1. The IRB and the Portal databases do not currently share data directly. How are projects linked (for communication and to avoid duplication of effort) in the IRB and the Portal databases?
CTSI is working with the IRB to identify all projects currently in the IRB database that CTSI also touches. We are currently working with the IRB to automatically add the nomenclature "UMNCTSI" in the "Full Title" field for all current CTSI projects in the IRB database. Going forward, there will be an opportunity to indicate CTSI involvement on an IRB application, automating the addition of the "UMNCTSI" nomenclature.
There is a concern that adding "UMN CTSI" to the full title on the IRB application will result in issues with Sponsors, as it will be modifying the title of the study. This concern has been expressed to the IRB and is currently under review by the IRB.
2. RPMs are not able to edit project information after the first time a record is created in the CTR Portal. Why not? What is the process for a CTSI staff member to update project information?
System permissions and roles are still in development, and permissions within the My Projects module are set to "Read Only" for both CTSI staff and study team members. It is helpful to remember that the Portal has a broad potential user base with widely variable needs and levels of access to information. Overall security of the system will be taken into consideration when determining roles and related permissions.
CTSI staff members should complete a Project Update Request Form to update information on a single project. In order to simultaneously and efficiently update many projects, a spreadsheet can be completed and submitted to Beth Mohr (firstname.lastname@example.org).
3. The "Quick Search" box does not display results when the query includes both a first and last name of an investigator, but rather, it only displays results when either the first or last name is used.
This issue has been passed along to the programmer for correction.
4. RPMs often need to access protocol documents, as well as create and submit cost estimates related to those protocols. How can an RPM access protocols and submit cost estimates?
Personnel assigned to create cost estimates should have access to view protocols within the new Request for Services System. Please contact Carolee Wieneke (email@example.com) or a back up checker (Patti Hatchett [firstname.lastname@example.org] or Rachel Pappas [email@example.com]) if you believe you do not have appropriate access.
RPMs cannot currently upload documents after a Request is "In Review" status. Please send all documents, including cost estimates, to Carolee Wieneke or a back up checker (Patti Hatchett or Rachel Pappas); the checker will upload documents on your behalf. Enhanced access to documents will be addressed as part of the Asset Management System development.
UPDATE (8/10/11): A new role of "Cost Estimator" will be added to the system, to allow for RPM access, once they have been assigned as the person responsible for the Cost Estimate. This access will allow for reviewing of all materials once the request is submitted and will allow for direct upload of the Cost Estimate by the person assigned to this role. This functionality will be completed prior to development work beginning for the scheduling system.
5. Documents and application forms submitted to the GCRC or through the old Application for Services system are not yet available in the Portal. Where can I access documents, such as protocols, submitted prior to the launch of the Portal?
• For CTSI IDs greater than 20602: Portal→ My Projects→ Documents tab
• For CTSI IDs between 20000-20602: old Application for Services
• For CTSI IDs beginning with 15xxx: refer to share drives
• For CTSI IDs less than 15000: eDocs
6. How will protocol amendments be handled in the new system?
Protocol amendments will continue to be handled manually, via IRB or investigator notification to the CTSI Front Door. Carolee Wieneke will continue to work with appropriate CTSI administrators and staff members to process amendments and resulting changes to projects, services, and cost estimates. The Portal development team has, however, communicated with the SIRC team about the critical need for improved and automated communication around protocol amendments. This discussion will continue as CTSI engages more fully with the SIRC team.
7. RPMs often submit Request for Services forms for investigators, and it was helpful in the past to view reviewer and/or editor comments. Why can't an RPM see reviewer and editor comments and deadlines/due dates for decisions?
Programmers are currently working on this functionality. The "back end" or "review side" of the Request for Services system was developed to meet basic operational needs, and will be enhanced over time. The current goal is to show decisions once they are made and provide a relevant summary at that point. In the past, pre-decision notations were problematic, particularly when CTSI staff members took some action prior to decision. Finally, it was determined that scientific reviewers should not see other reviewers' comments before their own decision has been made.
8. Some projects use only regulatory and clinical trial monitoring services, and it appears that not all of these projects are included in the database. How are regulatory projects added?
The CTSI regulatory team provided a list of projects, which was uploaded into the database. New regulatory projects must be registered in the Request for Services system, indicating that clinical trial monitoring services are requested.
UPDATE (8/10/11): Functionality to display the date submitted, expected date review due, and request completed dates will be added prior to the start of the scheduling system development.
9. The search functionality in the My Projects module does not currently include some useful terms from other systems. Will this be included in the future?
These would be future enhancements. Requirements have been gathered to include these data elements. However, importantly, staff can still use TASCS to access these data. TASCS will remain viable until a Clinical Trial Management System (CTMS) is in place and full integration with Portal.
10. Can a CTSI staff member update information about the study team (i.e., a new coordinator)?
Not directly. The Principal Investigator (PI) must approve changes to study personnel by completing the Access Request Form. In conversations with AHC's privacy officer, it became clear that the approach for modifying access to project information must be more fully investigated. For example, if IRB approval is required, it may be necessary to maintain tighter control over who has access to make these changes in system.
11. Some short or full titles are not consistent across systems (i.e., the Portal, TASCS, BDAC). Is there a plan for cleaning up data to ensure consistency?
All data in the Portal were pulled from other systems/databases, such as the GCRC or BDAC databases or spreadsheets. Corrections can be made; see question #2 above. The development team recognizes that an easier process is needed and a plan for data clean up will be developed and shared for your input. However, with any system implementation, dirty data in is dirty data out. On a positive note, by the end of August, we will have all IRB approved information without necessarily requiring manual update.
12. How should investigators respond to stipulations from the Administrative and/or Scientific Review Committees?
Investigators receive a letter detailing the committee's concerns and specific stipulations. That letter also instructs investigators to forward their response and any associated documents to firstname.lastname@example.org. The checker uploads the response and documents into the Request for Services system and facilitates a review of the response. Communication with the investigator continues via formal letter attached to an email.
13. What is the Front Door Initial Contact Database and how is it being used?
The Initial Contact Form (https://ctsi.ahc.umn.edu/public/contact/) and the associated "back end" contact database were developed to track and report on all inquiries received by the CTSI Front Door. We would also like to use this database as a way to facilitate and document communication among CTSI teams related to specific projects. At this time, the Front Door Coordinator is using the database in a limited manner, by logging all inquiries. The Front Door Coordinator may email a specific CTSI staff member, attaching a PDF file with details about an inquiry, in order to facilitate better communication. CTSI staff members are not asked to enter any data about inquiries at this time, but discussion and decisions are needed about how this database might help facilitate communication and improve quality of service provided to investigators.
14. How should CTSI staff complete the personnel tab for his/her role when completing the Request for Services?
Statisticians and Coordinators should select "CTSI Staff." RPMs should also select "CTSI Staff," but may select "Protocol Contact" if he or she is the individual (designated by the PI) as holding responsibility for protocol amendments.