STATEMENT_OF_WORK.NINR.RESOURCE.CTR..doc

RFP No. HHS-NIH-OLAO-263-(NINR)-2017-NR

ATTACHMENT #1: STATEMENT OF WORK

February 13, 2017

BACKGROUND

As part of its overall research mission, the National Institute of Nursing Research (NINR) conducts basic and clinical research on the interactions among molecular mechanisms underlying a single symptom or cluster of symptoms and environmental influences on individual health outcomes. It encompasses the individual variability inherent in symptoms associated with digestive disorders, cancer related fatigue, traumatic brain injury, and post-traumatic stress disorders as well as clinical interventions to alleviate these symptoms.

The Office of the Clinical Director (OCD) manages the intramural clinical research program. A goal of the OCD is to coordinate resources to facilitate high quality as well as safe and efficient research protocols.

PROJECT DESCRIPTION

The purpose of the proposed contract is to establish a Resource Center to assist the NINR Division of Intramural Research (DIR) with specific research process tasks.

Independently, and not as an agent of the Government, the Contractor shall provide all necessary personnel, facilities, supplies and services (except for those to be furnished by the Government as specified) to perform the work required by this contract as set forth below. Specifically, the contractor, in collaboration with NINR staff, shall perform the following tasks:

TASKS:

Task 1. Protocol Navigation

The Resource Center shall participate with the Principal Investigators (PIs) of the NINR in the design and development of clinical protocols, consent, and regulatory documents for all studies approved for Resource Center support by the NINR OCD. The Resource Center shall revise these protocols and regulatory documents as necessary for completion of the study, including responding to recommendations from the Institutional Review Board and any Independent Monitoring Committees or Data and Safety Monitoring Committees. Specifically, the Contractor shall:

a. Participate with all study investigators to develop documents in support of the clinical protocol, consent and regulatory activities.

b. Assist study investigators with the development and submission of communications (memos, submissions, reports, conference calls, etc.) necessary for completing all steps in the protocol review and regulatory processes within the applicable deadlines.

c. Assist study investigators with the development and submission of supplementary documentation (safety reports, protocol deviations, adverse events, etc.) to the appropriate Institutional Review Board, Independent Monitoring Committee and other oversight bodies.

d. Assist study investigators with the development and submission of communications (memos, submissions, reports, conference calls, etc.) with outside study sponsors and collaborators including adherence to Material Transfer Agreements (MTAs), Cooperative Research and Development Agreements (CRADA)s and other agreements.

e. Prepare regulatory documentation for submission to the Food and Drug Administration (FDA) and other regulatory agencies as necessary.

f. If requested by the OCD, provide training to NINR DIR staff about the process of protocol navigation.

g. Provide logistical support for study meetings when necessary.

CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. To fulfill this task, the contractor must have:

--Expertise in research protocol development, writing, and revision

--Past experience includes submissions of a similar type spelled out under this task.

--Expertise in regulatory requirements for the Food and Drug Administration and other regulatory agencies

Task 2. Development of Manuals of Procedure, Study Forms, and Procedures

The Resource Center shall participate with the PIs and OCD in the design, development and revision of detailed manuals of procedures and data forms for studies approved for Resource Center support by the NINR OCD. Specifically, the Contractor shall:

a. Participate with study investigators to develop and revise selected study manuals, forms and procedures.

b. Assist study investigators to develop an on-site subject recruitment plan.

c. Assist study investigators to develop publicity materials to improve patient recruitment.

CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. To fulfill this task, the contractor must have:

--Expertise in research protocol development, writing, and revision

--Past experience includes development of materials of a similar type spelled out under this task

--Expertise in participant recruitment efforts for research protocols

Task 3. Study Monitoring and Communications

The Resource Center shall be responsible for monitoring selected NINR studies for problems and deviations and shall notify the NINR OCD about these problems and deviations. Specifically, the Contractor shall:

a. Create a monitoring plan and schedule for selected NINR DIR studies.

b. Monitor adherence of NINR DIR to protocol and Institutional Review Board requirements and update the NINR OCD of the results through monitoring reports and at planned meeting times.

c. Identify any trends in protocol non-adherence among NINR DIR protocols and update the NINR OCD of these results at planned meeting times.

CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. To fulfill this task, the contractor must have:

--Expertise in quality assurance and protocol audits and monitoring.

--Past experience includes monitoring clinical research studies

Task 4. Data Analysis

The Contractor shall prepare analyses of all data requested by the NINR OCD. Specifically, the Contractor shall:

a. Prepare detailed analyses of accumulated data for Data Safety Monitoring (DSMB) Committees and Independent Monitoring Committees to monitor the study for adverse and beneficial treatment effects at intervals determined by that committee. These analyses shall assess positive and negative aspects of the effectiveness of any treatments under study.

b. In collaboration with the NINR OCD or Monitoring Committees, review the database for possible analyses to aid in monitoring or improving the quality of the data including data capture, analysis and reports.

c. Prepare a proposed schedule of analyses required for obtaining data for publishing results for selected approved studies.

d. After approval by the NINR OCD, generate statistical analyses as suggested by the NINR DIR study investigators, NINR OCD, and NINR Monitoring Committees.

e. Prepare statistical analyses for publication of study data in conjunction with study investigators.

CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. To fulfill this task, the contractor must have:

--PhD prepared Biostatistician, or a Master’s prepared Biostatistician with a PhD Biostatistician for oversight

--Expertise working with Safety Monitoring Committees Task 5. Data Reporting

The Contractor shall assist, if so requested, the study investigators in the preparation of the following:

a. After NINR OCD approval, the Contractor will assist with the preparation and entry of data and publications into national databases (e.g. PubMed, National Library of Medicine, ClinicalTrials.gov) as well as NIH administrative databases.

CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. To fulfill this task, the contractor must have:

--Expertise working with national databases, specifically expertise with ClinicalTrials.gov entry for FDA Amendments Act (FDAAA) reporting

Task 6. Management and Quality Control

The Contractor shall develop methods, in conjunction with the Project Officer, for evaluating its own quality control procedures for various aspects of the data monitoring procedures. The Contractor shall conduct this work in a cost-effective and prudent manner and in accordance with high professional standards.

a. The contractor shall conduct periodic internal audits of procedures and performance for data monitoring activities.

CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. To fulfill this task, the contractor must:

--No certifications required. This task will be a deliverable to the vendor awarded the contract.

--Provide a plan detailing management of contractor personnel and quality of procedures and performance of data monitoring activities.

Task 7. Reporting Requirements / Deliverables

In addition to the progress reports that are required by the tasks already outlined in this Statement of Work, the Contractor shall submit the following reports to the Contracting Officer Representative and the OCD in an electronic format:

a. A brief progress report shall be furnished at the end of each quarter describing the work performed during the reporting period, problems encountered, cost by protocol name and number (if assigned), principal investigator, and anticipated activities. The reporting period shall consist of the first full three months of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. A Quarterly Progress Report is not required when an Annual or Final Report is due.

b. The Contractor's activities shall be reviewed by the COR after each quarterly report and priorities shall be established.

c. A comprehensive annual report shall be submitted that consist of the following:

i. A summation of the previously submitted progress reports.

ii. A description of the work performed since the last quarterly report, problems encountered, cost by protocol name and number (if assigned), principal investigator, and anticipated activities.

iii. Rationale and supporting data for the recommended continuance of any clinical trials, natural history, and outcomes research.

iv. The reporting period shall consist of the first full twelve months of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of twelve full calendar months. An Annual Report is not required when the Final Report is due.

d. The Final Report shall consist of the work performed and results obtained for the entire contract period of performance, including the following:

i. A description of the work performed for the duration of the contract, cost by protocol name and number (if assigned), principal investigator, and results obtained.

ii. A discussion of the problems encountered in meeting contract objectives along with suggested solutions, and recommendations for future research and development in the design of new natural history studies, clinical trials, outcomes research, and epidemiologic studies.

iii. The Final Report shall be submitted electronically to the COR and Contracting Officer no later than the completion date of the contract.

The following are examples of some of the tasks described in the Statement of Work above for which the contractor shall report progress: development of protocols, consents, and regulatory documents; development of manuals, study forms and procedures; data analysis; study monitoring, data reporting; and development and distribution of publicity for patient recruitment.

CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. To fulfill this task, the contractor must:

--No certifications required. This task will be a deliverable to the vendor awarded the contract.

Protocol Support (On-Site)

Approximately twenty (20) studies may be conducted simultaneously, including Clinical Trials as well as Natural History and Evaluation/Treatment studies. The level of support for each trial will be approved by the NINR DIR OCD.

DELIVERY SCHEDULE

Overall

Overall Kick-off meeting

Task Order Management Plan – Plan for development and submission of tasks 1 - 7 Within 15 days after award

Draft – within 15 days of work start, Final – within 30 days of work start

All Tasks

All Tasks