3 Months Free Update
3 Months Free Update
3 Months Free Update
According to the ICH/GCP Guideline, which of the following should a sponsor provide to the clinical investigator before entering into a clinical trial agreement?
A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?
In accordance with the ICH GCP Guideline and the CFR, who is directly responsible for ensuring that an IRB/IEC will conduct the initial and continuing review of a study?
In accordance with the ICH GCP Guideline, which of the following should the investigator refer to when a subject returns unused medication at the completion of a study?
In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?
Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?
A nonrandomized study of 30 subjects entitled "A study to evaluate the effectiveness of and to determine the common short-term side effects associated with the drug 'PainStop' for the treatment of subjects with chronic arthritis" is an example of a:
A sponsor-investigator implemented a protocol deviation in a device trial to eliminate an immediate hazard. Before applying this change to all subjects, what must occur?
In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:
A subject on a multi-drug regimen could not tolerate a non-investigational drug. Can the investigational regimen continue?
After completion of a Phase III trial, which document should IRB/IEC retain?
A clinical investigator wants to publish a subject’s unique results. The consent form did not mention publication. What is required?
If a subject experiences a serious adverse event related to the study drug and only minimal information is available, the investigator must submit the information to the:
While reviewing site records during a monitoring visit, a monitor can cite which of the following as a site violation of informed consent regulations?
Before approving a research protocol, an IRB/IEC must determine compliance with which of the following requirements?
In accordance with 21 CFR Part 11, in order for an electronic record to be equivalent to a paper record the electronic record must be:
After the sponsor’s auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is responsible for providing the audit certificate to the clinical site?
A subject was instructed to do a glucose check 4 times a day for 10 days using an investigational glucose meter. The meter requires one new glucose test strip for each test. The subject received the meter along with 45 glucose test strips. How many unused test strips should the subject have after the 10 days?
According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?
A research assistant on a study was recently promoted to a clinical research coordinator (CRC) role after one year on the study. In order to fulfill the significant new responsibilities, the CRC completed additional institutional training. According to ICH GCP Guidelines and 21 CFR, which of the following must be filed in the regulatory binder?
A clinical investigator is planning to conduct a quality of life medical device study in the United States. The study has been designed to comply with the approved indication for use of the device. In this situation, who must approve the investigator’s proposed patient recruitment materials?
In accordance with the CFR, which of the following statements regarding the informed consent document is correct?
In accordance with the ICH GCP Guideline, at what intervals should the on-site study monitoring be performed?
Which of the following statements about the FDA's authority to inspect IRB/IEC records is correct?
A physician wants to conduct research using an approved/marketed cardiac stent for use in the carotid artery, which is not an indication for which the device is approved. In this case, the physician must obtain which of the following?
An approved investigational device exemption (IDE) permits a device to be:
Which of the following identifies content that should be included in a clinical research protocol?
A physician with 20 years of experience is planning to be the site investigator for a multi-center, Phase I oncology clinical trial. In accordance with the ICH GCP Guideline, which of the following documents should the physician provide to the sponsor and the IRB/IEC?
In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days. The product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2 mg of the product twice a day for 10 days. How many tablets should the subject have after the 10 days?
A clinical investigator is developing the assent procedure for the enrollment of children into a new pediatric clinical trial. The ages of the children are described in the IRB/IEC submission. A description of which of the following must also be included in the submission?
During an IND study closeout, a monitor discovered remaining investigational product. Which procedures must be followed for disposition?