Essential Documents and Investigator Brochure

What is the minimum duration for retaining essential documents at a trial site after no pending or contemplated marketing applications in an ICH region?

• 2 years

• 5 years

• Indefinitely

• 10 years

Essential documents at a trial site are retained at least 5 years after last approval of marketing application in ICH region

• True

• False

Essential documents at a trial site are retained at least 2 years have elapsed since formal discontinuation of clinical development of IP

• True

• False

It is the responsibility of the sponsor to inform investigator when the essential documents are no longer needed to be retained

• True

• False

Essential documents location at the investigator's site BEFORE trial commencement are as following

• Signed agreements

• Sample of labels

• Pre-trial monitoring report

Essential documents location at the sponsor's site DURING trial commencement is:

• Monitoring visit reports

• Subject identification code list

• Signed informed consent form

• Source documents

Which essential documents be located at the sponsor's file AFTER trial commencement?

• Final report by investigator to IRB/IEC

• Audit certificate

• Complete subject identification code list

• Final trial close-out monitoring report

For an investigational product that is marketed and has a widely understood pharmacology, what alternatives may exist to an IB?

• Product information brochure

• Package leaflet

• Labeling

How frequent should an IB be reviewed?

• at least every 2 years

• at least every 5 years

• at least every 6 months

• at least annually

It is not necessary for an IB to be submitted to IRB/IEC for review and approval.

• True

• False