MCQ on IMPD and IB

MCQ on Investigational medicinal product dossier (IMPD) and Investigational brochure (IB)

1. MCQ on Investigational Medicinal Product Dossier (IMPD) and
Investigational Brochure (IB)
1. According to ICH GCP when should the Investigator's Brochure be reviewed?
A. Periodically
B. According to the sponsor's standard operating procedures
C. As significant new information becomes available
D. At least annually
2. According to ICH GCP, a …………. should generally participate in the editing of an IB,
but the contents of the IB should be approved by the disciplines that generated the
described data.
A. Physician
B. Sponsor
C. Sponsor-Investigator
D. Owner of the institution
3. The Investigator's Brochure (IB) is a compilation of the……………… on the
investigational product(s) that are relevant to the study of the product(s) in human
subjects.
A. clinical data
B. nonclinical data
C. clinical and nonclinical data
D. previous study data
4. According to ICH GCP, if a subject is unable to read or if a legally acceptable
representative is unable to read, an impartial witness should what?
A. be present during the entire informed consent discussion
B. sign the informed consent document on behalf of the subject
C. be available to explain the process to the subject
D. both a and b

2. 5According to ICH GCP what are the absolute minimum requirements for essential
documents at site before IMP can be sent to the site?

A CV of investigator and Clinical Trial Authorization (CTA)
B. Ethics Committee Approval and signed protocol
C. CTA and Ethics Committee Approval
D. CTA, Ethics Committee Approval and signed protocol
6. Who should ensure that it is specified in the protocol or other written agreement that the
investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review,
and regulatory inspection(s), providing direct access to source data/documents?
A. Monitor
B. Sponsor
C. Institutional Review Board/Independent Ethics Committee
D. Regulatory authority
7. Before the Clinical Phase of the Trial Commences where should the Investigator’s
brochure be filed?
A. the Sponsor file only
B. The investigator file only
C. Both the sponsor and investigator files (where required)
D. Both the sponsor and investigator files and third party (if applicable)
8. Document mandatory to enroll subject in clinical research study?
A. Protocol
B. Case Report Form
C. Informed Consent Form
D. Investigators Brochure
9. Whose responsibility is to prepare essential documents like protocol/ investigators
brochure/ informed consent form/ case report form in clinical trials?

3. A. Investigator
B. Ethics committee
C. Scientist
D. Sponsor
10. The IB should be presented in a concise, simple, objective, balanced, non-promotional form
to enable understanding and allow own unbiased risk-benefit analysis
A. True
B. False
11. how many sections are there in IMPD
A. 1
B. 3
C. 2
D. 4
12. The Investigational Medicinal Product Dossier (IMPD) is one of several pieces of
Investigational
Medicinal Product related data, required whenever the performance of a clinical trial is
intended
in …………….
A. United states
B. European countries
C. Asian countries
D. all of the above
13. summaries of chemical, pharmaceutical and biological data of any Investigational
medicinal Product (IMP) is stated under which section of IMPD ?
A. Quality (Chemistry, Manufacturing and Controls data)
B. Non-clinical pharmacology and toxicology data
C. Previous clinical trial and human experience data

4. D. Overall risk and benefit assessment.
14. In case where preparation of the formal IB is impractical, the ……………………should
provide, as substitute, an expanded background information section in the trial protocol
that contains the minimum current information described in this guideline.
A. Sponsor-investigator
B. Ethical committee
C. Physician
D. Owner of the firm
15. Which data should be submitted to concerned authority in case of placebo?
A. Quality
B. Non-clinical
C. Clinical
D. All of the above
16. If the investigational medicinal product is placebo which kind of quality data is to ne
submitted ?
A. Data related to investigational medicinal product
B. Appendices to current version of guidelines on the requirements to the chemical and
pharmaceutical quality documentation concerning IMP in clinical trials.
C. Both A and B
D. None of the above
17. The 2.2.1.P.8 section of IMPD is related to
A. Container closure system
B. Reference standards or materials
C. Stability
D. Characterization of impurities
18. The section 2.2.1.P of IMPD is related with
A. Medicinal product

5. B. Drug substances
C. All of the above
D. Non of the above
19. The section 2.2.1.S of IMPD is related with
A. Medicinal product
B. Drug substances
C. All of the above
D. None of the above
20. If the IMP is manufactured in the EU and does not have a marketing authorization in
the EU the documents to be submitted are
A. A copy of the manufacturing authorization.
B. Certification of the Qualified Person that the manufacturing site work in compliance with the
GMP at least equivalent to EU GMP.
C. Certification of the GMP status of any active biological substance.
D. Copy of the importer’s authorization.
21. If the IMP is not manufactured in the EU and does not have a marketing authorization
in the EU the documents to be submitted are
A. Certification of the Qualified Person that the manufacturing site work in compliance with the
GMP at least equivalent to EU GMP.
B. Certification of the GMP status of any active biological substance.
C. Copy of the importer’s authorization.
D. All of the above.

22. SmPC stands for
A. Summary of Product Characteristics
B. Standards for product characterization
C. Summary of Process Characteristics

6. D. All of above
23. Which of the following is the goal of dossier?
A. Is the drug safe and effective in its proposed use when used as directed, and do the benefits of
the drug outweigh the risk?
B. Is the drug’s proposed labeling (Package insert) appropriate and what it contains?
C. Are the methods used in manufacturing the drug and the controls used to maintain the drug’s
quality adequate to preserve drug’s identity, strength, quality and purity.
D. All of the above
24. When little or no information about an IMP has been previously submitted to
competent authorities is called ….
A. Simplified IMPD
B. Full IMPD
C. Partial IMPD
D. None of above
25. A …………………..may be submitted if information has been assessed previously as part of
a Marketing authorization In any Member State or a clinical trial to that competent authority or
when it is possible to cross-refer to data In some other documents.
A. Simplified IMPD
B. Full IMPD
C. Partial IMPD
D. None of above
26. Which of the following is not in the list given by ICH GCP for the factors guiding the audit
plan and procedures for a trial audit? section 5.19.3b

A. Importance of the trial to submissions to regulatory authorities
B. Number of subjects in the trial
C. Type and complexity of the trial

7. D. Duration of treatment for each trial subject
27. Section 6 of ICH GCP states the protocol should generally include stopping rules for
individual subjects, parts of trials and entire trial. What other term does it specify in addition to
Stopping Rule? section 6.4.6

A. Interim Analyses
B. Endpoints
C. Termination Criteria
D. Discontinuation Criteria
28. According to the Multicentre Trials section of ICH GCP when should supplemental
Case Record Form (CRFs) be provided? section 5.23.2
A. For investigators who are collecting additional data
B. For country/region specific requirements
C. To collect screening data to ensure consistency across all trial sites
D. To allow for additional recruitment at specific sites
29. The …………. is responsible for the ongoing safety evaluation of the investigational
product.
A. Investigator
B. Sponsor
C. IEC/IRB
D. Regulatory authority
30. according to ICH GCP - Any public or private entity or agency or medical or dental
facility where clinical trials are conducted is ………………..
A. Trial site
B. Investigational site
C. Institution (Medical)
D. Trial institution

8. Answers:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
D
A
C
A
C
B
C
C
D
A
D
B
A
A
A
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
C
C
A
B
A
D
A
D
B
A
D
D
A
B
C