ABSTRACT

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

chapter |12 pages

MON-009.0: Reviewing Regulatory Documents

chapter |2 pages

MON-013.0: Telephone Contact Reports

chapter |4 pages

SITE-007.0: Recruiting Study Patients

chapter |2 pages

SITE-012.0: Managing Biological Samples

chapter |6 pages

IRB-002.0: IRB Membership and Training

chapter |4 pages

IRB-004.0: IRB Record Keeping

chapter |6 pages

IRB-005.0: IRB Review of Research

chapter |4 pages

IRB-007.0: IRB Review of Advertisements

chapter |2 pages

Amendment: Protocol Amendment Form

chapter |2 pages

CRF Review: CRF Review Form

chapter |2 pages

DCF Form: Data Clarification Form

chapter |2 pages

Dispense: Drug Dispensing Log

chapter |2 pages

Drug Return: Drug Return Form

chapter |2 pages

Expedited: Expedited Review Form

chapter |8 pages

Initial Sub: Initial Submission Form

chapter |2 pages

IRE3 Member: IRB Membership Roster

chapter |2 pages

Monitor Log: Monitoring Log

chapter |2 pages

Patient Master: Master Subject Log

chapter |2 pages

Phone Rpt: Telephone Contact Report

chapter |2 pages

Progress Rpt: IRB Progress Report Form

chapter |2 pages

Review Cklist: Reviewer's Checklist

chapter |2 pages

Review Results: IRB Review Results Form

chapter |6 pages

SAE: Serious Adverse Experiences

chapter |2 pages

Safety Rpt: Safety Information Form

chapter |2 pages

Training Plan: Training Plan Form

chapter |4 pages

Training Record: Training Record Form