MODIFICATION
D -- Clinical Trial Data Entry System, National Cancer Institute, Center for Bioinformatics
- Notice Date
- 12/10/2002
- Notice Type
- Modification
- Contracting Office
- Minerals Management Service GovWorks (Franchise) 381 Elden Street, MS 2500 Herndon VA 20170
- ZIP Code
- 80225-0165
- Solicitation Number
- 14350403RP70144
- Response Due
- 1/10/2003
- Archive Date
- 12/10/2003
- Point of Contact
- Shanda Georg Business Specialist 7037871758 Shanda.George@mms.gov;
- E-Mail Address
-
Point of Contact above or IDEASEC HELP DESK
(EC_helpdesk@NBC.GOV)
- Small Business Set-Aside
- N/A
- Description
- RFQ 70144 Technical Questions For Clinical Trial Data Entry System National Cancer Institute, Center for Bioinformatics / Dec 10, 2002 Solicitation Due Date: January 10, 2003 4:30pm to shanda.georg@mms.gov. SOW and solicitation instruction letter can be found: www.govworks.gov/vendor/csolicit.asp 1. Are there any architectural constraints on the solution/approach? E.g. will the servers be UNIX-based, NT-based, or other? Government Response: The current and preferred platform is UNIX. 2. Should the application be web (HTML and/or Java)-based or is a Client-Server type application preferred? Government Response: The preferred solution will be web-based. 3. Is there an incumbent contractor? Can you provide information about the number of FTE's currently supporting the systems? Government Response: There is currently an incumbent contractor. However, there are multiple contractors and government staff engaged in the construction and support of the larger system 4. What is the start date for the period of performance? Government Response: At award, the contract is for a 12 month period (base period), and may include 3, 12 month option periods. 5. What is the user community likely to be? Government Response: The Center for Cancer Research (CCR) clinical research community and its outside partners. 6. Are they geographically dispersed or centralized, How many? Government Response: The majority of the user community will be based in the greater Bethesda MD area. However, it is anticipated that a minority of trials will be inter-institutional in nature. It is not possible to provide an absolute number at this time. 7. What sort of clients will they be accessing the system with? E.g. win clients/Mac clients? Government Response: CCR is standardizing on Win platforms as clients although there are MAC distributed throughout the Center. 8. Are there any requirements for users to input data in non-standard ways? E.g. spreadsheets rather than the remote data capture or forms? Government Response: It is important to have the capacity to obtain data through mechanisms other than data entry forms. 9. Is there an incumbent contractor? Can you provide information about the number of FTE's currently supporting the systems? Government Response: Contractor shall propose an adequate level of support for this effort. 10. What is the start date for the period of performance? Government Response: At award of contract for a period of one year with possible options (options=12 months). 11. How many end users are there of the Oracle Clinical product, the Clinical Trial Data Warehouse and the other integrated modules? Government Response: Current projections of the number of users range from 150-200. 12. Are user manuals the only method of end user training that will be required for the Oracle Clinical system, the Clinical Trial Data Warehouse and the other integrated modules under the terms of this contract? Government Response: Yes. 13. Will NCICB require the contractor to use a particular type of training materials development tool, or will that be at the discretion of the contractor? Government Response: No. 14. The Statement of Work does not include organizational change management tasks or deliverables customarily associated with enterprise systems implementation -- such as organizational impact assessment, workforce transition, and communications. Are NCI staff resources rather than contractor staff resources being applied to these activities? Government Response: Change Management tasks are covered by other entities. However, the contractor is expected to utilize best practices for development and as such should include effort tracking the development process and ongoing efforts to assess user needs. [Reference, Section 4.1 - Develop and Implement the Clinical Trial Data Entry System] 15. Will only the core Oracle Clinical application be implemented or are there to be additional modules? E.g. AERS, RDC? Government Response: Part of the scope of work is to determine the most effective means of deploying the Clinical Trials Data Entry System. It is currently planned to utilize Oracle Clinical RDC and NORMLAB. Other modules will be considered as well. 16. What is the nature of the Reports generation for both Theradex and CDUS? Would the system simply generate a feed for these systems? Government Response: These reports are structured data feeds to different regulatory bodies. The regulatory body determines the report format. In addition to generating the reports, the reports must be logged and inspected prior to transmittal. [Reference, Section 4.2 - Develop and Implement the Clinical Trial Data Warehouse] 17. Oracle Discoverer workbooks was mentioned in the RFQ as a reporting tool. Has a decision been made to use that tool, or are you open to alternate solutions?] Government Response: Current plans call for the use of Oracle Discoverer. Other cost-efficient approaches that permit the generation of ad hoc views of the Oracle Clinical data would be considered. [Reference, Section 4.3 - Design and Develop Patient Registry Module Integrated w/ Oracle Clinical] 18. Is there an existing Patient Registry? Government Response: A Registry currently exists that contains information that will ultimately need to be incorporated in a final design. 19. Will there be any Data Conversion? i.e. from an existing registry Government Response: Yes. 20. What sort of data manipulation is envisioned-data entry, update, deletion, reporting? Government Response: All of the above. 21. Will any of the information in this system feed a data warehouse? Government Response: Yes. 22. Who should have access to this system? What levels of access? Government Response: Multiple groups will need to access this system, each with different levels of access. 23. What does "Oracle Clinical Development Team" mean? Is this Oracle Corporate's development staff or an internal NCI development staff? Government Response: This represents staff with Oracle Corporate that manages and develops the proprietary interfaces that are provided by the Oracle Clinical application. 24. Who is responsible for delivering the Interface into Oracle Clinical? Government Response: It will be co-developed between the government, Oracle Corporation, and the awardee of this contract. [Reference, Section 4.5 - Design, Develop and Integrate Specimen Tracking Module w/ Oracle Clinical] 25. Is there an existing Specimen Tracking system? Government Response: There are multiple specimen tracking systems deployed on a variety of platforms. 26. Will there be any Data Conversion? Government Response: Yes. 27. Will the Specimen Tracking system involve any actual physical archiving of patient specimens? Government Response: No. 28. What sort of data manipulation is envisioned-data entry, update, deletion, reporting? Government Response: All of the above. 29. What is meant by "links" from the Specimen Tracking module to the Patient Registry and or Oracle Clinical? Would this be a drill down into the Forms of OC or the Registry? Government Response: Both. It is desired that all of these components would be able to access one another. 30. If an API or Interface into Oracle Clinical is not available for this drill down ("link"), who is responsible for providing this OC Interface? Government Response: It will be co-developed between the government, Oracle Corporation, and the awardee of this contract. [Reference 2.0 Scope] 31. Please clarify the full wording of "CCR". Government Response: Center for Cancer Research - an Intramural Division of the NCI (National Cancer Institute). 32. Can prospective offerors review the information on the legacy system that contains the clinical study data? If so, then will the Government provide the location of the legacy system documents such as operation/user manuals and technical descriptions that prospective offerors can review? Government Response: This will not be possible. Briefly, this system is a forms based database deployed using 4th Dimension on a MAC platform. The forms provide minimum field checking, Toxicity grading, and a collection of standard reports. The form content is very similar to that present in the Theradex paper. 33. Please identify the release version of the Oracle Clinical, such as "version 4i". Government Response: Version 4.03. 34. What is the size of the data that is required for the data warehouse? Government Response: This will be determined as the warehouse is designed and deployed. It is intended to hold legacy as well as all new trial information from CCR. CCR initiates 50 to 100 new trials per year. [Reference 4.4, Reuse and Integrate Document Management Module with Oracle Clinical] 35. Can prospective offerors review the system specifications (or technical description) of the FDA PHARM Document Management System in preparing our proposals? Government Response: This system is not available. [Reference 5.1, Develop and Implement the Clinical Trail Data Entry System] 36. "5 day training class" Who is the intended audience of the training class? Is it for Government Staff to operate the customized OC? Is it an Oracle training class for contractor staff such as "Introduction to Oracle Clinical" or "Data Modeling"? Government Response: The attendance and audience for this class will evolve over time. The goal will be to teach the user community to develop protocols in the CCR's customized environment. 37. Please elaborate on the term of "Theradex". Government Response: This is the contractor group that currently manages the NCI's CTMS system (and the data which must be submitted to it). [Reference 5.2, Develop and Implement the Clinical Trial Data Warehouse] 38. "Oracle Discover" Pease verify that the "Oracle Discoverer" mentioned in Section 5.2 is the Discover that is part of the Oracle 9i Application Server Package. Government Response: Yes. 39. Please specify "KA" as mentioned in "KA session notes" [Reference 5.3, Design and Develop Patient Registry Module Integrated with Oracle Clinical] Government Response: KA: Knowledge Acquisition. 40. Is the Government seeking: Proposed firm-fixed hourly rates, or hourly rates, staff efforts, and the total cost/price for the Base Year Contract? Government Response: All hourly rates will be fixed for duration of each labor category for the contract period. The contract is to be proposed as a time and material type of contract. 41. What is the Government estimation of the staff effort? Government Response: The contractor will propose the staffing strategy. 42. The RFP cover letter only listed the email address of the Contracting Officer for delivering the RFQ. Will the Government also accept hard copies of the proposal? Government Response: Electronic copy per RFQ instructions will be the only acceptable format for this process. [Reference 7.0, Contractor Qualifications] 43. Regarding "In-depth knowledge of the NCI Enterprise Models". Government Response: This information is posted on the NCI Enterprise Models on the NCICB WWW site: http://ncicb.nci.nih.gov. 44. Please relate this requirement to the Specific Tasks in Section 4.0. Which tasks require the in-depth knowledge of the NCI Enterprise Model and why. Government Response: The NCI Enterprise Model should inform all aspects of response. Information on the NCICB's approach to systems architecture and current status of its data models is present on its public WWW site (http://ncicb.nic.nih.gov). Knowledge of current models is intended to facilitate use/reuse of previous work conducted in service of the NCI, rather than starting anew, de novo. It is the intention that new efforts extend these investments, where practical. 45. Are there written documents of the Enterprise Models? If so, please provide the location of the documents such as the library or website. Government Response: Documentation for the NCI Enterprise Models is present only at the NCICB website (http://ncicb.nci.nih.gov). 46. Please provide a few samples of the case report forms. Government Response: The entire collection of case report forms to be initially deployed is available through Theradex (http://www.theradex.com/CRF&Manual.htm). 47. Is there any current contractor support in performing this contract's requirements? If so, please identify the incumbent contractor. Government Response: The primary contractor currently performing this work is Oracle Corporation. 48. Please identify by Office or Division (such as Office of Education and Special Initiative or the Division of Cancer Prevention at NCI) who is responsible for implementing the Oracle Clinical System and administering the contractor. Government Response: The NCI Office of the Director, NCI Center for Bioinformatics. 49. Please clarify NCI Strategies on the implementation of the Oracle Clinical Trial System. Government Response: This strategy is currently under development. 50. Please provide the important features of Oracle Clinical that NCI is implementing along with the core of the Central Database for clinical data, such as Remote Data Capture Product, Layout Editor in JAVA for the Data Entry Screens, and Mass Changes Utility. Government Response: Currently NCI is deploying RDC and NORMLAB modules. Other modules are under consideration 51. Upon the successful implementation of Oracle Clinical, please clarify NCI's plan on the CTEP CDUS. Government Response: it will be necessary to develop capabilities to report data from Oracle Clinical to CTEP CDUS. 52. Does this solicitation require data entry services? Government Response: No. 53. Is there a mandatory bidder's conference? When? Where? Government Response: A bidders conference is not planned. All bidders shall submit a proposal via email to Shanda.georg@mms.gov. 54. Has this ever been up for bid before? Government Response: No. 55. What was the last bidding price? Government Response: Refer to #54. 57. If it requires data entry services and there is a sample document, we would appreciate a copy of it. Government Response: N/A.
- Web Link
-
Please click here to view more details.
(http://www.eps.gov/spg/DOI/MMS/WPB/14350403RP70144/listing.html)
- Place of Performance
- Address: NIH/NCI/OD/NCICB Rockville, Maryland
- Zip Code: 20852
- Country: USA
- Zip Code: 20852
- Record
- SN00221075-F 20021212/021211052935 (fbodaily.com)
- Source
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