DEE; effective, basic data management for Clinical Investigators is a method that uses commonly available office software to collect, structure and verify clinical study data with. The method is suitable for Post Marketing Research and Investigator initiated research.
Do you (plan to) conduct clinical studies and
- are you looking for a user friendly data capture system with which you could collect, structure and verify your clinical study data with?
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would you like a flying start by receiving DEE CDM SOPs & User Manuals to start working with?
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could you use a specialist to support you collecting your first study ready for analysis?
With the DEE method; effective, basic data management for Clinical Investigations; you'll get the material, training and 6 weeks support to be able to conduct clinical data management for your studies yourself.
Background
DEE is the abbreviation of Data Entry Export. Set-up in 2008 to just handle clinical study data completed on paper CRFs (data entry) and re-structure the collected to data files ready for statistical analysis (data export).
Nowadays, DEE evolved to:
- to a digital CRF; a paper look-a-like CRF in which the data are recorded electronically,
- 'soft' query pop-ups during data recording when data is considered 'inconsistent',
- ‘hard’ queries for data inconsistencies that need to be resolved before the CRF is signed for completion. E.g. required data that is missing.
- English material.
Benefits:
- User-friendly, look-a-like paper CRF, to electronically record data in.
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All recorded CRFs stay at the hospital. Because recorded CRFs are e-mailed to the data management center.
- The directory to store the recorded CRFs in, easily reveals shows how many subjects and CRF forms (CRF visits) are completed.
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The completed CRF files can be printed for Auditors.
- Data checks incorporated in the CRF forms to be completed, assure the recorded data are as clean as possible within a completed CRF form (CRF visit).
- User-friendly, look-a-like paper query forms, to electronically answer up on queries from the data management center.
Requirement at the study site(s):
Adobe Reader (version 9 or higher) is required to be able to record CRF data. In other words, the IT Managers of your study sites need to allow for this Reader version.
Requirements at the data management center:
- Acrobat X (
www.adobe.com)
- People interested in study data collection and data management.
- Persistent people, with eye for detail and a natural preference to categorize incoming information (analytic skills).
If you decide to invest in the DEE method for effective, basis data management for clinical Investigators, you'll get:
- DEE SOPs to start working with. SOPs written for the WHY, WHO, WHAT, WHEN questions concerning the DEE clinical data management method.
- practical user manuals with screenshots to actually perform the work and generate documented evidence with. In fact, they answer the HOW and WHERE questions for the DEE method.
- data check programming language (scripts) to copy and adjust for your clinical study. All different types of data checks ProCDM applied within the DEE method.
- computerized system validation documentation to start with. Including a risk analysis for your first DEE study,
- support to a maximum of 6 weeks to get your first study ready to receive and export real study data to desired datasets
You'll need:
- a software license of approximately € 700 (once only), if you don't already have the software
- SAS or MsExcel
- at least one dedicated user; the (to be) allocated clinical data manager
- at least one dedicated reviewer; to check output versus input at quality control steps (E.g. CRA, Clinical Study Manager or Quality Assurance Officer)
- internal IT support for back-up of files, directory access and installation.
Experience recording a digital DEE CRF form yourself by downloading one from the home page >
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Take a look at the DEE SOPs >
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