Quality Management Plan Chart Audit Tool
Reviewer Name: Protocol Number: Reviewed From Date to
Date:
Date of Review: Subject Number: Number of visits reviewed:
Instructions: This chart QA Tool will be used for the review of Source Documentation and Protocol for agreement. Check the appropriate boxes for each
question listed in Section I. If more than one visit, indicate the # of visits with “Yes” and # of “No” per indicator in the appropriate column. Any issues and
resolutions noted within Section I “Comments” will be summarized in Section II including Source Documentation Date, Date Resolved, and the name of the
individual responsible for resolution. When the review and any resolutions are completed, this chart QA tool will be signed and dated by the QA Reviewer and
filed within the Quality Management binder. Note: Other indicators or criteria may be added as determined by site staff.
SECTION I - INDICATORS AND CRITERIA
Indicator(s) Criteria Y N N Comments
E O /
S √ A
√ √
Informed Consent Is it documented that the study has been
and Assent Process explained to the participant and/or legally
and Documentation authorized representative allowing for the
opportunity to ask questions?
A Current valid and approved version of the
Informed Consent and/or Assent Form has
been signed and dated in ink by participant or
legally authorized representative?
The participant signed and dated the Informed
Consent, prior to study-specific procedures?
Eligibility Criteria Has the participant met all Inclusion Criteria
and Exclusion Criteria for the study?
Has a chart note or eligibility checklist that
addresses each specific criterion been
completed & signed?
Has the note or checklist been signed,
credentialed, and dated by the clinician (or
Investigator) responsible for enrolling the
study subject?
Prohibited/ Documentation of concomitant medications is
Concomitant complete with start/stops times and consistent
Medications with protocol?
Is participant taking any prohibited Must ck protocol – N/A if no prohibited med.
medications? If yes, was this finding
documented and the PI notified?
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Quality Management Plan Chart Audit Tool
SECTION I - INDICATORS AND CRITERIA (cont.)
Indicator(s) Criteria Y N N Comments
E O /
S √ A
√ √
Study Drug Has study drug been administered per
Administration protocol/SOP and documented accordingly?
Processes Note: This includes a review of the
documentation supporting double-checking
of medications as indicated.
Start and stop times recorded at appropriate
timeframes with appropriate follow-up and
documentation? (if applicable)
Study Device Has study device been used or implanted per
Use/Implantation protocol/SOP and documented accordingly?
Processes
Adverse Event (AE), AEs and SAEs identified, recorded, and
and/or Serious reported properly and according to CRU
Adverse Event (SAE) policy?
Identification and Are there any AEs unreported?
Reporting
Are there any SAEs unreported?
Missed Visits and Has the participant missed any visits?
Follow-up
If yes, are they documented according to the
protocol and institutional requirements? Is
there documentation of attempts to contact
the participant noted? (i.e. Phone call,
certified mail, etc.)
Missed Have all protocol-required lab tests and
Tests/Procedures procedures been performed?
If no, have the missed tests/procedures been
reported as Protocol Deviations?
Treatment/Study If the participant has discontinued treatment
Discontinuation or study, have all protocol-required steps
been followed?
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Quality Management Plan Chart Audit Tool
SECTION I - INDICATORS AND CRITERIA (cont.)
Indicator(s) Criteria Y N N Comments
E O /
S √ A
√ √
Miscellaneous Are all source documents labeled with
participant ID?
24 hour contact information given to subject.
Data from source document matches CRF or
database record for the visit?
Are all entries signed and dated?
Are all error corrections clear (strikethrough,
initial and date)?
All diagnostic tests ordered have
corresponding results in the chart according to
the protocol.
Physician notes are written to document
exams or procedures done.
SECTION II – ISSUES AND RESOLUTIONS
Issues and corrective action Recommend adding a separate Date Type of source Date Resolved by (Name)
corrective action column (Source) Resolved
(refer to “comments” in above Section I)
Quality Assurance Review Completion: ___________________________________________________ Date: __________________________
Signature of Person Performing QA Review
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