occurs after all data cleaning, validation, and QC activities have been finalized.
The second step is called HARDLOCK or DATABASE LOCK –At this stage the database is handed over to statistics for data analysis.
DATA TRANSFER
Traditional Data Transfer
CRFs developed by sponsor and supplied to the site along with completion/instruction manual .
Use a black or blue ball point pen for permanency – and PRESS HARD.
At the time of a monitoring visit, CRFs are reviewed for adherence to
guidelines and verified against source documents by the Monitor.
During the monitoring visit, site staff make required corrections to CRFs
Verified/corrected CRFs are submitted to the sponsor, leaving a legible
copy of the CRF at the site.
4. WHAT IS CLINICAL TRAIL DATA MANAGEMENT?
CDM is defined as the process of collection, cleaning, and management of subject data in compliance with
regulatory standards.
A database must be accurate, secure, reliable and ready for analysis.
OBJECTIVES OF CDM:-
to provide high-quality data
keep the number of errors and missing data as low as possible.
gather maximum data for analysis.
CDMS is the tool for clinical data management.
4
5. CLINICAL TRAIL DATA MANAGEMENT
RESPONSIBILITES OF CDM
STUDY SET UP (15%) - this includes all the activities that are done before at the starting of the study.
STUDY CONDUCT (60%)- this starts once a subject enrollment begins or with first patient‘s first
visit.
STUDY CLOSEOUT (25%) -the data is final and ready for statistical analysis.
5
6. CASE REPORT FORM
6
Data Manager
Database Administrator
Database Programmer
Clinical Data Associate
7. Case Report Form (CRF): A paper or electronic data collection document used in human research.
It is a tool used to collect data on each study participant.
Study protocol provides the detailed methodology for running the trial, the CRF provides the main day-to-
day information.
CRF should be clear, and easy to follow and complete.
Types of CRF
1. PAPER CRF
2. e-CRF
7
CASE REPORT FORM
10. CRF TRACKING AND CORRECTIONS
CRFs tracking:
All CRFs should be tracked.
CRFs are tracked to detect missing pages too.
Check the quality and completeness of the documents.
If corrections are necessary, make the change as follows:
Draw one horizontal line through the error
Insert the correct data
Initial and date the change
DO NOT ERASE, SCRIBBLE OUT, OR USE CORRECTION FLUID OR ANY OTHER MEANS WHICH COULD
OBSCURE THE ORIGINAL ENTRY
10
11. DATA ENTRY
Data entry is a process of entering or transferring data from case report form ( paper or image ) to clinical
data management system (electronic storage ).
Data entry may take a form of direct computer entry by a person transferring data from paper-based CRFs into
a computer database, using optical mark reading (OMR)
Data entry may be entirely manual or partly computerized using optical character recognition (OCR).
The three basic types of data entry system:
(a) Local data entry system - data entry is done on site
(b) Central data entry system - data entry is done at data management centre from the received CRFs;
(c) Web based data entry system - data entry is done through web (secure link) using internet connection.
11
12. DATA CLEANING
12
Data cleaning: Process of detecting, diagnosing, and editing faulty data.
Scrub for Duplicate
data is coming from different sources or users, for any reason, submit their entry more than once.
Scrub for Irrelevant Data
Irrelevant data is the type of information that doesn’t have any formal errors but is just not useful for
your project.
Scrub for Incorrect Data
Incorrect data is often easy to spot, as it’s just illogical.
Handle Missing Data
Missing data is just unavoidable.
13. MANAGING LABORATORY
13
• TYPES OF LABORATORY :-
CENTRAL LABS:-
• Samples are collected from different sites (hospitals) and they are sent to one special laboratory which is
called central lab (sponsor assigned) for testing purpose.
LOCAL LABS:-
• Local labs are the regular lab facilities that are available in the hospital or nearby location.
• Each site (hospital) will have their lab.
• Sample of the patients on a particular site will be analysed in lab in that particular hospital.
14. MANAGING ADR DATA
14
ADR data are collected from clinical trials and marketed products.
All ADR are reported to clinical data management system or safety system.
During clinical trials-ADR information is also received through CRF or EDC.
These information are stored in clinical data management database.
15. DATA TRANSFER
Traditional Data Transfer
CRFs developed by sponsor and supplied to the site along with completion/instruction manual .
Use a black or blue ball point pen for permanency – and PRESS HARD.
At the time of a monitoring visit, CRFs are reviewed for adherence to
guidelines and verified against source documents by the Monitor.
During the monitoring visit, site staff make required corrections to CRFs
Verified/corrected CRFs are submitted to the sponsor, leaving a legible
copy of the CRF at the site.
If data is not retrieved at the time of the monitoring visit, sponsor may
Want the CRFs submitted via mail.
15
DATA TRANSFER
eCRF PAPER CRF
16. DATA TRANSFER
Sponsor enters the CRF data into a centralized database (generally done by 2 separate individuals, called
double data entry) and reviews the data for errors.
If inconsistencies are found, the sponsor generates data queries (forms may vary slightly from sponsor to
sponsor) and sends to the site.
Site staff investigates these queries and responds to them either directly on the data query form or on the CRF.
The data correction is then re-submitted to the sponsor for entry into their database.
16
17. Electronic CRF (eCRF)
Site records data to the electronic database.
Data periodically electronically transmitted to Sponsor/CRO or in Sponsor database
Review of data performed by in house CRAs
Less frequent CRA visits
Electronic queries generated and sent to site
Database lock
17
Missing Data at Time of Transfer
Missing data elements
Source Document (SD) not supporting CRF
CRF not supporting SD
Referred to as:
Discrepancies
Queries
Clarifications
Identified by:
Sponsor
Database
18. DATABASE LOCK
Data base closure (database lock): The database closure for the study is done to ensure no manipulation of
study data during final analysis.
DATABASE LOCK/FREEZE is a TWO step process:-
The first step is often referred as SOFTLOCK or DATABASE FREEZE- occurs after all data cleaning,
validation, and QC activities have been finalized.
The second step is called HARDLOCK or DATABASE LOCK –At this stage the database is handed over to
statistics for data analysis.
18
19. DATABASE LOCK PROCESS
Before the lock , the following individuals sign indicating the database can be locked :
Data manager – data is accurate and complete
Clinical project manager – site activities are complete
Medical monitor - data is medically accurate
Biostatistician - data is ready for evaluation and analysis.
Data manager asks for the database to be locked .
Done through the company’s IT department.
Once locked, no data can be changed.
Signed process for locking the database is placed in Trial Master File (TMF)
User access is turned off.
19
20. References
20
1. Textbook of clinical reaserch – by GURU PRASAD
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1198040/
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/#!po=38.1579
4. Clinical Data Management -Sponsored by Center for Cancer Research National Cancer Institute
5. https://youtu.be/WhGksOUyMP4
6. https://www.slideshare.net/MaheshKoppula2/clinical-data-management-58285393
7. https://www.slideshare.net/DivyaDabbeta/clinical-data-management-190218435
8. https://www.slideshare.net/DivyaDabbeta/clinical-data-management-190218435
9. https://lifepronow.com/2020/05/28/difference-between-the-central-lab-and-local-lab-in-clinical-
research/
10.https://www.iteratorshq.com/blog/data-cleaning-in-5-easy-steps/
11.https://www.slideshare.net/KatalystHLS/data-management-plankatalyst-hls