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W81XWH21R0078
Task Order 1 Deliverables
ATTACHMENT 8: TASK ORDER 1 DELIVERABLES
Request for Proposal: W81XWH21R0078
A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E) unless otherwise stated. If a deliverable is due on a calendar day that falls on a weekend day or a Government holiday, the deliverable or report is due the following business day.
Deliverable Chart
| Item |
| Ref. |
| Title |
| Distribute To |
| Initial |
| Subsequent |
| Deliverable 1 |
| PWS Section 6.2 |
| Monthly Task Progress Report (MPR) |
| COR |
| NLT 45 calendar days after award |
| NLT 15th of each month of performance |
Deliverable 2 – Reserved for Base Contract Deliverable
| Deliverable 3 |
| PWS Section 6.4 |
| Task Order Program Management Plan (PMP) |
| COR |
| With Proposal Submission |
| Update as needed after changes are identified and provide within 7 business days |
Deliverable 4 – Reserved for Base Contract Deliverable
| Deliverable 5 |
| PWS Section 6.9 |
| Organizational Conflict of Interest Certification |
| COR |
| With Proposal Submission |
| Submit with all new sub-Contractors, teaming partners/consultants prior to tasking |
Section 6.10
| Verification of Contractor Manpower Reporting Submission |
| COR and Contract Specialist |
| NLT 31 Oct |
| Annually, NLT 31 October |
Section 10
| Non-Disclosure/Non-Use Agreements |
| COR |
| Signed statements are due, for each employee assigned, prior to that employee performing ANY work on this task order. |
| Deliverable 8 |
| PWS Section 6.5 |
| Quality Control Plan (QCP) |
| COR |
| With Proposal Submission |
| Update as needed after changes are identified and provide within 7 business days |
| Deliverable 9 |
| PWS Section 6.6 |
| Accountability |
| COR |
| By 9 AM |
beginning the first day of period of performance Daily, by 9 AM Monday – Friday, except recognized Federal Holidays as shown in PWS section 4.4
| Deliverable 10 |
| PWS Section 5.2.2 |
| Regulatory Strategy |
| COR & Team Lead |
| within 60 business days of request |
| Verified annually or NLT 15 business days after an update has been identified |
| Deliverable 11 |
| PWS Section 5.2.2 |
| Target Product Profile |
| COR & Team Lead |
| within 60 days after project assignment |
| Verified annually or NLT 15 business days after an update has been identified |
| Deliverable 12 |
| PWS Section 5.2.3 |
| Study Protocol and Related Document Reviews / Revisions |
| COR & Team Lead |
| NLT 10 business days of revisions |
| NLT 10 business days of change request |
| Deliverable 13 |
| PWS Section 5.2.3 |
| Sample Handling Instructions |
| COR & Team Lead |
| NLT 30 business days after assignment |
| NLT 15 business days prior to study start or after update request |
| Deliverable 14 |
| PWS Section 5.2.3 |
| Study Specific Grading Criteria |
| COR & Team Lead |
| Complete NLT 5 business days prior to visit |
| As requested, NLT 5 business days after update request |
| Deliverable 15 |
| PWS Section 5.2.3 |
| Sample Accountability Log |
| COR & Team Lead |
| NLT 5 business days after project assignment or update request to previously developed logs |
| As requested, NLT 5 business days after update request |
| Deliverable 16 |
| PWS Section 5.2.4 |
| Clinical Monitoring Plan (CMP) |
| COR & Team Lead |
| NLT 21 calendar days prior to site initiation visit |
| Updated within 30 calendar days of changes to monitoring or study |
| Deliverable 17 |
| PWS Section 5.2.4 |
| Clinical Monitoring Reports |
| COR & Team Lead |
| Draft delivered within 10 days of the visit and final reports delivered within 30 days of visit |
| Updated within 30 calendar days of each visit |
| Deliverable 18 |
| PWS Section 5.2.4 |
| Protocol Deviation, Violation and Non-compliance Reports |
| COR & Team Lead |
| Delivered within 24 hours of major deviation / violation/ non-compliance |
| Within 10 calendar days or of becoming aware of minor deviation |
| Deliverable 19 |
| PWS Section 5.2.5 |
| Data Management Plan (DMP) |
| COR & Team Lead |
| NLT 14 business days prior to study start |
| As requested, NLT 14 business days prior to study start |
| Deliverable 20 |
| PWS Section 5.2.5 |
| Blank Case Report Form(s) |
| COR & Team Lead |
| NLT 14 business days prior to study start |
| As requested, NLT 30 business days prior to study start |
| Deliverable 21 |
| PWS Section 5.2.5 |
| CDASH/CDISC Compliant Annotated Case Report Forms (eCRF) |
| COR & Team Lead |
| NLT 7 business days prior to database release for production |
| As requested, NLT 7 business days prior to database release for production in compliance with approved DMP |
| Deliverable 22 |
| PWS Section 5.2.5 |
| CDASH/ |
CDISC Compliant Database Specifications
| COR & Team Lead |
| NLT 7 business days prior to database release for production |
| As requested, NLT 7 business days prior to database release for production in compliance with approved DMP |
| Deliverable 23 |
| PWS Section 5.2.5 |
| Database Testing & Validation Documentation |
| COR & Team Lead |
| NLT 7 business days prior to database release for production |
| As requested, NLT 7 business days prior to database release for production in compliance with approved DMP |
| Deliverable 24 |
| PWS Section 5.2.5 |
| Completed medical coding reports, Case Report Forms and Related Queries and Audit Trial Report |
| COR & Team Lead |
| NLT 30 business days after study-specific database lock |
| As requested, NLT 30 business days after study-specific database lock in compliance with approved DMP |
| Deliverable 25 |
| PWS Section 5.2.5 |
| Data Quality Evaluation Documentation |
| COR & Team Lead |
| NLT 30 business days after study-specific database lock |
| As requested, NLT 30 business days after study-specific database lock in compliance with approved DMP |
| Deliverable 26 |
| PWS Section 5.2.5 |
| Data Reconciliation Documentation |
| COR & Team Lead |
| NLT 5 business days after reconciliation is completed |
| As requested, NLT 5 business days after reconciliation is complete in compliance with approved DMP |
| Deliverable 27 |
| PWS Section 5.2.5 |
| Final RAW Data in Statistical Analysis Software (SAS) and compliant to CDASH and applicable CDISC standards |
| COR & Team Lead |
| NLT 30 business days after database lock |
| As requested, NLT 30 business days after database lock in compliance with approved DMP |
| Deliverable 28 |
| PWS Section 5.2.6 |
| Statistical Analysis Plan (SAP) |
| COR & Team Lead |
| NLT 15 business days for review and approval prior to study start |
| As requested, NLT 15 business days prior to study start for review and approval |
| Deliverable 29 |
| PWS Section 5.2.6 |
| Statistical Programming Validation Plans and Reports |
| COR & Team Lead |
| NLT 15 business days for review and approval prior to study start |
| Verified annually or NLT 15 business days after update identified |
| Deliverable 30 |
| PWS Section 5.2.6 |
| Randomization Plan |
| COR & Team Lead |
| NLT 15 business days for review and approval prior to study start |
| Verified annually or NLT 15 business days after update identified |
| Deliverable 31 |
| PWS Section 5.2.6 |
| Statistical Programs for Tables, Listings and Figures (TLFs) |
| COR & Team Lead |
| NLT due date requested to meet regulatory timelines |
| Ongoing until study completion in compliance with approved SAP |
| Deliverable 32 |
| PWS Section 5.2.6 |
| Populated TLFs |
| COR & Team Lead |
| NLT due date requested to meet regulatory timelines |
| Ongoing until study completion in compliance with approved SAP |
| Deliverable 33 |
| PWS Section 5.2.6 |
| CDISC Validation Plan and Reports |
| COR & Team Lead |
| NLT due date requested to meet regulatory timelines |
| Ongoing until study completion in compliance with approved SAP |
| Deliverable 34 |
| PWS Section 5.2.6 |
| Develop CDISC- compliant Datasets |
| COR & Team Lead |
| NLT due date requested to meet regulatory timelines |
| Ongoing until study completion in compliance with approved SAP |
| Deliverable 35 |
| PWS Section 5.2.6 |
| CDISC Reviewer's Guide |
| COR & Team Lead |
| NLT due date requested to meet regulatory timelines |
| Ongoing until study completion in compliance with approved SAP |
| Deliverable 36 |
| PWS Section 5.2.6 |
| Written response to FDA requests/queries |
| COR & Team Lead |
| NLT due date requested by FDA |
| As requested, NLT due date requested by FDA |
| Deliverable 37 |
| PWS Section 5.2.7 |
| Safety Surveillance Plans |
| COR & Team Lead |
| NLT 30 business days after request |
| NLT 15 business days after update identified |
| Deliverable 38 |
| PWS Section 5.2.7 |
| Safety Management Plan |
| COR & Team Lead |
| Within 30 days of site initiation visit |
| NLT 15 business days after update identified |
| Deliverable 39 |
| PWS Section 5.2.7 |
| Final Signed DSMB Charter |
| COR & Team Lead |
| NLT 1 business day after obtaining all signatures and prior to study start |
| NLT 15 business days after update identified |
| Deliverable 40 |
| PWS Section 5.2.7 |
| DSMB Agenda |
| COR & Team Lead |
| NLT 5 business days prior to DSMB meeting |
| As requested, NLT 5 business days prior to DSMB meeting |
| Deliverable 41 |
| PWS Section 5.2.7 |
| DSMB Meeting Minutes |
| COR & Team Lead |
| Meeting minutes draft due 1 business day after meeting and final after DSMB chair approval signature |
| NLT 1 business day after meeting for the draft meeting minutes and final after obtaining all signatures |
| Deliverable 42 |
| PWS Section 5.2.7 |
| DSMB Chair Recommendation |
| COR & Team Lead |
| NLT 1 business day after meeting |
| As requested, NLT 1 business day after meeting |
| Deliverable 43 |
| PWS Section 5.2.7 |
| Pharmacovigil-ance Document Review, Analysis and Development |
| COR & Team Lead |
| NLT 15 business days after request |
| As requested, NLT 15 business days after request |
| Deliverable 44 |
| PWS Section 5.2.8 |
| Written report of CMC Support and Investigational Product Support |
| COR & Team Lead |
| NLT 30 business days after project assignment |
| Update monthly |
| Deliverable 45 |
| PWS Section 5.2.8 |
| Regulatory Submission Documents |
| COR & Team Lead |
| NLT 10 business days or as requested by the Government |
| As requested, NLT 10 business days for clinical protocols after document receipt and NLT 30 business days for Module 2 and 3 after document receipt |
| Deliverable 46 |
| PWS Section 5.2.8 |
| IP Storage and Handling Instructions |
| COR & Team Lead |
| NLT 5 business days after document receipt |
| As requested, NLT 5 business days after document receipt |
| Deliverable 47 |
| PWS Section 5.2.8 |
| IP Testing Data Review, Analysis and Corrective and Preventive Action (CAPA) Plans |
| COR & Team Lead |
| NLT 10 business days after document receipt |
| As requested, NLT 10 business days after document receipt |
| Deliverable 48 |
| PWS Section 5.2.8 |
| IP Shipment, Accountability and Cold Chain Management Documentation and Files |
| COR & Team Lead |
| NLT 2 business days after document receipt |
| As requested, NLT 2 business days after document receipt |
| Deliverable 49 |
| PWS Section 5.2.8 |
| Manufacturing Site Visit Reports |
| COR & Team Lead |
| Review and approve site visit agenda and report within 30 days of site visit |
| Conducted as requested with report due NLT 30 business days after site visit |
| Deliverable 50 |
| PWS Section 5.2.8 |
| Master Batch and/or Batch Production Record Review and Analysis |
| COR & Team Lead |
| NLT 30 business days after document receipt |
| As requested, NLT 30 business days after document receipt |
| Deliverable 51 |
| PWS Section 5.2.8 |
| Stability Protocol and/or Stability Report Reviews and Revisions |
| COR & Team Lead |
| NLT 10 business days after document receipt |
| As requested, NLT 10 business days after document receipt |
| Deliverable 52 |
| PWS Section 5.2.8 |
| Bioanalytical/ Analytical Method Qualification and Validation Protocol and Report |
| COR & Team Lead |
| NLT 30 business days of request |
| As requested, NLT 30 business days after request |
| Deliverable 53 |
| PWS Section 5.2.8 |
| GMP and GLP Audit Support |
| COR & Team Lead |
| Review and approve audit agenda and report within 30 days of site visit |
| Conducted as requested with report due NLT 30 business days after site visit |
| Deliverable 54 |
| PWS Section 5.2.8 |
| Equipment Qualification and Validation Reports |
| COR & Team Lead |
| Conducted as requested with report due NLT 30 business days after site visit |
| Conducted as requested with report due NLT 30 business days after site visit |
| Deliverable 55 |
| PWS Section 5.2.8 |
| Review of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Protocol and Reports |
| COR & Team Lead |
| NLT 10 business days after document receipt |
| As requested, NLT 10 business days after document receipt |
| Deliverable 56 |
| PWS Section 5.2.8 |
| Review of CMC Deviation Reports |
| COR & Team Lead |
| NLT 5 business days after receipt of report |
| As requested, NLT 5 business days after receipt of report |
| Deliverable 57 |
| PWS Section 5.2.8 |
| Out-of-Specification (OOS) Reports/ Documentation Review |
| COR & Team Lead |
| NLT 5 business days after receipt of report |
| As requested, NLT 5 business days after receipt of report |
| Deliverable 58 |
| PWS Section 5.2.8 |
| Validation Protocol and Report Review and Analysis |
| COR & Team Lead |
| NLT 5 business days after receipt of report |
| As requested, NLT 5 business days after receipt of report |
| Deliverable 59 |
| PWS Section 5.2.9 |
| Non-Clinical Study Designs, Protocols and Reports |
| COR & Team Lead |
| NLT 5 business days after receipt of report |
| As requested, NLT 30 business days after support request or document receipt |
| Deliverable 60 |
| PWS Section 5.2.9 |
| GLP and non-GLP Protocols and Reports |
| COR & Team Lead |
| NLT 30 business days after request of document |
| As requested, NLT 30 business days after request or document receipt |
| Deliverable 61 |
| PWS Section 5.2.9 |
| Nonclinical Documents |
| COR & Team Lead |
| NLT 30 business days after request and document receipt |
| As requested, NLT 30 business days after request and document receipt |
| Deliverable 62 |
| PWS Section 5.2.10 |
| Regulatory Documents for FDA Submission |
| COR & Team Lead |
| NLT 5 business days after project assignment or as requested by the Government |
| Support is conducted as needed to meet regulatory submission timelines |
| Deliverable 63 |
| PWS Section 5.2.10 |
| Writing Product Tracker |
| COR & Team Lead |
| Delivered bi-weekly |
| Update weekly |
| Deliverable 64 |
| PWS Section 5.3.1 |
| e-submission ready documents |
| COR & Team Lead |
| NLT 10 business days after submission workflow initiation |
| As requested, NLT 10 business days after submission workflow initiation |
| Deliverable 65 |
| PWS Section 5.3.1 |
| Initial Published outputs and validation report of eCTD dossiers |
| COR & Team Lead |
| NLT 10 business days after submission workflow initiation |
| As requested, NLT 10 business days after submission workflow initiation |
| Deliverable 66 |
| PWS Section 5.3.1 |
| Quality Assurance and re-published eCTD Dossiers Review Comments |
| COR & Team Lead |
| Completed within 2 calendar days with no errors |
| As requested, NLT 10 business days after submission workflow initiation |
| Deliverable 67 |
| PWS Section 5.3.1 |
| FDA gateway submission acknowledge-ment |
| COR & Team Lead |
| Delivered upon receipt |
| As requested, NLT 10 business days after submission workflow initiation |
| Deliverable 68 |
| PWS Section 5.3.2 |
| Audit ready sponsor's electronic regulatory files |
| COR & Team Lead |
| NLT 30 business days after request or document receipt |
| Verify or update monthly |
| Deliverable 69 |
| PWS Section 5.3.2 |
| Log of Sponsor File Tracking |
| COR & Team Lead |
| Delivered within 5 business days of request |
| Verify or update monthly |
| Deliverable 70 |
| PWS Section 5.4.2 |
| Quality Audit Plans and Reports |
| COR & Team Lead |
| Conducted as requested with plans due as requested by the Government and the report due NLT 30 business days after site visit |
| Conducted as requested with plans due to the Government as requested and the report due NLT 30 business days after site visit |
| Deliverable 71 |
| PWS Section 5.4.3 |
| Clinical Quality Assurance Management Plans |
| COR & Team Lead |
| NLT 30 business days after site visit |
| As requested, NLT 30 business days after notification of requirement |
| Deliverable 72 |
| PWS Section 5.4.4 |
| Cold Chain Management Plans |
| COR & Team Lead |
| Plans delivered complete and accurate and within the time frame as requested by the Government |
| As requested, NLT 30 business days after notification of requirement |
| Deliverable 73 |
| PWS Section 5.4.6 |
| Quality System and Procedure SOPs |
| COR & Team Lead |
| Complete and accurate and within the time frame as requested by the Government |
| As requested but NLT 30 business days after request |
| Deliverable 74 |
| PWS Section 5.6 |
| Certified Translated Documents |
| COR & Team Lead |
| NLT 30 business days after request |
| As requested, NLT 30 business days after request |
Department of the Army Medical Command