Frequently Asked Questions

Prior to starting an experiment, collecting data, or writing a grant. Typically collaborators think of reaching out to QDSC after data has been collected for downstream analysis. Although interpreting data is something we often do, proactively reaching out to a QDSC member can ensure timely collaboration, high-impact results, and optimal study design.

Please note, it is QDSC policy that the Principal Investigator be present at the initial meeting to discuss and develop research questions, study goals and analysis plans.

Please complete a brief project request form to request a QDSC collaboration. Please note, it is QDSC policy that the Principal Investigator be present at the initial meeting to discuss and develop research questions, study goals and analysis plans.

QDSC collaboration is free for Lurie Cancer Center (LCC) members. Exceptions for cancer researchers who are not LCC members including fellows and post-doctoral researchers can be made with LCC approval.

To become a LCC member to here.

Not sure if you are a LCC member. Check the list here.
https://www.cancer.northwestern.edu/research/membership/member-directory.html 

The QDSC encompasses cancer research with Lurie Cancer Center members.

• For non-cancer biostatistics research at FSM, NU and its clinical partners please contact the Biostatistics Collaboration Center (BCC).
• For non-cancer bioinformatics research at FSM, please contact the NUSeq Core.

Please get in touch with us as early as possible to ensure sufficient time for meaningful contribution from QDSC. Typically a request should be made at least:

• 1-2 weeks prior to desired meeting for 1-hour consultations
• 2-4 weeks for LOI or a brief clinical trial concept
• 4-6 weeks for grant proposal development, and longer for P, U and other large grants
• 6-8 weeks for data analysis, including abstracts that require data analysis

You can submit a request in two ways.

1. Submit a QDSC request and select the relevant choices under the “Clinical Informatics” question. 
2. Submit an EDW request in the EDW portal by logging in with your NU or NM credentials.

If you are requesting clinical data with Protected Health Information(PHI) or a limited data set (See HHS guidance definitions), the following are required: 

• An approved NU IRB project. 
  • All cancer-relevant IRB projects should be submitted to the Lurie Cancer Center (LCC) Protocol Review & Monitoring System by being uploaded to the LCC clinical trials management system (NOTIS).  
  • Email SRC.CCSG@northwestern.edu for guidance. 
  • Every IRB project will need to be approved by the LCC Scientific Review Committee. 
• Be on the Authorized Personnel List (APL) of the submitted NU IRB project. 
• A list of data collection variables.  When specifying the data points necessary for an IRB project, avoid using generalized language. For example: ‘All medical history and all comorbidities’.

If you are requesting feasibility/aggregate counts, an approved NU IRB is not required (for example, for grant submissions). A NU IRB is useful for QDSC tracking purposes if you already have one.

If you are requesting de-identified patient-level data, you must have an approved NU IRB project or a non-human subject determination from the NU IRB.

IRB project and determination templates are available from the NU IRB. 

It depends on the complexity of the request and existing workload of the team. On average, it takes 3-4 weeks to deliver the data.  EDW report pre-deployment process includes

• Data steward approval
• Cohort development
• Report development
• Peer review

Authorship is generally expected whenever substantive input on the design or analysis is provided. We endorse the criteria recommended by the International Committee of Medical Journal Editors (https://www.icmje.org/recommendations/), which state that authorship credit should be based on meeting the following criteria:

• Substantial contributions to conception and design, or acquisition of data, or analysis, or interpretation of data; and
• Drafting the work or revising it critically for important intellectual content; and
• Final approval of the version to be published.

Activities

• Formulating Specific Aims
• Study Design
• Protocol Development
• Power/Sample Size

All manuscripts and grants presenting work supported by QDSC should include the following acknowledgement: “Research reported in this publication was supported by the NCI Award Number P30CA060553.”

• You can request a new REDCap project in two ways. 
  • Submit a QDSC request and select the “REDCap Setup” choice under the “Clinical Informatics” question. Note that you will have to provide an approved NU IRB project. 
  • Complete a one-hour REDCap project owner training session and request a new REDCap project yourself and reach out to us for designing the project. Contact REDCap support at redcap@northwestern.edu for more details about the REDCap project owner training session. 
• QDSC clinical informatics research analysts can help with instrument design, survey setup, e-consent setup, maintenance, and integration with NOTIS and EDW data.
• QDSC clinical informatics has created disease-specific REDCap project templates covering fundamental oncology data points relevant to each disease site. 
• Project templates ease the integration of EDW data because integration logic does not need to be customized per REDcap project. 
• REDCap projects can be integrated with PathCore biorepositories. 
• If a REDCap project needs to chart abstract data from a Northwestern Medicine clinical system, the study team of the NU IRB project will need to ask for an ‘EDW Exception’.  See here.