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Challenge: Clinical Study Reports

Question Number 1:
What is the number of the ICH Guideline entitled STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS?
A
 E3
B
 E4
C
 E6
D
 E9

Question Number 2:

Which of the following should appear on the Title Page of the Clinical Study Report according to the relevant ICH Guideline:

  1. development phase of study
  2. study initiation date (first patient enrolled, or any other verifiable definition)
  3. study completion date (last patient completed)
  4. name of company/sponsor signatory
  5. statement indicating whether the study was performed in compliance with Good Clinical Practices (GCP), including the archiving of essential documents
A
 1, 2 and 5 only
B
 2, 3 and 4 only
C
 2, 3, 4 and 5 only
D
 All of them

Question Number 3:

According to the relevant ICH Guidelines on Clinical Study Reports which of the following is true concerning the Synopsis?
A
 A brief synopsis that summarises the study should be provided. The synopsis should include numerical data to illustrate results, not just text or p-values.
B
 A brief synopsis that summarises the study should be provided. The synopsis should be no longer than a single page.
C
 A brief synopsis that summarises the study should be provided. The synopsis should contain a textual summary of the results of the Study.
D
 A brief synopsis that summarises the study should be provided. The synopsis should contain only the results of the primary outcome variable.

Question Number 4:
The ICH Guideline on Clinical Study Reports suggests that the synopsis is usually limited to:
A
 500 words
B
 2 pages
C
 5000 words
D
 3 pages

Question Number 5:

According to the ICH Guidelines on Clinical Study Reports which of the following should appear in the report or appendices to the report?

  1. Batch numbers of the investigational products
  2. A sample patient consent form
  3. A sample case report form
  4. A protocol
A
 3 and 4 only
B
 2 and 4 only
C
 1, 2 and 3 only
D
 All of them

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