Download PATIENT CHART REVIEW AUDIT GUIDANCE A successful

PATIENT CHART REVIEW AUDIT GUIDANCE
A successful patient chart review entails adherence to the following key elements:
• Compliance to protocol requirements
• Accurate reporting of research data on the CRFs in a timely manner
• Maintenance of adequate source documentation to support all reported data
• Use of good documentation practices
The following sections of the protocol are most relevant and should be reviewed carefully prior to
registering a patient:
• Sec. 5 – Eligibility checklist
• Sec. 7 – Treatment plan
• Sec. 8 – Toxicities/Dose modifications
• Sec. 9 – Study Calendar
• Sec. 10 – Disease/Endpoint Assessment
• Sec. 14 – Data Submission Schedule
• Sec. 15 – Special Instructions
ELIGIBILITY
Ensure that every item on the eligibility checklist is met and that documentation is available to support
each item prior to registering a patient, including the following:
• A pathology report that confirms histology and stage of disease as well as stratification factors, if
applicable.
• Pre-study tests are done within required time frames and values are within institutional and protocol
limits.
• Detailed H & P that covers past history including any previous treatment to rule out exclusion criteria
and current history to determine if there are any co-morbid conditions that prohibit entry.
Clarifications for eligibility
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No exceptions to the eligibility criteria are allowed!
If labs are done to assess general health and the ability to receive treatment (CBCs, chemistries,
etc.) then the most recent values should be evaluated to determine eligibility. If the labs are done
for disease assessment (PSA, etc.) then any lab value during the required timeframe is adequate
to determine eligibility
If the timeframe for prestudy tests ends on a holiday or weekend, a one day extension is allowed
for prestudy requirements
Supporting documents such as lab results, x-ray reports, etc. need to be available for source
documentation; an MD note alone will not suffice
Contraceptive counseling should be documented in a progress note (description in the consent
form is not sufficient)
Chart notes to address each individual entry criterion is preferable but as a minimum, a signed
eligibility checklist to support exclusion criteria is adequate. A general note that states patient met
all exclusion or inclusion criteria is not sufficient.
Effective 1/01/13, the registering investigator must affirm eligibility by signing the Registration
Worksheet or comparable documentation PRIOR to registering the patient
COMPLIANCE WITH PROTOCOL TREATMENT
Ensure the patient is treated per protocol and that documentation is available for the following:
• The patient’s height and weight to support body surface area (BSA) calculations, if applicable.
• Initial treatment should be started within timeframes required by protocol (Section 13.0), otherwise an
explanation to explain any treatment delays should be documented
• Dates of treatment, medication and route of administration should be per study parameters
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Doses of medication should be calculated according to protocol specifications
Dose modifications should be performed per protocol requirements
No inappropriate use of non-protocol therapy
Records for other treatment modalities such as surgery or RT must be available
Clarifications for treatment
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Dose calculations should follow Policy #38 Dosing Principles unless specified otherwise in the
protocol
Study drug use must be documented in the research record. Drug orders or a copy of prescriptions
as well as documentation of drug administration through chemo flowsheets, progress notes, etc.
must be available. Pharmacy records alone are not adequate for investigational agents.
Name of agent, quantity, dose dispensed, start date or date dispensed, missed doses should all be
documented.
Oral medications must show quantity and dose, start date, and quantity returned or other
documentation of compliance. Pill diaries or calendars are encouraged but a detailed progress
noted is sufficient.
Dose modifications or treatment delays must be documented in sufficient detail to support and
provide explanation for the change. Documentation should include reason for change and actual
dosage change or reason for hold
Concomitant medications should be documented per protocol requirements.
DISEASE ASSESSMENT/RESPONSE DETERMINATION
Ensure disease assessment/response is evaluated according to protocol:
• Measurable disease vs. evaluable disease must be determined appropriately at baseline
• Evaluation of status of disease/endpoints must be performed according to the Study Calendar
• Protocol-directed response criteria (Section 10.0) must be followed by review of x-rays, scans,
pathology reports, lab reports or records of physical examinations
• Reports of scans or physical assessments must be available to support any responses (CR or PR)
Clarifications for disease assessment/response determination
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For clinical or laboratory-based endpoints, documentation of the specifics of the event or test result
must be present through a chart note, lab report, radiology report, etc.
Disease assessments must use a consistent method from baseline and throughout the study
Tumor measurements should be performed by a consistent reviewer from prestudy through
endpoint and must be documented. Notations of “smaller, larger or the same” are not adequate.
TOXICITY ASSESSMENT
Toxicities must be assessed according to protocol, using baseline and required follow-up studies as
outlined in the Study Calendar (Section 9.0):
• Drug-related toxicities must be coded and recorded according to the Group's toxicity criteria
• Attribution and status must be assigned by a qualified person
• Toxicities must be properly graded and accurately reported on the CRFs
• Serious Adverse Events (SAEs) must be reported within required timeframes via the Adverse Event
Expedited Reporting System (AdEERS)
Clarifications for toxicity assessment
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Toxicity or symptoms including those reported by the subject must be documented and assessed
for clinical significance by: 1) Grading per toxicity table in Sec. 16 of the protocol,
2) A written description, 3) Relationship to drug for SAEs or reportable AEs and 4) Attribution of
likely, possible, probable, etc.
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If non-study staff (i.e. ER staff) document toxicities then study staff must document grade, etc.
Absence of toxicity should be documented or it appears that side effects were not assessed
When reporting toxicity, the worst grade observed since last reporting should be reported
DATA QUALITY
Complete and accurate data from the primary record must be reported on the CRFs in a timely manner:
• Pay special attention to ensure accuracy in the reporting of all study parameters on the CRFs
• Ensure data (including pathology and imaging submissions) are submitted per timelines outlined in
Section 14.0.
• Ensure good documentation practices are in use (i.e. all corrections made by drawing a single line
through the error and initialing and dating the correction, no white out)
• Mandatory specimens and optional specimens (with patient’s consent) must be collected at required
time points and submitted in a timely manner
Clarifications for data quality
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Performance status must be documented numerically at prestudy and follow-up per the Study
Calendar.
Good documentation practices must be in use: All source documents must be signed and dated
and ALCOA (Attributable, Legible, Current, Original, and Accurate).
Research records should be organized in a sequential fashion and tagged to identify key
information to facilitate the auditors’ review.
A Site Authority Log should be on file at each institution. All staff who participate in the research
process must sign this log and note what responsibilities they have authority to perform. This log
must be available during the audit so that auditors may verify signatures or initials on data or areas
of responsibility if concerns or questions arise
INFORMED CONSENT
Ensure the following when the patient signs the informed consent:
• The patient has been provided the most current version of the approved consent form
• The patient dates his/her own signature when signing the consent and writes the correct date
• Any other required signatures are obtained on the consent
• All questions related to specimen collection or ancillary studies are answered by the patient
• The patient has signed a HIPAA Authorization allowing SWOG to have access to PHI
• Patients are informed or reconsented per requirements of protocol updates
Clarifications for informed consent
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Updated versions of the consent form should be implemented within 10 days of approval
Signatures of a witness or person obtaining consent should be dated the same date as the
patient’s signature. Any discrepancies should be explained by a note to file.
Documentation of the consent process should be made in the research record.
Patient responses to specimen or ancillary study questions must be reported accurately at the time
of patient registration. Any changes in patient response for use of specimens must also be
reported.
3/14/14
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