Advance Information Management through etmf and CTMS Convergence. Troy Deck Wingspan Technology

Transcription

1 Advance Information Management through etmf and CTMS Convergence Troy Deck Wingspan Technology

2 Agenda Purpose of and Intersections between etmf and CTMS Benefits of Integration Challenges of Integration Integration Scenarios Success Factors

3 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

4 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

5 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/subinvestigators 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

6 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

7 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 nondocument requirements

8 Benefits of etmf/ctms Integration Decreased manual data entry increased accuracy Timely updates that are not dependent on 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

9 etmf CTMS Integration Challenges Literally dozens of CTMS vendors and 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

10 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

11 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

12 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

13 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

14 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

15 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

16 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

17 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

18 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

19 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?

20 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

21 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

22 QUESTIONS?