Handbook of SOPs for Good Clinical Practice, Second edition

October 1, 2004

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-10-01-2004,

Celine M. Clive (Interpharm/CRC Press, 2004), 288 pages with CD-ROM, hardcover, ISBN: 0849321816, $229.95

Handbook of SOPs for Good Clinical Practice, Second edition
Celine M. Clive (Interpharm/CRC Press, 2004), 288 pages with CD-ROM, hardcover, ISBN: 0849321816, $229.95

Handbook of SOPs for Good Clinical Practice was prepared as a tool to aid organizations in the development of standard operating procedures (SOPs) for groups involved in the conduct of clinical trials. It is a revision of an earlier version of the handbook prepared by different authors. The book is divided into three sections covering SOPs for the sponsor and/or contract research organization, the study site, and the institutional review board (IRB). In addition to providing templates of standard SOPs that can be customized and adapted for use, the book also contains examples of common forms and checklists that are useful in the implementation and execution of the SOPs. Another advantage of the book is the inclusion of a CD-ROM that contains an electronic copy of all of the templates and forms for ease in preparing the customized versions for personal use.

The book is a very basic resource and contains only the minimum set of SOPs that an organization would need to cover activities related to the execution of a clinical trial. It also lacks any kind of explanation of the origin or genesis of some of the SOPs and the roles of persons described. And as a result, the book might be a better resource if accompanied by some discussion of what GCP is, how it is applied, and the role of different individuals. The book also makes numerous assumptions without explanation regarding the organization and role of individuals involved in the clinical studies. Many of the SOPs contain statements regarding GCP practices that are not supported, nor consistent with most interpretations of GCP. For example, the SOP for the Sponsor regarding study clinical supplies refers to interactions with the site pharmacist only. This assumes that all sites have a pharmacist on staff. The SOP discusses the role of the monitor, pharmacist, and coordinator, but never mentions the role of the Principal Investigator-who is ultimately responsible for the clinical supplies, regardless of whether there is a site pharmacist available. The SOP regarding obtaining informed consent directs the coordinator to contact the IRB and ensure that the draft is compliant with the regulations. This is clearly a task that is the regulatory responsibility of the Investigator. This SOP also indicates that a witness is required for informed consent when a non-English speaking person signs the consent, also not required by GCP.

Despite some of these deficiencies, Handbook of SOPs for Good Clinical Practice is a good beginner's reference for someone who needs to prepare a set of SOPs.

Michael R. Hamrell,PhD, is with Moriah Consultants, Yorba Linda, CA, email: michael@moriahconsultants.com.