Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the:
PI and Sponsor.
In the case of an incapacitated subject, who should receive a copy of the signed
...
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the:
PI and Sponsor.
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF?
The subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol?
The subject inclusion and exclusion criteria
During a multi-site clinical study, whose responsibility is it to report subject recruitment rate?
The CRA
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be:
Phase II
What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP?
IB
When considering participation in a study, the investigator should determine if he/she:
sees enough patients who would qualify for the study.
When would an impartial witness be needed during the consent process for an illiterate subject?
To observe the consent process
During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments?
Electronic medical record
A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion criteria is a score of 25 or less on a psychometric test, a research-specific tool which measures cognitive ability. Which of the following individuals can administer the psychometric test to the potential subjects?
A research assistant who is certified to administer the psychometric test
A research study, in which there is no intended clinical benefit to the subject, is being submitted to the IRB/IEC. What benefit information should be included in the ICF?
Wording indicating that there is no expected benefit should be included.
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