Download Data Management Plan

WCHRI
Study Title
Data Management Plan
Study:
Version:
Date:
Study Details
Study Title:
Investigator:
Code:
Document History
Version
Date
Reason For Change
1
dd mmm yyyy
Initial draft
Introduction
This document defines the data management approach for the named study. Specifically it defines data
sources, data handling practice and relevant additional documentation.
Document Control
This document is to be authorized by xxxx. The study sponsor (sponsor initiated studies) or Principle
Investigator (investigator initiated studies) should also review and authorize the production version and
any subsequent modifications.
Following authorization a read-only ‘controlled’ copy will be created and the document will be allocated a
version number. Subsequent changes will be authorized (see above) and the version number
incremented. Each authorized version will be retained on file for audit purposes.
Distribution
Each authorized version is to be circulated to the following individuals who will make it available to staff
as required.
John Smith – Edmonton
Fred Bloggs - Calgary
Study Overview
[Overview of study taken from Protocol, ethics application or other document as appropriate. Detailed
descriptions of Clinical Data Management (CDM) tasks will follow in a later section.]
Study Title
[The study title.]
Outline Description
[Brief overview of the study.]
Primary Efficacy Variables
[Details of the primary efficacy variables. This is required so that appropriate data management focus can
be applied to this critical data.]
Secondary Efficacy Variables
[Details of the secondary efficacy variables.]
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Study Title
Data Management Plan
Study:
Version:
Date:
Safety Data
[Details what data constitutes the safety data (if any) for the study, (Normally this would be the adverse
events and lab data, however some studies may include additional safety data).]
Definition of Analysis Populations
[Under some circumstances these definitions may be required to focus data management activity, for
instance an interim analysis involving certain sub sets of the study population.]
Patient Numbers
[Details the number of patients required in each group treatment/placebo/enrolled/randomized/completed
as appropriate]
Study Timelines
[Details of first patient first visit, last patient last visit, scheduled visit intervals, interim analysis, database
lock, final delivery, etc.]
Ethics Status
[Is the study interventional or observational? Is this a drug/device trial? Is the use of the drug/device
within its approval? Trials of a medication or device that are outside the scope of its approval require CTA
submission to Health Canada]
[Is ethics approval required and has it been obtained? Typically ethics approval is required for the
collection of subject related data. Note that where the subjects of the study are practising medical
personnel ethics approval may still be required]
Data Sources
[Detail all sources of data – both paper and electronic]
Standard Operating Procedures
Data management work performed by xxxx will be undertaken using the current version of their SOPs.
Scope of Work
[This section is an overview of the primary tasks performed by data management and all tasks on which
data management depends. Each sub-section should include a high level overview of the task and
include responsibilities (site / Global / Sponsor) and interfaces.]
Data Collection Mode
[EDC, paper, or a combination. For a combination which sites/regions are using EDC and which are not]
CRF Design
[Who is designing the CRFs is CRIC input required?]
Data Collection System
[What systems are to be used to collect the data]
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Data Management Plan
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Version:
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Randomization
[Describe how the study will be randomized/blinded and any applicable code break procedures]
Study Monitoring
[Paper CRFS]
Monitoring will be performed by xxxxI / Sponsor / other personnel. Monitored CRFs will be torn down and
returned to xxxx for data entry.
[EDC]
Electronic CRFs (OpenClinica, REDCap, etc) will be monitored electronically for accuracy (source
document verification), adherence to the protocol and GCP conformance. This will be done by xxxx /
sponsor / other staff. Additional data validations will be performed by xxxx as detailed below.
Document Tracking
[For documents received directly from investigational staff]
CRFs and other documents required for data entry should be delivered to xxxx accompanied by a CRF
Transmittal Form. This will detail the documents in the delivery. xxxx personnel will reconcile the
transmittal form against the delivered documents. Any discrepancies will be noted on the transmittal form,
which will be returned to the PI by way of receipt.
[For documents stored within the xxxx filing area]
When required for data entry CRFs and other required documents will be collected from the xxxx filing
area. Removal of the documents will be logged on the document tracking sheet.
[Where CRFs are photocopied]
On receipt the original documents will be photocopied and the originals filed.
Data Entry
[Paper CRF]
CRFs will be subject to single/double data entry according to current SOPs.
[Data entry from photocopies]
Data entry from the photocopied forms will proceed in a timely manner in the approximate order in which
the forms are received. As data entry proceeds the working copies will be dated and initialled by the
individual performing the entry. Any self evident corrections or data interpretations made by data entry
staff will be indicated on the working copy.
If any questions arise that cannot be resolved at the time of entry then a discrepancy will be recorded for
resolution at a later date.
[Where CRFs are NOT photocopied]
Data entry will proceed from the original forms in a timely manner in the approximate order in which the
forms are received. As data entry proceeds the forms will be discretely dated and initialled by the
individual performing the entry taking care not to obscure any text on the forms. Any self evident
corrections or data interpretations made by data entry staff will be noted in the data handling log.
If any questions arise that cannot be resolved at the time of entry then a discrepancy will be recorded in
the database for resolution at a later date.
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Data Management Plan
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[EDC]
The sites will complete electronic CRFs contained within the data collection system based on the
contents of the patient records and other data sources.
Data Handling
Data handling practices for this study are documented in the study’s data handling manual. This
document will be updated throughout the study as practices are refined and as new situations arise.
Specifically this document covers issues such as data handling conventions, self evident corrections, data
query practice and will also serve to log data handling exceptions.
Data Quality
The approach to data quality is based on key points contained within ICH GCP. These are:

Complete
Minimal missing values

Accurate
Database values match original observation

Precise
Units and measurability clearly understood

Timely
Minimal time between observation and recording

Verifiable
Independent assessment or monitoring
 Traceable
Actions taken are logged
The above points will be ensured as follows:
Data Validation and Queries
[Overview of data validation and query process. Should summarize relationship between data
management / monitors / site / sponsor for query processing.]
[EDC]
Electronic data collection forms will be programmed with online validation checks (also known as edit
checks). Based on an understanding of the data collection forms these checks will:
 Alert data entry users to missing data
 Check that numeric variables and dates are within reasonable ranges
 Check for consistency within the data
Entered data will be subject to visual and electronic validation by data management staff according to an
approved data validation plan. Issues that arise will be notified to the sites as queries, for resolution.
[Paper CRFs]
Such notification may be by any practical means including fax, email or 3-part query forms. Notification
may be direct to the site or via the monitor.
[EDC]
Data issues will be entered into the data capture system in the form of queries/discrepancies. Sites will
respond to the queries, directly in the data collection system. Query responses will be reviewed by data
management staff and closed once the issue has been resolved.
[REDCap]
Authorized staff will review data quality using REDCap’s Data Quality module. Any identified issues will
either be corrected or documented in the study data handling manual.
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Data Management Plan
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Version:
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Source Document Verification
The above procedures only partially address the issue of transcription errors arising during form
completion, some of which will be caught by online data validation. It is strongly recommended that
procedures are implemented within the research clinic in order to identify and correct transcription errors.
An example of such a procedure is an ongoing, systematic review of source documents (patient chart) for
a randomly selected sample of subjects.
Data Quality Audit
At intervals throughout the study a subset of entered data will be compared with the original data
collection forms. The number of compared forms and error counts will be recorded in order to measure
the percentage data entry error rate.
These audits will be conducted using random samples as follows:
 10 of the first 100 subjects
 100 of the first 1,000 subjects
 Every subsequent 1,000 subjects as follows:
The error rate for study data will be maintained below 0.1% (one in 1,000). If the error rate from the
preceding sample was above these limits then the sample will be 200 subjects. If the preceding error rate
was within these limits then the sample size will be 50 subjects.
If error rates remain high for three consecutive samples the team will need to consider alternative
remedies in order to bring the error rate within acceptable limits.
Serious Adverse Events
[Interventional studies only] Overview of SAE handling, including relationship between site / sponsor /
monitor and CRIC regarding SAE handling.]
Serious adverse events (SAEs) are to be reported to the sponsor (or PI for investigator initiated studies)
and ethics board, by the sites, as defined in the study protocol. Periodically the sponsor (or PI) will
forward copies of SAE reports to the data management team for reconciliation with the CRF data.
Data Coding
[Is data coding required,(for example adverse event coding). If so what data and which dictionaries
MedDRA? WHODDE?]
Data Extract and Delivery
[Define how data is to be extracted and delivered]
[REDCap]
Data can be exported by authorized users using REDCap’s data export module.
Archiving and Destruction
[Amend as appropriate]
After study completion all study materials will be returned to the Principle Investigator / Sponsor for
archiving.
Electronic data will be retained in CRIC secure systems until such time as these systems are
decommissioned.
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Study Title
Data Management Plan
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Version:
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Tasks and Responsibilities
These are summarized in the following table:
Task
Responsibility
Notes
CRF design
Database configuration
Database documentation
Database acceptance testing
Monitoring
Document flow and tracking
Data entry
Data validation
Discrepancy resolution
Data extract
Analysis database creation
Study materials archiving
Data archiving
Authorization:
Author:
(Signature)
Date:
Authorised by:
(PI or Sponsor)
Date:
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