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With the increasing need for oversight of studies taking place across the globe, effective TMF management through an eTMF is just the tip of the iceberg for enhancing your organizations’ collaboration strategies. By utilizing an eTMF in conjunction with a CTMS, the opportunity to improve management of information is afforded.
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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?