Attach1_SOW.pdf

Attachment 1

Statement of Work

The NIEHS plans to procure a commercial system that is currently being used in the marketplace to support the collection, management and maintenance of the reproductive, perinatal and developmental

NTP studies. These studies are done predominantly at contractor laboratories at various sites. This system shall have as its components a hosted central database and a distributed data collection mechanism that uses the web to transmit the collected data back to the host.

Requirements for an NTP Toxicology Data Collection and Reporting System

1. Protocol Creation o allow the creation of all types of studies (chronic, subchronic, multigenerational, perinatal, etc), o be able to be modified at any stage of a study o provide for the definition of the test article, preparations, procedures, treatment groups, etc.

o allow for the ability to copy/duplicate a previously defined protocol.

2. Data Collection o provide animal randomization, animal/cage/rack assignment, balance calibration, growth validation, the collection of all types of toxicology data including dosing and dosing time, animal and organ weights, food and water consumption, clinical observations, removal action information, necropsy information, gross and histopathology. *

3. Procedure Actions - The system must provide procedure actions which follow the protocol but allow valid deviations from the protocol.

4. Error Correction – The system must provide audited error correction of collected data with appropriate authority for both in life and pathology data collection.

5. Real-time data review – The system must provide near real-time and remote review of the collected data via reports and screens.

6. Database – o All of the toxicology data must reside in a hosted Oracle database which is fully accessible to NTP staff for data exports and queries.

o The database structure, tables, indices must be well documented via data dictionary and available to NTP staff.

7. Database Maintenance – Must provide a way for selected NTP staff to maintain the reference tables including adding or deleting chemical names, study types, species, strains, routes, facilities, new pathology morphologies, topographies, qualifiers, etc.

8. Reference Reporting – o There must be a mechanism for reference data reporting available via the web-based reports menu.

o This includes a chemical directory describing all studies in the database, their species, strain, route, study type, treatment groups, etc.

9. Web-based - The entire process from protocol definition through final report generation must be web-based.

10. Logical flow of data screens - The web-based screens should adhere to usability standards, and logically follow NTP standard operating procedures.

11. Pathology Dictionary – o It must be possible for the NTP to use its own pathology code table.

o There must be a way to create subsets of the code table for each study or for types of studies, for example, all dermal or gavage studies.

12. Secured –

Attachment 1 RFP Number: NIHES2009078 o There must be multiple layers of security to ensure that only selected staff have access to each level of the system including protocol and data entry and report generation.

o There must be a way to assign operators to each phase of the study.

13. Reports – o There must be a mechanism for the generation of simple and complex custom reports that can be added to the web-based reports menu.

o There must be a web-based mechanism to order custom or standard reports, view reports, print reports, save reports to web directories and delete reports from these directories.

o There must be a way to monitor the reports and print queue.

14. Open source software - Open source software should be used to allow for easier adoption of new technologies.

15. Statistics - There must be the ability to add custom statistical reports like the historical control database report based on selected current studies.

16. User Assistance - There must be a help desk available during normal working times for the labs and NTP staff.

17. Documentation – The system must be fully documented including user manuals for each aspect of data collection and retrieval, system and database documentation.

18. Section 508 Standards—The web interface must meet the Section 508 Standards outlined at www.section508.gov. Section 508 standards for ―Software Applications and Operating Systems‖ and ―Web-based Intranet and Internet Information and Applications‖, in addition to Subparts C and D apply to this requirement.

Additional requirements specific for, but not limited to, a Reproductive Toxicology data collection and reporting system

Pre-mating dosing date

Cohabitation date

Sperm positive date

Direct dosing date

Cull date

Foster date

Weaning date

Birth date

Litter weights (by sex and total)

Ability to track lineage and data of offspring derived from multiple litters over several generations with the same and/or different parents

Ano-genital distance (at different ages)

Number of nipples (at different ages)

Testicular descent

Vaginal patency

Preputial separation

Sperm count and motility (including data derived from CASA machines) http://www.section508.gov/

Number pregnant

Number of live births

Number born dead

Number with external malformations using an NTP classification system

Calculate birth index and mating index

Live birth index and viability index on different days (eg PND 1,4,7,14, and 21) by litter and generation

Number mated

Number sperm positive

Analysis of pregnancy in dams that fail to litter (implants, corpora lutea)

Ability to track and maintain data for culls used in ancillary studies

Ability to add custom statistical operations and tests for reproduction and developmental toxicology studies as defined by the NTP statistician

Ovarian follicle counts

Individual fetal observations such as uterine position in a litter for assessment of external, skeletal, and visceral effects together with standard assessments in the dam (food consumption, body weight, clinical observations, number of implants, number of live and dead fetuses, pre-and post-implantation loss, number of corpora luteas, number of non-pregnant, fetal weight (by sex and litter), placental weight (by sex and litter).

Pinna detachment

Incisor eruption

Eye opening

Nipple retention

Hypospadias

Ability to record data from functional observation battery

Ability to change the order of data entry to reflect work practices