Clinical research coordinator handbook /

Clinical research coordinator handbook /

Đã lưu trong:
Chi tiết về thư mục
Tác giả chính: Norris, Deborrah
Định dạng: Sách
Ngôn ngữ:English
Được phát hành: Medford, NJ : Plexus Pub., c2009.
Phiên bản:4th ed.
Những chủ đề:
Clinical trials > United States > Handbooks, manuals, etc.
Clinical Trials as Topic > standards > United States > Handbooks.
Clinical Trials as Topic > methods > United States > Handbooks.
Records as Topic > standards > United States > Handbooks.
Research Design > standards > United States > Handbooks.
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Mục lục:
  • Federal regulations governing the obligations of clinical investigators of regulated articles
  • The clinical research organization
  • Investigator responsibilities
  • Duties of the clinical research coordinator
  • The creation of study source documents
  • Obtaining informed consent and assent approval
  • Pertinent forms and study records
  • The prestudy site visit
  • Recruiting and enrolling subjects
  • Conducting the study and keeping records
  • Preparing for an FDA audit
  • Clinical research : potential liability
  • Writing the study sumary
  • Achieving credibility and recognition as a Clinical Research Coordinator
  • Electronic data capture and clinical trials.

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