Data Management overview
Clinical Data Protocol
CRF Design
Management Best Database Design/ Building
Practices Edit checks/Specifications.
Data Entry
Data Validation/ Coding
SAE Reconciliation
Database Lock/ Transfer
Statistical Analysis
Data Management Components Data Management Objectives
Data Acquisition Primary:- Ensure Data Integrity
Data Privacy
Data storage Secondary :
Data Entry Accelerate timelines from data
Data Archival collection to data analysis and
Quality in Data Management publication.
Data Security and Confidentiality Work closely with researchers in
every stage of the project life cycle
Data Acquisition Data Privacy
Design the forms to collect the data Educate and train all project personnel.
specified by the protocol. Minimize identifiers in data collection.
Protect non-entered data which could impact
Keep questions, prompts and client confidentiality.
instructions clear and concise. Ensure privacy during data transfer.
Use multiple choice avoid open ended Design policies and regulations.
questions if at all possible. Implement contract contingencies when
utilizing external services.
Maintain consistency throughout Maintain proper physical and electronic
instruments. security measures.
Make the forms available for review at Signed the confidentiality agreement from all
the clinical site prior to approval. 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
Functional service provider
Protocol design and study start up
Patient and investigator recruitment IT superpower and Clinical Trial hub
Clinical trial management Quality and fast response-buzzword
Clinical data management Meeting global stringent regulatory
Data Analysis standards
Clinical supplies
Regulatory and Safety
Proactive risk management and
Electronic Data Capture innovative in technology
Questions ?
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