Transcript Auditing Clinical Documents

Auditing Clinical
Documents
Sue Batdorf
Alliance Research Consulting
February 20, 2004
Rules of the “Game”
Informal Survey of various clinical
document audit systems in use and the
issues regarding them.
The audience will participate.
All situations will be considered
hypothetical.
What types of documents do we
audit?
Protocols
Investigator Brochures (ROPI)
Clinical Study Reports
Informed Consents
What types of documents do we
audit?
Data Listings
Integrated Reports – ISS/ISE
Risk/Benefit
Instructions for Use (IFU)
Subject Diaries
Dosing Instructions
Recruitment Materials
Subject ID Card
Why do we audit clinical
documents?
Improve Compliance
Improve Data Integrity
Inform QA of study events and timing
Inform QA of study participants

CRO, central lab, specialty lab, # and location
of sites, whether there will be a DSMB
Provide an independent review of
documents
What standard do we apply to
clinical documents?
Protocols – ICH 6.1-6.16
Investigator Brochure – ICH 7.1-7.5
Clinical Study Report – ICH E3
Informed Consent – ICH 4.81-4.8.15
Are templates provided for protocols and
reports?
Are separate templates utilized for Phase I vs
Phase II & III?
Who writes your clinical
documents?
Internal clinical development
Consultant collaboration
External professional writing group
Internal dedicated writing group
Are all submissions made
electronically?
All or partial
Drugs vs devices
Do you audit the electronic record, the
paper record, or both?
Do you perform QC and QA for
clinical documents?
Is there a requirement for QC in Data
Management?
Is there a requirement for QC in Clinical
Development?
Are QA audits required? If so, on what
documents?
Are peer reviews required?
Characterize the “typical” range of
QC/QA findings
Perfect documents, never any findings
Average of 7 pages of observations
Who receives results of the QC or
QA review?
Author only
Author and their management
Results are shared with all author groups
What results?
Is there any tracking and trending
of document audit results?
If yes,

What effect does this have and why?
If the effect is negative, how could this be
improved?
If the effect is positive, could this be
strengthened?
Are authors required to take
corrective action based upon
audit results?
If yes, what requires them to do so and
who verifies the corrective action is
adequate?
If no, should this be changed?
What are the reasons document
audit observations occur?
Unrealistic development timelines
Prior documents used as templates
Lack of experience and training of author
Inadequate QC process prior to audit
Inadequate peer review
Validation issues for electronic data
References
ICH GCP: Consolidated Guideline, Section
6, Published in the Federal Register CFR
62:25691-25709, released May 9, 1997
ICH Guideline on the Structure and
Content of Clinical Study Reports (ICHE3)
Published in the Federal Register (CFR
61:37319-37343) released July 17, 1996
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PARTICIPATION