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Pharmaceutical SOP Reference from C.H.I.P.S.

Handbook of SOPs for Good Clinical Practice

Second Edition
by Celine Clive


  • Covers informed consent, drug accountability, regulatory documents, adverse experiences, and IRB responsibilities
  • Provides descriptions of the activities which should be accomplished at each type of site visit and templates for the trip reports
  • Contains templates for SOPs applicable to sponsors, study sites, and IRBs
  • Includes a CD-ROM containing an electronic copy of the SOPs and forms in the handbook

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.

Contents

  1. 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

  2. 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

  3. 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

  4. 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

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Handbook of SOPs for Good Clinical Practice
Second Edition by Celine Clive
288 pages $298.95 + shipping

Texas residents please add 6.75 % sales tax

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