Rev ReportingRequirementsandDeliverableItems.doc
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- Attached to
- CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM (CDISC) STUDY DATA TABULATION MODEL (STDM) TRAINING
- Solicitation number
- FDA-SOL-08-00570A
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Updated reporting and deliverable requirements
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| File | Type | Posted |
|---|---|---|
| Responses to Questions.doc | DOC document | |
| Commercial RFP.doc | DOC document |
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1. PWS No.
| 2. Activity |
| 3. Deliverable |
| 4. Timeframe (work days) |
| 1 |
| Project Management |
| Project Plan and Schedule |
| 45 days after effective date of contract |
| 5. |
| 6. |
| Status Report, covering: |
Activities completed during the prior month
Activities planned for the next month
Problems/Issues
Recommended Solutions Monthly, by 10th day of the month (for the previous month)
| 7. |
| 8. |
| Detailed Invoice, including: |
Hours billed by labor category
Cost per hour of staff
Category of work Monthly, by 10th day of the month (for the previous month)
| 2 |
| Course/Materials Development |
| Training plan and schedule covering development and delivery of classroom training and web-based materials |
| 45 days after effective date of contract |
| 3 |
| Preparation of Training Materials |
| Description of each module, including slides, materials for hands-on exercises, and other materials to be used during each of the following modules: |
· Module 1 (CDISC Basics)
· Module 2 (Introduction to SDTM)
· Module 3 (Introduction to ADaM)
· Module 4 (Advanced Principles and Concepts)
Electronic copies of slides, handouts, exercises, and other material.
Description of web-based courses/materials Based on an approved training plan and schedule
| 4 |
| Delivery of Classroom Training |
| Module 1 (CDISC Basics) (seven 2-hour sessions) |
Module 2 (Introduction to SDTM) (five 4-hour sessions)
Module 3 (Introduction to ADaM) (three 4-hour sessions)
Module 4 (Advanced Principles and Concepts) (one 4-hour session) 90 days after contract award 45 days after the initial delivery of each module 160 days after approval of training plan and schedule
| 9. |
| Web-based courses |
| Web-based version of four classroom modules |
| 10. |
| 11. |
| 12. |
| Web-based courses (four one-hour tutorials plus FAQs) |
| 13. |
Issue—delivery date for classroom training—this is wrong. We don’t want all of the training delivered on one day. Can we say “Beginning 60 days after contract award, based on an approved training plan and schedule”?
File details come from the government source that posted it. Updated .