Database Designing in Clinical Data Management

Welcome
Database Designing in CDM
Mohd Suhail Ansari
B. Pharm
CSRPL_INT_OFL_WKD_142/0822
10/21/2022
www.clinosol.com | follow us on social media
@clinosolresearch
1

Clinical data
management
CDM Team
Data Flow in
CDM
Database
Designing in
CDM
Conclusion

CLINICAL DATA MANAGEMENT
Clinical data management (CDM) is the collection, integration and validation of clinical trial data. During the clinical
trial, the investigator collect the 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.
Clinical data management (CDM) consists of various activities involving the handling of data or information that is
outlined in the protocol to be collected/analyzed. CDM is a multidisciplinary activity.
A multi-disciplinary activity that includes:
✔ Research nurses
✔ Clinical data managers
✔ Investigators
✔ Support personnel
✔ Biostatisticians
✔ Database programmers
10/21/2022
@clinosolresearch
3

Clinical data management team and stages
CDM activities start early in the clinical trial process, once the trial protocol, describing the study objectives and
methodology, is designed. As a rule, data-related responsibilities are allocated across-
❖ a clinical data manager who supervises the entire CDM process;
❖ a database programmer or designer;
❖ data entry associates;
❖ a medical coder who translates diagnosis, procedures, adverse events, and other health data into industry
specific codes and
❖ a quality control associate.
Why CDM
10/21/2022
@clinosolresearch
4

Data flow in CDM
10/21/2022
@clinosolresearch
5

CDM PROCESS OVERVIEW
10/21/2022
@clinosolresearch
6

Database design
10/21/2022
@clinosolresearch
7
Data from clinical trial will be collected and stored in the CDMS. A database is simply a structured set of data. A
clinical trial database is a set of data collected during the study and organized in rows and columns. It’s designed
with the CRF structure in mind. In other words, the database incorporates a questionnaire schema of the case
report forms.
Subject ID Name of the patients Age Sex
A23691 XYZ 23 M
A23692 XYA 24 M
A23693 XYB 25 F
A23693 XYC 26 M
Some Database management system (DBMS) are-
1. QAData CDMS
2. MS Access
3. Oracle
4. Clintrial
5. Medidata Rave

Designing of eCRF
The case report form is a printed or electronic questionnaire for collecting data from study participants and reporting it
to trial sponsors. The document is created specifically for each research project in accordance with
• the trial protocol, and
• recommendations of the Clinical Data Acquisitions Standards Harmonization (CDASH). They are developed by Clinical
Data Interchange Standards Consortium to streamline industry-wide data exchange. Say, CDASH dictates dd/mm/yy
format for collecting dates.
• Starting from the early 1990s, electronic CRFs (eCRFs) have been gradually replacing their paper-based analogs which
leads to faster data collection and better quality of information. As of 2020, 84% of sites, sponsors, and CROs either
go paperless or plan to make this transition soon.
10/21/2022
@clinosolresearch
8

CRF Annotation
10/21/2022
@clinosolresearch
9
⮚An annotated CRF is generally defined as a blank CRF with markings, or annotations, that coordinate each
datapoint 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 annotated the CRF by establishing variable for each item to be entered.
⮚Review by CDM and statistician

Data Collection
10/21/2022
@clinosolresearch
10
Data collection is done using the CRF that are available in an electronic version. In the e-CRF-based CDM, the
investigator or a designee will be logging into the CDM system and entering the data directly at the site. In e-CRF
method, chances of errors are less, and the resolution of discrepancies happens faster. Since pharmaceutical
companies try to reduce the time taken for drug development processes by enhancing the speed of processes
involved, many pharmaceutical companies are opting for e-CRF options (also called remote data entry).
CRF Tracking
The entries made in the CRF will be monitored by the Clinical Research Associate (CRA) for completeness and filled up
CRFs are retrieved and handed over to the CDM team. The CDM team will track the retrieved CRFs and maintain their
record.
Data Entry
Data entry is a process of entering/ transferring data from case report form to clinical data management system
(CDMS)
Data Validation
Data validation is the process of testing the validity of data in accordance with the protocol specifications.
Edit check programs are written to identify the discrepancies in the entered data, which are embedded in the
database, to ensure data validity.

Discrepancy Management
10/21/2022
@clinosolresearch
11

Medical coding
10/21/2022
@clinosolresearch
12
Medical coding helps in identifying and properly classifying the medical terminologies associated with the
clinical trial. For classification of events, medical dictionaries available online are used. The dictionaries used
for the study are –
Adverse Events: MedDRA
Medications: WHODD
Database Locking
▪ After a proper quality check and assurance, the final data validation is run. If there are no discrepancies, the
SAS datasets are finalized in consultation with the statistician.
▪ All data management activities should have been completed prior to database lock. To ensure this, a pre-
lock checklist is used and completion of all activities is confirmed.
▪ This is done as the database cannot be changed in any manner after locking. Once the approval for locking is
obtained from all stakeholders, the database is locked and clean data is extracted for statistical analysis.
▪ Data extraction is done from the final database after locking. This is followed by its archival.

CONCLUSION
10/21/2022
@clinosolresearch
13
CDM has evolved in response to the ever-increasing demand from
pharmaceutical companies to fast-track the drug development process
and from the regulatory authorities to put the quality systems in place
to ensure generation of high quality data for accurate drug evaluation.
To meet the expectations, there is a gradual shift from the paper-based
to the electronic systems of data management.

Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
10/21/2022
@clinosolresearch
14

Database Designing in Clinical Data Management

More Related Content

What's hot

Similar to Database Designing in Clinical Data Management

More from ClinosolIndia

Recently uploaded

Database Designing in Clinical Data Management