Handbook of SOPs for Good Clinical Practice
2nd Edition

Everything you need to develop effective SOPs

Handbook of SOPs for Good Clinical Practice gives you the tools you need to create effective SOPs for monitoring functions, study site responsibilities, and IRBs.  The book includes a CD containing an electronic copy of each of the SOPs shown in the handbook so that you can easily customize the text to reflect your organization's processes.  Electronic copies of all forms used to support the SOPs are also included.  All of the SOPs and forms are in a Word format so that they can be easily customized to your organization.

  SOP topics include:

Sponsor/Monitor/CROs

Investigational Sites

• 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
  
• Close-out Visits
  
• Telephone Contact Reports
  
  

• 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
  
• Organizational Chart for the Study Site
  
• Interaction 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
  
• Interactions with Sponsor/CRO
  
• Study Files and Record Retention

  Institutional Review Boards

• IRB Responsibilities
  
• IRB Membership and Training
  
• IRB Meetings IRB Record Keeping
  
• 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 Include:

• Advertisement Review Checklist
  
• Biological Samples Inventory
  
• CRF Review Form
  
• CTM Disposition Form
  
• Data Clarification Form
  
• Drug Dispensing Log
  
• Drug Return/Destruction Form
  
• Expedited Review Form
  
• Initial Submission Form
  
• Investigational Drug Shipping Order
  
• Investigational Product Receipt Form
  
• IRB Meeting Minutes Template
  
• IRB Membership Roster Template
  
• IRB Notification of Study Termination Form
  
• IRB Progress Report Form
  
• IRB Review Results Form
  
• IRB Study Termination Acknowledgement
  
• Master Subject Log
  
• Monitoring Log
  
• Periodic Site Visit Trip Report

• Protocol Amendment Form
  
• Reviewer's Checklist
  
• SAE Reporting Form
  
• Safety Information Form
  
• Screening and Enrollment Log
  
• Site Evaluation Visit Trip Report
  
• Staff Training Request Form
  
• Staff Training Verification Form
  
• Study Initiation Documents Tracking Worksheet
  
• Study Initiation Visit Trip Report
  
• Study Responsibilities Form
  
• Study Site Personnel Signature Sheet
  
• Study Subject Investigational Product Dispensing Record
  
• Study Termination Visit Trip Report
  
• Subject Information and Consent Form Checklist
  
• Telephone Contact Report Form
  
• Training Plan Form
  
• Training Record Form