This document discusses clinical trial management systems. It describes key application areas such as protocol development, data collection and analysis, safety reporting, and regulatory submission. It outlines stakeholders in the clinical trial process like sponsors, investigators, and sites. It also explains how clinical trial systems support management of studies, sites, data, adverse events, and integration with external systems. Clinical trial systems help standardize, automate and manage the complex clinical trial process.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
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.
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.
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
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Regulatory Requirements For New Drug Approval.
This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester.
It include rule and regulations related to new drug approval for clinical use.
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.
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.
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
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Regulatory Requirements For New Drug Approval.
This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester.
It include rule and regulations related to new drug approval for clinical use.
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
An brief introduction to the clinical data management process is described in this slides. These slides provides you the information regarding the data evaluation in the clinical trials , edit checks and data review finally data locking,then the data is submitted to the concerned regulatory body.
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2. Clinical Trial Systems – Key Application Areas
Protocol Development
Investigator/Site Selection and Trial Preparation
Subject Identification and Enrollment
Collection, Monitoring and Processing of Data
Data Analysis and Reporting
Safety and Adverse Event Reporting - Pharmacovigilance
Submission for Review by Regulatory Authorities
2
3. Clinical Trial Systems – Stakeholders
Protocol Development –
Principal Investigator
Trial Sponsor
Investigator/Site Selection and Trial Preparation
Sites
Trial Sponsor
IRB
Subject Identification and Enrollment
Sites
Collection, Monitoring and Processing of Data
Trial Sponsor
Sites
3
4. Clinical Trial Systems – Stakeholders – Cont…
Trial Management
Trial Sponsor, Sites
Data Analysis and Reporting
Trial Sponsor
Submission for Review by Regulatory Authorities
Trial Sponsor to agency
4
5. Clinical Trial Systems – Technology Usage
• Protocol Development –
– Word Processing software such as Word, Adobe
– Document Management Solutions such as Documentum for organizing
and standardizing the process of protocol development
– Protocol Authoring / Modeling tools
– Simulation software
• Investigator/Site Selection and Trial Preparation
– Excel Sheets
– In House Tracking systems to track receipt/ approvals of documents
– Internet based software systems
5
6. Clinical Trial Systems – Technology Usage – Cont…
• Subject Identification and Enrollment
– Media Advertisements
– Databases from local hospitals -
– Call centers
– Publicly available subject data from organizations such as Center Watch
• Collection, Monitoring and Processing of Data
– Clinical Data Management Systems (Paper based)
– Electronic Data Capture
• First Generation EDC tools
– OCR and OMR (Post Marketing Trials)
– Remote Data Entry
– IVRS (Interactive Voice Response Systems)
6
7. Clinical Trial Systems – Technology Usage – Cont…
• Second Generation EDC tools
– Integrated functionalities with much more clinical trial process
functionalities
– Extensive usage of internet
– Hybrid systems with 2 modes of operations, online and offline
– Enhanced IVRS
– ePRO systems
7
8. Integrated CTMS
Regulatory Compliant
Study Site Staff
Management Management Management
Offline and Online Capability
Subject Contracts Data
Management Management Management
Secure
Document Patient Diary
Medical Coding
Management Integration
Adverse Supplies
Monitoring
Event Reporting Management
LAB Data External Interfaces Randomization
Data Standards
compatible
8
10. Clinical Trial Systems – Study Management
A Program represents the top level in the
grouping hierarchy of studies. Program_DrugA
(Drug under Investigation)
Typically a Program is matched to a drug
under investigation.
Project maps to an indication or a
formulation of the drug. Project1 Project2 Project3
Project is a collection of multiple studies.
Assign multiple compounds to a program.
Create a Program and the Projects Study1 Study2
associated with a Program
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11. Clinical Trial Systems – Study Management – Cont…
Organizational Unit defines the sponsors of a study
Sponsor A
Sponsor B
Geographical Regions can be added to a study and one of
them can be made as the Master geographical region
United States (Master)
India
SriLanka
Historical events may be one of two kinds: event recording
triggered by the system, or a user-defined event
Creation of this study
Creation of a study version
Setting or changing the randomization access codes for a study
Setting or changing the study status
11
12. Clinical Trial Systems – Study Management – Cont…
Set start and end dates for studies
Set Study Objectives – A study can have more than one objective
Set Enrollment Criteria – The list of criteria for including /
excluding a subject in a trial
Set Termination Criteria – The reasons for terminating a subject
from a study
Set Study Comment – Comments about the study
Manage study design – One of the several clinical trial designs
available to conduct a clinical trial
12
13. Clinical Trial Systems – Site/Investigator Management
• Create Sites
• Assign a site to a study
• Assign an investigator to a study site
• Link Patient positions to the site
• Maintain Investigator data
• Assign Treatments to a site
• Creating Strata and Randomization criteria
• Creating, Reviewing or Canceling blind breaks
13
14. Clinical Trial Systems – Treatments/ Events and
Randomization
Active Substances- Active substances are the New
chemical entities which are being investigated
Active Drug- The drug currently under investigation
Treatment Regimen (A systematic Plan)
defining the details about a drug’s dosing a single regimen is created
combinations of single regimens is a Combination Regimen
14
15. Clinical Trial Systems – Treatments/ Events and
Randomization
Timelines, Periods, Sub periods and Phases
Strata and Randomization
strata means groupings of patients that have common characteristics;
they are representations of particular expressions of factors.
Randomization is the process of hiding patients’ treatments by
assigning treatment patterns to patient positions in an unpredictable
order
Patient positions represent potential study participants
Each factor describes a single characteristic, such as sex or age.
15
22. Clinical Trial Systems – Patient Diary
• Get Quality of Life Questionnaires filled by patients.
• Scheduled and Unscheduled entries - Send reminders to subjects,
administer questionnaires, alert them for any invalid entries.
• Patient Compliance Tracking – Enables to track patient compliance by
using date time stamps, edit checks and automatic scheduled
reminders.
• Data can be secured and provide instant access to Investigators and
Sponsors on a 24/7 basis.
22
23. Clinical Trial Systems – External data
Import / Export data between clinical trial systems, AERS
systems, Financial and ERP systems
Can be CDISC or non CDISC based data transfer
Operational Data can be typically split into Admin, Study,
Subject, Audit trail sections
LAB data can be transferred between LIMS and CTMS
Adverse Event integration would happen with systems like
Oracle Clinical
Contracts and other financial data can be transferred from
financial and ERP systems
Inventory related information such as Supplies can be
integrated with manufacturing controls
23
24. Clinical Trial Systems – External data – Cont…
• Randomization details could be integrated from IVRS based systems
• Contract details could also be retrieved from Document Management systems such
as Documentum, ERP systems or Financial systems
• Document management systems like Documentum and Adobe can be integrated
with CTMS easily.
24