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Monitoring Reports: 10 Rules of Effective Report Writing October 2011

Course Description

The CRA creates reports that have many audiences, one being regulatory authorities reviewing essential documentation of clinical trials linked to marketing application approvals. This web seminar presents 10 categories of scientific report writing in the context of the role of the CRA and the reports that they write. The applicable reports are monitoring visit reports, e-mails, telephone reports, Memos to File, and more. The concepts of writing in a scientific voice versus first person, objective versus subjective, and many more are presented. This course is invaluable for the CRA, as well as the individual who critiques the various reports.

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Learning Objectives

  • Examine the impact of poor report writing
  • Apply the definitions and concepts of scientific report writing
  • Implement the 10 rules of quality report writing for CRAs
  • Apply the 10 rules to CRA activities
  • Write action items, deviations, queries
  • Integrate essential document mapping within a monitoring report
  • Appreciate the challenges of CRA report writing and report review

Who Should Attend

  • CRAs
  • Contract CRAs
  • CRA Managers
  • Project Managers

Instructor

Gary B. Freeman, M.S., C.C.R.A., C.C.R.T. 

Click here for complete trainer biographies 

Course Length Time

3 hours; 12:00 - 3:00 p.m. Eastern

Course Dates

October 17, 2011

Registration Fees

$795

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-10-042-L01-P. Released: 9/10. 

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 

 

 

 

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Live SeminarLIVE SEMINARS

Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

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Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)