ATTACHMENTs_1-8_(Solicitation_Atts.).pdf

Stat. and Data Coordinating Center (SDCC) for Clin. Research in Infectious Diseases ATTACHMENT 1 RFP-NIAID-DMID-NIHAI2013180 Packaging and Delivery

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Packaging and Delivery of the Proposal for Research and Development and Research and Development Support—for Use with eCPS

I. PROPOSAL SUBMISSION

A. The National Institute of Allergy and Infectious Diseases (NIAID) currently requires proposals to be submitted via two methods:

1. Disc (CD or DVD)

2. Online

Notes:

• Submission of proposals by facsimile or e-mail is not acceptable.

• Disc and online proposals must be exactly the same.

II. DISCS (i.e., CD or DVD)

A. Delivery Instructions:

If Hand Delivery or Express Service If using U.S. Postal Service

Mr. Frank Vidergar Contract Specialist Office of Acquisitions, DEA, NIAID, NIH 6700B Rockledge Drive, Room 3214, Bethesda, Maryland 20817-1824

Mr. Frank Vidergar Contract Specialist Office of Acquisitions, DEA, NIAID, NIH 6700B Rockledge Drive, Room 3214, MSC 7612, Bethesda, Maryland 20892-7612

1. Mark each package with the following items:

The solicitation number: RFP-NIAID-DMID-AI2013180

“TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY”

2. All material sent to this office by courier should be sent to the Hand Delivery or

Express Service address.

3. The U.S. Postal Service's "Express Mail" does not deliver to the hand delivered (20817 zip code) address. Any package sent to this address via this service will be held at a local post office for pick-up. The Government is not responsible for picking up any mail at a local post office.

4. Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in

Stat. and Data Coordinating Center (SDCC) for Clin. Research in Infectious Diseases ATTACHMENT 1 RFP-NIAID-DMID-NIHAI2013180 Packaging and Delivery

p. 2 of 4 the solicitation, it will be considered a “late proposal”, in accordance with FAR Clause 52.215-1 Instructions to Offerors – Competitive Acquisition.

B. Discs – Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. The Business Proposal must be comprised of the following files:

a. The first file must be a PDF of your Business Proposal, with all attachments, including the Solicitation Section J, Attachment entitled “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet.” The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned and merged into the Business Proposal PDF file.

b. The remaining file(s) must be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” in its original Excel format, not PDF.

Multiple Excel files may be included, as necessary.

3. A separate Disc must be submitted for the Technical Proposal and Business Proposal.

Offerors who submit both Technical and Business Proposals on the same Disc will be required to resubmit the proposals on separate Discs.

4. Each of the proposals, Technical and Business, must be separate and complete in itself, so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other.

5. File naming convention: It is required that the filenames for both your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number, and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

III. ONLINE SUBMISSION OF ELECTRONIC PROPOSALS

A. eCPS PROPOSAL SUBMISSION PROCESS.

1. In addition to discs, offerors are required to submit an electronic copy of proposals online through the NIAID electronic Contract Proposal Submission (eCPS) website at: https://ecps.niaid.nih.gov.

2. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: http://ecps.niaid.nih.gov/NIAID/home/howto http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls https://ecps.niaid.nih.gov/ http://ecps.niaid.nih.gov/NIAID/home/howto

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IV. FORMATTING, NUMBER OF COPIES, AND PAGE LIMITATIONS:

A. Formatting for discs and proposals submitted online through eCPS

1. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

2. Font size must be legibly 10 to 12 points.

3. Spacing should be legible and no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

4. Margins must be at least one-inch on all sides.

5. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in entirety. NIAID reserves the right to disqualify a proposal if it exceeds the stated page limit and font size.

B. Number of copies and applicable page limitations:

1. Total page count does not include: Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section.

2. Pages in excess of this limitation will be removed from the proposal and will not be considered.

NUMBER OF COPIES AND APPLICABLE PAGE LIMITATIONS

Document Number of Copies

Page Limits

Technical Proposal DISC (i.e., CD or DVD) One (1) Disc containing one electronic copy of the Technical Proposal (including all Attachments)

ONLINE (using the eCPS website) One (1)electronic copy of the Technical Proposal (including all Attachments)

Not to Exceed 175# pages (inclusive of all Attachments)

Business Proposal DISC (i.e., CD or DVD) One (1) Disc containing two files, as instructed in section II.B above.

ONLINE (using the eCPS website) One (1) submission containing two files, as instructed below.

1. One (1) electronic PDF copy of the

Business Proposal (with all Attachments including the PDF rendering of the

N/A

Stat. and Data Coordinating Center (SDCC) for Clin. Research in Infectious Diseases ATTACHMENT 1 RFP-NIAID-DMID-NIHAI2013180 Packaging and Delivery

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Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet).

2. One (1) Electronic Cost Proposal Excel Workbook See Solicitation Section J, Attachment entitled Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet to access the Excel Workbook. Microsoft Excel 2007 version or later is required.

http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls

ATTACHMENT 2 - PROPOSAL INTENT RESPONSE SHEET

RFP-NIAID-DMID-NIHAI2013180

RFP Title: Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

Please review the attached Request for Proposal. Furnish the information requested below and return this page by December 31, 2013. Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

[ ] DO INTEND TO SUBMIT A PROPOSAL

[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING

REASONS:

Company/Institution Name (print): ______________________________________ Address (print): _______________________________________________________

Project Director's Name (print): ________________________________________ Title (print): _________________________________________________________ Signature/Date: ________________________________________________ Telephone Number and E-mail Address (print clearly):

Business Representative Name: __________________________________________ Title: ___________________________________________________ E-Mail Address: __________________________________________ Telephone Number: _______________________________________

Names of Collaborating Institutions and Investigators (include Subcontractors and Consultants) (print):

(Continue list on a separate page if necessary)

RETURN VIA FAX OR E-MAIL TO:

OA, DEA, NIAID, NIH

6700-B Rockledge Drive, Room 3214, MSC 7612 Bethesda, MD 20892-7612

Attn: Mr. Frank Vidergar, Contract Specialist

RFP-NIAID-DMID-NIHAI2013180

FAX# (301) 402-0972

Email: vidergarf@niaid.nih.gov

Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases ATTACHMENT 2 RFP-NIAID-DMID-NIHAI2013180 Proposal Intent Response Sheet mailto:vidergarf@niaid.nih.gov

ATTACHMENT 3: STATEMENT OF WORK

Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

RFP-NIAID-DMID-NIHAI2013180

I. BACKGROUND and INTRODUCTION

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, medical devices and diagnostics, which are funded through a variety of research grants and contracts.

The evaluation of new and improved vaccine, device and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of DMID. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center clinical research and Phase 0 through 4 clinical trials evaluating bacterial, viral and parasitic vaccines, therapeutics, and other biologics, drugs, medical devices, and approaches as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. Support is also provided for a variety of other studies, examples include: targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. Clinical trials and clinical studies are also supported to evaluate the safety and efficacy of vaccines, medical devices and therapeutics for a wide variety of emerging and re-emerging infectious diseases (http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx), which includes NIAID Category A-C Priority Pathogens to meet critical public health needs.

This contract provides for the establishment and management of a Statistical and Data Coordinating Center (SDCC) to support DMID’s extramural clinical research programs through the provision of: statistical design and analysis expertise; computerized systems for the collection, storage, management, reporting and quality control of study data; assistance in the preparation of study-related materials; a system for the tracking of clinical specimens; data collection and management user training; clinical site capability assessment for data collection and management;

project/site management; and, a data repository for completed DMID-sponsored clinical studies.

The current SDCC contract was awarded under contract number HHSN272200800013C. The current 7-year contract was effective March 1, 2008 and provides centralized statistical and data management services essential to support a wide variety of DMID clinical research studies/trials across multiple infectious disease programs involving domestic/international sites.

II. SCOPE

The scope of activities to be performed by the Contractor shall encompass data management;

statistical design and analysis; clinical specimen tracking services support for clinical trials and clinical studies to evaluate the safety and efficacy of vaccines, devices and therapeutics for infectious diseases; and provision of clinical site training, assessment, and technical assistance.

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p. 1 of 12 http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx

III. TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work as stated herein, including the following system features and capabilities:

1. Data Collection and Management

The Contractor shall operate and maintain a state-of-the-art computer-based clinical data system for data collection, storage, tracking and retrieval. This system must be in place and fully operational within 60 calendar days from the effective date of the contract. The Contractor shall provide the following system features and capabilities:

a. Receiving, entering, verifying, labeling, processing, coding, editing (including within and across form validity, logic, and consistency checks), updating, correcting, freezing, locking, storing, securing, tracking, and retrieving all clinical and laboratory test results data at a central data management facility.

b. Compliance with all current applicable Federal regulations located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm and http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html (e.g., 21 CFR 11, 21 CFR 50, 56, 312, 612 and 812 as applicable, 45 CFR 46 and/or similar statutes), including U.S. Public Law 110-85 or the Food and Drug Administration Amendments Act of 2007, as well as local regulations as applicable.

c. Adherence to current globally-accepted standards, including the following:

1) International Conference on Harmonization (ICH) E2, Clinical Safety Data Management, ICH E3 Clinical Study Reports, ICH E6 Good Clinical Practice, located at:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesI nformationSheetsandNotices/ucm219488.htm.

2) Compliance with coding to M1 MedDRA Terminology and ICH M5, Data Elements and Standards for Drug Dictionaries, located at:

http://www.ich.org/products/guidelines.html.

3) Compliance with coding to the World Health Organization Drug Dictionary, located at http://www.who.int/medicines/services/medicines_etools/en/print.html protocol-specific requirements, and all applicable NIH/NIAID/DMID policies and procedures.

4) Compliance with current industry standards for clinical data management, current example – Clinical Data Interchange Standards Consortium (CDISC) located at:

http://www.cdisc.org. Provisions to maintain compliance with changing industry standards must be in place, at no cost to the Government.

d. Central computerized study subject registration and randomization, and non-computerized methods as needed on a limited basis for select study sites and as a backup process.

e. Computerized study forms and 21 CFR Part 11 compliant clinical data system for remote/direct data entry and transmission of subject data from study sites and laboratories to the central data management facility; non-computerized methods when necessary as designated by the Contracting Officer’s Representative (COR) and/or DMID staff designated by the COR.

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p. 2 of 12 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219488.htm http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219488.htm http://www.ich.org/products/guidelines.html http://www.who.int/medicines/services/medicines_etools/en/print.html http://www.cdisc.org/

f. Real-time electronic notification provided to designated DMID personnel in the event of data triggering pre-specified protocol criteria. This includes notification to relevant DMID staff on pre-specified schedule key elements of study status (e.g., enrollment, adverse events of special interest, etc.).

g. Provision of a system for off-line data entry, as necessary. Data may be transmitted at a later time when internet connection is available.

2. Data Quality Assurance and Control

a. The Contractor shall provide and maintain a quality control system for monitoring the accuracy, completeness and timeliness of the data entered into the SDCC clinical data system by study sites at each stage of a study beginning with study initiation/patient enrollment and proceeding to the generation of final data sets. The system shall have the following features and capacities and shall provide for verification of 100 per cent of study data:

1) Computerized validation and error-checking (e.g., range checks, user logics) to evaluate and improve the accuracy, timeliness and completeness of data submitted by the clinical sites.

2) Strategies to assure uniform standardized data collection and implementation of multi-center studies across participating clinical sites.

3) A computerized data query system to notify and request resolution from clinical and laboratory sites when aberrant and/or missing data are identified.

4) Periodic (at least annually) review and revision of manuals and procedures documenting data collection, editing and validation procedures and standards.

5) Evaluation of the quality of data generated in connection with the clinical studies/trials, with implementation of data quality improvement plans, as necessary.

b. Independent Audits – The Contractor shall undergo independent quality audits initiated by the Government for review of Contractor processes, procedures and operations at the Contractor’s central office to ensure regulatory compliance.

1) The COR will notify the Contractor of plans for independent audits with advance notice two weeks in advance of the scheduled audit. The Contractor shall ensure that designated staff and all necessary information/documents are available.

2) “For cause” audits may also be performed at any time and without advance notice to the Contractor in instances of non-performance and/or suspected non-compliance with federal and/or local regulatory requirements.

c. The Contractor shall develop a Quality Management Plan (QMP) to cover all contract activities, including a plan to identify any gaps. This initial plan and any updates shall be approved by the COR prior to implementation. The initial draft QMP shall be sent by the Contractor for COR review/approval within 30 days of the effective date of the contract.

The final initial QMP shall be finalized by the Contractor within 14 days of receiving comments from the COR on the draft document. The Contractor shall also provide performance reports from the QMP for approval by the COR on a schedule to be determined by the COR.

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3. Protocol and Other Study-Related Materials

The Contractor shall prepare materials (including revise, finalize and distribute) for the implementation of clinical trials and clinical studies, including electronic Case Report Form (eCRFs), Manual of Procedures (MOPs) and other study related materials as needed/requested by the COR.

4. Clinical Study Website(s)

Within 60 calendar days after the effective date of the contract, operate and maintain a website to share clinical research information and study materials with the DMID staff and participating study sites. This shall include the following:

a. The establishment, operation, maintenance and updating of a study-specific, password-protected website to access protocol information and real-time study data.

b. Updating the SDCC website documents and materials, including new or modified versions of website materials, during the course of a clinical trial/study and providing timely notifications to participating study sites to alert them about the availability of new or revised materials. In the future, documents will be posted on a NIAID-wide information system (currently under development).

c. The provision of real-time access by DMID and DMID-designated clinical site personnel to aggregate study data as well as by pre-specified search criteria for key study matrices.

Examples include accrual, adverse event and serious adverse event listings, protocol deviations, specimen tracking and inventory, missing forms, visit schedule compliance, data queries, site performance metrics and progress monitoring information/materials.

d. Grant access for DMID-approved users to the electronic website, data system and related study-specific materials. Develop a procedure for such access granting, monitoring, and revoking. Perform periodic (at least annually) review of users and remove inactive users.

5. Study Communication, Collaboration and Reporting

a. The Contractor shall coordinate and collaborate with DMID and other DMID clinical research support services contractors to facilitate study implementation, assess study progress and evaluate processes and procedures. This shall include coordination and collaboration with the: (i) DMID Clinical Research Operations and Management Support (CROMS) contractor responsible for pharmacovigilance (PVG) and other activities, including Serious Adverse Event (SAE) reporting and safety oversight, collecting essential documents, activating study sites, reporting of clinical trial/study data to ClinicalTrials.gov, clinical site monitoring and quality assurance services; (ii) DMID Regulatory Affairs Support and Clinical Agents and Specimen Repository contractors responsible for regulatory compliance and the receipt, storage and distribution/shipment of specimens; (iii) Clinical site personnel as designated by DMID; and (iv) NIAID-wide information system (currently under development).

b. Specifically, the Contractor shall perform the following:

1) Coordinate and collaborate with the DMID-CROMS contractor regarding the following:

a) Study initiation: Participate in study initiation meetings as needed with the relevant DMID staff and the DMID-CROMS contractor staff.

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b) Protocol-specific and site-specific randomization and data entry screens: Provide site personnel access to protocol-specific and site-specific randomization and the SDDC clinical data system following approval from the COR and/or DMID staff designated by the COR.

c) Non-serious and Serious Adverse Events: Compare and reconcile Adverse Events in the SDCC clinical data system with the separate DMID-CROMS pharmacovigilance (PVG) Serious Adverse Event (SAE) database. The Contractor shall develop an SOP to describe the process for such reconciliation in collaboration with the DMID-CROMS contractor, with a delivery schedule for the SOP and any updates determined by the COR and/or DMID staff designated by the COR. SAE reconciliation reports will be provided to the DMID-CROMS contractor as specified in the SAE Reconciliation Process SOP.

d) Study data that meets pre-specified protocol criteria: Provide reports in a timely manner to the DMID study team and/or other personnel as designated by the COR immediately after a study meets any pre-specified protocol criteria. This includes provision and maintenance of an alert table/system for notification to appropriate study team members, as determined by the COR and/or DMID staff designated by the COR.

e) Reports for Safety Oversight Structures: Generate and submit to the DMID-CROMS contractor reports for distribution to and review by study Safety Oversight Structures as specified by the clinical protocol, the safety charter and the Safety Oversight committees. The Contractor shall develop plans to meet the timelines necessary for DMID review and approval of such reports prior to the distribution to the DMID- CROMS contractor. Such reports will include ad hoc safety profiles of individual subjects.

f) Study site-specific reports: Generate site-specific reports for the DMID and the DMID-CROMS contractor. Examples of such reports include accrual, demographics, line-listings of AEs and SAEs, protocol deviations, data queries, timeliness of data submission, and response to queries for quality assurance purposes.

g) Reports to support clinical site monitoring: The SDCC clinical data system should include integrated features and functions in support of DMID-CROMS clinical site monitoring requirements as specified in the DMID’s study-specific clinical monitoring plan. At a minimum, the system should assist in subject selection, source data verification, manual monitor data query tracking, and data status reports for each study subject at each site. The system report features should also allow for analysis of deficiencies identified during data submission (e.g., out-of-range or out-of-window data) or during previous site visits. A system to provide reports to support clinical site monitoring requirements shall be in place and fully operational within 60 calendar days from the effective date of the contract.

h) Randomization and study products: Assess compliance with randomization and administration of study product.

i) Reports for the DMID-CROMS data system: The Contractor shall establish an electronic data exchange system to communicate and provide real-time information for the DMID-CROMS data system. This exchange system shall be due within 60 calendar days from the effective date of the contract. Related reports and data to be exchanged, as well as the timing of that exchange, will be determined by the COR and/or DMID staff designated by the COR. Examples of data exchange categories include safety, regulatory, monitoring, site performance metrics, protocol non-adherence and other protocol-specific data.

j) Data via electronic data exchanges system with the NIAID-wide information system:

The NIAID-wide information system (currently under development) will be a comprehensive system to support NIAID clinical research management and oversight responsibilities. The Contractor shall collaborate with NIAID/DMID to provide data transfer capabilities specified by the COR from the SDCC clinical data system into

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p. 5 of 12 this NIAID-wide information system. Related reports and data to be exchanged, as well as the timing of that exchange, will be determined by the COR and/or DMID staff designated by the COR. Any timeframe for SDCC implementation of related tasks will be specified by the COR.

k) Ad hoc reports. Provide real time ad hoc reports generated from the data system at the request of DMID personnel and/or DMID staff designated by the COR.

2) Coordinate and collaborate with the DMID Clinical Agents and Specimen Repository and

Regulatory Affairs Support contractors to perform the following.

a) Specimen tracking: Track information regarding date, time, inventory of study specimens collected at sites, courier service and timeliness of shipments to the repository maintained by the DMID Clinical Agents and Specimen Repository contractor.

b) Specimen inventory management: Generate specimen lists from the electronic specimen inventory and submit to the DMID Clinical Agents and Specimen Repository contractor to select and ship specimens to specified laboratories or other destinations as designated by DMID.

c) Regulatory reports: The Contractor shall provide the clinical data to finalize Clinical Study Reports, Annual Reports, http://clinicaltrials.gov/ results reporting and other reports at intervals designated by the COR and/or DMID staff designated by the COR to support the Regulatory Affairs Support contract.

3) As requested by the COR, participate in any annual meeting(s) of the contracts and grants supported by this contract.

4) Participate in periodic teleconferences and/or meetings with the COR and/or DMID staff designated by the COR to discuss the status of ongoing clinical trials/studies, identify and develop approaches to resolving problems encountered in study implementation regarding SDCC responsibilities, and review plans for the design and initiation of upcoming studies.

6. Statistical Design and Analysis

The Contractor shall provide expertise, advice and assistance in the development of statistical designs and statistical analysis plans and in the preparation of interim and final analyses for clinical trials/studies supported under DMID-funded clinical research programs. Concepts and protocols for DMID-supported clinical trials/studies will emanate from various sources, including clinical investigators, DMID staff and industry collaborators. Specifically, the Contractor shall work with the COR and/or DMID staff designated by the COR, clinical investigators and industry collaborators designated by the COR to perform the following:

a. Statistical Design

1) Develop and refine experimental study designs, including appropriate control/comparison groups, sample size and power estimates, primary and secondary endpoints, randomization and stratification/blocking methods, and masking approaches for a variety of clinical study and trial designs.

2) Review protocols and provide recommendations on statistical design issues.

3) Develop and refine interim and final data analysis plans.

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p. 6 of 12 http://clinicaltrials.gov/

4) Provide statistical advice concerning issues such as approach, power, sample size, and impact of interim analyses. Provide other statistical analysis as requested by the COR and/or DMID staff designated by the COR (e.g., summary information for FDA submissions, review of Statistical Analysis Plans of other studies, etc.).

5) Develop new applications of statistical or information science theory, as necessary.

This includes the provision of: bioinformatics, pharmacokinetic (pK) and pharmacodynamic (pD), genetics, systems biology and other non-conventional statistical design and analysis support; pre-concept early (pre-concept) statistical consultation to DMID and COR-designated site personnel; input to DMID on DMID-designated trials/studies for which another data coordinating center (DCC) is providing related services; the ability to analyze datasets not generated by this contract; and, review of other companies’ statistical analysis plans, CSR tables/listings, and safety shells/templates as necessary.

6) Provide statistical input to DMID to assist with DMID decision-making.

7) Provide all SAS analysis Programming to DMID/DMID designee as determined by the

COR.

b. Statistical Analysis

1) Statistical Analysis Plan (SAP): Prior to each clinical study/trial implementation, develop the SAP in accordance with the approved protocol, safety plans and other documents as necessary. Maintain and update the SAP throughout the life of the study/trial.

2) Interim analyses: Perform interim analyses for safety, immunogenicity and/or efficacy and other parameters as specified in the SAP. Summarize and present interim findings to the designated Safety Oversight Structures.

3) Final analyses: Conduct comprehensive final statistical analyses, in accordance with the SAP. Additional analysis might be performed in support of requests by Safety Monitoring Committees (SMCs), Data Safety Monitoring Boards (DSMBs), DMID, or study investigators, for use in safety monitoring and in the preparation of abstracts, journal articles and scientific presentations. The Contractor shall develop a process for approval and prioritization of such requests.

4) Regulatory Submissions for Vaccines, Biologics, Drugs and Devices: Prepare and present, in conjunction with DMID, study investigators and industry collaborators, statistical designs, statistical analysis plans and study-specific analyses for interactions with the U.S. Food and Drug Administration (FDA) in connection with pre- and post-regulatory submissions. Assist DMID, study investigators and industry collaborators in responding to FDA inquiries regarding clinical trial design and analysis at any point during a study.

5) Expedited analyses: Conduct expedited analyses of data for selected high-priority studies and provide for the rapid transfer of data, data documentation and analyses to the DMID at any point during a study.

6) Pre-Publication/Presentation Analyses: Prior to presentation or submission for publication, review for accuracy all abstracts, manuscripts, and presentations that include data generated from clinical trials and clinical studies supported under this contract.

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7) Ad hoc analyses: Conduct ad hoc analyses as requested by the COR and/or DMID staff designated by the COR, including analyses on datasets not generated by this

7. Clinical Site Training, Assessment and Technical Assistance

The Contractor shall participate in training of clinical site personnel, along with DMID and other contractors, with respect to procedures for study implementation as they relate to the data management aspect of the clinical study/trial. Specifically, the Contractor shall perform the following.

a. Prepare and make available, to DMID staff and study and laboratory sites, the data entry system user’s manual within 60 calendar days after the effective date of the contract.

b. Within 60 calendar days after the effective date of the contract, implement a “training data entry module” on the remote and/or direct data entry system to allow study site staff to learn, practice and refresh skills in the use of the data entry system. The training data entry system should include an electronic audit trail to track completion by different users, thus confirming site staff eligibility to use the system.

c. Prepare instructional materials regarding data management procedures and conduct training sessions for DMID and study site staff via face-to-face meetings, conference calls and/or webcasts. Examples of training topics include: design of data collection materials; data entry; data management; data validation; audit trails; and use of the electronic specimen tracking system. Training may be provided in a variety of time zones and settings including at clinical sites or at group meetings, and may require travel of Contractor staff to domestic and international clinical sites. The Contractor shall submit a written site visit report within 14 calendar days following any training site visit.

d. Provide and maintain a 24 hour/7-day per week accessible help line to receive statistical and data management questions and related requests for SDCC assistance from study sites.

This help line shall be in place and fully operational within 60 calendar days from the effective date of the contract. The help line should be accessible from domestic and international locations and should be independent from a site power source. A help line report on the current Help Line operations status and key frequently asked questions (FAQs) is due monthly as specified by the COR.

e. Assess the capabilities of DMID-supported study sites that do not utilize SDCC computerized data entry and management systems in terms of on-site technical expertise and data systems in place to collect, manage, secure, validate, and analyze data. Provide findings of such assessments to these study sites, the COR and/or DMID staff designated by the COR within 15 calendar days of the assessment in a written report, and provide guidance, direction and follow-up to assist such clinical sites in establishing and maintaining data systems in accordance with federal and local regulations and ICH/GCP guidelines (http://www.ich.org/cache/compo/276-254-1.html).

8. Electronic Specimen Tracking System

The Contractor shall provide and maintain an electronic specimen tracking system, for use by the SDCC, study sites, laboratories and others as designated by the COR to track study specimens in real time. This system must be in place and fully operational within 60 calendar days from the effective date of the contract. The electronic specimen tracking system shall have the following features and capabilities:

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a. Integration with the SDCC clinical data system.

b. Use of an automatic labeling system (e.g., bar code) on specimen aliquots that link a unique label to a specific study, subject, study site and time point/visit. Generally, study specimens are collected, processed and stored at the clinical site until they are shipped to the DMID specimen repository; information is located at:

http://www.niaid.nih.gov/LabsAndResources/resources/dmid/Pages/clinrep.aspx. The repository stores the specimens until they are shipped to a central laboratory.

c. Generation of an electronic shipping manifest for receipt by the receiving facility as specimens are being prepared for shipment.

d. Provision of labels to study sites for specimen aliquots, ensuring protection of confidentiality and blinding of laboratory staff to specimen identity.

e. Provision of a real-time global inventory of all study specimens and the location of individual specimens for each specific study.

9. Data Storage

The Contractor shall serve as a DMID clinical data storage facility for those studies conducted by DMID-supported investigators and collaborative groups, and for study sites that do not have access to long-term clinical data storage. Transfer of data, medium, timeframe and other details shall be determined by the SDCC and the transferring study sites or investigators with COR approval. The Contractor shall provide an SOP to the COR for review and approval describing the data storage and transfer process within 60 calendar days from the effective date of the contract.

10. Project Management

a. Overall Contract Project Management

1) Provide for the overall management, integration and coordination of all contract activities, including the management and coordination of activities carried out under subcontracts if applicable. The Contractor shall provide and update, as needed and/or requested by the COR, a comprehensive Project Management Plan (PMP) to be approved by the COR for the effective overall management, budgeting and tracking of contract activities, including work performed by subcontractors if applicable. This PMP is due within 60 calendar days of the effective date of the contract.

2) Provide and maintain an infrastructure to ensure the efficient planning, initiation, implementation and timely completion of all projects carried out under this contract and effective communications with the COR and Contracting Officer.

3) Provide for a Principal Investigator with responsibility for overall project management and communications, tracking, monitoring and reporting on project status and progress, and recommending modifications to project requirements and timelines, including projects undertaken by subcontractors if applicable.

4) Ensure the effective and efficient coordination of specified functions identified in the Statement of Work in collaboration with the DMID clinical research support services contractors and clinical sites.

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b. Meetings and Teleconferences

1. Contract Initiation Meeting: Within 30 calendar days after the effective date of the contract, participate in a one-day Contract Initiation Meeting with the COR, the Contracting Officer and other NIAID personnel designated by the COR to be held at the Contractor’s site or a DMID site. The Contractor will generate an agenda in cooperation with the Contracting Officer and COR. The purpose of the Contract Initiation Meeting shall be to orient the Contractor to NIAID contract procedures and to:

a) Introduce Contractor and DMID staff;

b) Discuss the terms and conditions of the contract;

c) Report on progress/accomplishments to date; and

d) Establish priorities and timelines for specific activities.

2. Monthly Status Meetings/Teleconferences: The Contractor’s PI and/or designee(s) will participate in meetings at a minimum of monthly intervals, either in person or via teleconference, to review overall progress with the COR and discuss: key issues requiring any SDCC plan(s) for resolution/improvement; quality management plan updates/issues; results of any independent audits made by the government; SDCC accomplishments or challenges; SDCC performance metrics; any matters relevant to the scientific and financial administration of the contract and future activities; and, any initiatives proposed by the SDCC and/or COR to further support DMID research studies.

The schedule of these meetings/teleconferences will be established by the COR and the Contracting Officer after contract award. The Contractor will prepare and distribute the agenda and meeting/teleconference materials to all participants, as well as provide a summary of all meetings and teleconferences in the Semi-Annual Progress Reports.

3. Annual Site Visits: At a minimum, one site visit shall be conducted in each contract year by the COR and CO or Contract Specialist (CS) (joint visit). In addition, the COR and CO/CS may elect to perform site visits (or reverse site visits) at any time during the contract period of performance. The Contractor shall organize the annual joint visit by the COR and CO/CS, during which the following topics will be reviewed and discussed:

project progress; problems and obstacles and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, objectives and research approaches/methodologies based on outcomes to date; and, future plans. These site visits shall be attended by the Contractor’s Principal Investigator, the Contractor’s business representative, and all Contractor key personnel.

The Contractor shall be responsible for:

a) Planning and submitting the agenda to the COR for approval on a timeline agreed upon by the COR;

b) Developing written and oral presentation materials, with draft versions approved by the COR;

c) Arranging for the logistics associated with the site visit; and

d) Preparing and submitting Annual Site Visit reports to the COR and CO within 30 calendar days of completion of each annual site visit.

c. Study/Trial-Specific Project Management Services

1) Provide and maintain study/trial-specific project management support to DMID personnel, as requested by the COR and/or DMID staff designated by the COR. This may include, for example: providing protocol development and implementation status updates to the DMID Clinical Project Manager (CPM)/designee(s) as requested on a frequency established by the COR and/or COR designee; establishing project

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2) As applicable, the COR will approve delivery of project management services by the

Contractor for select trials/studies prior to implementation. For those approved trials/studies, the Contractor shall also respond to study/trial-specific project management-related questions in collaboration with the designated DMID project management staff.

11. OPTIONS

In addition to the services/quantities outlined above to be provided for the base requirement, the following Option(s) for additional services/quantities under the contract may be exercised at the discretion of the Government and are defined as follows:

OPTIONS 1-6: EXTEND TERM OF THE CONTRACT

The Government may include Options to extend the period of performance by up to one (1) year (twelve (12)-months). The total period of performance resulting from the base period plus all potential Term Options is seven (7) years. If Options 1-6 are exercised, the services required will be the same as provided during the base year.

OPTIONS 7-9: INCREASE IN LEVEL OF EFFORT

The Government may exercise Options for increased level of effort that may result from unanticipated increases in demand, with the services required under these Options to be of the same scope provided during the base year. The FTEs associated with each Option (7-9) are as follows: Option 7 = 2 FTEs; Option 8 = 3 FTEs; and Option 9 = 5 FTEs.

Should the Government elect to exercise any of these Options, the Contractor shall provide resources for the associated increase in work volume. These Options may be exercised up to three (3) times within the base period (and within each year that Options 1-6 are exercised) as needed, up to a maximum of 20 FTEs per year over the base Level of Effort of 41.40 FTEs per year, using any combination of Options 7, 8 or 9.

Funds and FTEs for increased quantities of effort may only be used in the contract year in which the Option is exercised and may not be used beyond the applicable one (1) year (12-month) funding period. The exercise of these Options is subject to the availability of funds.

OPTION 10: Initial Transition Effort

Initial Transition from Incumbent SDCC Contractors

Unless the incumbent is awarded the contract that results from this solicitation (in which case no initial transition effort will be necessary), NIAID will provide a transition plan according to which the awardee shall coordinate with the incumbent contractor to ensure an orderly, secure, and efficient transition of contract-related materials and activities to the Government.

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OPTION 11: Final Transition Effort

Final Transition

1) The Contractor shall ensure an orderly, secure, and efficient transition of contract-related materials and activities to the successor Contractor or to the Government, to be completed by the expiration date of the contract.

2) A description of transition activities, timelines, and assigned staff shall be provided in

Draft and Final Transition Plans, which will be reviewed and approved by the COR. The Draft Transition Plan shall be submitted six months prior to the expiration date of the contract, and the Final Transition Plan (approved by the COR and Contracting Officer) shall be submitted three months prior to the expiration date of the contract. The final transition effort shall be accomplished in its entirety by the expiration date of the

[END OF STATEMENT OF WORK]

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Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases ATTACHMENT 4 RFP-NIAID-DMID-NIHAI2013180 Definitions and Info.

ATTACHMENT 4: DEFINITIONS AND INFORMATION

Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

The following provides information about NIAID resources and support services, including related Contractor interactions, as specified in the Statement of Work.

DMID Clinical Research Operations and Management Support (CROMS)

The DMID-CROMS contractor provides a broad range of services for clinical research operations and management for DMID extramural clinical research programs, including:

a) assistance in preparation/review of protocols and related documents;

b) assistance with site clinical quality management plans and tools for implementation;

c) training related to conduct of studies/trials under DMID's requirements;

d) pre-study activities, including clinical site assessment;

e) clinical site monitoring and reporting;

f) safety monitoring;

g) document management through web-based systems; and

h) receipt, assessment and maintenance of essential regulatory documentation.

Collaboration with the NIAID DMID-CROMS contractor is determined by the COR as specified in the SOW.

Clinical Site

A clinical site is a NIAID contractor, grantee or their subcontractor(s) consisting of a team of healthcare research professionals and the healthcare organization for whom they work. A clinical site conducts clinical research for one or more protocols and transmits protocol-specified clinical data to the SDCC. The SDCC will collaborate with clinical site personnel as specified in the SOW.

Safety Oversight Structures

The Safety Oversight Structure is established by NIAID/DMID and will…