ACRP 2017 Meeting & Expo

15-7 - Master Series Program, Part II -- Mastering the Art of Writing Monitoring Reports

May 1, 2017 3:45pm ‐ May 1, 2017 4:45pm

Expiration Date: May 2, 2020


Credits: None available.

Standard: $75.00
Members: $25.00

Description

Mastering the Art of Writing Monitoring Reports is a Master Series program delivered in two parts. While the sessions can be taken individually or as a set, attendees are encouraged to take both sessions to maximize this learning opportunity.

(Part I will be delivered immediately before Part II in a separate meeting room.)

Part I -- An important aspect of monitoring involves documenting tasks performed during a monitoring visit. The monitoring visit report is confirmation of the monitoring processes followed during the site monitoring visit and demonstrates due diligence by the monitor. It also validates the sponsors' regulatory obligation. The monitoring visit report is one of the documents viewed by auditors prior to an inspection at the site. It is, therefore, essential to have a detailed, accurate and complete report. In addition to recording findings, the report must include a summary on the conduct, oversight and ongoing safety evaluation of participants. All queries should be clear, succinct and well documented so that they are understood by site personnel and any other sponsor personnel.

(Part II will be delivered immediately after Part I in a separate meeting room.)

Part II -- This workshop encompasses effective writing skills for documenting monitoring activities appropriately and highlights the importance of a well-written monitoring report. Participants will write a mock monitoring report based on scenarios provided.

Learning Objectives:

  1. Create detailed and accurate monitoring reports
  2. Identify the key elements of a complete monitoring report
  3. Develop clear, succinct and well-documented queries that are understood by site and sponsor personnel

Speaker(s):

  • Jan Peterson, MS, CCRA, RAC, ASQCBA, ACRP-CP, Senior Regulatory Affairs Advisor, Project Director, EMMES Corporation
  • Suheila Abdul-Karrim, CCRA, MiCR, CSci, RQAP-GCP, Clinical Research Consultant, Auditor & Trainer

Credits Available


Master Series Program, Part II -- Mastering the Art of Writing Monitoring Reports Exam

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