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GCP Tests

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.

Test: GCP What is Missing?

Question Number 1:

What comes next in the following list?

  • Glossary
  • Principles of ICH GCP
  • Institutional Review Board/Independent Ethics Committee

 
A
 Sponsor
B
 Investigator
C
 Clinical Trial Protocol
D
 Essential Documents

Question Number 2:

What comes next?

  • Principles for Clinical Evaluation of New Antihypertensive Drugs
  • The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
  • ......................

 
A
 Studies in Support of Special Populations : Geriatrics
B
 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
C
 Clinical Investigation of Medicinal Products in the Pediatric Population
D
 Choice of Control Group and Related Issues in Clinical Trials

Question Number 3:

What comes next. What should an IRB/IEC should safeguard for all trial subjects?

  • Rights
  • Safety
  • ......

 
A
 Confidentiality
B
 Well-being
C
 Protection
D
 Treatment

Question Number 4:

What is missing from the following statement:

None of the oral and written information concerning the trial, including the written informed consent form, should contain any language that causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, ...................., the sponsor, or their agents, from liability for negligence.
A
 Site
B
 Investigational Site
C
 Institution
D
 Contract Research Organisation (If applicable)

Question Number 5:

What is missing from the following: The sponsor should obtain the investigator's/institution's agreement:

  • to conduct the trial in compliance with GCP, with the applicable regulatory requirement(s), and with the protocol agreed to by the sponsor and given approval/favourable opinion by the IRB/IEC;
  • to comply with procedures for data recording/reporting;
  • ......................................
  • to retain the trial related essential documents until the sponsor informs the investigator/institution these documents are no longer needed.
A
 to permit access to subject records as required
B
 to the financial aspects of the trial
C
 to the usage of institution resources
D
 to permit monitoring, auditing and inspection

 
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