Data Management overview
Clinical Data
Protocol
Management Best
Practices
Data Management Components

Data Acquisition

Data Privacy

Data storage

Data Entry

Data Archival

Quality in Data Management

Data Security and Confidentiality
Data Acquisition

Design the forms to collect the data
specified by the protocol.

Keep questions, prompts and
instructions clear and concise.

Use multiple choice avoid open ended
questions if at all possible.

Maintain consistency throughout
instruments.

Make the forms available for review at
the clinical site prior to approval.

CRF Design

Database Design/ Building

Edit checks/Specifications.

Data Entry

Data Validation/ Coding

SAE Reconciliation

Database Lock/ Transfer

Statistical Analysis
Data Management Objectives
Primary:- Ensure Data Integrity
Secondary :
Accelerate timelines from data
collection to data analysis and
publication.
Work closely with researchers in
every stage of the project life cycle
Data Privacy

Educate and train all project personnel.

Minimize identifiers in data collection.

Protect non-entered data which could impact
client confidentiality.

Ensure privacy during data transfer.

Design policies and regulations.

Implement contract contingencies when
utilizing external services.

Maintain proper physical and electronic
security measures.

Signed the confidentiality agreement from all
project personnel.
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Data Storage Data Entry

Store all original data collected in
Independent Double Entry
secured areas such as rooms with
controlled access.
Double entry with blind verification.

Document the procedures for granting
Double entry with interactive
access to database servers establishing verification.
system controls and assigning
passwords.
Single entry with manual review.

Store electronic data in such a way that
backups can be made easily and
frequently.

IT disaster recovery plan.

Data Archival
Quality in Data Management

Lock the database to prevent data
Betterment in quality leads to
modification. increases in productivity rate of

Create database design innovation and profitability.
documentation.

Preserve raw data.

ICH- GCP: Section: 5.1.3

Scope of Clinical Data

Data Security and Confidentiality
Management

Aspects of Security
System

Physical Security

Data Security
Study

Communication Security

Software Security.

Data protection act-1998/ ISO-IEC-17799,
Compound
BS-7799 part 2: 1999

FDA 21 CFR part 11: Final rule-Federal
Register Vol-62, No-54 13429 March
Corporate
1997.

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 Study Level
System Level

Plat form
CRF Design

Security
Database Design

Study Configuration

Availability

Security

Configuration
Data Procession[ Entry/Validation]

Dictionaries
Data Tracking

Work Flows
Data Reporting

Acquisition/ Integration
Data Audits

Data Lock

Secure regulated environment Complete Accurate, Auditable Data

Compound Level Corporate Level

Data Integration
Tracking

Data Reporting
Metrics

Statistical

Timelines
Analysis

Resources

Business objective planning

Data Management Set-up Data Validation

Data Validation Guidelines

Automated and manual procedures

SAE Reconciliation Guidelines

Creation and Implementation of a Quality to detect missing entries, illogical
Control plan data or data that conflict with the

Coding of Clinical Data

Handling Data Transfer protocol requirements.

Designing a Case Report Form
To ensure Data accuracy and

Handling Non-CRF Data

Data Handling Report
Completeness.

Building a Project Database

Account management, Security and Access

Data Entry/Tracking Guidelines

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Discrepancy Management Data Validation Guidelines

Is the process of identifying and managing potential problems
with data collected during a study.
Global Ruling

Discrepancy is a variance between an actual response and the
Edit
expected response as defined in validation procedures.

Discrepancy doesn’t necessarily indicate an error with the data
specifications
only that the data doesn’t meet expectations.

Data/DCF flow

Discrepancies are resolved according to the protocol and
Guidelines.

Batch Validation: A process to programmatically run all

associated procedures against all accessible data for a
specified study.

Data Clarification Form: Form used to clarify discrepancies

identified in the clinical data reported on CRFs and to document
modifications.

Clinical Data Management-

SAE Reconciliation Guidelines
Outsourcing to India

Business Need:-

Reconciliation is the process where
data management ensures that the
A Detailed Data Management Plan
SAEs that are recorded in the
Preparation of database in a desired software

Comprehensive electronic validation and
CDMS match those recorded in the consistency checks
Drug Safety database [
Data entry including double entry
Pharmacovigilence Database]
Query generation, handling, editing and
tracking.

Database lock

100% quality control of the efficacy parameters
and safety data

21 CFR part 11 compliant

Data Management setup Cost Challenges and Opportunities

Cost of manpower
Perceptions versus ground realities in India

Office maintenance
Lack of Intellectual property protection

Data Management software
Ethical Standards- GCP compliance and Law

Thesaurus management system
Acceptance of Indian data for submission to the FDA and

Application Server committee for proprietary medicinal products.

Media charges
Regulatory reforms to facilitate global trials in India

Dictionary
Indian GCP guidelines and its regulatory status.

Statistical Software
Investigator capability status

Servers
Setting up in-house dedicated clinical operations.

Operating System
Back office services support

Implementation & Training Expenses
e-CRF and Database development

Personal computers
Data Management

Cost of Hardware, Software
Statistical analysis and SAS programming

Telephone charges

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Improving Clinical Trials by
Implementing Information Conclusion
Technology

India- Emerging Outsourcing Model

Core functions-Target for Improvement:-
Preferred full service provider

Protocol design and study start up

Patient and investigator recruitment

Clinical trial management

Clinical data management

Data Analysis

Clinical supplies

Regulatory and Safety

Electronic Data Capture

Functional service provider

IT superpower and Clinical Trial hub

Quality and fast response-buzzword

Meeting global stringent regulatory
standards

Proactive risk management and
innovative in technology

Questions ?

Thank you