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Worksheets03. Responsibilities of IRB/IEC & Investigator
Total questions: 5
Worksheet time: 4mins
Select what is the responsibility of the IRB/IEC
To review study documents before their use (protocol, ICF, IB, subject diary…)
To write study documents (protocol, ICF, IB, subject diary…) before their review by investigators.
Select the investigator responsibilities below ?
To be aware of and comply with GCP and applicable regulatory requirements
To obtain Inform Consent, the investigator has to threaten or harm the patient
To allow monitoring visits, audits and inspections,
The investigator has to influence the patient to sign the inform consent form
To ensure accuracy, completeness, legibility and timeliness of the data reported in the CRFs and all required reports, and their consistency with source documents
Source data have to be ALCOAC this is ?
Attributable
Legal
Corrected
Original
Accurate
Complete
Actual
Legal
Created
Organic
Applicable
Compliant
Attributable
Legible
Contemporaneous
Original
Accurate
Complete
Attributable
Legible
Created
Organic,
Accurate
Complete
What is not the responsibility of the investigator?
To obtain and document informed consent in awritten and signed Informed Consent Form
To report SAEs and AEs to the sponsor in accordance with the protocol
To review the amount and method of payment to subjects
To be qualified by education, training andexperience
Conduct continuing review of ongoing trials, is the responsibility of...
the monitor
IRB/IEC
the investigator
of the pharmacist
