RFP_N01DA-14-2237_Data _Statistics _and_Clinical_Trial_Support_for_NIDA_(DSC4).pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: P.L. 102-321 as amended

2. Request for Proposal (RFP) Number:

N01DA-14-2237

3. Issue Date:

01/10/2014

4. Set Aside:

[ ] No

[X] Yes See Part IV Section L

5. Title : Data, Statistics, and Clinical Trial Support for NIDA (DSC4)

6. ISSUED BY:

NIDA R&D Contracts Management Branch Office of Acquisitions National Institute on Drug Abuse National Institutes of Health 6001 Executive Boulevard Suite 4211 MSC 9559 Bethesda, Maryland 20892-9559

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3 pm EST local time on 02/24/2014. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." The OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the Rockville address provided for the OFFICE OF ACQUISITIONS in Attachment #1.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR Clause 352.215-70, "Late Proposals and Revisions"

LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Ryan C. Cleary, Contract Specialist

PHONE: 301.443.6677

e-MAIL: clearyrc@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Kenneth E. Goodling Contracting Officer NIDA R&D Contracts Management Branch Office of Acquisitions, NIDA http://www.sam.gov

RFP Number : N01DA-14-2237

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NOTICE OF SMALL BUSINESS SET-ASIDE

c. NAICS CODE AND SIZE STANDARD

d. TYPE OF CONTRACT AND NUMBER OF AWARDS

e. TASK ORDERS UNDER SINGLE AWARD INDEFINITE DELIVERY CONTRACTS

f. ESTIMATE OF EFFORT

g. COMMITMENT OF PUBLIC FUNDS

h. PROMOTING EFFICIENT SPENDING

i. COMMUNICATIONS PRIOR TO CONTRACT AWARD

j. RELEASE OF INFORMATION

k. PREPARATION COSTS

l. SERVICE OF PROTEST

m. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

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8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. Past Performance Information

14. Information and Physical Access Security

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

Registration and Results Reporting for Applicable Clinical Trials in ClinicalTrials.gov

5. Obtaining and Disseminating Biomedical Research Resources

6. Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. HUBZone Small Business Concerns

7. Total Compensation Plan

8. Other Administrative Data

9. Qualifications of the Offeror

10. Subcontractors

11. Proposer's Annual Financial Report

12. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. TECHNICAL EVALUATION CRITERIA

4. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

5. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS, IF NECESSARY, AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall provide resources to support NIDA in its goal of conducting clinical trials to test the effectiveness of new science-based drug abuse treatments in community settings.

ARTICLE B.2. PRICES/COSTS

a. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $500,000 (minimum) nor more than a total of $21,500,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period July 3, 2014 through July 2, 2019.

c. The Government will issue Task Orders based on the work described in SECTION C of this contract.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. I. Background Information and Objectives

A. Background Information

The National Institute on Drug Abuse (NIDA) was established in 1974, and in 1992 it became part of the National Institutes of Health, Department of Health and Human Services. NIDA's mission is to "…lead the Nation in bringing the power of science to bear on drug abuse and addiction." NIDA supports over 85 percent of the world's research on the health aspects of drug abuse and addiction. NIDA-supported science addresses the most fundamental and essential questions about drug abuse, ranging from the molecule to managed care, and from DNA to community outreach research.

NIDA conducts single and multi-site clinical trials through grants, contracts and cooperative agreements in sites located across the nation and in other countries. These are usually studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous, clinical trials to determine efficacy, effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations and to transfer research results to physicians, clinicians, providers, and patients. These studies could be Phase I, Phase II, Phase III, and/or Phase IV type trials. They may also include registry type trials or surveys.

NIDA is currently looking for a data and clinical research organization to support and provide resources in managing and carrying out multiple trials in drug abuse research. We are seeking a Contractor to provide support for systems, procedures, and expertise in data management, statistical support, and information support and services. The systems will be used to support data collection, data analysis, document management, information exchange, scientific discovery efforts and clinical evaluation of promising new anti-addiction therapies and companion behavioral interventions in order to further NIDA's mission.

B. Objectives

The Contractor shall provide resources to support NIDA in its goal of conducting clinical trials to test the effectiveness of new science-based drug abuse treatments in community settings. The clinical trials performed will be Phase I, Phase II, and Phase III/IV medication trials and/or stage I/II and stage III behavior therapy trials. The studies will be carried out in multiple sites across the country in a variety of treatment settings. Activities will support the trials carried out under cooperative agreements, grants, or other funding mechanisms and expert consultation in clinical research.

II. Services to be Performed

A. Acronyms

AE - Adverse Event CCTN - Center for Clinical Trials Network (NIDA) COR - Contracting Officer Representative CRF - Case Report Form CTA - Clinical Trials Agreement CTN - Clinical Trials Network (RRTCs + CTPs + CCTN) CTPS - Clinical Trials Portfolio System DEA - Drug Enforcement Administration DSMB - Data and Safety Monitoring Board EC - Executive Committee (CTN) ECG - ElectroCardioGram EDC - Electronic Data Capture

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EHR - Electronic Health Record EMR - Electronic Medical Records FDA - Food and Drug Administration GC/MS - Gas Chromatography / Mass Spectrometry GCP - Good Clinical Practice GLP - Good Laboratory Practice HCV - Hepatitis C Virus HHS - U.S. Department of Health and Human Services HIPAA - Health Insurance Portability and Accountability Act HIV - Human Immunodeficiency Virus IND - Investigational New Drug IRB - Institutional Review Board LI - Lead Investigator MedDRA - Medical Dictionary for Regulatory Activities NDA - New Drug Application NIDA - National Institute on Drug Abuse NIH - National Institutes of Health NLM - National Library of Medicine PI - Principal Investigator PRB - Protocol Review Board QA - Quality Assurance RFP - Request For Proposal RTC - Regional Research and Training Center SAE - Serious Adverse Event SC - Steering Committee (CTN) SOP - Standard Operating Procedure STD - Sexually Transmitted Disease SUD - Substance Use Disorder

B. General Requirements

1. Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services (except as otherwise specified herein) and perform the work set forth below.

2. The Government Contracting Officer's Representative (COR), whose position is defined in Section G of this contract, will monitor all work under this contract.

3. The Contractor shall work closely with other NIDA Contractors to coordinate efforts and cooperate in all areas to maximize efficiency and effectiveness. This contract does not obligate NIDA to acquire all services described herein from this contract exclusively. Once NIDA has ordered the minimum amount as set forth in SECTION B, NIDA is not obligated to make additional purchases for services under this contract.

4. Transition Period - If a transition period is necessary to provide an orderly transition to a subsequent Contractor, the work to be performed during the last 90 days of the task order period of performance will consist of the following:

a. At least 90 days prior to the completion date of a task order, the incumbent Contractor shall submit to the COR and designee(s) a written transition plan that will ensure a secure and orderly transfer of all contract-related materials to a successor Contractor or the Government. This plan shall include provisions for transferring all computer files, computer programs including all source codes, study supplies, records, and all written documentation for all studies and for general operating procedures. The plan shall also include providing detailed instructions for employees of the new Contractor on the operation of each information management system, as well as on particular study records and datasets.

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b. During the first 60 days of the transition phase, the incumbent Contractor is expected to perform all the tasks at 100% effort while working closely with and familiarizing the new Contractor with the tasks. During the last 30 days of the transition phase, the incumbent Contractor will scale down its effort to 25% level before the contract ends. At the end of the contract period, all records, supplies, computer files and source code, software and programs developed under this contract, and any other related materials will be turned over to the COR and his/her designee(s).

C. Specific Requirements

For proposal purposes only: The following is a more detailed description of the tasks that will be assigned to the Contractor under this contract, although all these tasks may not be carried out necessarily in every year. The Contractor shall not perform any work for the Government unless authorized by an appropriately awarded task order.

The minimum amount of services that may be ordered under this contract is valued at $500,000. The maximum amount of services that may be ordered under this contract is valued at $21,500,000.

The Contractor shall perform the following tasks as specified in each task order (offerors should address each task (1-7) listed below in their technical proposal):

Task 1. Establish and administer systems for the collection, management and storage of study data

This includes the following subtasks:

a) Establish and maintain state-of-the-art, efficient, reliable, responsive and secured electronic, web-based systems for the collection, storage, management, quality assurance and reporting of all study data, including data extracted from CRFs in a foreign language (e.g. Spanish) with foreign language data dictionaries. Entry and editing of study data shall be in real time. Data collection systems shall be electronic and web-based. An interactive voice response system or comparable technology for centralized randomization shall be available for the clinical trials.

b) Establish and maintain a secured and automated computer system for data query resolutions between the Data and Statistics Center, the Lead Investigator (LI) team and the participating trial sites.

c) Establish and administer a web-based document management system for secure electronic communications.

d) Maintain computer software and hardware necessary to process, store and analyze data furnished by the clinical trial sites.

e) Provide the Clinical Coordinating Center and other NIDA contractors or grantees with data needed for Investigational New Drug (IND) applications, resolution of Adverse Events, and Serious Adverse Events reporting.

f) Establish and maintain an appropriately staffed toll-free telephone service for providing to participating site staff technical support related to the use of data management, randomization and communications systems. This technical support should be available from 8:00 AM (Eastern Time) to 8:00 PM Eastern Time) Monday through Friday, 5 days a week, excluding holidays.

g) Participate in study orientation and study closeout meetings for research staff and site investigators.

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h) Provide training (and retraining as necessary) to clinical site staff on data acquisition, transfer, verification and editing, other basic data management procedures, and data-related protocol procedures as outlined in the study protocols and manuals of operations.

i) Develop the electronic Case Report Forms, assessments, and necessary trial instruments;

obtain copyrights when necessary; pay user fees if applicable; distribute data collection instruments and manuals to participating sites as needed.

j) Conduct discussions prior to initiating programming of data bases for new trials with the Lead Investigator, NIDA, and other key personnel. Discussions will be held at NIDA, at the offeror's facility or other location to be determined. These discussions will serve as a 'walk through' for each new NIDA trial to see how the data and statistical processes and the project flows in the real world and to assure that there are no major workflow issues. A second purpose would be to problem-solve potential issues, proactively, before the database is moved into production (all programming complete). Individuals involved in these discussions would review the CRFs and other EDC systems to:

• Determine each variable, is it worded correctly;

• Look at the responses, are these the only responses;

• Assess possible ranges and values;

• Review instructions to the research staff and patient;

• Consider missing codes;

• Decide what to query;

• Agree on skip logic;

• Identify critical variables;

• Look at the sequence of questions and answers, position of buttons, etc.

• Focus on reducing participant (patient) burden and the site burden by reducing the number of CRFs and questions where possible

The Contractor shall identify CRFs prior to these discussions. At the end of these discussions, there shall be sign-off, without editing, amending, or revisions to the entire CRF/EDC package.

The Lead Node is expected to have a DSMB and NIDA approved protocol and approved CRF prior to the discussion date. The protocol shall be well-defined with a comprehensive understanding of exactly what data is being collected and the primary and secondary endpoints that will be analyzed.

k) Maintain confidentiality and security of all data files and documents (hard copy as well as electronic) produced in fulfilling all tasks specified in this Statement of Work.

l) Prepare a complete, final, cleaned, edited and documented data set containing all study data, upon completion of each study and deliver it in electronic form to:

- the Lead Investigator

- the COR and designee(s)

- the NIDA Clinical Data Repository

m) Maintain a subscription for the Medical Dictionary for Regulatory Activities (MedDRA), and code all adverse events according to the MedDRA coding scheme.

n) De-identify each trial's final database for public use (e.g. according to HIPAA), and handle database requests from the public (see the NIH's public data sharing policy website at http:// grants.nih.gov/grants/policy/data_sharing/). Transfer the databases, along with corresponding documentation (data dictionary, protocol, Case Report Forms) to NIDA's Data Share for posting. Create and maintain a public website to house the completed databases if needed.

o) Periodically review and update policy and guidance documents on data management, in collaboration with the COR and disseminate to all members involved in data management.

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Task 2. Assist in the design of trials, provide support for protocol development and perform statistical analyses

This includes the following subtasks:

a) Develop in collaboration with Lead Investigators, the statistical sections of protocols, including study design, randomization and stratification methods, power and sample size calculations, interim monitoring and analysis plans, and data analytic plans.

b) Work closely with Lead Investigators to determine the most appropriate and effective approaches for analyzing the data to address specific issues related to the objectives of each study.

c) Perform data analyses in collaboration with Lead Investigators or designees and according to the protocol.

d) Establish and maintain, for the randomization of participants:

- a central computerized system that generates random assignments, based on various randomization methods (e.g. simple, stratified, block or adaptive);

- appropriate safeguards against tampering with the random sequences;

- an appropriate back-up system in case of computer failure;

- an automated system (e.g. telephone, web site) that informs the clinical site of participants' assigned treatment arm.

e) Assist in preparing protocol-related documents such as data management plan, design and analytical plan, and data and safety monitoring plan (including an interim analysis plan), following a standard protocol template; and in preparing the sections of Final Study Reports related to data management and statistical analysis.

f) Prepare materials related to data management and statistical analysis for protocol reviews by the Protocol Review Board (PRB) and DSMB.

g) Develop and update the sections for all study operations manuals that are related to data management and statistical analysis, including corresponding amendments.

h) Work closely with Lead Investigators in the reporting of trial results and the preparation and writing of scientific reports and manuscripts for publication. Every attempt should be made to follow the CONSORT (Consolidated Standards of Reporting Trials) guidelines (see for example Altman et al. in the Annals of Internal Medicine, Volume 134, Number 8, 17 April 2001, pages 663-694).

i) Develop and review general design and analysis guidelines that would be helpful to future Lead Investigators and their teams.

j) Provide one or more experienced biostatisticians (with a Ph.D. in statistics and experience in statistical design and analytical methods for clinical trials) to be on call (within 48 hours) to respond to ad hoc inquiries made by the COR and designee(s).

Task 3. Review and monitor the quality of study data

This includes the following subtasks:

a) Develop and manage a computerized data monitoring system that executes quality assurance and quality control procedures to evaluate and, when necessary, improve the accuracy, timeliness and completeness of data submitted by the clinical sites, including verification of the clinical and laboratory data used to determine that study participants have reached protocol-defined endpoints.

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b) Perform ongoing data checks and data error resolutions. Create daily and monthly reports for each trial to track the quality of the data, number and type of errors, originator of queries, query resolution, dates of queries, etc. These reports will be shared with the COR and Lead Team for each trial.

c) Provide input to NIDA's Clinical Coordinating Center and other relevant contractors that will help identify issues to be pursued during site visits, and that will facilitate the monitors' data verification efforts.

d) Develop a system to keep track of incoming Help Desk calls. Create a monthly tracking report by trial which will be distributed to the COR and Lead Team for each trial. Periodically assess the incoming calls and recommend changes to the data base, CRFs, training of trial staff, etc. in order to use this information for performance improvement.

Task 4. Monitor trial performance and progress

This includes the following subtasks:

a) Submit trial progress reports for each trial to the COR and designee(s). These reports will track the lifecycle of each study from concept generation, through protocol development, review, approval, and participant accrual, to final closeout and publication of main results. The reports should be updated on a daily basis for every study. More specifically, these reports will include the following trial progress indicators (by site and overall), as well as others that may be determined to be worth tracking:

- Basic protocol information and timeline

- Expected and actual randomizations

- Data quality based on queries

- Data quality based on data audits

- Significant issues from trial monitoring visits

- Regulatory issues

- Availability of primary outcome measure(s)

- Treatment exposure

- Attendance at follow-up visits

- Other protocol implementation issues

The NIDA Clinical Coordinating Center will provide some of the information needed to populate the reports.

b) Inform in a timely manner the COR and designee(s) of protocol implementation issues related to data management or statistical plan that are causing important delays or unexpected expenses, and provide suggestions on how to resolve them.

c) Particpate, in collaboration with Lead Investigators, in all protocol discussions with study coordinators and site research staff to discuss and resolve issues related to data management and statistical analysis, and serve as liaison between the LI team and NIDA's Center for the Clinical Trials Network (CCTN) staff or other NIDA division personnel. These discussions occur during the entire lifespan of each protocol, including protocol development, implementation, closeout and analysis/reporting stages.

Task 5. Prepare reports and hold meetings for the Data and Safety Monitoring Boards (DSMB)

This includes the following subtasks:

a) In collaboration with the Clinical Coordinating Center, prepare and present to the DSMB, safety, data integrity and site performance reports, which include information on, analysis of, and problems and concerns associated with:

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- Accrual and retention;

- Safety;

- Adverse Events (AEs) and Serious Adverse Events (SAEs);

- Outcome measure results;

- Availability of primary outcome measure(s);

- Treatment exposure;

- Attendance at follow-up visits.

Recommendations for improvement and resolution should also be included.

b) Design, perform and present to the DSMB interim analyses that are planned and described in the protocol. It is important that a firewall within the Data and Statistics Center be established between the statistician who reports to the DSMB (un-blinded) and the one who collaborates with the Lead Investigator on design and implementation issues (blinded).

c) Provide support for the Data and Safety Monitoring Board (DSMB) Meetings. The DSMB is an independent expert board that oversees and monitors the conduct of clinical trials to ensure the safety of participants and the validity and integrity of trial data. DSMBs will typically include 6-8 board members, selected by NIDA, and will meet approximately once per protocol each year of the contract. Meetings will be called by the NIDA COR and are expected to be held in the Washington, D.C. area. The DSMB Meetings include:

• Logistical and operational support - confirming meeting space and audiovisual requirements, agenda preparation (with input from NIDA staff), preparation and distribution of meeting materials, note taking, and distribution of meeting summaries.

Meetings are anticipated to be held at NIDA or at Contractor's facility, thereby limiting meeting costs. In some cases meetings will be held using virtual meeting technology.

• Participant support - preparation and delivery of meeting invitations, meeting logistical letters, and attendance confirmation requests to all meeting participants (six to eight board members plus eight to ten additional meeting participants); providing honorarium (up to $250 per day), travel, and per diem expenses for non-Federal board members.

d) Attend all DSMB meetings.

Task 6. Participate in relevant committee and subcommittee meetings and conference calls

This includes the following subtasks:

a) Commit one senior staff member (and an alternate) with extensive experience in data management and analysis of clinical trials data, to represent the Data and Statistics Center on the CTN Steering Committee, and to participate in all Steering Committee face-to-face meetings (about two times a year) and conference calls (about once a month) if needed.

b) Commit staff members to participate in all activities of relevant CTN committees, subcommittees and workgroups as needed.

Task 7. Provide other expert consultation and support services

The Contractor shall provide expert staff, subcontractors and/or consultants will be required to provide expertise in certain fields, and that the Contractor will need to make agreements with them at the direction of the COR. These consultants, as requested by the COR, may be needed to perform additional services relating to study design and analysis, compiling and editing of clinical data, and other services related to clinical trials operations that might be required but not yet identified. Some of these tasks may include:

a. Support for EHR/EMR Project

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Provide a variety of support for medical record development for a consensus-based, standardized core set of common data elements (CDEs) on drug use disorders to support clinical decision support, clinical performance measures, and interoperability in vendor electronic (EMR) products and SUD clinical research. NIDA's efforts to develop CDEs for substance abuse have been directed first to developing a hierarchy for domains, sub-domains and core questions, which have then been reviewed at workshops and symposia to obtain feedback by experts in clinical care and clinical research across a broad range of stakeholders in the federal government, state government, community treatment providers, large health care providers, primary and specialty care practitioners as members of various professional organizations, and vendors of electronic medical record products. Future efforts will likely follow similar lines, but may require efforts to field test the proposed EMR or CDEs.

b. Common Data Elements

NIDA EHRs Common Data Elements development team will continue collecting transforming questions and permissible values sets used on case report forms used in the NIDA trials into metadata CDEs. These CDEs will be expert generated and consensus based and will be housed in the NCI's Cancer Data Standards Repository (caDSR), a metadata database built to conform with ISO-11179, the international standard for the creation, storage, and transfer of metadata. The CDE development team also works to standardize the proposed question text and/or permissible values to meet identified standard reporting requirements to limit the variability of questions and increase the data aggregation potential. The Team then creates metadata representations of each CRF in the caDSR Form Builder tool, providing users with a programming interface to allow content to be downloaded and used to build either the frontend or backend database for the electronic data capture system.

NIDA has developed a panel of core data elements for research, including clinical trials, grants, and epidemiological studies. Preparation of CRFs to capture these core data elements either as a separate series of CRFs or embedded within trial/study specific CRFs will be included. The Core Data Elements will be taken from common data elements housed on the PhenX website and include from 20-160 items including demographics; body mass index;

quality of life; HIV risk status; tobacco use; alcohol use; substance use; socioeconomic status;

family history for nicotine, alcohol, and substances; co-morbidity, peer/partner use; and social networks.

c. General Consultant Services

Provide general and scientific consultation, across various disciplines in areas such as development of best practices, design of pre-clinical and clinical studies, identification of scientific gaps and medication development.

D. Task Orders for Proposal Evaluation

For purposes of proposal preparation, offerors are to provide a technical proposal and cost estimates for each of the four types of task orders described below. NIDA has divided clinical trial support into four types: Type A, Type B, Type C and Type D. Type A involves protocol development after a concept has been reviewed for development. Type B involves clinical trial support after a protocol is approved for implementation. Type C involves expert consultation and support services. Type D involves administrative and concept support services. The types summarized below are general descriptions of task orders that NIDA anticipates ordering under the contract. However, throughout the ordering period of this contract, task orders may involve one or more of the tasks (1-7) described above and are not limited by the types (A, B, C and D) described below.

1. Task Order Sample of Type A - Protocol Development

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The Contractor shall provide support for protocol development after a concept has been approved for development. Protocol development support shall proceed to the point right before database development. This support shall include identification of CRFs, design of study, expertise that may be needed by the Lead Team, securing copyrights to assessments when necessary, attending meetings related to the development of the study, attendance at the Protocol Review Meeting, etc. This task order shall require the Contractor to perform services described in Tasks 1 - 6 above. The offeror will demonstrate their understanding of this task by describing the work needed to be performed from the Tasks 1-6 above. Samples of previous studies and assessments (CRFs) can be found on the NIDA CTN Data Share at http:// www.ctndatashare.org/.

For Task Orders of Type A, offerors may assume, for proposal preparation purposes that this task order requires 4,250 hours of effort for the tasks indentified above and shall be performed over a period of one year. Additionally, offerors may presume as it relates to Task 1, subtask g, that there will be one 3-day investigator training prior to the initiation of each clinical study. These meetings will be held in the Washington, D.C. area. Staff from the DSC will attend these meetings and offer training on data base procedures, randomization, query resolution, Help Desk, and other data-related procedures as outlined in the protocol and manual of operations. The offeror would make data base training related materials available to each participant at these meetings. Offerors may assume 100 participants at these investigator trainings.

Also, for proposal purposes, offerors may presume as it relates to Task 5, six 1-day DSMB meetings per year in the Washington metropolitan area. Offerors may also presume as it relates to Task 2, subtask f, that there will be one 1-day PRB meeting.

Furthermore, the offeror may assume as it relates to Task 6, that there will be one face-to-face meeting and 48 calls per protocol per year.

2. Task Order Sample of Type B -Clinical Trial Support

This task order requires services after the concept and protocol development stage, and CRFs have been identified, the Contractor shall develop an electronic system for capturing study clinical data. The time line will include the entire recruitment period, data base closeout procedures, data lock, statistical analysis, support for the final report to NIDA and the primary outcome paper. In addition, 18 months after data lock or upon acceptance of the primary outcome paper for publication, the Contractor shall prepare a de-identified data set, along with annotated CRFs, final protocol, and data dictionary. Each task order shall include a trial that has completed protocol development and review. Each trial shall involve preparation of sites and procedures, actual patient recruitment and creation and collection of data, data analysis, publication, and dissemination stage. This task order shall require the Contractor to perform services described in Tasks 1 - 6 above. The offeror will demonstrate their understanding of this task by describing the work needed to be performed from the Tasks 1-6 above. Samples of previous studies and assessments (CRFs) can be found on the NIDA CTN Data Share at http://www.ctndatashare.org/.

Offerors may assume, for proposal preparation purposes that each task order will require 6,500 hours of effort over a period of two years with an average of 10 participating clinical trials per trial, 60 randomized participants per site, 50 CRFs per protocol averaging three pages of data for each form. Due to the confidentiality of the protocol developed by the Lead Investigator, the actual study documents shall not be made available for each task order in the first year of performance.

Additionally, for proposal preparation purposes, offerors may presume as it relates to Task 1, subtask g, that there will be one 3-day investigator training prior to the initiation of each clinical study. These meetings will be held in the Washington, D.C. area. Staff

- 14 -from the DSC will attend these meetings and offer training on data base procedures, randomization, query resolution, Help Desk, and other data-related procedures as outlined in the protocol and manual of operations. The offeror would make data base training related materials available to each participant at these meetings. Offerors may assume 100 participants at these investigator trainings. Also, offerors may presume for proposal preparation purposes, as it relates to Task 5, that there shall be six 1-day DSMB meetings per year in the Washington metropolitan area. Offerors may also presume as it relates to Task 2, subtask f, that there will be one 1-day PRB meeting.

Furthermore, for proposal purposes, the offeror may assume as it relates to Task 6, that there will be one face-to-face meeting and 48 calls per protocol per year.

3. Task Order of Type C - Expert Consultation and Support Services

This sample task order requires services described in Task 7.

For Task Orders of Type C, offerors may assume, for proposal preparation purposes that each task order will require 700 hours of effort over a period of one year with an additional 500 consultant hours at a rate not to exceed $100 per hour.

4. Task Order of Type D -Administrative and Concept Support Services

This task order requires services to support preliminary research and discussions on new concepts up to approval for protocol development. It will also include support for administrative tasks such as report writing, invoicing, maintaining certifications, and other tasks necessary to support NIDA's mission.

NIDA intends to award a Task Order D at the time of contract award.

For Task Orders of Type D, offerors may assume, for proposal preparation purposes that each task order will require 2,000 hours of effort over a period of one year

b. The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, hardcopies of each report shall be submitted to the Contracting Officer, in accordance with Section F.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract http://www.hhs.gov/web/508/index.html

- 15 -award. The Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) 2-3 hard copies of these reports will be required as follows:

a. Quarterly Progress Report:

Quarterly progress reports shall be brief reports describing by task order:

- work accomplished during the period;

- progress on all trials/ projects

- planned activities for the upcoming period; and

- a description of any problems experienced during the month or anticipated in the upcoming period.

One (1) copy of this report will go to the COR and one copy to the Alternate COR within ten (10) days following the end of each contract quarter . The first reporting period consists of the first full three months of performance plus any fractional part of the initial month.

Thereafter, the reporting period shall consist of each three month quarter.

b. Annual Progress Report.

This report shall include a summation of the work accomplished under the contract for the period covered. An annual report will not be required for the period when the Final Report is due. A quarterly report shall not be submitted when an annual report is due.

c. Task Order Final Report

This report shall include a summation of the work accomplished under each issued task order. This will cover the entire period of performance for that task order. It should include highlights, issues and their resolution, recommendations or lessons learned, etc.

d. Final Contract Report

This report is to include a summation of the work performed for the entire contract period of performance. The Final Report shall be submitted in accordance with F.2. Deliveries of this contract. Quarterly and annual reports will not be required for the period when the Final Report is due.

2. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

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See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

3. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit the IT-SP within thirty

(30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit the IT-RA within thirty

(30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

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The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.

d. FIPS 199 Assessment

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

e. IT Security Certification and Accreditation (IT-SC&A)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

f. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.3.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

g. Contractor - Employee Non-Disclosure Agreement(s) The Contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information

- Contractor Agreement" form for each Contractor and subcontractor employee who…