Frequently Asked Questions
General
What is the PLS MOP?
The PLS MOP is a general guide for the procedures regarding prospective Longitudinal Study. It can be found at here.
What assessments are done during a BL and FU visit?
The PLS MOP lists each assessment for each type of visit in detail. Baseline visits consist of enrollment assessments as well as baseline assessments. As a quick check, you can use the Enrollment checklist and BL checklist on the Best Practices webpage. The re-check (follow-up) visits consists of shortened or reduced assessments and the Re-check (follow-up) checklist is also available on the Best Practices webpage. These checklists are not comprehensive because some assessments have specific requirements to be administered (EX: if a participant is active duty the disability questionnaire will not be administered.) Not all PLS sites conduct every assessment as well. Confirm with your local coordinator on which assessments are not done at your site.
How long do visits take?
Visit length depends on a variety of factors. Most PLS sites usually take 2 full days with participants to complete either a baseline or re-check (follow-up) visit. To reduce burden and fatigue, we recommend taking frequent breaks as well as having snacks or refreshments available. Site staff can also rotate who is conducting each assessment with the participant. As you become more familiar with conducting a visit, it will take less time to complete. Some PLS sites have local methods or resources available to help with timely visit completion as well. Please reach out to the Coordinating Center for any additional questions or concerns about completing visits in a timely manner.
What do I do when there are technical issues?
If there are technical issues with any LIMBIC-CENC systems, then please submit an issue ticket in the operational support portal detailing the issue. If applicable, please provide example subject ID numbers and which browser you are using in the ticket description.
What is the difference between re-check and follow-up?
All follow-up assessments and visits have been renamed to re-check. Please reach out to the Coordinating Center if you find any documentation still using the follow-up naming convention. Re-check documents and visits are only used in subsequent visits after baseline visit completion.
How do I submit a publication to the website’s database?
Publications are submitted to the committee through the publication portal. You can access the portal by logging into the LIMBIC-CENC website, selecting the Consortium Operations tab from the homepage, and clicking on the Publication Committee Requests button. Follow the link to the publication portal and select the Submit New Request button. This will bring you to the publication form where you can enter all the necessary information for your submission.
Data Management
How to upload a clinical referral log to SFTP?
The clinical referral log is uploaded to SFTP by going to your PLS recruitment site folder, selecting the clinical referral folder, then clicking the upload button in the bar directly above and selecting the log file. An SFTP account with special permissions is required to both view these folders as well as upload to the system. If you are not able to view or if the upload button is greyed out, then please submit an issue ticket on the operational support portal specifying what site, the clinical referral folder, and the need to be able to upload files to SFTP. These files are audited monthly so, please reach out to the Coordinating Center about any issues or questions before the end of the impacted month. If there were no clinical referrals that month then a log does not need to be uploaded.
How do I get an account for each electronic data management system?
LIMBIC CENC uses iMedidata, Study Portal, and SFTP for electronic data management and storage. To request an account for one of these systems, please submit an operational support ticket and select each system you need. Additional electronic systems are used to capture participant data that are listed in the PLS MOP. However, the Coordinating Center and DBC do not manage all the accounts associated with such devices. If you are having a technical issue with one of these additional electronic data capture systems, please submit an operational support ticket and state the device and assessment there are issues with. If your site uses an electronic data management or capture system that is not listed in the PLS MOP, please contact the Coordinating Center and DBC immediately.
What is a Medidata query?
Queries in Medidata are either automatically generated or manually generated by the data quality audit staff when a data field has a potential issue. They are the main method used to audit and track data in Medidata. Queries are required to have a response within 5 business days unless there is a special exemption. Due to the size and scope of LIBMIC-CENC and the PLS, the audit team utilizes query reports that include query responses to determine if an issue has been resolved. Visits with unresolved queries on any of the assessments are not integrated into the LIMBIC-CENC database. If there are questions or a situation that requires additional action, then please contact the DBC before any data entry or query resolution deadline passes.
How do I run a query report in Medidata?
The most common way to run a query report in Medidata is to select the “View Site Reports” at the top right of your site’s main EDC webpage. A pop-up listing various reports should appear then select “Query Detail – Query Detail Report.” If you do not see any reports listed then please, submit an issue ticket in the operational support portal. After selecting this report, it will generate in a new tab. It is recommended to export this report to Excel by selecting “Excel – Data only” for Export to at the top of the report then clicking the export button. Once in Excel, you can filter the query status to only show those that are currently open. Queries that are closed or cancelled have been fully resolved and do not require any additional action. Queries that are opened by the system for remote data collection visits or for fields that are blank, and you will be completing, are not required to have a response. Those queries will automatically close once data has been entered.
How do I respond to queries in Medidata?
In Medidata, when there is a query, a red notification will appear to the right of the impacted field. The notification content will be specific to the related field and a reply box will also populate underneath. To respond to a query, please use that reply box to provide updates about that query. Only one response may be provided for each query so, please provide relevant updates as opposed to just acknowledgement. Queries will usually ask for confirmation that the data entered matches the data stored locally. Do not reach out to a participant unless a query specifically requests it. It is recommended to enter as much data as possible while the participant is present so such queries can be quickly resolved without having to contact the participant outside of a visit.
When does the data get audited?
The data quality audit occurs at the beginning of each month. All data is required to be entered by the 3rd business day of the following month. The quality audit begins the next business day and takes 5 business days to complete. This audit is of all visits that were completed the previous month, including remote data collection visit whose window has closed. Visits are not audited until either complete or their window has closed so, it is important to note visit completeness in the Visit Gateway of the corresponding visit year in iMedidata. When auditing, both iMedidata and SFTP data files are reviewed. A printable calendar of the data audit cycle can be found on the Events Calendar webpage.
Call Center
How do I schedule a BTACT in the Study Portal?
After updating the actual visit date on the participants visit schedule page a pop up will appear asking you if you want to navigate to the Appointments module to schedule the BTACT. If you click ‘Yes’, you are re-directed to the Call Center calendar where you can schedule the BTACT for the subject.
Alternatively, you can schedule a Baseline BTACT by clicking on the Add new appointment plus icon at the top left corner of the appointments page.
Please keep in mind, in order to schedule an in person visit with the Call Center for their BTACT appointment you must first enter their Actual visit date on their visit schedule page for the corresponding visit year.
Should you have any additional questions regarding the use of the Study portal, please refer to the Study Portal Workshop notes.
What Saturdays is the Call Center Open?
The Call Center is generally open the 1st and 3rd Saturdays of each month. Holidays and various other reasons may change this though. Calendars for the Call Center Saturday openings as well as other various important dates can be found on the events calendar webpage along with printable versions.
What number should the participant expect a call from when the call the Call Center is reaching out?
Participants will see the incoming call from (804) 828-0308 when the Call Center is reaching out to them. If a participant wants to call the Call Center, then please use (804) 828-0308. It is recommended to have the participant save the incoming number (804) 828-0308, if able, to increase the likelihood of answering. The Call Center pamphlet is available on the PLS Forms and Templates webpage.
Coordinating Center
Who do I contact to re-schedule a site call?
The Coordinating Center handles the scheduling of all site-specific calls. If you have any scheduling conflicts or questions about your site’s call schedule, please contact them at cenc@vcuhealth.org.
How do I submit an onboarding or offboarding form?
The current site staff will submit an onboarding on behalf of the new staff member while current site staff can submit their own offboarding form. Both forms can be accessed by logging onto the LIMBIC-CENC website, navigating to the Longitudinal Study Operations tab, and selecting the Operational Support button. This will take you to the Operational Support portal where you’ll click on Submit Request before selecting the ticket type you need from the drop down and filling out the appropriate form. The Operational Support portal can also be found here.
Who do I contact if my contact information has changed?
If your contact information has changed, you can navigate to the operational support portal through the website to submit a ticket for updating the information. If you have any issues doing so, please contact the Coordinating Center at cenc@vcuhealth.org and they will be able to update your information manually.
What do I need to do for site call agendas?
The agenda for each site-specific call is sent to site staff three business days in advance. On the agendas, there are sections that must be filled out and sent back to the Coordinating Center by the deadline given at the time the agenda is received. Sites will typically be given two full business days to complete their sections of the agenda before returning it to the Coordinating Center for review.
Training and Development
How do I start the training process?
There are multiple steps to beginning the training process. When the current staff member submits the onboarding form for the new staff member, they will request access to LIMBIC-CENC website access in the form. Once the new staff member has access to the website, they will be able to access the training center webpage, which hosts links to various training resources, including the MOP which should be reviewed by all new staff members. After they have reviewed the training materials on the website, new staff members can request specialized training as needed. These instructions are only for the new staff member’s LIMBIC-CENC specific training, any local training requirements will need to be requested and completed through the local site.
How do I receive the NP and PCE mapping training?
After your onboarding ticket has been received, the training and certification coordinator will email you all requested training materials.
How do I start PCE mapping training?
Each recruitment site can only have a few PCE mapping trained personnel in an effort to maintain administration consistency. PCE mapping training can be requested in the operational support portal but, please provide reasoning for requesting this training in the comments section of the request. The data entry portion of this training requires an iMedidata account and all iMedidata required training to be completed before gaining access to the study EDC. An iMedidata account can be requested in the operational support portal at the same time as the training request. If leadership approves the training request, then the training coordinator will need to be informed when the requestor has been approved by the IRB. Once confirmation of approval has been received by the training coordinator, they will email the PCE mapping training materials.
Who do I send NP training submissions to?
All NP training should be submitted to Nancy Hsu for review. You can submit your training videos by uploading them to SFTP, in your site’s neuropsych certification folder. Afterward, please ensure to email the Coordinating Center at cenc@vcuhealth.org to notify them of your submission.
What do I do if I have an issue or question while training?
If you have any technical issues, then please submit an issue ticket to the operational support portal detailing the issue. General questions about LIMBIC-CENC or the PLS can be emailed to the Coordinating Center or discussed during a meeting. Neuropsych training material questions can be emailed to Dr. Nancy Hsu and PCE mapping training material questions can be emailed to the DBC. Questions about the Study Portal use and navigation can be emailed to Yasmonia Mack or Santia Ramos. Issues or questions about biospecimen can be emailed to Dr. Jessica Gill and neuroimaging questions can be emailed to Dr. Elizabeth Wilde. If there are any issues with contacting a LIMBIC subject matter expert, please notify the Coordinating Center.