1 / 104

ISIS BioComp & TFR/Tox

ISIS BioComp & TFR/Tox. This is a demo about ISIS BioComp and TFR/Tox To advance the slides, click with the right mouse, press the Enter Key or the Page Down key To reverse, press the Page Up key To stop the demo at any time press the Esc key. ISIS BioComp. Computing for Bioresearch

redford
Download Presentation

ISIS BioComp & TFR/Tox

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ISIS BioComp & TFR/Tox • This is a demo about ISIS BioComp and TFR/Tox • To advance the slides, click with the right mouse, press the Enter Key or the Page Down key • To reverse, press the Page Up key • To stop the demo at any time press the Esc key

  2. ISIS BioComp Computing for Bioresearch Established in 1988 Offices: Murrieta, California Stockton, New Jersey

  3. ISIS BioComp Presents TFR/Tox

  4. TFR/Tox • TFR/Tox provides General Toxicology and Reproductive Toxicology in a single integrated system • TFR/Tox is a client/server system • TFR/Tox can operate in Windows 95, 98, ME, or Windows NT, 2000 • The database is Oracle

  5. Hardware Requirements • Workstations should have PC’s with a Pentium processor with at least 32 MB of memory • A VAX, Digital Alpha, Unix server or Windows NT system, or any other Oracle server system, can be used as the database • A modem or Internet connection is required for support

  6. Software Requirements • Oracle Database • SQL*Net v2 or Net8 • SQL Plus • SQR (Brio.Report) • pc Anywhere

  7. TFR/Tox Peripherals • TFR/Tox interfaces with a wide variety of peripherals • Scales (Mettler, Arbor, Ohaus and Sartorius) • Barcode Readers • BMDS and Avid Animal Identification Scanners

  8. TFR/Tox Support • Support is provided by Glenn Koehler located in Stockton, New Jersey • Glenn originally worked for Exxon Biomedical Sciences and was involved in the daily use and validation of TFR/Tox • ISIS BioComp can run and evaluate remote systems with the use of a modem and softwaresuch as pc Anywhere

  9. TFR/Tox Users • Bristol-Myers Squibb • Exxon Mobil Biomedical • Aventis • Sanofi-Synthelabo • Glaxo SmithKline • Wyeth Ayerst Research

  10. Why TFR/Tox? • May solve your present problems - It’s flexible and configurable - Very user-friendly - Graphical interface - Emphasizes reliability and ease of use - Data is highly usable

  11. Why TFR/Tox? • It will save time and money • It’s completed, validated, documented and in everyday use • It may relieve your present system’s major deficiencies

  12. Why ISIS BioComp? • Preclinical Software is our only business • Exceptional technical support • Capability and Integrity

  13. Important Concepts - TFR/Tox • Scheduling • Phases & Phase Triggers • Subgroups • Global Glossaries • Lookup Tables • Data Collection Order Lists • Supervisor Approval • Blind Accession Numbers • Study Templates

  14. Scheduling • Animals are scheduled for data collection (body weights, clinical signs, dosing, etc.) automatically each night • A list of observations can be reviewed at the beginning of each day • The list is updated as the tasks are completed during the day

  15. Scheduling This screen can be reviewed to see what is scheduled for this study today. It will be filled in by the system as data collection exams are started and completed.

  16. Scheduling of Exams • Examinations can be scheduled for phase day, study day, phase week or study week • Schedule Types include • Absolute Day (e.g., July 4, 1998) • Discrete Day (e.g., Day 19 of Gestation) • Frequency (e.g., every 3 days) • Days of week (e.g., Monday & Friday) • By Parameter (e.g., following dosing)

  17. Scheduling Observations can be scheduled for animals in specific phases. Observations are scheduled by what phase the animal is in at the time of scheduling.

  18. Scheduling This observation will be scheduled starting on Day 1, a frequency of every day, no tolerance and for the duration of the study.

  19. Phases • An animal is assigned to a phase at the start of study • All phases can start on either Day 0 or Day 1 for scheduling purposes • Triggers are set to automatically shift an animal into another phase • Manual phase shifting is also available

  20. Scheduling This screen lists the available phases. Any number in the Duration (Days) column changes the In Use Column from "n" to "Y" indicating it is available for the study.

  21. Phase Triggers • Animals can be phase shifted manually by the user at anytime during the study • Triggers can be defined to result in automatic phase shifts

  22. Scheduling Animals can be automatically triggered from one phase to another. For example, both "In Situ Plug Present" and "Sperm Present" trigger a female from Pregestation to Gestation.

  23. Subgroups • All animals can be scheduled for an examination or select animals can be assigned to subgroups • Animals can be assigned to a subgroup if only select animals will be scheduled for an examination • Satellite Animals • Interim Sacrifice • Blood Collection

  24. Scheduling Subgroups are used to schedule a subset of animals for a specific observation (e.g., Blood Collection).

  25. Scheduling Animals can be assigned to subgroups either manually or randomly. The dashed arrow indicates that an animal has been assigned to a subgroup. Clicking with the mouse or highlighting and pressing <Enter> or the Spacebar will select or deselect the animal.

  26. Global Glossaries • Topography, morphology and descriptor glossaries are user-defined • Glossary terms can be defined for up to five levels • Level 1 - Topographies - are based upon body systems : nervous, urinary cardiovascular, digestive, etc.

  27. Scheduling This is the Global Topography Glossary. The first level (Level 1) is based on body systems. Each topography can have up to five different levels. Topographies can be identified as being sex specific (e.g., Female Reproductive System or Male Reproductive System) The number in the # MEMB column indicates how many entries exist at the next lower level.

  28. Scheduling This shows the Level 2 Glossary items for the female reproductive system.

  29. Scheduling This is the Global Morphology Glossary. The first level (Level 1) is based on a specific examination. Each morphology can have up to five levels. This shows the Level 2 Glossary items for the female reproductive system.

  30. Scheduling This shows the Level 2 Glossary items for the female reproductive system. This screen shows the Level 2 glossary items for the Fetal Gross Exam. Morphologies can be classified as either malformations or variations. An optional description of the morphology can also be entered.

  31. Lookup Tables • Defined by user • Popup tables used in study configuration and data collection • Selection with mouse or by highlighting and pressing enter • Lookup tables can be multiple selection

  32. Scheduling Lookup Tables are a list of popup entries which can be user defined. Lookup Tables are defined or altered in Global Management.

  33. Scheduling These are the entries for the Audit Reason Lookup Table. They are user defined. New reasons can by added by the User in Global Management.

  34. Data Collection Order Lists • Random generated lists of animal numbers for any data collection endpoint • Can be generated anytime manually • Can be generated automatically at time of data collection

  35. Scheduling Data Collection Order Lists are random lists of animals presented to the user at the time of data collection. These lists can be generated at the time the study is set up or at the time of data collection

  36. Scheduling This is a random list of animals generated for Blood Collection.

  37. Password Protection • Protection is hierarchical • Global Authority is necessary to access any part of the system • Access can be authorized on a study and/or an examination basis • In team functions, a password is required from each team member • Complies with 21CFR11 regulations

  38. Scheduling Users must be initially identified to the system in Global Management. This is a list of users with their User IDs, Passwords, initials and their Module Authority.

  39. Scheduling Module authority can be assigned to a specific user. The arrows indicate which functions the user can perform.

  40. Audit Trail • Once a study is marked active, an audit record is required for any change to the data • Audit Trail retains the original data and the change, along with who made it, when it was made (date/time) and a reason for the change • An audit log can be printed out for each study

  41. This audit log lookup table automatically pops up when a change is made. The actual change, who made the change, why the change was made, and the date and time are all recorded in the audit log. A reason can be typed in via the keyboard if an appropriate selection is not available.

  42. Scale Calibration • Scales can be calibrated prior to and at the completion of an examination that uses scales • Up to six calibration weights can be defined • Scales can be divided into three classes

  43. Scheduling The scale can be calibrated using up to six (6) calibration weights. A log is maintained of the calibration results. Scales classes are used for identifying scales with different weight ranges (e.g., Scale Class 1 for body weights and Scale Class 2 for small organ weights).

  44. Supervisor Approval • Data Collection Sessions can be approved by a supervisor • Specific morphologies can be approved by a supervisor • Data can be approved at the time it is collected or at a later date

  45. Scheduling The data collection can be reviewed and approved by the supervisor at the end of the data collection session or at a later date at the discretion of the supervisor.

  46. Scheduling Specific morphologies can also require Supervisor Approval at the discretion of the User.

  47. Accession Numbers • Accession numbers are used to display and access study animals for exams in a "blind" mode • Operator does not know the dose group associated with an individual animal during exam data collection • The user can either manually assign accession numbers for the animals, or request that accession numbers be randomly assigned by the system

  48. Scheduling Accession numbers are blind numbers used in data collection without reference to group or dose level. Accession numbers can be assigned manually or randomly by the system. These have been assigned randomly by the system.

  49. Study Templates • Templates can be set up for various types of studies • Templates can be quickly copied when setting up a new study • Templates contain all study information except animal identification numbers • After animal allocation, study setup is complete

  50. Help Screens • Context-sensitive help is available at any point in TFR/Tox • The user may request either a general help screen or a field-specific help • The user can customize the help information

More Related