Download RGUHS (Rajiv Gandhi University of Health Sciences) 5th Sem Pharm D Question Bank Clinical Research (Latest Important Questions Unit Wise)
Chapter
No
Topics Questions Marks
Drug Development Process
1 Introduction With schematic representation, discuss integrated drug
development process.
5
1.1 Pharmacological
approach
Define therapeutic index 2
Short note on Helsinki declaration 2
What is LD50? and ED50 2
What is Human Equivalent Dose (HED)? How to convert animal
dose to HED?
2
Explain the different pharmacological action studies in the
drug development process
5
explain pre-clinical trials 5
write a note ADME profiling 5
Define Proof of Concept 2
define maximum tolerated dose 2
Write a note on lead selection and optimization drug
development process.
5
1.2 Toxicological
approach
Importance of chronic toxicity 2
Explain the toxicological approach to drug development
process
5
mutagenecity and carcinogenicity 2
Sub acute toxicity 2
1.3 IND Application
Discuss in detail the IND application 10
What is IND? Enlist the different criteria for IND application 5
1.4 Drug
characterization
Discuss various drug characterization techniques in drug
development process
5
1.5 Dosage form
biopharmaceutical classification of drugs 2
name the critical Pharmacokinetic parameter in drug
development
2
drug bioavailability 2
Fixed dose combinations 2
Explain the importance of dosage form design in pre-clinical
and clinical stages
5
Clinical Development of Drug
2.1 Introduction to
Clinical trials
Requirements to conduct clinical trials as per schedule Y 10
What is clinical trail 2
define single blind method 2
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CLINICAL RESEARCH CHAPTERWISE QUESTION BANK
Chapter
No
Topics Questions Marks
Drug Development Process
1 Introduction With schematic representation, discuss integrated drug
development process.
5
1.1 Pharmacological
approach
Define therapeutic index 2
Short note on Helsinki declaration 2
What is LD50? and ED50 2
What is Human Equivalent Dose (HED)? How to convert animal
dose to HED?
2
Explain the different pharmacological action studies in the
drug development process
5
explain pre-clinical trials 5
write a note ADME profiling 5
Define Proof of Concept 2
define maximum tolerated dose 2
Write a note on lead selection and optimization drug
development process.
5
1.2 Toxicological
approach
Importance of chronic toxicity 2
Explain the toxicological approach to drug development
process
5
mutagenecity and carcinogenicity 2
Sub acute toxicity 2
1.3 IND Application
Discuss in detail the IND application 10
What is IND? Enlist the different criteria for IND application 5
1.4 Drug
characterization
Discuss various drug characterization techniques in drug
development process
5
1.5 Dosage form
biopharmaceutical classification of drugs 2
name the critical Pharmacokinetic parameter in drug
development
2
drug bioavailability 2
Fixed dose combinations 2
Explain the importance of dosage form design in pre-clinical
and clinical stages
5
Clinical Development of Drug
2.1 Introduction to
Clinical trials
Requirements to conduct clinical trials as per schedule Y 10
What is clinical trail 2
define single blind method 2
explain inclusion and exclusion criteria in selection of clinical
trial subjects
5
define double blind method 2
name different types of clinical trials 2
investigation product/drug 2
What is Belmont report? 2
Nuremberg trials 2
Explain the role of BPOs in conducting clinical research in India 5
what is ?The Orange Book? 2
Note on Non-inferiority clinical study 2
define bias 2
Regulations for orphan drugs 2
Regulations for Counterfeit drugs 2
drug labeling requirement in clinical studies 2
What is scurvy trail? 2
2.2 Various phases of
clinical trial
Discuss in detail the various phases of clinical trial 10
note on randomized clinical trial 2
Briefly explain phase 1 and phase 2 clinical trials 5
write short note on clinical trial design 5
define phase Zero 2
objectives of phase 1/2/3/4 5
methods of randomization 5
Note on open labeled clinical trails 2
Methods of sample size calculations in clinical trials 2
difference between phase 2a and phase 2b 5
what are the objectives of phase 2 studies 2
Use of Placebo in clinical trials 2
principles of trial subject sampling 2
2.3 Methods of post
marketing
surveillance
Discuss about the different methods of post marketing
surveillance
10
write a note on case control studies 5
difference between retrospective and prospective study 5
observational studies 5
write a note on meta analysis 5
note on cohort studies 2
differentiate ADR and ADE 2
retrospective study 2
cross sectional study 2
Epidemiological study 2
Define false positive result with an example 2
FirstRanker.com - FirstRanker's Choice
CLINICAL RESEARCH CHAPTERWISE QUESTION BANK
Chapter
No
Topics Questions Marks
Drug Development Process
1 Introduction With schematic representation, discuss integrated drug
development process.
5
1.1 Pharmacological
approach
Define therapeutic index 2
Short note on Helsinki declaration 2
What is LD50? and ED50 2
What is Human Equivalent Dose (HED)? How to convert animal
dose to HED?
2
Explain the different pharmacological action studies in the
drug development process
5
explain pre-clinical trials 5
write a note ADME profiling 5
Define Proof of Concept 2
define maximum tolerated dose 2
Write a note on lead selection and optimization drug
development process.
5
1.2 Toxicological
approach
Importance of chronic toxicity 2
Explain the toxicological approach to drug development
process
5
mutagenecity and carcinogenicity 2
Sub acute toxicity 2
1.3 IND Application
Discuss in detail the IND application 10
What is IND? Enlist the different criteria for IND application 5
1.4 Drug
characterization
Discuss various drug characterization techniques in drug
development process
5
1.5 Dosage form
biopharmaceutical classification of drugs 2
name the critical Pharmacokinetic parameter in drug
development
2
drug bioavailability 2
Fixed dose combinations 2
Explain the importance of dosage form design in pre-clinical
and clinical stages
5
Clinical Development of Drug
2.1 Introduction to
Clinical trials
Requirements to conduct clinical trials as per schedule Y 10
What is clinical trail 2
define single blind method 2
explain inclusion and exclusion criteria in selection of clinical
trial subjects
5
define double blind method 2
name different types of clinical trials 2
investigation product/drug 2
What is Belmont report? 2
Nuremberg trials 2
Explain the role of BPOs in conducting clinical research in India 5
what is ?The Orange Book? 2
Note on Non-inferiority clinical study 2
define bias 2
Regulations for orphan drugs 2
Regulations for Counterfeit drugs 2
drug labeling requirement in clinical studies 2
What is scurvy trail? 2
2.2 Various phases of
clinical trial
Discuss in detail the various phases of clinical trial 10
note on randomized clinical trial 2
Briefly explain phase 1 and phase 2 clinical trials 5
write short note on clinical trial design 5
define phase Zero 2
objectives of phase 1/2/3/4 5
methods of randomization 5
Note on open labeled clinical trails 2
Methods of sample size calculations in clinical trials 2
difference between phase 2a and phase 2b 5
what are the objectives of phase 2 studies 2
Use of Placebo in clinical trials 2
principles of trial subject sampling 2
2.3 Methods of post
marketing
surveillance
Discuss about the different methods of post marketing
surveillance
10
write a note on case control studies 5
difference between retrospective and prospective study 5
observational studies 5
write a note on meta analysis 5
note on cohort studies 2
differentiate ADR and ADE 2
retrospective study 2
cross sectional study 2
Epidemiological study 2
Define false positive result with an example 2
2.4 Abbreviated New
Drug Application
submission
explain briefly about ANDA submission 10
Explain in detail NDA submission 10
write a note on ANDA 5
basic methodology and study designs of BA/BE studies 5
limitations of post marketing surveillance 2
2.5 Good Clinical
Practice ? ICH,
GCP, Central drug
standard control
organization
(CDSCO)
guidelines
discuss the principles of ICH-GCP guidelines 10
explain clinical trial protocol as per ICH-GCP guidelines 10
Explain Clinical trials and monitoring. Discuss different types of
monitoring visits in detail
10
What do you mean by expedited reporting in clinical trial?
Discuss the safety reporting as per schedule Y
10
discuss the recent amendments in schedule Y with special
reference to ethics committee
10
what the note on ICH-GCP guidelines 5
essential documents in conducting clinical trials 5
Discuss in detail about CDSCO guidelines 5
Role of ICMR in clinical research 2
list the guidelines and acts that govern the conduct of clinical
trials in India
2
selection and withdrawal of subjects in clinical trail 2
multicentre trails 2
Write a short note on new amendments to Schedule Y. 5
what are medical devices and classify with suitable examples 5
preparative termination of clinical trail 2
statistical design in clinical trails 5
unblinding 2
drug master file 2
subject identification code 2
write a note on Clinical Study Reports 5
Note on CIOMS 2
Premature Termination or Suspension of a Study 5
ICH E6 2
contract research 2
clinical trial registries 2
clinical trial insurance 2
comparative studies 2
coding of investigation products 2
importance of confidentiality statement in IB 2
Phases of Vaccine Trials 2
FirstRanker.com - FirstRanker's Choice
CLINICAL RESEARCH CHAPTERWISE QUESTION BANK
Chapter
No
Topics Questions Marks
Drug Development Process
1 Introduction With schematic representation, discuss integrated drug
development process.
5
1.1 Pharmacological
approach
Define therapeutic index 2
Short note on Helsinki declaration 2
What is LD50? and ED50 2
What is Human Equivalent Dose (HED)? How to convert animal
dose to HED?
2
Explain the different pharmacological action studies in the
drug development process
5
explain pre-clinical trials 5
write a note ADME profiling 5
Define Proof of Concept 2
define maximum tolerated dose 2
Write a note on lead selection and optimization drug
development process.
5
1.2 Toxicological
approach
Importance of chronic toxicity 2
Explain the toxicological approach to drug development
process
5
mutagenecity and carcinogenicity 2
Sub acute toxicity 2
1.3 IND Application
Discuss in detail the IND application 10
What is IND? Enlist the different criteria for IND application 5
1.4 Drug
characterization
Discuss various drug characterization techniques in drug
development process
5
1.5 Dosage form
biopharmaceutical classification of drugs 2
name the critical Pharmacokinetic parameter in drug
development
2
drug bioavailability 2
Fixed dose combinations 2
Explain the importance of dosage form design in pre-clinical
and clinical stages
5
Clinical Development of Drug
2.1 Introduction to
Clinical trials
Requirements to conduct clinical trials as per schedule Y 10
What is clinical trail 2
define single blind method 2
explain inclusion and exclusion criteria in selection of clinical
trial subjects
5
define double blind method 2
name different types of clinical trials 2
investigation product/drug 2
What is Belmont report? 2
Nuremberg trials 2
Explain the role of BPOs in conducting clinical research in India 5
what is ?The Orange Book? 2
Note on Non-inferiority clinical study 2
define bias 2
Regulations for orphan drugs 2
Regulations for Counterfeit drugs 2
drug labeling requirement in clinical studies 2
What is scurvy trail? 2
2.2 Various phases of
clinical trial
Discuss in detail the various phases of clinical trial 10
note on randomized clinical trial 2
Briefly explain phase 1 and phase 2 clinical trials 5
write short note on clinical trial design 5
define phase Zero 2
objectives of phase 1/2/3/4 5
methods of randomization 5
Note on open labeled clinical trails 2
Methods of sample size calculations in clinical trials 2
difference between phase 2a and phase 2b 5
what are the objectives of phase 2 studies 2
Use of Placebo in clinical trials 2
principles of trial subject sampling 2
2.3 Methods of post
marketing
surveillance
Discuss about the different methods of post marketing
surveillance
10
write a note on case control studies 5
difference between retrospective and prospective study 5
observational studies 5
write a note on meta analysis 5
note on cohort studies 2
differentiate ADR and ADE 2
retrospective study 2
cross sectional study 2
Epidemiological study 2
Define false positive result with an example 2
2.4 Abbreviated New
Drug Application
submission
explain briefly about ANDA submission 10
Explain in detail NDA submission 10
write a note on ANDA 5
basic methodology and study designs of BA/BE studies 5
limitations of post marketing surveillance 2
2.5 Good Clinical
Practice ? ICH,
GCP, Central drug
standard control
organization
(CDSCO)
guidelines
discuss the principles of ICH-GCP guidelines 10
explain clinical trial protocol as per ICH-GCP guidelines 10
Explain Clinical trials and monitoring. Discuss different types of
monitoring visits in detail
10
What do you mean by expedited reporting in clinical trial?
Discuss the safety reporting as per schedule Y
10
discuss the recent amendments in schedule Y with special
reference to ethics committee
10
what the note on ICH-GCP guidelines 5
essential documents in conducting clinical trials 5
Discuss in detail about CDSCO guidelines 5
Role of ICMR in clinical research 2
list the guidelines and acts that govern the conduct of clinical
trials in India
2
selection and withdrawal of subjects in clinical trail 2
multicentre trails 2
Write a short note on new amendments to Schedule Y. 5
what are medical devices and classify with suitable examples 5
preparative termination of clinical trail 2
statistical design in clinical trails 5
unblinding 2
drug master file 2
subject identification code 2
write a note on Clinical Study Reports 5
Note on CIOMS 2
Premature Termination or Suspension of a Study 5
ICH E6 2
contract research 2
clinical trial registries 2
clinical trial insurance 2
comparative studies 2
coding of investigation products 2
importance of confidentiality statement in IB 2
Phases of Vaccine Trials 2
Non-Therapeutic Study 2
Validation of clinical study 2
Selection and recruitment of Study Subjects 5
Clinical Trials with Surgical Procedures / Medical devices. 5
2.6 Challenges in the
implementation of
guidelines
comment on the challenges in the implementation of ethical
guidelines
5
2.7 Ethical guidelines
in Clinical
Research
write a note on clinical data management in clinical trials 10
research involving children 2
Inclusion of pregnant women and nursing mothers in CT? 2
vulnerable subject 2
define Ethics 2
Ethical issues involved in Genetic Screening 2
explain clinical trials for vaccines 5
pregnant women as research participant 5
Explain the ethical guidelines for clinical research 5
write a note on compensation for clinical Trial subjects as per
ethical guidelines
5
Conflict of interest in clinical trials 5
2.8 Composition,
responsibilities,
procedures of IRB
/ IEC
members of ICH 2
explain composition and responsibilities of IRB 5
Discuss in detail about institutional review board 5
2.9 Overview of
regulatory
environment in
USA, Europe and
India
write on European Clinical Directive 2
function of dcgi 2
Note on 21CFR Part 312 2
Note on Marketing Authorization Holder (MAH) 2
note on centralized marketing and decentralized marketing 2
Note on Clinical Trial Document (CTD 2
MHRA 2
EMEA 2
USFDA 2
what are different regulator system in USA, europe and India 5
give an overview of regulatory environment in India 5
expand forms of the following MHRA, CRO, CRF, MAH, EMEA,
CTA, GLP, CFR
5
write a note on regulations for OFF-Label Use 5
Write a note on pharmaceutical regulations in regard to
clinical trials in European union
10
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CLINICAL RESEARCH CHAPTERWISE QUESTION BANK
Chapter
No
Topics Questions Marks
Drug Development Process
1 Introduction With schematic representation, discuss integrated drug
development process.
5
1.1 Pharmacological
approach
Define therapeutic index 2
Short note on Helsinki declaration 2
What is LD50? and ED50 2
What is Human Equivalent Dose (HED)? How to convert animal
dose to HED?
2
Explain the different pharmacological action studies in the
drug development process
5
explain pre-clinical trials 5
write a note ADME profiling 5
Define Proof of Concept 2
define maximum tolerated dose 2
Write a note on lead selection and optimization drug
development process.
5
1.2 Toxicological
approach
Importance of chronic toxicity 2
Explain the toxicological approach to drug development
process
5
mutagenecity and carcinogenicity 2
Sub acute toxicity 2
1.3 IND Application
Discuss in detail the IND application 10
What is IND? Enlist the different criteria for IND application 5
1.4 Drug
characterization
Discuss various drug characterization techniques in drug
development process
5
1.5 Dosage form
biopharmaceutical classification of drugs 2
name the critical Pharmacokinetic parameter in drug
development
2
drug bioavailability 2
Fixed dose combinations 2
Explain the importance of dosage form design in pre-clinical
and clinical stages
5
Clinical Development of Drug
2.1 Introduction to
Clinical trials
Requirements to conduct clinical trials as per schedule Y 10
What is clinical trail 2
define single blind method 2
explain inclusion and exclusion criteria in selection of clinical
trial subjects
5
define double blind method 2
name different types of clinical trials 2
investigation product/drug 2
What is Belmont report? 2
Nuremberg trials 2
Explain the role of BPOs in conducting clinical research in India 5
what is ?The Orange Book? 2
Note on Non-inferiority clinical study 2
define bias 2
Regulations for orphan drugs 2
Regulations for Counterfeit drugs 2
drug labeling requirement in clinical studies 2
What is scurvy trail? 2
2.2 Various phases of
clinical trial
Discuss in detail the various phases of clinical trial 10
note on randomized clinical trial 2
Briefly explain phase 1 and phase 2 clinical trials 5
write short note on clinical trial design 5
define phase Zero 2
objectives of phase 1/2/3/4 5
methods of randomization 5
Note on open labeled clinical trails 2
Methods of sample size calculations in clinical trials 2
difference between phase 2a and phase 2b 5
what are the objectives of phase 2 studies 2
Use of Placebo in clinical trials 2
principles of trial subject sampling 2
2.3 Methods of post
marketing
surveillance
Discuss about the different methods of post marketing
surveillance
10
write a note on case control studies 5
difference between retrospective and prospective study 5
observational studies 5
write a note on meta analysis 5
note on cohort studies 2
differentiate ADR and ADE 2
retrospective study 2
cross sectional study 2
Epidemiological study 2
Define false positive result with an example 2
2.4 Abbreviated New
Drug Application
submission
explain briefly about ANDA submission 10
Explain in detail NDA submission 10
write a note on ANDA 5
basic methodology and study designs of BA/BE studies 5
limitations of post marketing surveillance 2
2.5 Good Clinical
Practice ? ICH,
GCP, Central drug
standard control
organization
(CDSCO)
guidelines
discuss the principles of ICH-GCP guidelines 10
explain clinical trial protocol as per ICH-GCP guidelines 10
Explain Clinical trials and monitoring. Discuss different types of
monitoring visits in detail
10
What do you mean by expedited reporting in clinical trial?
Discuss the safety reporting as per schedule Y
10
discuss the recent amendments in schedule Y with special
reference to ethics committee
10
what the note on ICH-GCP guidelines 5
essential documents in conducting clinical trials 5
Discuss in detail about CDSCO guidelines 5
Role of ICMR in clinical research 2
list the guidelines and acts that govern the conduct of clinical
trials in India
2
selection and withdrawal of subjects in clinical trail 2
multicentre trails 2
Write a short note on new amendments to Schedule Y. 5
what are medical devices and classify with suitable examples 5
preparative termination of clinical trail 2
statistical design in clinical trails 5
unblinding 2
drug master file 2
subject identification code 2
write a note on Clinical Study Reports 5
Note on CIOMS 2
Premature Termination or Suspension of a Study 5
ICH E6 2
contract research 2
clinical trial registries 2
clinical trial insurance 2
comparative studies 2
coding of investigation products 2
importance of confidentiality statement in IB 2
Phases of Vaccine Trials 2
Non-Therapeutic Study 2
Validation of clinical study 2
Selection and recruitment of Study Subjects 5
Clinical Trials with Surgical Procedures / Medical devices. 5
2.6 Challenges in the
implementation of
guidelines
comment on the challenges in the implementation of ethical
guidelines
5
2.7 Ethical guidelines
in Clinical
Research
write a note on clinical data management in clinical trials 10
research involving children 2
Inclusion of pregnant women and nursing mothers in CT? 2
vulnerable subject 2
define Ethics 2
Ethical issues involved in Genetic Screening 2
explain clinical trials for vaccines 5
pregnant women as research participant 5
Explain the ethical guidelines for clinical research 5
write a note on compensation for clinical Trial subjects as per
ethical guidelines
5
Conflict of interest in clinical trials 5
2.8 Composition,
responsibilities,
procedures of IRB
/ IEC
members of ICH 2
explain composition and responsibilities of IRB 5
Discuss in detail about institutional review board 5
2.9 Overview of
regulatory
environment in
USA, Europe and
India
write on European Clinical Directive 2
function of dcgi 2
Note on 21CFR Part 312 2
Note on Marketing Authorization Holder (MAH) 2
note on centralized marketing and decentralized marketing 2
Note on Clinical Trial Document (CTD 2
MHRA 2
EMEA 2
USFDA 2
what are different regulator system in USA, europe and India 5
give an overview of regulatory environment in India 5
expand forms of the following MHRA, CRO, CRF, MAH, EMEA,
CTA, GLP, CFR
5
write a note on regulations for OFF-Label Use 5
Write a note on pharmaceutical regulations in regard to
clinical trials in European union
10
Write a note on Centralized procedure and Decentralized
Mutual Recognition Procedure in European union
10
write a note on Accelerated Approval 5
write a note on Accelerated Approval, Fast Track, and Priority
Review
10
write a note on Fast Track, and Priority Review 5
2.10 Role and
responsibilities of
clinical trial
personnel as per
ICH GCP
a. Sponsor
b. Investigators c.
Clinical research
associate
d. Auditors
e. Contract
research
coordinators
f. Regulatory
authority
write a note on CRA 5
Explain in detail the role and responsibilities of a)investigator
b) clinical research associate c) Regulatory authority as per
ICH-GCP
10
explain about clinical trials audit and inspection with special
emphasis on national regulatory authorities
10
Expand the following: IND, DCGI, PvPI, BPO 2
role of CRC 2
Role of auditor In clinical data 2
What is an Investigators brochure and explain its content? 5
role and responsibilities of auditors 5
explain the role of investigators I clinical trials 5
criterias for selection of an investigator/s 2
Role and responsibilities of sponsor in clinical trials 5
2.11 Designing of
clinical study
documents
(protocol, CRF,
ICF, PIC with
assignment)
Explain in detail the process of designing study protocol in
clinical trials. Add a note on importance of CRF
10
explain designing of CRF with a suitable example 5
define protocol 2
2.12 Informed consent
Process
Discuss about designing of inform consent form for clinical
study?
5
explain confidentiality and impartial witness 2
Explain in detail the informed consent process 5
difference between consent and assent forms 2
explain Waiver of consent 2
2.13 Data management
and its
components
write a note on QA and QC 5
Discuss data management and its component 5
write the application of computers in clinical data
management
5
write a note on clinical data archive 5
What is ANOVA? 2
FirstRanker.com - FirstRanker's Choice
CLINICAL RESEARCH CHAPTERWISE QUESTION BANK
Chapter
No
Topics Questions Marks
Drug Development Process
1 Introduction With schematic representation, discuss integrated drug
development process.
5
1.1 Pharmacological
approach
Define therapeutic index 2
Short note on Helsinki declaration 2
What is LD50? and ED50 2
What is Human Equivalent Dose (HED)? How to convert animal
dose to HED?
2
Explain the different pharmacological action studies in the
drug development process
5
explain pre-clinical trials 5
write a note ADME profiling 5
Define Proof of Concept 2
define maximum tolerated dose 2
Write a note on lead selection and optimization drug
development process.
5
1.2 Toxicological
approach
Importance of chronic toxicity 2
Explain the toxicological approach to drug development
process
5
mutagenecity and carcinogenicity 2
Sub acute toxicity 2
1.3 IND Application
Discuss in detail the IND application 10
What is IND? Enlist the different criteria for IND application 5
1.4 Drug
characterization
Discuss various drug characterization techniques in drug
development process
5
1.5 Dosage form
biopharmaceutical classification of drugs 2
name the critical Pharmacokinetic parameter in drug
development
2
drug bioavailability 2
Fixed dose combinations 2
Explain the importance of dosage form design in pre-clinical
and clinical stages
5
Clinical Development of Drug
2.1 Introduction to
Clinical trials
Requirements to conduct clinical trials as per schedule Y 10
What is clinical trail 2
define single blind method 2
explain inclusion and exclusion criteria in selection of clinical
trial subjects
5
define double blind method 2
name different types of clinical trials 2
investigation product/drug 2
What is Belmont report? 2
Nuremberg trials 2
Explain the role of BPOs in conducting clinical research in India 5
what is ?The Orange Book? 2
Note on Non-inferiority clinical study 2
define bias 2
Regulations for orphan drugs 2
Regulations for Counterfeit drugs 2
drug labeling requirement in clinical studies 2
What is scurvy trail? 2
2.2 Various phases of
clinical trial
Discuss in detail the various phases of clinical trial 10
note on randomized clinical trial 2
Briefly explain phase 1 and phase 2 clinical trials 5
write short note on clinical trial design 5
define phase Zero 2
objectives of phase 1/2/3/4 5
methods of randomization 5
Note on open labeled clinical trails 2
Methods of sample size calculations in clinical trials 2
difference between phase 2a and phase 2b 5
what are the objectives of phase 2 studies 2
Use of Placebo in clinical trials 2
principles of trial subject sampling 2
2.3 Methods of post
marketing
surveillance
Discuss about the different methods of post marketing
surveillance
10
write a note on case control studies 5
difference between retrospective and prospective study 5
observational studies 5
write a note on meta analysis 5
note on cohort studies 2
differentiate ADR and ADE 2
retrospective study 2
cross sectional study 2
Epidemiological study 2
Define false positive result with an example 2
2.4 Abbreviated New
Drug Application
submission
explain briefly about ANDA submission 10
Explain in detail NDA submission 10
write a note on ANDA 5
basic methodology and study designs of BA/BE studies 5
limitations of post marketing surveillance 2
2.5 Good Clinical
Practice ? ICH,
GCP, Central drug
standard control
organization
(CDSCO)
guidelines
discuss the principles of ICH-GCP guidelines 10
explain clinical trial protocol as per ICH-GCP guidelines 10
Explain Clinical trials and monitoring. Discuss different types of
monitoring visits in detail
10
What do you mean by expedited reporting in clinical trial?
Discuss the safety reporting as per schedule Y
10
discuss the recent amendments in schedule Y with special
reference to ethics committee
10
what the note on ICH-GCP guidelines 5
essential documents in conducting clinical trials 5
Discuss in detail about CDSCO guidelines 5
Role of ICMR in clinical research 2
list the guidelines and acts that govern the conduct of clinical
trials in India
2
selection and withdrawal of subjects in clinical trail 2
multicentre trails 2
Write a short note on new amendments to Schedule Y. 5
what are medical devices and classify with suitable examples 5
preparative termination of clinical trail 2
statistical design in clinical trails 5
unblinding 2
drug master file 2
subject identification code 2
write a note on Clinical Study Reports 5
Note on CIOMS 2
Premature Termination or Suspension of a Study 5
ICH E6 2
contract research 2
clinical trial registries 2
clinical trial insurance 2
comparative studies 2
coding of investigation products 2
importance of confidentiality statement in IB 2
Phases of Vaccine Trials 2
Non-Therapeutic Study 2
Validation of clinical study 2
Selection and recruitment of Study Subjects 5
Clinical Trials with Surgical Procedures / Medical devices. 5
2.6 Challenges in the
implementation of
guidelines
comment on the challenges in the implementation of ethical
guidelines
5
2.7 Ethical guidelines
in Clinical
Research
write a note on clinical data management in clinical trials 10
research involving children 2
Inclusion of pregnant women and nursing mothers in CT? 2
vulnerable subject 2
define Ethics 2
Ethical issues involved in Genetic Screening 2
explain clinical trials for vaccines 5
pregnant women as research participant 5
Explain the ethical guidelines for clinical research 5
write a note on compensation for clinical Trial subjects as per
ethical guidelines
5
Conflict of interest in clinical trials 5
2.8 Composition,
responsibilities,
procedures of IRB
/ IEC
members of ICH 2
explain composition and responsibilities of IRB 5
Discuss in detail about institutional review board 5
2.9 Overview of
regulatory
environment in
USA, Europe and
India
write on European Clinical Directive 2
function of dcgi 2
Note on 21CFR Part 312 2
Note on Marketing Authorization Holder (MAH) 2
note on centralized marketing and decentralized marketing 2
Note on Clinical Trial Document (CTD 2
MHRA 2
EMEA 2
USFDA 2
what are different regulator system in USA, europe and India 5
give an overview of regulatory environment in India 5
expand forms of the following MHRA, CRO, CRF, MAH, EMEA,
CTA, GLP, CFR
5
write a note on regulations for OFF-Label Use 5
Write a note on pharmaceutical regulations in regard to
clinical trials in European union
10
Write a note on Centralized procedure and Decentralized
Mutual Recognition Procedure in European union
10
write a note on Accelerated Approval 5
write a note on Accelerated Approval, Fast Track, and Priority
Review
10
write a note on Fast Track, and Priority Review 5
2.10 Role and
responsibilities of
clinical trial
personnel as per
ICH GCP
a. Sponsor
b. Investigators c.
Clinical research
associate
d. Auditors
e. Contract
research
coordinators
f. Regulatory
authority
write a note on CRA 5
Explain in detail the role and responsibilities of a)investigator
b) clinical research associate c) Regulatory authority as per
ICH-GCP
10
explain about clinical trials audit and inspection with special
emphasis on national regulatory authorities
10
Expand the following: IND, DCGI, PvPI, BPO 2
role of CRC 2
Role of auditor In clinical data 2
What is an Investigators brochure and explain its content? 5
role and responsibilities of auditors 5
explain the role of investigators I clinical trials 5
criterias for selection of an investigator/s 2
Role and responsibilities of sponsor in clinical trials 5
2.11 Designing of
clinical study
documents
(protocol, CRF,
ICF, PIC with
assignment)
Explain in detail the process of designing study protocol in
clinical trials. Add a note on importance of CRF
10
explain designing of CRF with a suitable example 5
define protocol 2
2.12 Informed consent
Process
Discuss about designing of inform consent form for clinical
study?
5
explain confidentiality and impartial witness 2
Explain in detail the informed consent process 5
difference between consent and assent forms 2
explain Waiver of consent 2
2.13 Data management
and its
components
write a note on QA and QC 5
Discuss data management and its component 5
write the application of computers in clinical data
management
5
write a note on clinical data archive 5
What is ANOVA? 2
Role of DSMB in safety monitoring 2
Components of documentation form 2
Discuss Electronic Data Processing 5
2.14 Safety monitoring
in clinical trials
Explain the monitoring visits in initiation, conduction and
closing of clinical trial
10
List global ADR reporting Forms? 2
Define unexpected ADR 2
Minimum criteria to report ADR 2
List various criterias to classify a serious ADR 2
write about safety monitoring in clinical trails 5
Explain the purpose of the clinical trial monitoring and the
responsibilities of monitors in clinical monitoring
5
PVPI 2
PSUR 2
SUSAR 2
write a note on Active Surveillance in ADR reporting 5
Role of Eudravigilance in safety monitoring 5
Role of Uppsala monitoring centre (UMC) in safety Monitoring 2
Explain spontaneous reporting of ADR with suitable examples.
What are the merits and demerits of spontaneous reporting
10
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This post was last modified on 02 March 2020