IMV Checklist- Corcept Regional CRAs
Weekly: (30 minutes to 1 hour)
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Run Open Query Report and send to the site.
Review EDC for data entered and pending data entry based on data expected to be entered.
Ad-Hoc:
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Review IRT for inventory levels and IP shipping records
Review Open Action Items and status for resolution.
Document any relevant phone and email communication in ICOTrial/SimpleTrials and copy
Study mailbox on emails
1-2 weeks before IMV:
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Send Confirmation Letter
Review EDC for pending SDV, data entry status, and open queries
Review IRT for available IP kit inventory and assess for any expired IP to be returned/destroyed
Review iSite for available lab kit inventory and kit re-supply shipments. Order any necessary kits
Review CTMS for any open Action Items. Close them if possible
Review eTMF Study and Site levels for documents to be collected or expiring documents (i.e.
MLs, GCP training…etc)
Confirm IRB CR expiration date
Review Firecrest for SUSAR review status
2-5 days before IMV:
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Re-review EDC, IRT, iSite, CTMS and eTMF
Send an email to the site with the subject line “Monitoring Visit Preparation” to prepare the site
of the following expectations and providing/listing:
o Open Query Report (if applicable) listing open queries
o Review EDC for data entered and any missing CRFs and remind the site of any missing
data (if applicable)
o Request Lab Kit Inventory at the site
o Request IP Temp Storage Logs for a specific date range if applicable
o List any open Action Items requiring resolution
o List any missing SUSAR review the PI should complete prior to the visit
Confirm site has scheduled a PI meeting during the visit or a T/C within 2-3 days of the IMV
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During the IMV:
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Sign Monitor Sign-In Log
SDR/SDV:
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Review enrolled and screen-fail subject ICFs (dates and all applicable versions) and any
applicable re-consents (add these to the TR as applicable)
Review Incl/Excl Criteria and Screening Medical Hx for new subjects
Review source data for completeness and accuracy that includes PI review prior to SDV
Review data entered and SDR/SDV data entered. Document any missing or pending data entry.
Escalate site status of missing data entry in EDC to CTM as necessary.
Confirm Lab test results have been reviewed by the PI
Confirm AE log is accurate and current
Confirm Concomitant Medications list is accurate and current
Document and report any Protocol Deviations
IP/Pharmacy Binder Review:
Assess IP inventory and ensure that there is an adequate supply for any enrolled subjects
Check for any expired IP onsite
Perform IP Accountability and reconcile with IRT
Review any subject IP diaries and reconcile with EDC and Single Subject IP Accountability Log
Review the Pharmacy Binder for completeness
Return/Destroy any expired/used, returned IP
File IP Return/Destruction Form in Pharmacy Binder and collect a copy for the TMF
Investigator Site File (ISF) and Site Reference Binder (SRB) Review:
Check the following documents:
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1572
Site Responsibility Log (DOA)
Assess if any updated 1572 forms are filed and cross-reference with the DOA for any changes in
staffing
Notify the internal team of any updated staffing changes on site and collect any applicable
regulatory docs (i.e. MLs, CVs, GCP, ect.)
IRB Approvals and Continuing Review expiration date
Confirm all versions of the Protocol, ICFs, and IB are filed
Review all applicable MLs, CVs, FDFs, SDPCF. Collected any updated documents for the TMF
Confirm all applicable training documentation is completed and filed
Collected any updated documents for the TMF
Confirm SUSAR review
Reconcile eTMF with the ISF and Site Reference Binders
Provide the site with any missing documents that should be filed in the appropriate ISF/SRB
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PI Meeting:
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Discuss visit findings (Data, IP, ISF status, AEs, CMs site training; either missing or completed and
current)
Confirm no new SAEs occurred since the previous monitoring visit
Report any subject or site protocol deviations
Discuss recruitment efforts and any updates to recruitment
Report any study-related concerns regarding the protocol, study conduct or recruitment
challenges conveyed by the PI. Escalate to the internal team as applicable. Document concerns
in the TR.
CRA to schedule the next IMV before visit end
Post IMV:
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Draft TR within 5 business days of the IMV
Send FUL to the site upon TR finalization
Submit any regulatory or applicable study documents to the TMF
Monthly:
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Contact the site regarding recruitment efforts and report to the internal team as applicable.
Document applicable site contacts in CTMS.
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