# Presentation: 916000

## VA COOPERATIVE STUDIES PROGRAM QUALITY ASSURANCE & AUDITING

**Notes:**
Thank Marisue   
    1 – arranging this conference
    2 – opportunity for me and Darlene
Asked each of us to say a few words about auditing in our particular programs to set the context for this panel discussion
I have been part of the formal CSP site visit program since it began

## 
	Industry Trials (CROs)
  NCI (NIH) 
	VA Funded Research
		- CSP
		- HSRD
		- Single Investigator (local)
	Other Misc

- 	Industry Trials (CROs)
-   NCI (NIH)
- 	VA Funded Research
**	****	****- CSP**
- 		- HSRD
- 		- Single Investigator (local)
- 	Other Misc

-     CLINICAL RESEARCH AT VA FACILTIES

**Notes:**
View these as potential sponsors at VA facilities
Each sponsor brings its own unique set of benefits and risks
Daunting oversight responsibilities for any RCO

## Slide 3

**Notes:**
Overview of where Csp fits in under the Dept of Veterans Affairs VA R&D

## WHAT IS CSP & WHY DO WE AUDIT TRIALS 

- CSP - the arm of Clinical Science R&D that plans and conducts large multi-center clinical trials throughout the VA system
- 				  1946 - 2005

## WHY DOES CSP EXIST

- To answer clinical questions of particular interest to veteran population that will not be answered by Industry or elsewhere

**Notes:**
No profitability 
Examples –
Evaluating treatment strategies, combinations, etc using marketed products (no intent to apply for new indications) 
comparing various surgical procedures
Or even surgery vs watchful waiting for prostate cancer

## HOW DOES CSP DO THIS

- Maintain an organization to support VA practitioners in planning and conducting clinical trials
- 		- 7 statistical and data processing centers
- 		- 1 pharmacy support center
- Partner with Industry & NIH for mutual goals

**Notes:**
Most trials do not involve partners

## CURRENT CSP PORTFOLIO

**Active Trials:  ****	****	****	****	****	****	**** ****	****26**
**Investigative Sites conducting CSP trials: ****	****        299**
**VA facilities conducting CSP Trials: ****	****	****         ****	****89**
**Greatest number of CSP Trials at a VA Facility: ****	**** 8 ****	**
**	****	****            ****Hines, Houston & Palo Alto**

**Notes:**
REVIEW THE SLIDE . . .
But this is a constantly changing picture depending on our budget which is affected by many factors, not the least of which is the political climate
Also have some non-VA facilities in our trials but trials are primarily at VAs
Trend over the years - fewer and larger trials
“Large Simple trials”   when possible 

## PROFILE OF VA CSP TRIALS

- No drugs/devices	 6
- Drugs/devices		20

- 26 Ongoing Trials:

-    - Phase II		   1
- 	- Phase III		   6
- 	- Phase IV		   13

## PROFILE OF VA CSP TRIALS

- Size		300 – 2000  patients
- 				  10 – 20     study sites
- Duration	    2 – 5      years

- Typical trial:

## WHAT AUDITING REQUIREMENTS APPLY

- FDA* 	monitor trial adequately to prevent problems
- ICH    	monitor commensurate with nature of trial
- 		acknowledges audits as tool of Sponsor
- OHRP 	no Sponsor requirements - focus is on facility       	Human Research Protections Programs
- VAR&D 	auditing not specifically addressed
- VACSP  	self-imposed monitoring and auditing system
-            * applies only if data to be submitted to FDA

**Notes:**
We don’t monitor and audit simply because it is required – we are committed to taking the high road

## CSP MONITORING & AUDITING

***IS PART OF A PACKAGE OF GCP SUPPORT***
-   Four Cornerstones:
-  	  - Protocols include GCP standards for CSP & Sites
- 	  - Researcher training
- 	  - Study Conduct Tools for Sites
- 	  - Monitoring & Auditing of Study Conduct

**Notes:**
And we have demonstrated our commitment  by developing  package of GCP support
We will take more about the other cornerstone in the workshop session that follows, but for now we will focus on auditing

## CSP TRIALS ARE SUBJECT TO BOTH MONITORING & AUDITING

- Monitoring – A continual process of overseeing progress of clinical trial
- 	(a movie)
- Auditing  - A one-time examination of trial-related activities and documents
- 	(a snapshot)

**Notes:**
First it is important to make the distinction between monitoring and auditing
READ

## MONITORING AND AUDITING OF CSP TRIALS

**Monitoring** – **Is a routine program**
- 		Provided for every trial and every site
- 	      **(**Extent and Nature depends on the trial)
**Auditing** – **By request / “For-Cause”**
- 		Reserved for
- 			- suspected problems
- 			- QA needs & goals of Sponsor

## HOW MUCH MONITORING AND AUDITING IS TO BE PROVIDED

- Tailored To Inherent “Risk” Of Trial
- Patient Risk
- Regulatory Risk

## CSP AUDITING

**Principles and Methods (refined over past 10 years) **
-  	Monitoring - 1995    (>800 visits)
- 	Auditing    – 1998    (>500 audits)
**What we are trying to accomplish**
-  Monitoring
- verify data, consent & other details of study conduct
-  Auditing
- evaluate compliance and make recommendations to  ***improve research practices*** of _both_ sites and Sponsor

## CSP AUDITING

- Approach used for audits  (same as Industry)
- 	 - full review of regulatory file ***	****** ***
- 	 - full review of Informed Consent*** ***
- 	 - sampling of patient records
***More details at the CSP Workshop***