CRP 109 Lecture 5

Question 1

Data Management Plan (DMP)

Answer 1

 Written document that describes
the process for collecting and
managing data throughout the
life of a study
 Road map to handle the data
 Auditable document
 Developed specifically for each
study
 Must comply with regulations,
local laws, and organizational
SOPs
Describes clinical data management activities to be followed
in the trial:
 Personnel and roles
 Database design
 Data collection
 Data entry
 CRF tracking
 Medical coding
 Data validation
 Query/discrepancy management
 Database lock

Question 2

Tools when Writing a DMP

Answer 2

 Study protocol
 Study contract
 Monitoring plan
 CRFs
 Data from external sources (laboratory data, genetics report)

Question 3

Updating a DMP

Answer 3

 When study protocol is amended
 Addition/removal of a site
 Changes to CRFs
 When data handling procedures change
 Yearly; review by data manager

Question 4

Back Up Operations

Answer 4

 Disaster recovery in the event that randomization process
malfunctions via a hardware/power failure
 Should be defined in the Data Management Plan
 Back up is typically a paper-based process
 i.e. hard copy of randomization list maintained with the statistician

Question 5

Data cleaning

Answer 5

Usually done post data entry but
 data should be reviewed for a few subjects from every site at the
beginning of the study to identify EDC system problems or study team
member understanding; and
 at all stages through the data collection phase of a study (EDC systems
help to make this faster/easier)
 Important for end users to understand how EDC data checks
are attached to data fields
 Ensure clean data gets “locked” in the EDC system
 Ensure audit trail is tracking all data changes

Question 6

types of Data Cleaning

Answer 6

 Manual review of data
 Data entry errors (missing, typographical, copying, coding and range errors)
 Queries, monitoring visits
 Computer checks
 Inaccurate or invalid data using ranges, missing data, protocol violations and
consistency checks
 Edit checks
 Descriptive Statistics
 Unusual patterns in data
 Data conversion errors
 Deviations/Violations trending (frequency of missing data)
 Excluding patients from analysis
 Detecting outliers

Question 7

database maintenace

Answer 7

 Source Data Verification
 Changes to data fields:
 Testing & UAT
Security:
 Digital signatures
 Data Archiving
Software:
 Version control
Periodic backups of all application and system data
 Regular installation of updated software patches
 User management and authorization

Question 8

Policy

Answer 8

• Guiding principle used to set direction
• The ‘what’

Question 9

Procedure/SOP

Answer 9

• Series of steps to be followed
• The ‘how’

Question 10

Audit Trail

Answer 10

A secure, computer generated, time-stamped electronic record that allows reconstruction of the course of events relating to the creation, modification, and deletion of an electronic record
-Protects the authenticity, integrity, and the confidentiality of electronic records
-Must be retained for at least as long as that required for the subject electronic records, and must be available for
inspectors/auditors