Access Request Process - gpcnetwork/grouse-cms GitHub Wiki

Step 1: Define project and prepare Aim page (or equivalent documents with sufficient details on study scope and how GROUSE is expected to be used for the study)

• Aim page or equivalent project narrative

Step 2: Study Scope Preview – Submit the Aim page (or equivalent narrative) to GPC PMO and/or your institution’s GPC site PI or site PM for an initial scope discussion and determination on the appropriate GROUSE model.

• Initial contact with GPC PMO or site PI/PM

Step 3: Research Opportunity Assessment – Based on the final GROUSE service model determined from last step, GPC Committee (e.g., GPC PMO) will provide site budget and SOW templates for researchers to complete and submit with ROA request. (Review by ROA, ~14 days)

• Completion of ROA Request form:

https://showmeportal.missouri.edu/redcap/surveys/?s=RHRHLFC8FFF7THHM

• Aim page (required)
• Site scope of work (required)
• Site budget (required)
• Letter of Support template (optional but recommended)

Note: that both “GROUSE Use” service models don’t require ROA assessment but endorsement from ROA committee, as it is already pre-approved in GPC DSA, GROUSE DUA and amendments. But we still require a DROC request to seek endorsement from relevant GPC working groups.

Step 4: GPC DROC request – Upon ROA approval, researcher will need to submit DROC request to engage all or a subset of target GPC sites. Note that GPC sites can still opt out at this step, which may affect final site budget.

• Completion of DROC Request form:

https://showmeportal.missouri.edu/redcap/surveys/?s=TMME39DF9DC773YM

• Aim page (required)
• Site scope of work (optional if under master GROUSE IRB and endorsed by corresponding WG)
• IRB or Non-human-subject determination letter from PI site (optional if under master GROUSE IRB and endorsed by corresponding WG; optional for Co-I site)

Note: you only need to submit one DROC request for one project. For adding study team members to existing and approved DROC request, you will just need to submit a new GROUSE Access Request for each new team member.

Step 5: GROUSE Access Request – Upon DROC approval, research will need to submit the GROUSE Access Request for each study team member who needs to access GROUSE data.

• GROUSE Request Form completion:

https://showmeportal.missouri.edu/redcap/surveys/?s=P7JMY9MDMFAXFE7R

Step 6: Compliance and Training Requirements – in compliance with HIPAA and NIST-800-53 privacy security controls, all individuals accessing GROUSE are required to go through the following trainings with documented evidence. An automated RedCAP form will be sent out to guide researchers through the training and certificate collection process.

• Completion of Compliance and Training form
• CITI HSC Certificate still valid
• Security Awareness Training
• GROUSE Code of Conduct

Step 7: Account initialization and activation – Upon approval of GROUSE Access request, GROUSE honest broker will coordinate the creation of your GROUSE database and analytical workbench accounts as well as provide onboard training.

Step 8: Once accounts are activated, read training material in public repository and schedule an onboard training with GROUSE Honest Broker.