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.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
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.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
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 safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
Good Clinical Practice Guidelines (ICH GCP E6).pptMohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Clinical Research Regulations (MRA 103T)
Unit 4 - Clinical Research Related Guidelines: Good Clinical Practice Guidelines (ICH GCP E6)
THE PRINCIPLES OF ICH GCP
INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITEE
Principal Investigator
Sponsor
Investigator's Brochure
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug 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 safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
Good Clinical Practice Guidelines (ICH GCP E6).pptMohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Clinical Research Regulations (MRA 103T)
Unit 4 - Clinical Research Related Guidelines: Good Clinical Practice Guidelines (ICH GCP E6)
THE PRINCIPLES OF ICH GCP
INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITEE
Principal Investigator
Sponsor
Investigator's Brochure
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
IND Data Requirements and US FDA Submission Process.pdfProRelixInfo
A clinical trial is a culmination of the several stages of a drug or medical device development program that begins with the discovery of a candidate molecule followed by preclinical toxicology studies in ex vivo, in vitro, and animal models. Once the candidate molecule shows promising results in these stages, the next step involves clinical studies on human subjects. Drug testing in humans is often the most lengthy and expensive phase of the drug development timeline, and therefore requires extensive effort and careful execution to maximize the candidate’s chances of success. In addition to scientific evaluation, clinical studies require approval by the United States Food and Drug Administration (US FDA), the regulatory authority in the United States to administer the experimental drug in humans as well as ship it across state lines. This approval comes in the form of an Investigational New Drug (IND FDA) application that is required to be submitted by sponsors, investigators, or research institutes to the FDA to commence studies on human participants. The following figure shows the various stages of the drug development program (Figure 1) marking IND submission on the timeline.
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The Investigator's Brochure (IB) is a document that serves as a comprehensive reference manual for investigators who are conducting clinical trials. The IB typically contains information about the investigational product being studied, including its pharmacology, pharmacokinetics, safety and efficacy data, and other relevant information.
The IB is designed to provide investigators with all the information they need to understand the product being studied and its potential risks and benefits. It also provides guidance on how to conduct the clinical trial, including the study design, dosing and administration, monitoring and assessment of safety and efficacy, and other important aspects of the trial.
A clinical trial is a culmination of the several stages of a drug or medical
device development program that begins with the discovery of a
candidate molecule followed by preclinical toxicology studies in ex vivo, in
vitro, and animal models. Once the candidate molecule shows promising
results in these stages, the next step involves clinical studies on human
subjects. Drug testing in humans is often the most lengthy and expensive
phase of the drug development timeline, and therefore requires extensive
effort and careful execution to maximize the candidate’s chances of
success. In addition to scientific evaluation, clinical studies require
approval by the United States Food and Drug Administration (US FDA),
the regulatory authority in the United States to administer the
experimental drug in humans as well as ship it across state lines. This
approval comes in the form of an Investigational New Drug (IND FDA)
application that is required to be submitted by sponsors, investigators, or
research institutes to the FDA to commence studies on human
participants. The following figure shows the various stages of the drug
development program (Figure 1) marking IND submission on the timeline.
The US Food and Drug Administration (FDA) has established a comprehensive drug
development strategy for US FDA. This strategy is designed to ensure that the drugs
being developed meet the highest standards of safety and efficacy.The IND is a comprehensive document that contains all the information
gained from preclinical and other studies in an organized format. The
FDA reviews and makes the decision to support further clinical studies
from information in the IND that ultimately forms the basis of marketing
approval. INDs can be submitted at any phase during clinical
development to protect the safety and rights of subjects (Phase I) and to
assure adequate scientific evaluation of the drug’s effectiveness and
safety (Phase II and III). The Code of Federal Regulations CFR Title 21.
Part 312 Investigational New Drug Application contains information on
INDs as well as their content and format and should be reviewed
thoroughly by sponsors or investigators prior to submission of an IND
application.
The IND data requirements are important for the development of new drugs and
medical devices. They provide detailed information about the safety and efficacy of a
drug or device before it can be approved for use by the public
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Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
The investigator’s brochure (IB) is a compilation of the clinical and non clinical data on the investigational products(s) that are relevant to the study of the products in human subjects .
Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and many key features of the protocol, such as the dose , dose frequency/interval , methods of administration : and safety monitoring procedures .
Multi-cluster Kubernetes Networking- Patterns, Projects and GuidelinesSanjeev Rampal
Talk presented at Kubernetes Community Day, New York, May 2024.
Technical summary of Multi-Cluster Kubernetes Networking architectures with focus on 4 key topics.
1) Key patterns for Multi-cluster architectures
2) Architectural comparison of several OSS/ CNCF projects to address these patterns
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This 7-second Brain Wave Ritual Attracts Money To You.!nirahealhty
Discover the power of a simple 7-second brain wave ritual that can attract wealth and abundance into your life. By tapping into specific brain frequencies, this technique helps you manifest financial success effortlessly. Ready to transform your financial future? Try this powerful ritual and start attracting money today!
ER(Entity Relationship) Diagram for online shopping - TAEHimani415946
https://bit.ly/3KACoyV
The ER diagram for the project is the foundation for the building of the database of the project. The properties, datatypes, and attributes are defined by the ER diagram.
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Wireless communication involves the transmission of information over a distance without the help of wires, cables or any other forms of electrical conductors.
Wireless communication is a broad term that incorporates all procedures and forms of connecting and communicating between two or more devices using a wireless signal through wireless communication technologies and devices.
Features of Wireless Communication
The evolution of wireless technology has brought many advancements with its effective features.
The transmitted distance can be anywhere between a few meters (for example, a television's remote control) and thousands of kilometers (for example, radio communication).
Wireless communication can be used for cellular telephony, wireless access to the internet, wireless home networking, and so on.
1.Wireless Communication System_Wireless communication is a broad term that i...
Investigator's Brochure (IB).pptx
1. Investigator's Brochure
(IB)
PRESENTED BY ,
MR. RUPESH R. KURHADE,
ROLL NO. 609
PURSUING M. PHARMACY (PHARMACEUTICS),
GOVT. COLLEGE OF PHARMACY, AURANGABAD.
GUIDED BY MRS. PREETI SABLE.
2. Introduction
The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical
data on the investigational product(s) that are relevant to the study of the
product(s) in human subjects.
IB is a comprehensive document summarizing the information about the
investigational product obtained during a clinical trial.
The information should be presented in short, simple, objective, and non-
promotional form that enables a clinical or potential investigator to understand it.
IB is prepared by sponsor and having up to date information about IMP.
3. Purpose of IB
To provide the information to investigators and others involved in the trial such as
the dose, dose frequency/interval, methods of administration and safety
monitoring procedures.
The IB also provides insight to support the study, subjects to clinical management
during the course of the clinical trial.
For assessment of appropriate proposed clinical trial a medically qualified person
should be participate in editing of IB.
4. General consideration
The IB should include
1) Title Page: This should provide the
Sponsor's name:
Product:
Research Number:
Name(s): Chemical, Generic (if approved) &Trade Name(s).
Edition Number:
Release Date:
Replaces Previous Edition Number:
Date:
5. 2) Confidentiality Statement:
The sponsor may wish to include a statement instructing the investigator/recipients to treat the IB
as a confidential document for the sole information and use of the investigator's team and the
IRB/IEC.
Contents of the Investigator's Brochure:
The IB should contain the following sections-
Confidentiality Statement (optional)
Signature Page (optional)
Table of Contents:
Summary:
A brief summary (preferably not exceeding two pages) should be given, highlighting the
significant physical, chemical, pharmaceutical pharmacological. toxicological. pharmacokinetic
metabolic, and clinical information.
6. Introduction:
Contains the chemical name (generic and trade name when approved), all APIs, pharmacological
class, the rationale for performing research of the investigational products, and the anticipated
prophylactic, therapeutic, or diagnostic indication(s).
Physical, Chemical, and Pharmaceutical Properties andFormulation:
A description including the chemical and structural formula, relevant physical, chemical, and
pharmaceutical properties. description of the formulations, including excipients, Instructions for the
storage and handling of the dosage form.
7. Nonclinical Studies:
The information provided may include the followingo Species tested.
Number and sex of animals in each group.
Unit dose (e.g., milligram/kilogram (mg/kg)).
Dose interval.
Route of administration.
Duration of dosing.Information on systemic distribution.
Duration of post-exposure follow-up.
8. Results, including the following aspects:-
Nature and frequency of pharmacological or toxic effects
Severity or intensity of pharmacological or toxic effects
Time to onset of effects
Reversibility of effects
Duration of effects
Dose response
(a) Nonclinical Pharmacology:
Efficacy models, receptor binding, and specificity other than the intended therapeutic effect.
9. (b) Pharmacokinetics and Product Metabolism in Animals:
Absorption and the local and systemic bioavailability of the investigational product and its
metabolites, and their relationship to the pharmacological and toxicological effect in animal
species.
(c) Toxicology:
Described under the following headings where appropriate
Single dose
Repeated dose
Carcinogenicity
Special studies (e.g. irritancy and sensitisation)
Reproductive toxicity
Genotoxicity (mutagenicity)
10. Effects in Humans:
(a) Pharmacokinetics and Product Metabolism in Humans:-
Pharmacokinetics (including metabolism, absorption, plasma protein binding, distribution, and
elimination).
Bioavailability.
Population subgroups (e.g., gender, age, and impaired organ function).
Interactions (e.g., product-product interactions and effects of food).
(b) Safety and Efficacy:
Safety, pharmacodynamics, efficacy, and dose response that were obtained from preceding trials in
humans.(healthy volunteers and/or patient)
11. Summary of Data and Guidance for the Investigator:-
provides an overall discussion of the nonclinical and clinical data.
the published reports on related products should be discussed. This could help the investigator to
anticipate adverse drug reactions or other problems in clinical trials.
References :
Publications
Reports
