Thanks to visit codestin.com
Credit goes to www.scribd.com

Scribd
Upload
104 views16 pages

Study Conduct

Clinical data management involves several key activities including ensuring data completeness and quality through validation checks and query resolution, coding medical terminology and medications, reconciling data from external sources, and tracking metrics to measure performance. Data is entered into clinical databases either via paper case report forms with double data entry or directly into electronic data capture systems. Queries are used to resolve discrepancies and request clarification. Safety data is also reconciled between clinical trial and drug safety databases.

Uploaded by

Sarita
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
104 views16 pages

Study Conduct

Clinical data management involves several key activities including ensuring data completeness and quality through validation checks and query resolution, coding medical terminology and medications, reconciling data from external sources, and tracking metrics to measure performance. Data is entered into clinical databases either via paper case report forms with double data entry or directly into electronic data capture systems. Queries are used to resolve discrepancies and request clarification. Safety data is also reconciled between clinical trial and drug safety databases.

Uploaded by

Sarita
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
You are on page 1/ 16

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

You might also like