1. EDC Project Success [http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Project+Management/EDC-Project-Success/ArticleStandard/Article/detail/591995]
2. Putting a Face on EDC [http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Online+Extras/Putting-a-Face-on-EDC/ArticleStandard/Article/detail/588116?ref=25]
3. Switching Vendors Midstudy [http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2fSponsor/Switching-Vendors-Midstudy/ArticleStandard/Article/detail/579334]
(PHOTOGRAPHY: GETTY IMAGES ILLUSTRATION: PAUL A. BELCI)
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Once considered a rarity, the "rescue" or transition study is becoming more commonplace in today's fast-paced world of clinical
trials. For a variety of reasons, more and more sponsors are finding the need to switch vendors midstudy. Examples include
vendor inability to meet sponsor requirements, issues with the data capture system, and vendor collapse or acquisition.
While the transition process is relatively straightforward for a paper-based trial, this is not the case for an Electronic
Data Capture (EDC) trial. This is true even more so if the legacy and new EDC platforms are different. Detailed up-front planning
and collaboration are required for a successful transition. The transition itself is often the most challenging aspect of
the study. The main goal of the transition is to minimize the impact of change upon the clinical sites by making the process as seamless
as possible. It is critical to minimize the amount of downtime during the transition in order to maintain study momentum and
site motivation. Another goal is to make sure that the new system contains all the relevant data and is adequately equipped
with elements for success. Ideally there should be no interruption of protocol activities at the investigative sites during
the transition.
Planning & documentation
To accomplish this goal, a three-phased approach to the transition should be used (see Figure 1). The first phase involves
obtaining all documentation necessary to build the study in the new platform as well as initiating the build and testing processes.
Required documentation should include, at a minimum, the functional specifications, database schema, electronic Case Report
Form (eCRF) screen shots, eCRF completion guidelines, and edit check specifications (see Table 1).
Required Documentation
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The legacy system should be left active during this phase. Only at the point where the new system is ready to be populated
should the legacy system have site access restricted.
The second phase of the transition is the most critical in terms of interruption of site activities. A firm deadline for data
entry and clean-up activities should be established with the sites. The sites should be strongly encouraged to have their
data as up to date as possible at the time that site access to the system is restricted. In particular, the sites should make
every effort to resolve any open queries. Any open queries that are not resolved at the time of legacy system restriction
will refire in the new system.
Transition Plan Essentials
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The third and final phase of the transition is the migration of the investigative sites and, if necessary, the study monitors
to the new system. Adequate training must be ensured for all parties using the new system.
Transitioning to a New Vendor in Three Phases
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Prior to the initiation of any of these phases, an EDC Study Transition Plan should be prepared and distributed to all stakeholders
for review and adoption. [A list of the key elements of an EDC Study Transition Plan can be found in Table 2.] Upon approval
of the EDC Study Transition Plan, a meeting should be scheduled for all stakeholders to review the plan and agree on the tasks
and responsibilities required for the transition to be successful.
A review of the essential documents should be performed prior to the meeting and any issues arising from the review should
be discussed at the meeting. If the legacy vendor is still in existence and cooperative, they should be included as a part
of the transition team. Any additional vendors (IVR, Lab, ePRO) should also be included in the team.
