1. May 9, 20051 Data Management for Health Sciences Research Now More than Ever-- SIR is the Best Option Howard Andrews Data Coordinating Center Columbia University School of Public Health New York State Psychiatric Institute

2. May 9, 20052 SIR: Traditional Advantages I: Facilitating Structural Integrity of Data Case-structured SIR database option –Appropriate for virtually every health research project because person (or family) is the ‘case’ –Each record in each table must be ‘owned’ by a case ‘No New Cases’ option on data entry screens –In conjunction with case-structured option, can be used to enforce registration requirements –Eliminates ‘orphan’ records Sir Tables offer easy access to information that is not case-structured

3. May 9, 20053 SIR: Traditional Advantages II: Enhanced Variable Attributes Variable labels –No less valuable with 8+ character variable names Value labels –Still a significant lack in all major relational data management software systems other than SIR Missing value assignment (up to 3 per variable) –Reduces analytic error & effort by statisticians All variable attributes are directly associated with each variable, both in database creation & output –WRITE SCHEMA generates a ‘codebook’ containing all information required by investigators & statisticians

4. May 9, 20054 SIR: Traditional Advantages III: Interface with Stat Packages Procedural Query Language (PQL) facilitates: – extraction of database variables – creation of new variables – structuring of information SPSS, SAS, Stata files generated by a single command All variable attributes recognized by the stat package are ported seamlessly by SIR –Eliminates need to rebuild variable labels, value labels and missing value assignments in the stat package –Ensures that statistical system files are self-documenting

5. May 9, 20055 Policy shifts in medical research Increased scrutiny of database management plans –Proposals without adequate DBM plans are rejected Funding of multi-site projects and research centers –Individual projects (R01’s) benefit by center association Emphasis on cost, efficiency, productivity Emphasis on professional, ‘dedicated’ DBM staff –A need now widely recognized in the research community Databases often serve project management as well as data management functions, e.g., scheduling of followup examinations Greatly increased regulatory oversight of data –HIPAA Regulations / IRBs / DSMBs / PSMBs/Data Sharing

6. May 9, 20056 The Internet Factor Facilitates geographically dispersed data entry and access Puts a premium on data security Reinforces reliance on trained professionals and continuity of effort Requires close cooperation between IT and data management experts

7. May 9, 20057 What is the impact of these trends on management of research data? Data coordinating centers are emerging & growing –institutional and private sector Shift from DBM by researcher to external center puts a premium on efficiency & a focus on cost Use of sophisticated data management software is becoming the rule rather than the exception Increasing demand for building systems in which input & output is under end-user control –data entry by research staff rather than data center staff –direct access to by investigators and statisticians

8. May 9, 20058 SIR is well positioned to take advantage of these trends SIR research database management systems with user-friendly entry and data access interfaces can be set up quickly and efficiently –Tony Reardon, Advanced Training Traditional SIR advantages for research are enhanced in a competitive situation –SIR increases productivity of individual researchers –Data coordinating centers using SIR can run more efficiently and attract more research ‘clients’

9. May 9, 20059 What is the SIR community doing to take advantage ? Extending SIR’s reach: VPN / Secure web access custom interfaces connected to SIR database engine Citrix—makes the full range of SIR’s integrated systems available over the internet Improving user access –Enhanced menuing options in SIR (David Baxter) –Automatic updates of reports & statistical files –Direct user access to complex data systems DVQuery by DataVisor (Tom Shriver) Supporting multiple-project data management by Data Centers, e.g. DVSchema by DataVisor

10. May 9, 200510 What else ? The new version, SIR X/S: Tony Reardon Data Transfer/ODBC: –John Lemon/Jon Johnson Training a new generation of SIR users –Dave Doulton, Tony Reardon, Tom Shriver –John Lemon Heartbase update – Nick Gawrit And much more!