1. ICTR Data Managers Interest Group October 28, 2014

2. Best Practices Initiative Kelly Crowley

3. Best Practices Initiative How can we better prepare and protect ourselves? We don’t want a top down approach What policies already exist at Hopkins and other institutions? Examples: Oxford and DataOneOxford DataOne Also consider existing training opportunities Catalog current standards, and brainstorm what should be included in future JH policy Create three working groups to meet outside of interest group meeting times

4. Best Practices Initiative Continued Kelly Crowley can help to create email distribution lists, build collaborative web space, and find available conference rooms Groups should report back to advisory board; solicit their input and help, as well as from other interest group members Short term goal: Scheduling working groups meetings; First draft of guidelines by the end of the academic year Long term goal: Create modules to be included in IRB approval process

5. Barriers Identified in Best Practices Survey April 2014 What’s not working? Don’t know how to talk to when I have questions Need a direction of “who to contact” for further information No interaction beyond month presentations Need central location for resources on the intranet; more networking opportunities Suggestions going forward: Very focused on SOM, not the resources I have in SON We could become a more formal group than just an “interest groups.” We could work more to bring together a working community of analysts Create open forums Ask audience to help solve problems they face

6. Interest Group Web Resources ICTR Data Management Interest Group Presentation webinars and slide sets ICTR Data Management Interest Group Presentation webinars and slide sets ICTR Data Management Interest Group SharePoint site ICTR Data Management Interest Group SharePoint site Listserv : datamgrs@lists.johnshopkins.edu datamgrs@lists.johnshopkins.edu

7. Goals for Today Receive summary of what each breakout group discussed on September 5 Continue breakout discussions Agree on next steps for working groups *Note: We will return to our regular format next month

8. Data Backup and Security Group Leader: Scott Carey

9. Backup and Security Summary Backup Models What University/Enterprise Services are Available? Documentation of Backups Who is Responsible? Securing Shared Data Existing Policies? Discussion Points

10. Areas a Policy Could Address Data Backup How Often (daily, weekly, monthly…) Type (incremental, full…) Media (tape, cd, disk) Retention Period? Where are they stored? Security / Encryption?

11. Data DocumentationWhat type of documentation is needed to describe the shared data? ProceduresNeed to have documentation of the metadata associated with the archive FinancialHow will the archiving be funded? Areas a Policy Could Address Data Security Identifying Obvious and Subtle Identifiers Who has permission to access data HIPAA Waivers? Where does data reside? How is it secured? Existing Security Policies ( http://www.it.johnshopkins.edu/policies/) http://www.it.johnshopkins.edu/policies/

12. Plan for Today: Identifying Best Practices Create high-level outline of a policy document around data archiving and sharing Gather best practices Note existing resources, website, people Note where expertise is unknown Record definitions around key terms (e.g., data destruction) Project plan work (parsing of tasks, timelines, etc.)

13. Data Archiving and Sharing Group Leader: Betsy Gunia

14. Process Summary Broke into 3 subgroups to discuss definitions for and provide personal examples of activities around the following concepts: Data sharing (i.e., when you give data) Data reuse (i.e., when you receive data) Digital preservation/data destruction

15. Data DocumentationWhat type of documentation is needed to describe the shared data? De-identificationHow do you ensure that the data is fully de- identified and re-identification is not possible? Data ownership and rightsIssues of data ownership when sharing: If a researcher is given data by another entity, can THAT data be shared along with the data collected by the researcher? ProceduresResearchers should always keep a copy of the original consent form when sharing data Areas a Policy Could Address Data Sharing

16. Data DocumentationWhat type of documentation is needed to describe the shared data? ProceduresNeed to have documentation of the metadata associated with the archive FinancialHow will the archiving be funded? Areas a Policy Could Address Data Archiving

17. Plan for Today: Identifying Best Practices Create high-level outline of a policy document around data archiving and sharing Gather best practices Note existing resources, website, people Note where expertise is unknown Record definitions around key terms (e.g., data destruction) Project plan work (parsing of tasks, timelines, etc.)

18. Data Manageme nt and Planning Group Leader: Sharon Ghazarian

19. Notes from 9/5/14 Breakouts Discussion around important considerations prior to the study beginning –Most efficient use of data –Clear idea of database structure –Make sure a protocol exists and includes data management details –Create templates or boiler plates for use –Have clear idea of final goals –Discuss how data will be stored and secured

20. Notes from 9/5/14 Breakouts Action Items –SharePoint site with areas to populate  Examples of protocols already in use  Example templates  Example data dictionaries  Roadmaps  Checklists  Subway Map  Welch Center Resources  Pharma requirements  List of questions to ask a PI before a study begins  Phone-a-Friend

21. Next Steps Populate SharePoint site Examine entries and collate Begin putting together draft of guidelines

22. 10/28/14 Plans Brainstorm key terms/definitions pertinent to data management and planning for inclusion in draft guidelines List of resources to include in draft guidelines pertinent to data management and planning Discuss collating existing resources and format of draft documents –Draft timeline and assignment of key sections –Plan for group meetings outside of the larger format

23. Breakout Rooms A) Data Management Planning – Rm 9 B) Data Sharing and Archiving – Rm 305 C) Data Backup and Security – Rm 10