Authorised
by:
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Name:
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Role:
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Signature:
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Date:
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Prepared
by
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Name:
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Role:
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Signature:
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Date:
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1. Key Personnel
- a section that details the name,
their function in the trial, email address, telephone/fax number for all
the staff involved in the trial including the sponsor, the project
coordinator, the project manager, the investigators, study staff involved
in the data management (including computing staff responsibilities for
maintaining hardware and software), the monitors and anyone else
associated with the trial
2. Study Milestones
All activities are listed from the protocol development till the end of the study analysis and finalisation of a study report and especially first and last patients enrolled, first and last CRFs sent to the data management, data validated and locked. This includes dates for when key milestones should be and have been reached, and can help to organise day to day data management activities in order to relate them to the planned timelines.Example
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Activity
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Planned date
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Achieved date
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Final
protocol
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Final
CRF
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Edit
check designed and finalised
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Validation
checks specified and finalised
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Database
(field edition) specifications finalised
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Database
application and testing
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First
patient's first visit
centre X centre XX |
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First
monitoring visit (FMV)
centre X centre XX |
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First
CRF in data management centre (LDM)
centre X centre XX |
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Last
patient's last visit
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Last
CRF in data management centre
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Last
query resolved – data cleaned
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3. Data Flow
- a section that details the flow of the data
from the field to the final storage
4. CRF Completion Guidelines
- a section that details how to complete the paper CRFs
or how to enter data electronically. This document will be used to train
investigators
- This can be a separate document
and included in the DMP as an appendix
5. Monitoring Plan
- a section that detail the monitoring plan
if monitors are involved in the trial. It will detail for example, the
frequency of the monitoring visits, how the Source Data Verification will
be done, what are the laboratory ranges for verification/clinical
interpretation
6. Data Entry Guidelines
- a section that details data entry
- how to use the data
entry system set up?
- double or
single data entry?
- what are the
role and responsibilities of the study staff? For example, who has the
responsibility to for entering the data first, with which computer, who
will enter data for the 2nd time? Who will merge the file to check for
discrepancies? What are the procedures in case of discrepancy?
7. Data Edit Checks
- a section that details edit checks (data
entry checks and post entering data checks specifications) as described
previously in this Session
8. Coding
9. Data Validation
- a section that describes the post data entry validation system.
With for example:
- who checks the
consistency of the data?
- who queries the
investigator?
- what is the
format of a query form?
- how many days
are allowed to answer to a query?
- who decides
that a query is resolved?
10. Data Back-up and Archiving
- a section that describe
procedures in place to ensure data
protection including back-up system (if you don't do this
you could lose the data!)
