Transcript CTMB Guidelines version

CTMB Guidelines
(Rev. October 2006)
Section 5: Conducting the Quality
Assurance Audit
Source Documents
Used to verify protocol compliance and
data submitted
 May include items such as:

Inpatient and/or outpatient medical records
 Dx reports such as CT scans, CXR, EKG,
etc
 Pathology and lab reports
 PE & progress notes

Source Documents
Any patient record that is signed and dated
by a healthcare worker assessing the
patient
 Patient diaries
 DARFs
 Study drug invoices and returns
 Appropriately signed and dated ICF
 IRB documents and correspondence

Audit Findings

Three sections to an audit report:
1) IRB and informed consent content
 2) Pharmacy review & use of NCI DARFs
 3) Patient case review

Audit Findings

Each of the three elements will receive a
rating of:
1) Acceptable
 2) Acceptable Needs Follow-up
 3) Unacceptable

Audit Findings

Written corrective action plan is required for
any element that receives an Acceptable
Needs Follow-up or Unacceptable
 The CALGB Central Office must approve the
action plan before submission to CTMB
 Re-audits are required for any Unacceptable
rating w/n 1 yr or sufficient accrual
IRB Element

A minimum review of the following is
required for each audited protocol
Full board initial approval prior to first
registered patient
 Full annual review if study is open to
enrollment or patient receiving active tx
 All updates that affect more than minimal
risk w/n 90 days of group notification

IRB Element

External IND safety reports that are
unanticipated and > grade 3 attribution –
unless the institution’s IRB has a local
policy does not require report of these
events. (CO approval of these policies
must take place before audit.)
IRB – Consent Content
The content of ICFs must be reviewed
from a minimum of 3 protocols and must
include the elements listed in the Code
of by Federal Regulations
 All side effects and alternatives to
treatment listed in the model consent
forms must also be in each consent form
since they are NCI approved consents

Pharmacy Audit
A member of the DAC will perform an
audit of the pharmacy when study
supplied drugs are involved.
 Section 5.3 lists all procedures required
for drug storage and accountability along
with a list of compliant vs. non-compliant
elements.

Patient Case Review

A minimum of 10% of cases will be audited
since the last audit
 Categories to be audited:
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Signed and dated ICF
Eligibility
Protocol directed treatment, treatment sequence,
and dose delays or adjustments
Disease response
Treatment side effects
Quality of data collection
Patient Case Review

The responsible investigator and/or a
designee should be available to auditors
at all times to help locate data and
answer questions.

Source documentation that is not
available at audit time can be supplied to
the team leader within two weeks to be
included in the audit findings.
Exit Interview
An executive session will take place
between auditors only prior to the Exit
Interview to prepare discussion of preliminary findings.
 The team leader will lead the discussion
at the Exit Interview, however the
additional auditors may be asked to
provide clarification or feedback on
patients audited.
