A8_-_Sample_TORFP_1_SOW_-_Kickoff_Meeting_PMP.pdf

Sample Task Order #1 - Statement of Work

Project Management Plan and Kick-Off Meeting: Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics

SECTION B - SUPPLIES OR SERVICES AND PRICES/COST

ARTICLE B.1. PRICES

a. The total fixed price of this task order is $TBD.

b. Upon delivery and acceptance of the services described in SECTION C of this task order and identified in the schedule of charges below, the Government shall pay to the Contractor the unit price(s) set forth below:

SCHEDULE OF CHARGES FOR THE TASK AWARD PERIOD

Description of Service Quantity (Units)

Unit Price ($)

Extended Price ($)

Total ($)

Electronic Copy of Presentation Materials

Contract Kickoff Conference In-person and/or Video Webinar

Project Management Plan 1

ARTICLE B.2. ADVANCE UNDERSTANDINGS

a. Contract and Task Order Number Designation On all correspondence submitted under this TO, the Contractor agrees to clearly identify the base contract and TO numbers as follows:

Base IDIQ Contract Number: TBD Task Order Number: TBD

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

1. Contract Kick-off Meeting

The Contractor’s Key Personnel shall participate in a contract kick-off meeting in-person and/or by video conference call. The meeting shall be between 2-3 hours long and shall not exceed 4 hours. The conference call shall be scheduled at a date and time mutually agreed upon by the Government and Contractor that is within thirty (30) days of the base Indefinite- Delivery, Indefinite-Quantity (IDIQ) contract effective date. The Government will provide an agenda before the meeting and there will be time for questions and answers (Q&As) regarding the contract and its related projects.

The Contractor shall prepare a presentation outlining the following:

1. Overview of Key and support personnel that will be assigned to conduct clinical projecy studies/trials

2. Contractor Key Personnel reporting structure and point(s) of contact with the Government

3. Overview of Communication plan including subcontractor(s) and Government;

project planning, execution, delivery of reports, and communication with the NIH Contracting Officers (COs), Contracting Officer Representatives (CORs), and other stakeholders

4. Overview of how studies/trials will be subcontracted, scheduled, overseen, and executed

5. Overview of in-house and subcontractor facilities that will be devoted to performance of elated Task Orders

6. Overview of Quality systems at Contractor and subcontractor facilities

7. Overview of data security, storage, access and transfer to the NINDS

8. Overview of risk assessment and mitigation plans for overall Contract activities

2. Contract Management Plan:

The Contractor shall provide a general Project Management Plan (PMP) describing general procedures and processes of the vendor. (This isn’t trail-specific information;

that is required below as part of the clinical project.) The general PMP must be a single, well-organized document or folder that clearly connects document elements with the sections below. The PMP shall address and include, at a minimum, the following:

a. General standard operating procedures (SOPs) for the conduct of Phase I clinical trials and for all other integrated and collaborating services (such as pharmacy, database management, bioanalytic, etc.)

b. Personnel listing including their roles and responsibilities

c. General policies on human subject considerations (e.g., federal wide assurance (FWA), procedures for managing medical emergencies on-site, reporting of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events, hospitalizations and procedures for prompt reporting of SAEs in compliance with FDA regulations and NIH policies)

d. General data management procedures and systems planning

e. General pharmacy management procedures for receiving, storing and dispensing investigational agents

f. Clinical and laboratory quality monitoring procedures

g. General procedures for preventing, identifying, handling, reporting and resolving protocol deviations

h. Quality control plans and procedures

i. Demonstration for independence of oversight including quality assurance procedures

j. Protocols for protection of Contributors’ intellectual property and data procedures

k. Archival plans for securing completed trial data according to regulatory requirements

l. Contingency planning

m. Training: For human subject protection (HSP) or current Good Clinical Practices (cGCP), plan for training of technical staff, clinicians and/or scientists designated by the Contractor on techniques, methods, and best practices relevant to the conduct of clinical trials carried out under the IDIQ contract. Must also include any other relevant or mandatory trainings for the contract.

ARTICLE C.2. REPORTING REQUIREMENTS

No additional requirements beyond those of the base contract.

SECTION D - PACKAGING, MARKING, AND SHIPPING

No additional requirements beyond those of the base contract.

SECTION E - INSPECTION/ACCEPTANCE

No additional requirements beyond those of the base contract.

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. TASK ORDER PERIOD OF PERFORMANCE

a. The anticipated period of performance of this TO is three months.

ARTICLE F.2. TIME OF DELIVERY

No additional requirements beyond those of the base contract.

SECTION G - CONTRACT ADMINISTRATION

ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

a. The following Contracting Officer's Representative (COR) shall represent the Government for the purpose of this TO: TBD

b. All other terms and conditions of the base contract ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR) shall be considered to apply to this TO.

ARTICLE G.2. KEY PERSONNEL

a. The following individuals are considered to be essential to the work being performed hereunder for this TO:

Name Title Principal Investigator Senior Research Scientist Program Manager

b. All other terms and conditions of the base contract ARTICLE G.2. KEY PERSONNEL shall be considered to apply to this TO.

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND

CONTRACT FINANCIAL REPORT

a. Invoice Submission

The Contractor shall submit invoices in accordance with INVOICE INSTRUCTIONS FOR NIH FIXED-PRICE CONTRACTS, NIH(RC)-2, which are incorporated in the base contract and attached for reference.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

No additional requirements under SECTION H beyond those of the base contract.

SECTION I – GENERAL CONTRACT CLAUSES

No additional requirements beyond those of the base contract.

SECTION J – LIST OF ATTACHMENTS

No additional attachments beyond those of the base contract.

END OF SCHEDULE