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.
What completes this statement in ICH GCP section 4.9 Records and Reports?
"The investigator should ensure the accuracy, completeness, legibility and XXXXX of the data reported to the sponsor in the CRFs and in all required reports"?
What is needed to complete the following statement in ICH GCP Section 4.9?
"Data reported on the CRF, that are derived from source documents should be consistent with the source documents or ........"
What is needed to complete the following statement from ICH GCP Section 4.9?
"Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make available XXXXXXXXXX all requested trial related records"
What completes the following statement form ICH GCP Section 4.9 regarding Essential Documents?
"The investigator/institution should take measures to prevent XXXXXXX destruction of these documents"
What completes the following statement from ICH GCP Section 4.9?
"Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should XXXXXXXXX"
