Online Assessment For : International Symposium On Phase I And Ba/Be Research

15 Questions | By Vikas.patel | Updated: Mar 20, 2022 | Attempts: 267

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Online Assessment For : International Symposium On Phase I And Ba/Be Research - Quiz

Thank You for attending on August 23-24 2019, the International Symposium on Phase I Clinical and BA/BE Research and the 3rd Phase I Drug Clinical Trial Dongguan Forum which were held for regulatory overview, BE research design, quality management, bioanalysis, clinical practice best practices. Organized by Dongguan People's Hospital under the guidance of Guangdong Pharmaceutical Association Clinical Trial Professional Committee, Guangdong Pharmaceutical Association Pharmaceutical Engineering Committee, Guangdong-Hong Kong-Macao Phase I & BE (Consistency Evaluation) Clinical Research Joint Platform and Pharmazone Experts with rich experience in Phase I drug clinical trials, including experts from China, Hong Kong, Taiwan, New Zealand, India, and

Questions and Answers

1.

"The findings are classified by GCP Inspectors as “ XXXXX ”, “major” and “minor” according to the classification of GCP findings described in the “Procedure for reporting of GCP Inspections requested by the CHMP”:
- A.
  
  Serious
- B.
  
  Adverse
- C.
  
  Critical
- D.
  
  Abnormal
2.

The XXXXXX role is to coordinate between GCP inspectors and study site personnel, so as to ensure that all documents are present/made available during inspection
- A.
  
  Sponsors
- B.
  
  Principles Investigators
- C.
  
  Ethics Committee
- D.
  
  Institutional Review Board
3.

XXXXXXX is defined by the ICH for GCP as - “ A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”.
- A.
  
  Case Report Form (CRF)
- B.
  
  Informed Consent Form (ICF)
- C.
  
  Medical Screening Record (MSR)
- D.
  
  Financial Disclosure Form
4.

The Subject has the right to leave the study at any point of time after signing the Informed Consent Form with or without giving any reason. The above statement is :
- A.
  
  True
- B.
  
  False
5.

It is mandatory to provide a copy of the signed and dated Informed Consent Form to the study participant. The above Statement is :
- A.
  
  True
- B.
  
  False
6.

As per ICH GCP – Impartial witness, is a person…… :
- A.
  
  Who is Independent of the trial
- B.
  
  Who cannot be unfairly influenced by people involved in the trial
- C.
  
  Who attends the Informed Consent Process
- D.
  
  All of the above
7.

Who is responsible to maintain accountability of Investigational Medical Product (IMP)
- A.
  
  Sponsor’s Monitor
- B.
  
  Phlebotomist
- C.
  
  Nursing Staff
- D.
  
  Pharmacist
8.

Informed consent documents must be revised every time there is :
- A.
  
  New Safety information becomes available
- B.
  
  Change in Trial Procedure
- C.
  
  Change in study participant’s compensation
- D.
  
  Change in personnel noted on consent form
- E.
  
  All of the above
9.

The XXXXXX should oversee the manufacturing, packing and shipment of the Investigational Medicinal Product (IMP) to the study site :
- A.
  
  Independent Ethics Committee (IEC)
- B.
  
  Sponsor
- C.
  
  Innovator of Reference Listed Drug (RLD)
- D.
  
  Respective National Drug Regulatory Agency
10.

Spirometry is the most common pulmonary function test (PFT) that measures how an individual inhales or exhales volumes of air as a function of time. The above statement is :
- A.
  
  True
- B.
  
  False
11.

Risk management is an attempt to identify, measure and monitor risks – so as to manage uncertainty The above statement is :
- A.
  
  True
- B.
  
  False
12.

Informed consent Form (ICF) must be approved by XXXXXXX prior to its use in study
- A.
  
  Sponsor
- B.
  
  Institutional Review Board / Independent Ethics Committee
- C.
  
  Sponsor’s Monitor
- D.
  
  Pharmacist
13.

How much quantity of water is recommended for administration of IMP as per USFDA ?
- A.
  
  100 ml
- B.
  
  240 ml
- C.
  
  150 ml
- D.
  
  200 ml
14.

How many minimum number of subjects are required as per EU regulatory for pilot study ?
- A.
  
  8
- B.
  
  10
- C.
  
  12
- D.
  
  16
15.

What quantity of Investigational Medicinal Product (IMP) is to be retained as per USFDA ?
- A.
  
  At least two times of all the release test
- B.
  
  At least three times of all the release test
- C.
  
  At least four times of all the release test
- D.
  
  At least five times of all the release test