Quality Assurance (QA) Resources


Preparing for your NRG Audit

Review our Audit Policy.

A formal notification letter for the upcoming audit will be sent to the attention of your site's Contact PI, using this notification template.

If there are any questions, please contact us at 412-624-2666 and ask to speak with someone in Quality Assurance.

NRG Oncology Audit Components

The audit may include (but is not limited to) the following:

IRB/ICC Review

  • Documentation of all protocol approvals and annual renewals during the audit period
  • Documentation of approval of all protocol amendments during the audit period
  • Documentation of submission of external safety reports if applicable
  • Verification of appropriate and timely reporting of required local adverse events
  • Local informed consent content is consistent with model consent content (initial and all updated versions)
  • Delegation of Task Log (DTL) if applicable
  • Most recent consent form template
Example Major and Lesser deficiencies for Regulatory.

Pharmacy Review

  • NCI DARFs are completely and correctly filled out
  • DARFs are protocol and agent specific
  • Oral DARFs in use if applicable
  • Satellite DARFs and records are accounted for
  • Comparison of DARFs with patient records
  • Comparison of DARFs with shelf inventory at the audit location if applicable
  • Proper security and storage of investigational agents at the audit location if applicable
  • Retention of shipping, transfer and return forms
  • Verification of authorized prescription process
Example Major and Lesser deficiencies for Pharmacy.

Patient Case Review

  • Informed Consent
    Properly administered, original on file, re-consent obtained where applicable
  • Eligibility
    Confirmation that patient met eligibility criteria and that required examinations/tests were conducted within the protocol specified timeframes
  • Treatment
    Verification of dates of therapy/scheduling; correct dose calculations and appropriate modifications; pretherapy evaluations; documentation of therapy administration; compliance with all protocol requirements as well as appropriate reporting of non-compliance
  • Disease Outcome/Response
    Documentation of initial sites of involvement; evaluation of status of disease; claimed response verified; appropriate follow-up examinations/tests obtained
  • Adverse Events
    All studies required to assess adverse events performed; grades, types, dates of serious adverse events accurately documented and reported; appropriate and timely AdEERS/CTEP-AERS reporting
  • General Data Management Quality
    All source documents present; data reported accurately and timely; samples submitted in a timely manner
  • QOL/PRO Form Submission
Example Major and Lesser deficiencies for Patient Cases.

Final Audit Report Sample

An example audit report is provided for your review.

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