Protocol Abbreviated Name Data Management Considerations (Condensed) Tool Summary

Protocol Abbreviated Name Data Management Considerations (Condensed) Tool Summary

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Protocol: Data Management Considerations
(Condensed)
Tool Summary Sheet
==================
Tool:
Data Management Considerations (Condensed)
Purpose:
This tool lists important considerations when evaluating a group’s
ability to electronically capture and validate clinical research data.
Audience/User:
This tool can be used by Principal Investigators and others
responsible for evaluating either their own or another group’s ability
to perform data management for a clinical research study.
Details:
*
Data management includes a wide array of tasks required to capture
all study data into electronic form. Data management also includes
tasks designed to validate the entered data by means of a variety
of edit checks (e.g., subjecting the data to range checks, valid
value checks, cross-checks, and manual review) that provide
feedback to those entering/providing the data. The goal is to have
an electronic clinical database that accurately reflects the data
collected and is able to be used for purposes of analyzing study
data for regulatory submissions and professional publication.
*
Electronic systems that capture clinical data for purposes of
analysis and reporting of FDA regulated studies must also adhere
to 21 CFR 11 regulations for data management systems.
Best Practice Recommendations:
*
Table 1. Site Staff and Data Management Task List
*
This table lists major data management task areas spanning the
process from initial data capture through to database
archival. Each major task area comprises a number of dependent
activities.
*
For each task area, consider whether the team can satisfy all
listed dependencies. Consider the team’s ability,
availability, and experience when responding Yes or No.
*
Table 2. Electronic System Capabilities
*
This table lists major features a data management system would
need for studies using either paper or electronic CRFs.
*
Some elements are highly desirable. Others are obligatory for
regulated studies per 21 CFR Part 11 requirements.
*
For each feature area, consider whether the team’s data system
complies with all required features when responding Yes or No.
*
Table 3. Other Infrastructure Requirements lists infrastructure
that would be expected from the group responsible for the data
management.
Tool Revision History:
Version
Number
Date
Summary of Revisions Made:
1.0
19Jul2011
Approved version
Data Management Considerations (Condensed)
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Table 1. Site Staff and Data Management (DM) Task List
Site/DM Task
Dependencies
Can Satisfy Dependencies
1
Develop Case Report Forms (CRF) and Train on Implementation
Design CRFs (paper or electronic)
Create CRF completion guidelines
Train site staff on CRF best practices and system use
□Yes; □ No
2
Use paper CRFs
Enter data on CRFs from source documents
Authorize all participant data via paper signature
Securely store CRFs until delivery to data management group
□Yes; □ No
3
Use electronic CRFs
Have access to validated electronic data capture (EDC) system
Perform data entry into EDC system from source documents
Authorize all participant data via electronic signature
□Yes; □ No
4
Support use of paper CRFs
Print paper CRFs (may require multi-part forms)
Inventory and store CRFs
Perform data entry into clinical database from CRFs
□Yes; □ No
5
Support use of electronic CRFs
Host fully validated EDC system that is also 21 CFR Part 11-compliant,
if applicable (Table 2)
Develop, validate EDC interface with clinical database
□Yes; □ No
6
Hold clinical database
Design 21 CFR Part 11-compliant electronic database; implement and
test all data validation rules
Integrate data from other electronic sources into the clinical
database
Facilitate access by site monitors to clinical data to enable source
document verification
Provide test data transfer with validation results
Prepare data management plan, including data validation plan
Provide status reports for enrollment, CRF completion, outstanding
queries, query overrides
Perform medical coding of adverse events and concomitant medications
Conduct SAE database and AE clinical database reconciliation
Perform reconciliation between electronic data loads and clinical data
Provide database snapshots for interim analyses (e.g., DSMB reports)
Perform data cleaning, query generation, query resolution
Conduct manual review of data for data errors (e.g., Concomitant
medication for systemic hypertension but no corresponding AE or
Medical History)
Update database based on query responses
Perform closure checks to verify the integrity and completion of the
database
Perform audit of final database
Lock database
Archive database files, completed CRFs, and query records
□Yes; □ No
Table 2. Electronic System Requirements
Feature Area
Required Features
Investigator Data System Complies
1
21 CFR Part 11 compliance (required for data systems used in regulated
studies)
Validation to ensure accuracy, reliability, consistent intended
performance, and the ability to discern invalid or altered records.
Proper documentation of this validation is available upon request
Access control and management (e.g., username and password required
for access, able to provide differential levels of access to system
features based on the user’s role)
Audit trail of all database transactions, including names and dates
corresponding to each entry-of or change-to a field
Ability to capture electronic signatures with corresponding
authentication
□Yes; □ No
2
Dynamic content control
Dynamic field or form generation (i.e., fields or forms that
automatically appear based on certain decision rules)
Generate and display derived variables (e.g., display age based on
birthdate and visit date computation; BMI based on height and weight)
□Yes; □ No
3
Flexibility and extensibility
Arbitrary case report form design
Import and use data from other electronic systems
Print paper/pdf versions of blank and completed CRFs
Export data for long-term archival, analyses or storage in other
electronic systems, or for manual analyses by investigators
Generate progress reports (e.g., enrollment, visit status) and data
reports (e.g., AE listings, abnormal lab, outstanding queries)
□Yes; □ No
4
Real-time data quality control
Range checks
Valid value checks
Cross-checks within a CRF page/form
Cross-checks across CRF pages/forms
Capacity for complicated/custom edit checks
Independent double data-entry and reconciliation of discrepancies
(specifically for paper-based data entry)
□Yes; □ No
5
Robustness
Redundancy in data storehouses facilities (e.g., hard drives)
Redundancy in data servers for guaranteed always-on high-access user
experience
Uninterruptible power supply
Comprehensive malware protection
Routine, scheduled backups with a solid disaster recovery plan
□Yes; □ No
Table 3. Other Infrastructure Requirements
Item
Available
Notes
1
SOPs for receiving, storing, and processing clinical data, as well as
for creating guide documents to facilitate later reference back to
source documents
□Yes; □ No
2
SOPs for other data management processes including data backup
□Yes; □ No
3
Staff qualification and training records
□Yes; □ No
Template version 1.0-20110719 6