CAPÍTULO VIII DE LAS VEDAS
DEL REGISTRO NACIONAL DE PESCA Y ACUACULTURA
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Are needed now
(are in use in the current system, and are considered “necessary” for continuingoperation of currently ongoing trials and studies)
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Are expected soon
(are expected “by the industry” to become available in technologically current andSome of the features of our home-grown system we considered to be critical for study operation:
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Performance
Peak traffic of 6-8 CRF/sec. with tens ofon-line edit checks and no appreciable degradation of response time
Some of the features of our home-grown system we considered to be critical for study operation:
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Performance
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Skip Patterns
CRF sections to be skipped based on arbitrary boolean expressionsdepending on previously answered items in the CRF
Some of the features of our home-grown system we considered to be critical for study operation:
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Performance
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Skip Patterns
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Customizable Roles
Ability of a study to define roles and populate them with a set of fine-grained permissions, so as to determine which modules/items may be accessed/viewed by personnel in those roles
Some of the features of our home-grown system we considered to be critical for study operation:
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Performance
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Skip Patterns
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Customizable Roles
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Randomization
A module that checks eligibility of potential study participants using screening CRF data, randomizeseligible subjects according to one of a number of randomization schemes, and possibly assigns a medication kit
Some of the features of our home-grown system we considered to be critical for study operation:
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Performance
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Skip Patterns
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Customizable Roles
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Randomization
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Visibility/Accessibility
The ability of a study to
determine which roles and which sites may view specified CRFs and/or reports and which criteria determine if a CRF is currently accessible for data entry
(depending on previously entered data)
Some of the features of our home-grown system we considered to be critical for study operation:
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Performance
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Skip Patterns
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Customizable Roles
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Randomization
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Visibility/Accessibility
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Integrated Reporting
The ability of a study to define both summary and individual participant reports and integrate these into the structure of roles, visibility and accessibility
Some of the features of our home-grown system we considered to be critical for study operation:
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Performance
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Skip Patterns
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Customizable Roles
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Randomization
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Visibility/Accessibility
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Integrated Reporting
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Certification
An integrated process of testing clinic personnel in data entry speed and accuracy by
providing a testing environment and an automated grading
Some of the features of our home-grown system we considered to be critical for study operation:
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Performance
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Skip Patterns
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Customizable Roles
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Randomization
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Visibility/Accessibility
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Integrated Reporting
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Certification
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Discrepancy Management
A reasonable and usable method of identifying and managing missing data and data discrepancies. One that automates much of the process involved – needed when tens of thousands of such edit checks are
Some features that our homegrown system did not have yet, but should either be developed or be available in any new system acquired:
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Mobile/Paperless
The ability to perform full-service data acquisition on mobile devices and move toward a paperlessSome features that our homegrown system did not have yet, but should either be developed or be available in any new system acquired:
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Mobile/Paperless
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Events/Visits
A structure permitting CRFs to begrouped corresponding to visit types or other expected or unscheduled events
Some features that our homegrown system did not have yet, but should either be developed or be available in any new system acquired:
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Mobile/Paperless
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Events/Visits
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Visit Scheduling
A means of maintaining and planning scheduled visits by participant inSome features that our homegrown system did not have yet, but should either be developed or be available in any new system acquired:
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Mobile/Paperless
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Events/Visits
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Visit Scheduling
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Medical Management
A system of monitoring
participants’ longitudinal data and reporting on potential medical
issues, co-morbidities, SAEs, and other adverse events; and an
online structure for maintaining a discussion between clinics and a medical monitoring committee for resolving such issues
Some features that our homegrown system did not have yet, but should either be developed or be available in any new system acquired:
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Mobile/Paperless
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Events/Visits
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Visit Scheduling
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Medical Management
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Adjudication
An online means for discussing and adjudicating end-point and other status issues of study participants, including availability of relevant participant reportsSome features that our homegrown system did not have yet, but should either be developed or be available in any new system acquired:
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Mobile/Paperless
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Events/Visits
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Visit Scheduling
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Medical Management
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Adjudication
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Data Interchange
The ability to import and export study data based on CDISC (Clinical Data Interchange Standards Consortium) Standards
1. Devil in the Detail – Examine features and modules carefully – experience them; do not rely on the label or terse documentation
2. Scheduled Development – Features that are planned,
promised and scheduled don’t always materialize on time (or at all)
3. Home-made Add-ons – You can often add external modules where features are missing, but NOT ALWAYS. Examples:
• You could possibly add an external randomization module • It is difficult to add customized roles to an existing system • It’s not easy to enhance performance of an existing system
BE CAREFUL – The missing feature or module may only represent habituated modes of operation; alternative study designs or
modes of operation without this feature may suffice.
EXAMPLE –
• MIDAS included a feature of automatic removal of discrepancies as missing data were supplied or when data were corrected.*
• Other systems required manual approval of discrepancy correction. • Several studies had many thousands of discrepancies identified.
Showstopper? Can we find a workaround?
A “show-stopper” is a feature or module of a system that, if missing, renders the system inoperable in some way.
1. Created a list of ten areas subdivided into 142 questions about the features available in candidate systems
2. Narrowed the field to several Open Source and COTS candidate systems (and our own homegrown MIDAS system)
This is what we actually did:
3. Acquired these systems for testing or acquired demos and detailed documentation in order to answer the questions
4. Filled in the matrix – but relied only on current versions of systems, not on “roadmaps” or “future release plans.”
Remembering that features are ONLY A PART OF THE STORY, we quickly scroll through a partial view of the detailed feature list examined—