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CRC Exam Notes questions with answers.
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CRC Exam Notes questions withanswers.
What is the purpose of ICH-GCP? ICH E6 section 3.1.1 ANS - To standardize the design, conduct,
recording, and reporting of clinical trials.
This phase determines therapeutic benefit and is usually done in a larger, specific population. ICH E8
section 3.1.3.3 ANS - Phase 3
This phase investigates human pharmacology. It is the initial administration of an investigational new
drug into humans, most commonly in healthy subjects. ICH E8 section 3.1.3.1 ANS - Phase 1
Who is ultimately responsible for Source Data Verification (SDV)? ICH E6 section 5.18.4 ANS - The
monitor
The main goal of this phase of drug development is to explore therapeutic efficacy in patients. It is
important during this phase to determine the dose(s) and regimens that will be used for later trials. ICH
E8 section 3.1.3.2 ANS - Phase 2
Essential documents are... ICH E6 section 1.23 ANS - Documents which individually and collectively
permit evaluation of the conduct of a study and the quality of the data produced
What is the minimum number of members on an IRB/IEC? ICH E6 section 3.2.1 ANS - 5
This phase focuses on therapeutic use and begins after drug approval. ICH E8 section 3.1.3.4 ANS -
Phase 4
One of the primary purposes of a Phase 1 study is to: ICH E6 section 2.2 (Table 1) ANS - Determine the
metabolic and pharmacologic action of the drug in humans.
,Who is responsible for providing the trial protocol? ICH E6 section 5.4 ANS - The sponsor
Every research study involving human subjects must be registered in a publicly accessible database
before recruitment of the first subject. True or false? Declaration of Helsinki section 35 ANS - True
The World Medical Association (WMA) ethical principles for medical research involving human subjects
is called: Declaration of Helsinki section 3 ANS - The Declaration of Helsinki
Source data are: ICH E6 section 1.51 ANS - All information in original records and certified copies of
original records of critical findings, observations, or other activities in a clinical trial necessary for the
reconstruction and evaluation of the trial
What is the purpose of the Data and Safety Monitoring Board (DSMB)? ICH E9 Glossary ANS - To assess
the progress of a clinical trial, the safety data, and the critical efficacy endpoints
An investigator can be defined as: ICH E6 Glossary section 1.34 ANS - A person responsible for the
conduct of the clinical trial at the trial site; the responsible leader of the clinical research team at the site
and may be called the Principal Investigator
According to ICH, the abbreviation "LAR" stands for: ICH E6 section 3.1.1 ANS - Legally Acceptable
Representative
A sponsor can be defined as: ICH E6 Glossary section 1.53 ANS - An individual, company, institution, or
organization which takes responsibility for the initiation, management, and/or financing a clinical trial
What does "DSMB" stand for? ICH E9 Glossary ANS - Data and Safety Monitoring Board
A sub-investigator can be defined as: ICH E6 Glossary section 1.56 ANS - Any individual member of the
clinical trial team designated and supervised by the investigator at a trial site to perform clinical trial
related procedures and/or to make important trial related decisions
, The purpose of source documentation is: ICH E6 section 8.3.13 ANS - To verify that the subjects exist,
and to verify that the date in the case report forms are consistent with that in the source documents (to
substantiate integrity of trial data collected)
What are some examples of source documents? ICH E6 section 8.3.13 ANS - Original documents related
to the trial, medical treatment and history of subject
The Declaration of Helsinki was developed by: Declaration of Helsinki section 1 ANS - The World
Medical Association
List three things the Investigator is obliged to comply with during a trial. ICH E6 section 4.5 ANS - The
trial protocol, ICH-GCP, and all applicable laws and regulations
What does the IRB/IEC evaluate? ICH E6 3.1 ANS - The rights, safety, and well-being of the subjects
participating in the trial; the scientific tenability of the trial; the subject-selection procedure
(Level 2) What is the minimum amount of time after formal discontinuation of the clinical development
of an investigational product that essential documents should be retained according to ICH-GCP? ICH E6
section 4.9.5 ANS - Two (2) years after the last marketing application approval in an ICH-GCP region
A potential investigator usually only receives a protocol and Investigator's Brochure to review from a
Sponsor: ICH E6 7.2.2 and 7.5 ANS - After the signing of a confidentiality agreement
What are source documents? ICH E6 section 1.52 ANS - Original documents, data, and records, and
certified copies of original documents and records
A monitor is tasked to select investigators for a new upcoming oncology trial. What evidence of
qualifications should the potential investigator be able to provide to be considered for the conduct of
the trial? ICH E6 section 4.1.1 and 4.1.3 ANS - An up to date CV, showing evidence of adequate
education, training, and experience; evidence of awareness of and compliance with GCP and the
regulatory requirements
What is the most appropriate action for Adverse Event (AE) reporting? ICH E6 1.2 ANS - Documenting
and reporting all AEs, regardless of how trivial they may seem
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