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
10
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