Data Management for Large Studies Robert R. Kelley, PhD. Thursday, September 27, 2012
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1 Robert R. Kelley, PhD Thursday, September 27, 2012
2 Agenda Provide an overview of several tools for data management in large studies Present an extended Case Study in using REDCap to manage study data Offer tips for success in managing study data.
3 What is a large study? We defined a small study as: about cases with around (A-Z) variables per case A large study is anything else!
4 Examples of Large Studies (Division of Infectious Diseases) NIH CAP Study 1082 variables (~5500 cases) HIV Cohort Study 675 variables (~1200 cases) Bone and Joint Infection Study 1913 variables (~250 cases)
5 Open Clinica What tools can I use for larger studies? REDCap LabKey Medidata Rave Custom Software
6 Unlike Excel and Access these tools require infrastructure and specialized skills to maintain.
7 Infrastructure and Skills A place to host your application What type of infrastructure and skills will I need? Internal Server Cloud Server The technical skills to install and maintain the system Licenses for required software (e.g. MS SQL Server, Windows Server 2008, Oracle) Recommendation Hire a dedicated person to administer this system or contract it out.
8 OpenClinica Designed for capturing data for clinical trials Has paid and free versions Can be hosted locally or by Specifications Windows Server 2008 or Linux Variant Java Java Application Server (Apache) Database: PostgreSQL 8.4 or Oracle 10.2g Akaza Research LLC Supports exporting data to: HTML Tab-Delimited SPSS Syntax and Data CDISC ODM xml 1.3 and 1.2 CDISC OpenClinica Exentsion 1.3 and 1.2 Clinical Data Interchange Standards Consortium.
9 LabKey Software Specifications Windows Server 2008 or Linux Variant Java Java Application Server (Apache) Database: PostgreSQL 8.4 or Microsoft SQL Server Designed for storing lab data such as: Specimen data Gene Sequences Flow Cytometry Data Proteomics Data Any Assay Data It also supports storing other clinical data Has paid and free versions Can be hosted locally or by Akaza Research LLC Supports exporting data to: Excel Text Javascript R SAS
10 Medidata Rave A comprehensive commercial clinical data management system Very flexible Expensive and requires Specifications Windows Server 2003 or higher Database: Microsoft SQL Server 2005 or higher significant technical support Supports exporting data to: SAS CSV XML
11 REDCap A comprehensive open source clinical data management system Specifications Windows Server 2008 or Linux Variant PHP Database: MySQL Server SMTP server Supports creating: Surveys Data Entry Forms (ecrfs) Longitudinal Studies Free, but requires significant technical support Supports exporting data to: Excel SPSS SAS R STATA
12 Custom Software If your requirements are extremely particular you may want to build your own system Can be time consuming and resource intensive NOT RECOMMENDED
13 Using REDCap
14 Case Study Study Case Report Form
15 Annotated Case Report Form (See Handout)
16 Tips for developing a successful research database Documentation is Key Develop a process for changing the underlying structure of the database Keep the database and the paper case report forms in sync Clarify measurement units for all laboratory and clinical data.
17 Data Management for Small Studies Questions?
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