IRB
What does "IRB" stand for?
Institutional Review Board
Where can you pull an ISF checklist from?
Site Room or manual Excel checklist
Which type of visit evaluates whether a site has the staff, facilities, and patient population to conduct a clinical trial?
Site Selection Visit (SSV)
How often should you complete your TMF QC Checks?
Dependent on your monitoring plan and/or TMF plan
How often should you submit your timesheets?
Every two weeks
What are the types of IRBs?
Who can verify ISF documents?
CRAs and SMAs (check with monitoring plan)
How should you prepare for a site initiation visit (SIV)?
- Request vendor accesses for site team members
- Confirm lab kits/IP have been received onsite
- Determine if paper or electronic ISF
- Prepare binder (paper or electronic) with deed of transfer
- Send patient facing materials
How soon after receiving documents should you file them?
Within 5 days of receipt
Under which tab in CTMS do you track site-specific ICFs?
"Sites" tab
What are the central IRBs that we typically use?
Advarra and WCG
How can you send electronic ISF documents/eISF to a site?
Progress MOVEit Transfer
How should you prepare for a routine monitoring visit (RMV)?
- Send ISF checklist to CRA a few days before visit
- Check outstanding payments in CTMS
- Send pending items/docs to site (optional)
- Pull EDC report (missing pages, open queries)
What documents should you refer to when completing your TMF QC Checks?
TMF Plan & TMF Index
Who from PSI and the site typically attends a site management call?
PSI: CRA, SMA, CTL, lead CRA (optional)
Site: study coordinators, research coordinators, regulatory coordinators
What's submitted to IRBs?
Patient facing materials, ICFs, protocols, IBs, questionnaires, surveys, conflict of interest statements, continuing review, PI change, site location change
Picture of ICF first page (please find errors within the image)
Missing investigator information and missing emergency contact information
How should you prepare for a closeout visit (COV)?
- Ensure all outstanding docs are collected and filed
- Document verification
- Revoke vendor accesses
- Ensuring logs are complete
- Check with study team for specific procedures
What documents should be collected when there's a PI change at a site?
IRB submission/approval, new PI CV, ML, GCP, updated 1572, FDF, current PSP & IB AoR, training records as applicable per site
Which site events do SMAs enter?
PSP sent and received, IB AoR sent and received, SMCs, CV PI sent and received, FDF sent and received, FDA1572 sent and received
What types of studies require IRB approvals?
What does it mean to be ISF inspection/audit ready?
ISF up to date, no outstanding documents, documents filed correctly, logs are current
What are the timelines for when CRAs should send follow-up letters from their site visits and submit monitoring reports?
Sending follow-up letters/submitting monitoring reports: 5 days to draft, 10 days to submit final report/follow up letter
When you're filing a lab certificate in TMF, and you cannot find the correct "Account" associated with the certificate... what should your next steps be?
1. Go into CTMS and check under "Project Vendors" to make sure the account does not already exist.
2. If it does not exist, add the account in CTMS (see step 3). If the account already exists, then add the project vendor.
3. Once you add the account in CTMS, you can add it as a "Project Vendor"
4. Now the account is setup in CTMS, and you can associate the correct account to the certificate in TMF.
Your site is relocating to a new address. What steps do you need to take in CTMS?
Track IRB submission in CTMS under "Site Submissions" tab and track ICFs under "Site ICF Versions"; Changing address in CTMS: Go to CTMS Knowledge Center -> Fill out and submit "Site Details Update Request" Form