The document contains 30 multiple choice questions about good clinical practice (GCP) guidelines for investigational medicinal products (IMPs) and clinical trials. Specifically, it covers topics like the requirements for an investigator's brochure (IB), the content and sections of an investigational medicinal product dossier (IMPD), GCP guidelines on informed consent, essential documents required before starting a clinical trial, responsibilities of sponsors and investigators, and definitions of key terms and entities involved in clinical trials.
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)Vijay Banwala
this ppt covers all quary about the CDSCO ( central drug standard control organisation ,drug controller gernal of india and the organisation strectures
this ppt provides you all detail about the CDSCO
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)Vijay Banwala
this ppt covers all quary about the CDSCO ( central drug standard control organisation ,drug controller gernal of india and the organisation strectures
this ppt provides you all detail about the CDSCO
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...Dinesh Gangoda
Contents
Guidelines for Preparation of Documentation
Clinical Study Reports
Clinical Trial Monitoring
Safety Monitoring in clinical trials
Introduction
Proper documentation is critical to the success of a clinical study.
Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
Investigator’s Brochure (IB)
List of Abbreviations
Contents & Summary
Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product.
Physical, chemical and pharmaceutical properties and formulation of the medicinal product. Non-clinical studies & Clinical Studies and their results.
The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.
ABBREVIATED NEW DRUG APPLICATION (ANDA),INVESTICATION OF MEDICINAL PRODUCTS D...GOKULAKRISHNAN S
Introduction to ANDA
Regulations applied to ANDA process
Format and content of ANDA
ANDA approval process
Exclusivity
Hatch-Waxman amendments & 180 days exclusivity
Introduction to IMPD
Contents of IMPD
Introduction to IB
Contents of IB
FDA Enforcement: What Every Clinical Director Should KnowMichael Swit
Half day tutorial presentation on key compliance concerns for those involved in clinical studies, with an emphasis on the key issues FDA examines and also a review of FDA's enforcement powers, ranging from warning letters to criminal prosecutions.
Guidelines on the manner of application to Guidelines on the manner of applic...Serkan Kaçar
Guidelines on the manner of application to turkish medicine and medical device agency in clinical trials, published by Turkish Medicine and Medical Device Agency
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
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2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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How STIs Influence the Development of Pelvic Inflammatory Disease.pptx
MCQ on IMPD and 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