Letters to the Editor

Work practice guides and regulatory review

I read with great interest the article on work practice guidelines (Work Practice Guides,

Applied Clinical Trials

, May 2001). I think it makes a valuable contribution to the increasing number of resources that have been published on SOPs to which the article relates.

The author writes: As for any other instructions that guide clinical practice (SOPs, protocol), work practice guidelines are subject to regulatory review, and it is important to be prepared to justify any deviations to auditors and regulators. I wonder if she could help me to better understand that statement.

I agree that in many organizations, it is standard practice for internal compliance auditors to review WPGs (and other materials associated with SOPs). If regulatory authorities find problems during an audit, of course they will request WPGs. But standard practice is different from the requirement for regulatory review. Is there a specific regulatory reference or guideline that she has in mind with regard to regulatory review of WPGs?

Arna ShefrinPresident, Shefrin & Associates
Menlo Park, CA

The author responds
Thank you for your interest in the article about work practice guides in the May issue of ACT. You pose an interesting question about their regulatory review. Standard operating procedures (SOPs) provide procedural information about what needs to be completed to fulfill the obligations of the regulations and provide auditors and regulatory authority inspectors a tool to monitor adherence.

Work practice guides (WPGs) are not intended to be regulatory in nature. They provide the necessary information and level of detail to guide day-to-day clinical practice decisions and actions.

They promote efficiency within a groupespecially when forms and templates are developedand promote a consistent approach to work activities. For example, a monitoring WPG may include information on the format of the monitoring report, how many days after the monitoring visit the report should be completed, etc. This is especially helpful when several CRAs are monitoring the same study. The WPGs give suggestions that guide practice rather than mandate practice.

Work instructions, on the other hand, are open for FDA inspection as they are used to satisfy FDA regulatory requirements. A clinical research department needs to determine if supportive procedural information is intended to mandate practice (work instructions) or guide practice (WPG).

In an inspection situation, the FDA normally uses the SOPs and work instructions as its reference. FDA would not review guidance documents unless the SOP specifically refers to them. Guidance documents are open for FDA inspection if they are used to satisfy FDA regulatory compliance requirements that are referenced in the SOPs. Another reason inspectors might review WPGs is if SOPs or work instructions are unclear and you suggest that they look at your guidance documents. That would make the WPGs auditable. I hope this clarifies this issue.

Cindy ZehrerClinical Research Associate
3M Health Care, St. Paul, MN