Practice Questions Flashcards
Who is responsible for signing off a completed Case Report Form (CRF)?
Investigator or authorized personnel
How can AEs be described?
- Reported in previous clinical or pre-clinical trials
- Consistent with applicable product information
Which is necessary to contact the IRB/IEC?
When a serious unexpected adverse drug reaction occurs (SADRs)
Who’s responsibility is it to safeguard the rights and safety of subjects in clinical trials?
The investigator
Who does the investigator need to inform if they deviate from the protocol?
- Regulatory authorities
- Sponsor
- IRB/IEC
Who should have access to trial files?
- Monitor
- Investigator
An AE that is severe in intensity-
May not meet the definition of serious
Which is always true-
An adverse drug reaction is an adverse event
When is verbal consent prior to participation in a research study permitted?
When the subject is illiterate
Which is only filed in the investigator’s files?
Signed informed consent forms
Who is permitted to enter data into the case report form?
- Any person delegated by the investigator to carry out this task
- The investigator
Investigator documented and explained to sponsor premature unblinding that occurred in the trial. When does unblinding occur?
When the investigator wants to make sure a particular subject is not randomized to placebo in case of a SAE
Subject calls CRC 1 week before next scheduled visit to report pea-sized lump in neck. What should CRC do first?
Schedule subject on-site for an interim assessment
Small biotech company investigating an anti-tumoral property of scorpion toxin. After animal trials, the first trial in humans would likely involve-
- PK analysis
- Placebo control
Responsibilities of IDMC/DSMB?
- Assess the progress of a trial
- Recommend stopping a trial
