CLINICAL DATA MANAGEMENT

Study Conduct
 STUDY CONDUCT ACTIVITIES

CENTRAL
ENSURING DATA LABORATORY OR
DATA ENTRY
COMPLETENESS THIRD-PARTY DATA
TRANSFER

QUERY
DATA CODING SAE RECONCILIATION
MANAGEMENT

METRICS AND
TRACKING
 DATA ENTRY
Traditional Method

Single or Double Data

Paper CRFs Database
Entry
 DATA ENTRY
e-CRF-Based

Designee logging into the CDM system.

Entering the data directly at the site.

Chances of errors are less due to programmed system

checks.

Resolution of discrepancies happens faster.

 ENSURING DATA
COMPLETENESS

Data manager ensures that data is collected, validated,

complete, and consistent.

This is achieved by looking at the status of each CRF.

There are symbols used in EDC systems to identify field, page

or CRF status as complete, incomplete, or if it has a query.
 THIRD-PARTY DATA TRANSFER

There are external data which is not included in CDM liaises with the central laboratory and
CRFs but needs to be collected for subject decides upon data formats and transfer
screening. schedules in Data Transfer Agreement.

Sponsors often refer to third party or the

Date and time of the sample collected is
centralized vendors. reconciled against the CRF.

Non- CRF/eCRF data is transferred from external

sources into the sponsor database.
 DATA CODING

Gastroesophageal
Reflux

Medical coding helps

in classifying reported Acid reflux
medical terms on the
CRF to standard
dictionary. Pyrosis

Heart burn
 DATA
CODING
Adverse events are coded using the available medical dictionaries.

Medications are coded using the available drug dictionaries.

(MEDDRA) MEDICAL DICTIONARY FOR (WHO-DDE) WORLD HEALTH WHO-ART THIS DICTIONARY DEALS
REGULATORY ACTIVITIES - IS USED FOR ORGANIZATION-DRUG DICTIONARY WITH ADVERSE REACTIONS
THE CODING OF ADVERSE EVENTS AND ENHANCED -IS USED FOR CODING TERMINOLOGY.
OTHER ILLNESSES. MEDICATIONS.
 QUERY MANAGEMENT

Auto Query or
System Check

Discrepancy
or Query

Manual Query

Edit check or
Validation Check
 AUTOGENERATED QUERIES OR SYSTEMS CHECKS

These checks are run automatically, whenever Edit checks can identify problems with a single
user saves or submits the data. variable, between two or more variables.
 MANUAL QUERY

After review of the data Manual Queries

could be Opened or issued by a Data
Manager, Clinical Coder, or a CRA.

Queries can be issued or responded Manual Query

based on the user roles.
 MANUAL QUERY

Manual queries require actions

such as clarification or correction
to a specific item or variable.
 SAE
RECONCILIATION

SAEs entered The clinical data

into the clinical manager ensures
trial database are reconciliation of
also entered into data between
the drug safety the two
database. databases.

Clinical Trial Database Drug Safety Database

 METRICS AND TRACKING

Metrics helps to measure the performance of clinical trials.

STATUS OF PAGE STATUS OF DATA AVERAGE TIME TO CLOSED COMMONLY

COMPLETION. QUERIES QUERY DISCREPANCIES RAISED DATA
RESOLUTION QUERIES