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CRA Bridge Mentoring Visit Checklist
Interim Monitoring Visit
Sponsor:
<Sponsor>
Protocol No:
<Protocol No>
CRA Mentoring Visits are conducted to provide training and assessment opportunities for the Clinical Research
Associate (CRA) completing the Bridge program. The checklist will serve to document the activities, training
and performance of the CRA during the course of these mentoring Visits.
1.0 Visit Information
Visit Information:
CRA Name:
<CRA Name>
CRA’s Manager:
<CRA’s Manager>
Mentor Name:
<Mentor Name>
Mentor’s Manager:
<Mentor’s Manager>
Visit Date:
<dd-Mmm-yyyy>
City/State:
<City/State>
Therapeutic Area:
<Therapeutic Area>
PI Name:
<PI Name>
Site Number:
<Site Number>
Instructions for Completion:
This form is completed by the CRA conducting the on-site visit with the mentee (i.e. assigned mentor or
co-monitor). One form is completed for each on-site visit to document the activities
completed/reviewed.
Once the mentee has successfully demonstrated the tasks in Section 2, the task does not need to be
reassessed at a subsequent visit.
Sections 1, 3-5 are completed for each visit.
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2.0 Activities Checklist
2.1 Activity Prior to Site Visit
Comments
Not Done
Additional
Training
Needed
Demonstrated
by Mentee
Mentor Assessment
Observed by
or discussed
with Mentee
Activities Checklist
Comments required for additional
training, or if item was not
assessed or if item is not
required/applicable or if
proficiency previously
demonstrated.
1. Site visit scheduled, confirmed and
documented per requirements for the
program and/or monitoring plan (e.g.
confirmation letter, updated on
relevant team calendars/CTMS
system)
<Insert Comment>
2. Confirmed access to required
locations, source documents and
CRFs for the visit
<Insert Comment>
3. Obtained/reviewed Essential
Document, IP, IVRS/IWRS and/or CRF
tracking or reports if
applicable/available
<Insert Comment>
4. Obtained appropriate
forms/supplies to conduct visit (e.g.
transmittal forms, drug return labels,
tape, etc.)
<Insert Comment>
5. Previous visit report reviewed (to
determine if any outstanding issues
still need to be resolved)
<Insert Comment>
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2.2 Activity During Site Visit
Comments
Not Done
Additional
Training
Needed
Demonstrated
by Mentee
Mentor Assessment
Observed by
or discussed
with Mentee
Activities Checklist
Comments required for additional
training, or if item was not
assessed or if item is not
required/applicable or if
proficiency previously
demonstrated.
1. Site Visit Log signed by the CRA
(and the site if required by the
sponsor)
<Insert Comment>
2. CRFs/DCFs/eCRFs reviewed
<Insert Comment>
3. Appropriate tools (e.g. eCRF, TMF
reports) effectively utilized to
document needed clarifications and
changes to the CRF/DCFs/eCRFs and
Essential Documents
<Insert Comment>
4. Arrangements made for retrieval of
paper CRFs or finalization of eCRFs
(e.g. Investigator e-signature)
<Insert Comment>
5. Source documentation review
conducted (including informed
consents) per sponsor SDV plan.
<Insert Comment>
6. Verified access to all original site
source documents. Determined if the
site is utilizing Electronic Medical
Records (EMR) and
confirmed/effectively documented
site EMR compliance
<Insert Comment>
7. Adverse Events and Serious
Adverse Events reviewed and
reported to sponsor and IRB/IEC and
filed appropriately
<Insert Comment>
8. Verification of Investigator’s
assessment and documentation of
SAE/AE data, causality and
relationship to IP in the source
documents
<Insert Comment>
9. All SAE source documentation,
hospital records, con meds and
follow-up reviewed and verified
<Insert Comment>
10. Actions needed for unreported
Serious Adverse Events identified by
the CRA
<Insert Comment>
11. Site regulatory binder and site
essential documents reviewed and
reconciled with the TMF
<Insert Comment>
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12. Essential Documents collected
and routed to the sponsor
appropriately
<Insert Comment>
13. Site Signature Log (Delegation of
Authority Log) and site training
documentation forms reviewed and
verified
<Insert Comment>
14. Gaps or delays noted in reporting
expedited Serious- Unexpected ADRs
(IND Safety Letters, CIOMs reports,
SUSAR’s) by the Investigator to
IRB/IEC, if required
<Insert Comment>
15. Accountability, temp logs,
reconciliation, disposition of
Investigational Product (IP) and
maintenance of blinding (if
applicable) confirmed
<Insert Comment>
16. Verified that IP storage continues
to be secure and maintained per
study requirements
<Insert Comment>
17. Demonstrated the correct process
for conducting all steps for IP
Accountability (including/not limited
to: reviewing all shipping
documents, reviewing site logs to
verify entry of all received IP,
reviewing site logs to verify
dispensation of all IP and site return
and subject accountability of IP)
<Insert Comment>
18. IP dispensing and return
reviewed, verified against CRFs,
source documentation and if
applicable, study specific electronic
drug accountability system, and any
discrepancies documented
<Insert Comment>
19. Verified that all IP dosing was
calculated and administered
according to protocol. Confirmed
subject IP compliance was calculated
and documented
<Insert Comment>
20. IP accountability issues (if found)
addressed appropriately by the CRA
and site retrained on IP procedures,
as needed
<Insert Comment>
21. Arrangements made for retrieval
or return of Investigational Product
as per sponsor guidelines
<Insert Comment>
22. Clinical supplies inventoried,
expiration dates checked
<Insert Comment>
23. Clinical trials records and storage
facility reviewed
<Insert Comment>
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24. Biological sample storage
reviewed, including temp logs and
chain of custody verification
<Insert Comment>
25. Site resources/facilities assessed
for continued adequacy to
successfully conduct trial (e.g.
equipment maintained and calibrated;
adequate/qualified staff, etc.)
<Insert Comment>
26. Discrepancies between the
CRF/DCF/eCRF and source reviewed
with the Investigator/site staff
<Insert Comment>
27. Discrepancies between the
estimated and actual recruitment
rates reviewed with the Investigator
<Insert Comment>
28. Need to provide the IRB/IEC with
updates on SAEs and/or any other
progress reports reviewed with the
Investigator
<Insert Comment>
29. Maintenance of study
documentation reviewed with the
Investigator
<Insert Comment>
30. Source document deficiencies
identified (such as protocol defined
requirements, AE causality, lab
review, SAE site notifications) and
discussed with the Investigator
<Insert Comment>
31. Protocol deviations, violations or
exceptions noted appropriately per
sponsor process and escalation
process reviewed
<Insert Comment>
32. Open action items reviewed,
closed and/or addressed during the
visit and updates documented
<Insert Comment>
33. Next Monitoring Visit tentatively
scheduled per monitoring plan and
documented per sponsor practice
<Insert Comment>
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2.3 Activity Following Site Visit
Comments
Not Done
Additional
Training
Needed
Demonstrated
by Mentee
Mentor Assessment
Observed by
or discussed
with Mentee
Activities Checklist
Comments required for additional
training, or if item was not
assessed or if item is not
required/applicable or if
proficiency previously
demonstrated.
1. Reviewed visit report completion
timelines and guidelines, if available
<Insert Comment>
2. Visit report inclusive of all site visit
and follow-up activities.
Documentation accurate and
reflective of the events of the visit
<Insert Comment>
3. Investigator follow-up letter sent, if
required. FUL contained all of the
open site action items and all
identified protocol deviations, site
issues and other items discussed
during the visit
<Insert Comment>
4. Reviewed expectation of action
items resolved within sponsor
defined timeframe (e.g. within 2 visits
of discovery). Reviewed importance
of adequate documentation of efforts
made to facilitate resolution (i.e. more
action documented than “site was
reminded”)
<Insert Comment>
5. Adequate documentation of
escalation and resolution of issues
<Insert Comment>
6. Visit report and letter submitted to
the TMF with proper documentation.
All TMF processes completed
properly as applicable to sponsor
requirements
<Insert Comment>
7. Appropriate updates made to
sponsor specific systems (e.g. CTMS)
<Insert Comment>
8. Collected Essential Documents
forwarded to the TMF with proper
documentation and within sponsor
required timeframe
<Insert Comment>
9. Completed timesheet and expense
report appropriately for visit
<Insert Comment>
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3.0 Workplace Skills
Comments
Not Done
Additional
Training
Needed
Mentor Assessment
Demonstrated
by Mentee
Activities Checklist
Comments required for additional
training, or if item was not
assessed or if item is not
required/applicable.
1. CRA displayed knowledge of
ICH/GCP guidelines including
having copy or e-copy of the
CFR/ICH/GCP regulations
<Insert Comment>
2. CRA displayed knowledge of
applicable SOPs
<Insert Comment>
3. CRA displayed knowledge of
therapeutic area, if applicable to
mentee’s expected assignments
<Insert Comment>
4. CRA displayed working
knowledge of protocol/CRF
purpose and function related to
monitoring
<Insert Comment>
5. CRA conveyed understanding of
I/E criteria, primary and secondary
key endpoints and methods for
monitoring endpoint data as
related to monitoring functions
<Insert Comment>
6. CRA displayed an understanding
of purpose and required
compliance with any Monitoring
Plan. CRA conveyed
understanding of the study
monitoring and management
expectations related to an IMV,
including monitoring frequency,
escalation processes, study
specific criteria, and timelines
<Insert Comment>
7. CRA utilized appropriate tools, if
required and/or optional tools for
site management organization, e.g.
ICF or essential document tracker
<Insert Comment>
8. CRA demonstrated a working
knowledge of sponsor systems
<Insert Comment>
9. CRA worked efficiently to meet
visit requirements
<Insert Comment>
10. CRA displayed understanding
of study team roles/contacts
<Insert Comment>
11. CRA maintained a professional
demeanor
<Insert Comment>
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12. CRA displayed appropriate
interaction and verbal
communication skills with site
personnel
<Insert Comment>
13. CRA displayed adequate
written communication skills
<Insert Comment>
14. CRA displayed adequate time
management skills
<Insert Comment>
15. CRA displayed adequate
organizational skills and
techniques
<Insert Comment>
16. CRA dressed appropriately
<Insert Comment>
17. CRA displayed confidence in
monitoring functions
<Insert Comment>
4.0 Informed Consent/Source Document Verification
The mentor should record scope of subjects and subject visits reviewed by mentee and conduct re-review of
mentee work. Use Comments/Narrative section below to address any discrepancies or SDV errors not identified by
mentee.
Subj.#
Visits/ICFs Reviewed
Source Type (All that apply)
Original paper
<Subj #
<Visit/ICF reviewed>
Comments:
<Insert Comment>
Shadow
Electronic
<Insert Narrative>
Please include detail if any
issues were noted related to
site consenting process/SDV
that was not noted by mentee
5.0 Mentor Comments
1). What additional training is recommended by the Mentor?
Additional monitoring visits with mentor/co-monitor
Sponsor SOPs/Processes
Therapeutic Area
ICH/GCP
None
Other, please Comment: <Insert Comment>
Mentor Comments
YES
NO
2). Is the CRA ready to complete independent monitoring?
Additional Comments/Narrative: <Insert Comment>
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5.1 Confirmation of Mentor
Name of Mentor:
<Name (Print)>
Signature of Mentor/ Date:
<Signature /Date>
When the checklist is finalized, the mentor will forward to the mentee and mentee’s PRA manager. The manager is
responsible for ensuring all relevant tasks are completed prior to final sign off and the CRA conducting the visit type
independently. The PRA manager will also ensure the checklist is archived appropriately in the PRA designated
folder.
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