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CRA Training Series (7 Volume Set) (2000)

  • ID: 40321
  • Book
  • January 2000
  • Cambridge Healthtech Institute
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Learn the basics of being a CRA. Each volume can be purchased separately or the full 7-book series can be purchased for $405. Publications in this set include:

Vol.1-An Overview of Drug Development,
Vol.2-Identifying and Screening Investigators,
Vol.3-Conducting the Pre-Study Visit,
Vol.4-Conducting the Study Initiation Visits,
Vol.5-Conducting Routine Monitoring Visits,
Vol.6-The CRAs Reference for Adverse Events, and
Vol.7-Test Your Knowledge.

CRA Training Series - Spiral-Bound Softcover Books. An Overview of Drug Development:reviews the process of drug development from discovery to thewriting of the final study report. Teaches Good Clinical Practice(GCP) under the FDA regulations and the InternationalConference on Harmonization (ICH) Guidelines. (63 pages)

Topics covered:

- Preparing for the visit
- Group meeting
- study overview
- Group meeting
- Protocol/CRF
- Individual contacts
- Preparing documentation and following up
- Appendices and exhibits

Conducting the Study Initiation Visit: explains how to prepare the investigator and study staff toconduct critical trial tasks.
Contains the ICH GCP Essential
Documents Appendix to make sure all documentation is inplace. (90 pages)

Topics covered:- Significance of investigator selection- Identifying potential investigators- Contacting potential investigators- Selection criteria- Investigator’s access to subjects - Time and cost factorsIdentifying and Screening Investigators:covers the hows and whys, plus the critical steps required to findcompetent and experienced investigators to conduct clinical studies. Includes Needs Assessment, Study-Mandated Criteria and Basic Investigator Criteria. (45 pages)

Topics covered:- Preparing for the prestudy visit- Conducting the prestudy visit- Assessing the site- Documenting the prestudy visit- Exhibits - sample agendas, budgetworksheets and forms- Appendix covering ICH Guideline forGood Clinical PracticeConducting the Prestudy Visit:teaches how to evaluate a potential site and how to determineif a potential investigator has the experience, staff resources and facilities to conduct your study according to protocol and GCP. (92 pages) Conducting the Study Initiation Visit The Self-Instructional CRA Training Series Book Four of Seven A Publication of Barnett International/ParexelBerlin - Boston - Chicago - Frankfurt - KobeLondon - Madrid - Milan - Minneapolis - Paris - Philadelphia Raleigh-Durham - San Diego - Sheffield - Stockholm Sydney - Tokyo - Tel Aviv - Washington Conducting Routine Monitoring Visits The Self-Instructional CRA Training SeriesBook Five of SevenBarnett®Parexel®Barnett®Parexel®Topics covered:- Types of monitoring visits- Preparing for the visit- Making the first visit- Conducting routine monitoring visits- Closing out a study- Regulatory and certification requirements- Adverse events- Query verification- Monitoring reports Conducting Routine Monitoring Visits:identifies skills that must be mastered to effectively review CRFs,oversee clinical supplies and address typical problems. (131 pages)A Publication of Barnett International/ParexelBerlin - Boston - Chicago - Frankfurt - KobeLondon - Madrid - Milan - Minneapolis - Paris - Philadelphia Raleigh-Durham - San Diego - Sheffield - StockholmSydney - Tokyo - Tel Aviv - WashingtonTopics covered:- What is an adverse event?- Why are AEs so important?- CRF recording procedures- AE reporting procedures- AE reporting for marketed drugs- Adverse event management- Reporting adverse events under ICHGuidelines and FDA regulationsThe CRA’s Reference for Adverse Events:outlines why AEs are so important and how to deal with them.Explains how to identify, classify and report AEs in accordancewith current ICH Guidelines and FDA regulations. (80 pages) Test YourKnowledge The Self-Instructional CRA Training Series Book Seven of SevenA Publication of Barnett International/ParexelBerlin - Boston - Chicago - Frankfurt - KobeLondon - Madrid - Milan - Minneapolis - Paris - PhiladelphiaRaleigh-Durham - San Diego - Sheffield - StockholmSydney - Tokyo - Tel Aviv - WashingtonThe CRA’s Referencefor Adverse Events The Self-Instructional CRA Training SeriesBook Six of SevenBarnett®Parexel®Barnett®Parexel®A Publication of Barnett International/ParexelBerlin - Boston - Chicago - Frankfurt - KobeLondon - Madrid - Milan - Minneapolis - Paris - PhiladelphiaRaleigh-Durham - San Diego - Sheffield - Stockholm Sydney - Tokyo - Tel Aviv - WashingtonTest Your Knowledge:tests your knowledge with 175 questions/answers coveringbooks 1-6 in this series. (92 pages)
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