Attachment_1_-_CDMS_Software_Demonstration_Instructions_(FDA-RFP-1209563).pdf

FDA-RFP-1219563 ATTACHMENT 1

NCTR COTS CDMS SOFTWARE

DEMONSTRATION INSTRUCTIONS

These virtual Demonstrations will be conducted by vendors whose proposals are considered the most highly rated. FDA will notify vendors once selections are made.

1. Provide an overview of the software and how it is the best fit for the NCTR (1-hour maximum)

2. Execute scenario/protocol from Study Design to Data Entry to Pathology to Data Output/Reporting (3 hours maximum), as per the below list of Demonstration items.

3. Highlight any features that you feel are important to share; discuss any of the FDA’s requirements your software cannot meet (1-hour maximum)

Demonstrate the following:

A. IT

A.1. Demonstrate how to integrate ID badge access, single sign-on, and Windows Active

Directory.

A.2. Demonstrate how to define user roles and how to add and modify user-roles including user role logging and audit functions.

A.3. Demonstrate briefly how to export in SEND format.

A.4. Demonstrate the software’s interface with the dosing pumps, scales, and chip readers listed in the solicitation under the Description of Requirement/Statement of Work (SOW) Section.

A.5. Demonstrate the software’s dosing algorithm. Can the algorithm be adjusted to individual and/or group body weights?

B. Data Quality and Integrity Requirements

B.1. Demonstrate how the software incorporates the attributes of data quality and integrity ALCOA+ (see solicitation/SOW Section on Data Quality and Integrity Requirements).

B.2. Demonstrate how the software reduces/removes the need for manual entry. For example, demonstrate how the software reduces the need for paper and manual entry of data.

B.3. Demonstrate how data captured on a manual form is retroactively entered and how the software identifies this delayed entry. In other words, demonstrate how the software deals with this scenario and show the audit trail for this scenario.

B.4. Demonstrate how the software records all equipment being used and how each piece of equipment is accuracy checked (validated) via prompting from the system prior to use.

B.5. Demonstrate how the software assigns a unique animal identification to animals so that no two animals can ever have the same identification. Also demonstrate how unique animal identification is tracked throughout all periods of a study/protocol (inlife through pathology).

B.6. Demonstrate how the software can assign unique identification to studies/project (i.e.

project number) so that no two studies can ever have the same identification. This is an Animal Care and Use Committee (IACUC) must have.

B.7. Demonstrate various audit trails that the software utilizes.

B.8. Demonstrate the software’s weighing feature and how a user can correct errors made during this process.

B.9. Demonstrate the process for adding/omitting/correcting entries that may occur after the study activity was completed.

B.10. Demonstrate any quality control review features.

B.11. Demonstrate how the software consistently handles Study Day identification during staggered loading of animals onto the study.

C. Study Definition C.1. How do you define species/strains/phenotype or genotype after purchasing animals?

C.2. Can you define animal weight ranges for adult animals and pups? By day on study and percent deviations?

C.3. Can you define container weights ranges (min/max) with a percent deviation?

C.4. Can you define Cage Observation per protocol/test from a master table?

C.5. Can you define multiple treatments per cage/sex?

C.6. Can you define treatments in random order? (i.e. have gaps) (i.e. treatments 1, 2, 3, 10, 13, 17)?

C.7. Can you define more than 99 treatment per protocol/test?

C.8. Can you define more than 12 animals per cage?

C.9. Can you define multiple Building and Rooms per protocol/test?

C.10. Can you define multiple Rack Numbers per room for a protocol/test?

C.11. Demonstrate the following features (i.e. Modules) contained in the software: Breeding

(Colony), In-Life, Multigenerational (Reproductive), and Phototoxicity Studies (optional).

C.12. Demonstrate the ability to select from several dosing algorithms depending on the study.

C.13. Demonstrate how your solution can assign animals to studies based on statistically valid weight-ordered randomization for caging and treatment groups.

C.14. Demonstrate the software’s event scheduler and calendar feature. Scheduling should include daily activities such as body weights, dosing activities, clinical observations, cage changes, cage or rack rotations, feeder or bottle weight collections, blood collections;

sentinel and necropsy removal dates. This functionality should include completion checks for viewing what activities were completed and incomplete based on study definition/design.

C.15. Demonstrate how the software can track animals’ movement to a different building & rooms/cages/rack position within a protocol/test.

C.16. Demonstrate the unique functions/actions for each user role/permission (i.e. Data Collection role, Error Correction role, Data Export/Reporting role).

C.17. Can you perform weight ranking/allocation no more than two littermates per cage/treatment group?

C.18. Can you define that no first cousin can be mated for any filial/generations for F1’s or greater?

C.19. Demonstrate how the software can assign animals from one protocol/test to another protocol/test.

D. Reporting/Data Export

D.1. Demonstrate some standard reports contained in the software.

D.2. Demonstrate how different roles/users can run reports and at all times during a study.

D.3. Demonstrate the ability to see historical observation throughout the history of an animal.

D.4. Demonstrate the various data that can be exported in .CSV and SAS-compatible formats.

D.5. Demonstrate how a study can be locked down by authorized roles/users.

E. Data Collection

E.1. Demonstrate the software’s animal room scheduling/calendar, usage, and tracking system.

This feature shall be based on study definition/design setup derived from a protocol.

E.2. Demonstrate how the software contains the ability to guide user (e.g. animal care technician) through specified actions based upon study definition/design. The system shall ensure that study activities are being completed as designed and guiding the user through the tasks that need to be completed during a given session.

E.3. Demonstrate the ability to collect pre-study animal data on the system such as body weights, clinical observations, feed & water consumption.

E.4. Demonstrate the ability to capture site-specific measurements of masses (e.g. tumors and palpable mass) to monitor for growth and removal criteria to include palpable mass with mass location diagrams.

E.5. Demonstrate the ability to capture cage allocation date, start date on study, and the first dose date.

E.6. Demonstrate the ability reinstate adult animals and pups that were removed from the study by accident. For example, when the wrong cage was selected for necropsy in the system, but physically the correct animal(s) went to necropsy.

E.7. Demonstrate the ability assign phenotypes/genotypes in the Dam cage before weaning.

E.8. Demonstrate the ability to collect anogenital distance measurements.

E.9. Demonstrate the ability to collect veterinary observations and treatments from physical and ophthalmic exams. This includes type and amount of medication administered as well as the timeframe for treatments.

E.10. Demonstrate the ability to address when a partial dose was administered and include functionality to log this action. It should also be able to enter when no dose was administered and allow the technician to re-start the animal/cage actions. (This is required when a problem occurs when the dose is drawn up (e.g. air in line)). The dosing pump should function accordingly.

E.11. Demonstrate how additional shipments of animals (not born and then assigned) can be added to in-progress existing dose groups.

F. Pathology

F.1. Demonstrate the following features (i.e. Modules): Necropsy, Clinical Pathology, Histology, Histopathology, Vaginal Cytology, and Sperm Analysis.

F.2. Demonstrate how the software can import in-life data to pathology data collection modules to include: animal carcass identification (CID), reason for removal, removal observations, removal weight, treatment (number and text), sex, disposition, clinical observations.

F.3. Demonstrate the ability to set-up necropsy data collection per protocol requirements (protocol required tissue list dependent on receiving status, tissue review and disposition, organ weights, fixative and fixation limit).

F.4. Demonstrate the software’s progressive dictionary – glossary for each module that learns as you progress through the study

F.5. Demonstrate the ability to include the ability for user to enter receiving status disposition.

System configured so that receiving status (dead, moribund, terminal sacrifice, etc.) defines how the system functions for each group of animals received for sacrifice based on protocol.

F.6. Demonstrate how the software allows for import of digital images from gross observations and microscopic images.

F.7. Demonstrate how the software accurately captures quality control documentation.

Histology module/functions should allow user to document re-embeds, recuts, wet tissue retrims, discarding slides, submitting multiple slides, reprocessing tissue and re-staining slides.

F.8. Demonstrate how the software can accurately capture Vaginal Cytology procedures (e.g.

documentation of collection, fixation, stain/coverslip and labeling. Reading for cycling and removal in designated cycle and live read for sperm presence).

F.9. Demonstrate the capability of determining where a specific animal is in the laboratory or the status of a specific study.

F.10. Demonstrate the software’s bi-directional interface to allow demographics (study number, CID, date of collection, test required, etc.) to be transmitted to the analyzers in real-time mode. Collate the data with CID, sex and treatment.

F.11. Demonstrate how the software’s Clinical Pathology Module/functions have ability to interface with the following analyzers: 1) Alfa Wassermann Vet Axcel; 2) Horiba Pentra 60C+; 3) Bio/Data PAP-8.

F.12. Demonstrate how the software allows for individual study setup for histopathology data collection to include: protocol required tissues, morphologies, qualifiers and sites, microscopic correlation of gross and microscopic findings.

F.13. Demonstrate Histopathology module/functions and standardized reports available including reports for individual animal and summaries by treatment, sex, tissue, anatomic site as well as diagnostic criteria (e.g. neoplastic, non-neoplastic), cause of death and microscopic correlation of gross and microscopic findings.

F.14. Demonstrate how the software supports Sperm Motility and Vaginal Cytology Evaluation (SMCVC). Histopathology module/functionality must have ability to import data from IVOX Hamilton Thorne Sperm Analyzer. Vaginal Cytology system must allow for entry of manual collection and evaluation data (e.g. stage of estrus, presence of sperm for confirmation of mating). Module must have standardized reports available including individual animal reports and summaries by treatment and sex for sperm analysis and vaginal cytology data.

F.15. Demonstrate in-life reports (especially daily activity and in-life removal data) and how these can be viewed by users with different roles/permissions.

F.16. Demonstrate how the software’s histology module/functionality allows for tracking (task area, date, and user) of:

• verification of, presence of, and status of protocol required tissues at trimming and embedding.

• all areas as the tissues are processed through the lab.

• identification and protocol requirements including immunohistochemistry, special stains, image analysis, etc.

• tissues, blocks, slides and cases throughout lab.

In other words, demonstrate that the software can prompt the technician on all protocol requirements to include routine histology tasks (processing, embedding, microtomy, staining, etc.) or nonroutine special procedures such as immunohistochemistry, image analysis, etc. The technician will be able to track their work in all areas, routine and nonroutine, identified as protocol required.

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