Risk Based Clinical Data Monitoring. Protocol Number: P123456.

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Risk Based Clinical Data 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 9 a. Onsite monitoring b. Central monitoring 5. Types of visits and monitoring activities 14 a. Site initiation visit activities b. Interim monitoring visit activities c. For-cause visit activities d. Close-out…show more content…
Locations: Clinical Trial with locations in Brazil, France, Germany, Italy, Spain Representative Role Study Program John Dean Principal Investigator Scott James Study Contact Study Sites Kunal Patel Site PI John Deer Primary Site Contact Sponsor Staff Jessica Jones (Brazil Site) Program Official Scott Taylor Medical Monitor CRO Staff Ken Adams Robert Hugh Vendors Erik Mehigan Darren Jones Marylyn Jones Representative Role Germany Site Ishita Roy Site PI Kisha James Primary Site Contact France Aodhan Mccool Site PI David James Primary Site Contact Italy Monica Geller Site PI Ross Geller Primary Site Contact Required Documents before the conduct of the trial: 1: Investigator’s Brochure 2: Signed Protocol and Amendments and Sample Case Report Form 3: Informed Consent Form 4: Any other written information and advertisement for subject recruitment 5: Financial aspects of the trial 6: Insurance Statement 7: Signed Agreement between Investigator and Sponsor 8: Dated documented approvals of Informed Consent Forms, protocol amendments, subject compensation 9: CV and other relevant documents of all the employees and the investigator 10: Normal values and ranges of medical/ laboratory procedures. 11: Samples of labels attached to investigational product containers 12: Shipping records 13: Pre-trial monitoring report 14: Trial initiation report Trial Master File: A standard filing system which contains all essential documents which

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