The document provides guidelines for writing clinical trial protocols in India. It discusses that clinical trials prospectively assign human participants to health interventions to evaluate outcomes. A good protocol includes the study rationale, objectives, design, safety measures, and plans for statistical analysis and protecting human subjects. The protocol sections provide all relevant details about conducting the trial while meeting regulatory and ethical standards.
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
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.
A clinical trial protocol is a comprehensive document that outlines the objectives, design, methodology, procedures, and statistical considerations of a clinical research study. It serves as a detailed blueprint for conducting the trial and provides guidance to the investigators, study staff, ethics committees, and regulatory authorities involved in the study. Here are the key components typically included in a clinical trial protocol
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
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
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.
A clinical trial protocol is a comprehensive document that outlines the objectives, design, methodology, procedures, and statistical considerations of a clinical research study. It serves as a detailed blueprint for conducting the trial and provides guidance to the investigators, study staff, ethics committees, and regulatory authorities involved in the study. Here are the key components typically included in a clinical trial protocol
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
Definition. A clinical research protocol is a document that describes the background, rationale, objectives, design, enrollment criteria, methodology, data recording requirements, statistical considerations, and organization of a clinical research study.
Here's a list of steps on how to write a research protocol:
Write a project summary. ...
Create a section for basic information. ...
Offer the rationale for your research study. ...
State the study's goals and objectives. ...
Detail the study design. ...
Define the methodology. ...
List safety considerations. ...
Create steps for the follow-up process.
Role of protocol in clinical research.
The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analyzed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
Point Value Descriptive TitlePurpose and Analytical .docxLeilaniPoolsy
Point Value Descriptive Title
Purpose and
Analytical
Technique(s)
Summary of Results
Summary of
Conclusions
Error Analysis
Professional
Presentation
2
Title is complete and
informative, and written
in a scientific tone
A general purpose and
all relevant analytical
techniques are given
using the correct
scientific terminology
All major numerical
results are given with
correct units and
significant figures - All
important descriptive
results are given with
appropriate context
Conclusions are made
based on the results, any
accepted values are
given for comparison,
and percent error values
are provided
Errors are given,
followed through the
calculations, and the
effect on the result is
explained - Errors are
used to explain
deviations from the
expected results
Abstract is typed, proof
read, and printed on an
appropriate medium
1
Title is informative and
appropriate, yet is
somewhat incomplete,
contains errors, or is
written in an unscientific
tone
Purpose or techniques
are partially incomplete
or use layman's terms
Result section is mostly
complete, but some
relevant results are
omitted, or incorrect
units or significant
figures are used
Conclusion section is
mostly complete, but
some relevant
conclusions are omitted
Errors are given, but not
followed through the
calculations, or not used
to explain results
Abstract contains several
errors, or has
handwritten edits
0
Title is absent, or neither
informative nor
appropriate
Section is absent or not
relevant to the
experiment
Section is absent, less
than half complete, or
not relevant to the
experiment
Section is absent, less
than half complete, or
not relevant to the
experiment
Section is absent or not
relevant to the
experiment
Abstract is handwritten,
contains numerous
errors, or otherwise
unacceptably presented
Rubric for a Scientific Abstract
In general, abstracts will be graded on the six criteria below (column headings), worth two points each.
The resulting points out of 12 will be converted to a gradebook score out of five.
Score = (
5
/12 ) × Points
Some rules for it:
1. Font size 12, times new roman style.
2. 600 words
About Abstracts:
An abstract is a brief, written summary of the specific idea or concepts to be presented, and a statement of their relevance to practice or research.
This is one type to write abstracts:
Research abstracts: include a brief description of the author’s original objective or hypothesis research methodology, including design, participant characteristics and procedures, major findings, and conclusions or implications for dietetics.
All words should write by yourself, no quote from any website or paper.
Please check abstract grading rubric for get higher grade. Thanks.
PRACTICE APPLICATIONS
Business of Dietetics
Hospital-Acquired Conditions: Knowing, Preventing,
and Treating .
The purpose of this presentation is to describe step by step the transition of a SAS Programmer into a Clinical Statistical Programmer. It can be used as guidelines for SAS Programmers who wants to put their programming and technical expertise into industries.
A SAS Programmer is someone who uses SAS software for different scenarios. The person who uses it for different purposes is known as a SAS Programmer.
On the other hand, a Clinical Statistical Programmer performs all the procedures to generate future outputs and makes advanced and real-world developments to face further challenges. A primary role of Clinical Statistical Programmers is to use their technical and programming skills in order to enable clinical trial statisticians to perform their statistical analysis duties more efficiently.
This presentation will briefly discuss about the smooth transition that a SAS Programmer needs to go through in order to become a Clinical Statistical Programmer.
SDTM Training for personnel with Junior and Intermediate level Clinical Trial Experience. Covers summary of most domains. Salient features include order of domain creation, importance of making programming Data/Metadata Driven, Nature of Clinical Raw Data, Summary of the Clinical Trial process with regards to the data flow to arrive at the Study data to be submitted to regulatory authorities like FDA, Importance of deriving ADAM from SDTM and not directly from raw data, Information has been put together from variety of sources including my own programming work.
Systematic review of quality standards for medical devices and practice measu...Pubrica
A systematic literature search performed in databases (Medline, Cochrane Library, Scopus, Embase, CRD York), selected journals and websites identified articles describing either a general MDR structure or the development process of specific registries.
Learn More : https://pubrica.com/services/research-services/systematic-review/
Reference: https://bit.ly/3MCXLOK
Why Pubrica:
When you order our services, we promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Bio statistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
Systematic review of quality standards for medical devices and practice measu...Pubrica
A systematic literature search performed in databases (Medline, Cochrane Library, Scopus, Embase, CRD York), selected journals and websites identified articles describing either a general MDR structure or the development process of specific registries.
Learn More : https://pubrica.com/services/research-services/systematic-review/
Reference: https://bit.ly/3MCXLOK
Why Pubrica:
When you order our services, we promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Bio statistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
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2. As per ICMR, A clinical trail is any research/study that
prospectively assigns human participants or groups of
humans to one or more health-related interventions to
evaluate the effects in health outcomes.
The intervention could be drugs, vaccines, biologics,
phytopharmaceuticals, radiopharmaceuticals, diagnostic
agents, medical devices, surgical techniques etc…..
Clinical trails are usually well controlled studies.
At present, Due to huge patient load, wide variety of
diseases, low operational cost, sufficient infrastructure
India is a hub for clinical trails.
3. DRUGS AND COSMETICS ACT (schedule Y):
Requirements and guidelines for permission
to import and / manufacture of new drugs for sale or to
undertake clinical trails.
ICH GUIDELINES-E6(R2):
Good clinical practice addendum to ICH,
clinical trail protocol and protocol amendments.
INDIAN COUNCIL OF MEDICAL RESEARCH:
National ethical guidelines for biomedical
and health research involving human participants,
these deals with the ethical consideration.
4. It is housed at the National Institute of
Medical Statistics, ICMR, New Delhi
Trail registration is purely online, paperless
process and free of charge
The CTRI software application was modified
and implemented on 15 march 2011
It makes the information available to both
public and health care professionals
To increase awareness and accountability of
all the participants of the clinical trails and
also for public access
5.
6. To clarify the research question.
To compile existing knowledge.
To formulate a hypothesis and objectives.
To clarify ethical considerations.
To decide about a study design.
To apply for funding.
To have a guideline and tool for the research
team.
7. It is acomplete written description and scientific
rationale for a research activity involving human
subjects.
a)Objectives.
b)Design.
c)Methodolgy.
The PI must know the answers for;
# Is it reasonable? Do we have the resources?
# What are the significant risks?
# Do e have the patient population?
Should be able to write whole CT in few lines.
8. The written protocol language / content should be
understood by:
Other physicians
Nurses
CRAs (Clinical Research Associates)
Scientific reviewers
Board members
Press and Journals
IC (Informed Consent) for a lay person
9. 1. Title page.
2. Signature page.
3. Content page.
4. List of abbrevations.
5. Introduction/Abstract.
6. Objectives.
7. Background/Rationale.
8. Eligibilty Criteria.
9. Study design/Methods.
10. Safety/Adverse events.
11. Regulatory Guidence.
12. Statistical section.
13. Human subjects protection.
10. Title page intoduce the document, its title, precise, number,
sponsor and author to the reader.
Protocol identifying number and date.
Full title page should include summary, study design,
medicinal products, nature of treatment, patient population
setting indication (in-patient, out-patient), randomised
double multiple studies.
Name and address of sponsor and monitor. Sponsor names
and list of responsibilities ith agreed allocations.
Name and address of the person authorised to sign the
protocol. Generally, chief investigator for multicentric trial
or principle investigator for single centre trails.
Name and address of the clinical laboratory and other
institutions involved in the trail.
11. Signature page should include signatures of all health
care professionals and others, who participated in the
clinical trial.
Signature page should also include contact details of
participating site, sponsor and sponsor medical advisor.
signature of sponsor responsible persons not named on
the cover page.
12. This help navigation through the document by large
number of different people that will be needed
throughout the life of the trial.
In contet page, Table of in-text tables, Table of in-text
figures should be separetly written.
Table of in-text tables contains schedule of assessments,
instruction of trail periods,sampling collection schedule,
heamotology assessments, bilogical assessments,
estimated blood sample volumes per subject.
Table of in-text figures contains schematic chart of trial
design.
13. All abbrevations should be listed and defined.
Accepted international medical abbrevations should be
standardised within each project.
EXAMPLES:
1. DBP (Diastolic Blood Pressure)
2. CRU (clinical Research Unit)
3. ICF (Informed Consent Form)
4. SBP (Systolic Blood Pressure)
5. MDRD (Modification of Diet in Renal Disease)
6. SEM (Standard Error of the Mean)
14. This summary should be only one to two pages long.
It should give the reader sufficient information to
understand the rationale for the trial, its objective and the
methods that will be used to achieve these objective.
Introduction/Abstarct shoul be;
1. PRECISE (strictly conforming to a pattern, standard)
2. CONCISE (giving a lot of information clearly and in a
few words)
3. SPECIFIC (descriptive should be noted round the
point)
15. Objective should be stated clearly as hypothesis to be
tested.
Each objective should have a corresponding discussion in
the statistical section.
A) PRIMARY OBJECTIVES:
The primary research objective should be an abridged
(shortened) form of the problem statement.
B) SECONDARY OBJECTIVES:
The secondary objectives should try to establish a
relationship beteen the different variables of a research
topic and suggest possible recommendations for dealing
with the main research problems.
16. All protocols require a section detailing the scientific
rationale for a protocol and the justification in medical
and scientific literature for the hypothesis being
proposed.
Introductory section should be organized in a logical,
sequential flow.
Double check all citations.
common mistakes:
Name misspellings (including rong initials)
Wrong journal names
Wrong years of publication
Wrong volume numbers
17. Inclusion and Exclusion criteria are the conditions that
must be met in order to participate in a clinical trial.
A) INCLUSION CRITERIA:
Inclusion criteria contain only those items that
define the target population desired for study, within the
limits of known safety coverage, should generally allow
inclusion of the broadest representation of the population for
intended use, but usually not beyond.
B) EXCLUSION CRITERIA:
Exclusion criteria are defined as features of the
potential study participants who meet the inclusion criteria
but present with additional characteristics that could interfere
with the success of the study or increase their risk for an
unfavorable outcome.
18. Eligibilty criteria are the largest barrier to clinical trails.
There is no guideline for writing these criteria.
Poorly written or poorly conceived criteria may affect the
scientific validity of CT.
THE POINTS TO BE CONSIDERED TO WRITE A GOOD
ELIGIBILITY CRITERIA:
The number of eligibilty criteria should be kept to a
minimum.
Criteria should include only those absolutely necessary to
ensure scientific validity and patient safety.
Eligibilty criteria should be clearly defined and verifiable
by an external auditor.
Eligibility criteria should be straightforward and
unambigous (precise).
19. The study design section of the protocol should contain
a stepwise description of all procedures required by the
study.
A good study design section includes sufficient
information foe the participating size.
Parts of the study design section may include:
Initial evaluations.
Screening tests.
Required lab tests.
Details of treatment.
Device specifications.
Dose scheduling and monitorng
20. Adverse effect and sid effect are terms commonly
associated ith drugs.
They are used by nurses and doctors, to refer to
undesirable effects of a medication on a patient.
The safety section or adverse events section should
include;
Detailed information for reportin adverse events,
including reporting to the FDA and the sponsor.
If applicable, Unblinding process (code-breaking).
Lists of expected adverse events.
21. The study objectives and study design elements in the
statisitical section should be described in the objectives
section.
The descriptions and defintions of toxicities in the
statistical section match this in the safety or adverse
event section.
Elements included in the statistical section;
Efficasy analyses.
Safety analyses.
Missing value handling and subject evaluability.
Statistical adjustments for multiple endpoints.
22. A protocol ithout the human-subject protections section
ill not be accpted for review by the IRB (Institutional
Review Board).
This sction includes discussion of:
Subject selection and exclusion.
Proposed methods of patient recruitment.
Recruitment or exclusion of spcila subjects, including
vulnerable subjects.
Lists of potential risks and benefits, including
justification for risks.
23. Informed consent process ensures the individuals
autonomy, to voluntarily participate in a trail.
The protocol’s informed consent must provide;
Statement that the study involves research.
Purpose of the research and the length of the study.
Description of risks and benefits.
Discussion of alternative therapies.
Confidentiality policy.
Compensation for injury.
Contact for further questions and information.
statement of voluntary participation.