advance information management through etmf and ctms convergence
Post on 18-Nov-2014
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Advance Information
Management through eTMF
and CTMS Convergence
Troy Deck
Wingspan Technology
Agenda
• Purpose of and Intersections between
eTMF and CTMS
• Benefits of Integration
• Challenges of Integration
• Integration Scenarios
• Success Factors
Purpose of the Clinical Trial
Management System
• A CTMS manages the large amounts of data
involved with the operation of a clinical trial
– Maintains and manages the planning,
preparation, performance, and reporting of clinical
trials
– Emphasis on keeping up-to-date contact
information for participants and tracking deadlines
and milestones such as those for regulatory
approval or the issue of progress reports
Purpose of the electronic Trial
Master File (eTMF)
• Manages the documentation associated with a clinical trial to ensure that it is accurate, legible, contemporaneous, original, attributable, complete, consistent, and enduring
• Provides functionality to: – Upload and quality check trial documents
– Monitor the timelines and completeness of the TMF at any point in the trial
– Based on the receipt of all expected documents for a specific trial tied to milestones defined for that trial
Where do the CTMS and eTMF
intersect? (1 of 2) • To plan and monitor the TMF for a specific trial,
information is required about: – the countries in which the trial will be conducted
– the sites that will participate and the investigators/sub-investigators and subjects who will participate at each site
– the milestones defined for the trial and for each site specifically, the laboratories and other vendors that will support the study
– … and more
• The “source of truth” for this information is the CTMS – If it is independently created in the EDMS, errors will
inevitably result
Where do the CTMS and eTMF
intersect? (2 of 2)
• To make valid decisions about the study, such as when to ship the IP to each site or whether a site can be closed out, study managers need to understand if documents required by regulators and sponsor have been received and verified
– But the CTMS is not designed for document management
– It lacks the workflow and metadata tracking capacities needed to receive and verify documents efficiently and accurately
Where is the Authoritative Source?
eTMF
• Master list of TMF documents expected and received for a trial
• TMF document classification, content and metadata
• TMF document status
• Overall progress of documents needed for milestones
CTMS
• Trial data: study, sites,
milestones
• Overall tracking of
milestones including non-
document requirements
Benefits of eTMF/CTMS Integration
• Decreased manual data entry – increased accuracy
• Timely updates that are not dependent on email messages or other manual hand-offs
• Guaranteed impact to eTMF when conditions change (site added, PIs change, milestone dates change)
– That might otherwise result in missing documentation being detected at the end of the trial if ever
• Insight into decisions that require specific packets of documents
eTMF – CTMS Integration
Challenges
• Literally dozens of
CTMS vendors and 10 –
20 eTMF vendors in the
marketplace
• And they change
and upgrade all the
time
• Building a specific
integration between any
two has a very limited
audience
eTMF – CTMS Integration:
The Optimal Approach
• Integrations based on the architecture, design or functionality of a specific eTMF and CTMS are fragile and limiting
• Instead, look for an integration based on “loose coupling” of the systems
– Focused on exchanging data, not tightly integrating processes
– Designed to handle a superset of data, allowing any specific implementation to use a subset
– Runnable on demand or on a schedule
Scenario 1: Study Start Up
• CTMS has information about the study, Investigational Product, and initial countries, sites, milestones
– Which is pushed into/pulled into the eTMF
• This prepares the eTMF with the basic information needed to provision the study and sites
– Without manual data entry or duplicate work
But… the CTMS does not have all
the information in most cases
• The list of essential documentation is different for each trial. Just a few examples of conditions affecting TMF contents: – Is there an Independent Data Monitoring
Committee for the trial?
– Will there be subject recruitment materials such as posters or radio commercials?
– Will data be collected using paper CRFs, Electronic Data Capture, or both?
• Therefore, the CTMS cannot define the required contents of the specific TMF
CTMS and eTMF Working Together
• To make best use of both systems and the training and experience of their users:
– CTMS collects product, study, and site data and pushes into eTMF
– Study managers in eTMF use the information as a trigger to specify the specific documents needed in their TMFs, with those documents automatically attached to related milestones
– CTMS can then monitor progress against those milestones
Scenario 2: Mid-Trial Updates
• During the course of the trial, sites are added,
investigators change, milestones slip…
– Impact on documents in the TMF is significant
– New sites require whole new sets of documents,
monitored against their own milestones
– New PI requires new 1572, CV, protocol receipt…
– Updated milestones mean that the set of
documents considered overdue changes
CTMS and eTMF Working Together
• CTMS pushes updated information into
eTMF
• Placeholders automatically created
wherever possible (e.g., for new PI 1572)
• Notifications sent to study managers so
they can take actions that can’t be
automated, and are aware of new
milestone dates
Scenario 3: Milestone Status
• CTMS user needs to know whether IP
green-light has been achieved and drugs
can be released and shipped to a specific
site
• CTMS will track non-document
requirements but eTMF holds the
documents needed for the milestone
CTMS and eTMF Working Together
• Study manager has been monitoring status of the milestone documents in the eTMF and taking actions so the milestone can be achieved
• CTMS pulls information from TMF to understand completeness of document package
– Information is always up to date so IMP can be shipped as soon as all documentation is available
Sponsors and CROs
• Sponsors generally deal with a single
CTMS (or a few legacy systems)
– Making a more sophisticated integration
feasible
• CROs may have to accept CTMS data
from their sponsors instead of or in
addition to their own CTMS
– Making a simple, general approach even
more important
Success Factors: Risk vs. Reward
• Keep the integration as simple as reasonable
– Don’t attempt to trigger elaborate processes or handle fringe conditions in one system based on events in the other
• Always consider risk and validation impact
– Will changes in one system trigger the need to re-validate the other, or will a focus on the data that is exchanged largely de-couple the systems?
Success Factors: Alignment
• Only exchange data that is useful
– Otherwise you introduce complications and dependencies with no benefit
• Ensure that data is accurately mapped
– That is, has the same meaning in both systems
• Understand and agree upon the mapping of documents to milestones
– So that tracking data from the eTMF clearly expresses the completeness requirements of stakeholders using the CTMS
Success Factors: Focus
• Each system should be used for what it does best
• Think carefully before managing documents in the CTMS, even if it has that capability
– Consistency of QC processes
– Ability to support an audit
– Ability to determine completeness of documentation for a milestone or the overall TMF
• Avoid attempting to duplicate CTMS features in TMF as well
– For example, extending milestone tracking past documentation
QUESTIONS?
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