Form Inst-H
Local Sponsor-Investigator Monitoring Plan
Complete this form if a local investigator is listed as the sponsor on an FDA issued IND or IDE (Step 1 - Item 8A)
UTHSCSA Tracking Number
Item 1
Sponsor Experience
Describe the holder's
experience/ knowledge/
training related to serving
as a sponsor-investigator.
Item 2
Sponsor Resources
Describe other resources
available to the sponsorinvestigator to fulfill the
sponsor responsibilities.
Item 3
Data & Processes Critical
to the Study
List the critical data and
processes that if inaccurate,
not performed, or
performed incorrectly,
would threaten the
protection of human
subjects (safety) or the
integrity of the study
results.
Item 4
Greatest Risks
List the greatest risks that
could affect the collection
of critical data or the
performance of critical
processes.
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Select from list of data or processes typically considered critical when developing a monitoring plan,
and/or list your own
Verification that informed consent was obtained appropriately
Adherence to protocol eligibility criteria
Collection of study endpoint(s): list
Performance of protocol-required safety assessments [list]
Evaluating, documenting and reporting serious adverse events, UADEs, deaths, and withdrawals
Trial integrity (e.g., maintaining study blind, randomization)
Other
Select from the list of risks typically considered important when developing a monitoring plan, and/or list
your own
Types of study endpoints
Clinical complexity of the study population
Geography/multi-center trial
Relative experience of the clinical investigator and of the sponsor with the clinical investigator
Stage of the study
Quantity of data
Other
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Item 5
Key Monitoring Activities
Based on responses to above lists of critical data and greatest risks, summarize the key monitoring requirements.
What will be monitored?
Specify the monitoring responsibilities
State the methods of assessing compliance
(list each monitoring element on a
separate row)
Item 6
Where will the
investigational product
be obtained from?
Select from the list of typical sources and/or list your own
From hospital/commercial pharmacy stock From a compounding pharmacy Manufactured locally by investigator/study staff
Other
Item 7
Supporting sponsor documents
All FDA correspondence including 1571
and 1572
Document Included?
YES
NO
Case Report Forms (CRFs)
Monitoring Checklist/ Documentation
Drug Accountability Log
Delegation of Tasks Log
Other:
Document1
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N/A
Reason, if NO or N/A