Handbook of SOPs for Good Clinical Practice

by Celine Clive, Donald E. Maynard

Overview

Completely revised and updated, the second edition of a classic reference, Handbook of SOPs for Good Clinical Practice provides templates of SOPs ready for adaptation to your requirements and immediate use. This allows you to create new SOPs or benchmark your existing SOPs against an internationally accepted set of SOPs. The book includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that you can easily customize the text to reflect your organization's processes.

The author uses language ranging from the specific to the very general, depending on the activity described and the number of the existing regulations governing the activity. This provides you with a starting point for the development of your organization's SOPs, saving you the time and money that would normally be spent researching and documenting each of the procedures described. Modifying the SOPs supplied by this book will be a much more efficient task than developing new ones from scratch.

Containing templates for SOPs and forms applicable to sponsors, study sites, and Institutional Review Boards (IRBs), Handbook of SOPs for Good Clinical Practice, Second Edition gives you the tools needed to develop effective SOPs for your organization.

Product Details

ISBN-13:	9780203492062
Publisher:	CRC Press
Publication date:	02/17/2004
Sold by:	Barnes & Noble
Format:	eBook
Pages:	288
File size:	9 MB

Table of Contents

Sponsor / Monitor / CRO SOPs
Preparation, Issue and Revision of Standard Operating Procedures
Clinical Monitor Training
Selecting Investigators and Study Sites
Developing Informed Consent
Conducting Site Evaluation Visits
Conducting Study Initiation Visits
Conducting Periodic Site Visits
Reviewing Case Report Forms at the Study Site
Reviewing Regulatory Documents
Adverse Experiences, Serious Adverse Experiences, and IND Safety Reports
Managing Study-specific Clinical Supplies
Conducting Close-out Visits
Telephone Contact Reports

INVESTIGATIONAL SITE SOPS
Preparation, Issue and Revision of Standard Operating Procedures
Training Study Site Clinical Research Staff
Assessing Protocol Feasibility
Investigator Agreements with Sponsors or Contract Research Organizations
Study Personnel and Responsibilities
Interactions with the IRB
Recruiting Study Subjects
Study Initiation and Implementation
Reviewing and Obtaining Informed Consent
Adverse Experiences, Serious Adverse Experiences, and IND Safety Reports
Drug Storage and Accountability
Managing Biological Samples
Sponsor/CRO Interactions
Study Files and Record Retention

INSTITUTIONAL REVIEW BOARD SOPS
IRB Responsibilities
IRB Membership and Training
IRB Meetings
IRB Recordkeeping
IRB Review of Research
IRB Review of the Informed Consent Document
IRB Review of Advertisements
IRB Review of Unscheduled Mandatory Reports
Criteria for Exempt and Expedited Review

FORMS - BY TOPIC

Drugs
Study Subject Investigational Product Dispensing Record
Drug Dispensing Log
CTM Disposition Form
Investigational Drug Shipping Order
Investigational Product Receipt Form
Drug Return/Destruction Form

Site
Screening and Enrollment Log
Master Subject Log
Study Responsibilities Form
Study Site Personnel Signature Sheet

Training
Training Plan Form
Training Record Form
Staff Training Request Form
Staff Training Verification Form

Monitoring
Biological Samples Inventory
CRF Review Form
Data Clarification Form
Study Initiation Documents Tracking Worksheet
Monitoring Log
Telephone Contact Report Form

Trip Reports
Site Evaluation Visit Trip Report
Study Initiation Visit Trip Report
Periodic Site Visit Trip Report
Study Termination Visit Trip Report

IRB Operations and Interactions
Advertisement Review Checklist
Protocol Amendment Form
Expedited Review Form
Worksheet for the Adequacy of Informed Consent
Subject Information and Consent Form Checklist
Initial Submission Form
IRB Membership Roster Template
IRB Meeting Minutes Template
IRB Progress Report Form
Reviewer's Checklist
IRB Review Results Form
SAE Reporting Form
Safety Information Form
IRB Study Termination Acknowledgement
IRB Notification of Study Termination Form