Monitoring Protocol Number: P123456 Title: A Safety and Efficacy Extension Study of Pertuzumab in Patients with Solid Tumors Contract Research Organization Sponsor: Kunal Patel 360 Huntington Ave Boston, MA-02115 Table of Contents 1. Purpose 3 2. Introduction 3 3. Essential documents/Trial master file 7 a. Required essential documents b. Trial master file (TMF) c. Source documents d. Monitor’s role in essential document maintenance 4. Monitoring reports/Action items
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R1) Current Step 4 version dated 10 June 1996 (including the Post Step 4 corrections) This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the