Attach 1. EPI Draft SOW.pdf

Epidemiology Support Services Contract

DRAFT Statement of Work (SOW)

December 4, 2023

Epidemiology Support Services Contract DRAFT Statement of Work Page 1 of 18

INTRODUCTION/BACKGROUND

The purpose of this contract is to provide epidemiological, scientific, technical, data management, managerial, clerical, and statistical support to Principal Investigators within the Epidemiology Branch, Division of Intramural Research (NIEHS). The contract requires the Contractor to assist the

Government by identifying and enrolling subjects, and administering, managing, and conducting epidemiological studies designed and conducted by the Epidemiology Branch (EB) Principal

Investigators (PIs) alone, or in collaboration with other scientists inside or outside of NIEHS, and by carrying out directed analyses of the data and biological and environmental samples from such studies, for ultimate publication by EB Investigators in scientific journals. The Contractor will be expected to provide oversight for projects in remote locations, conducting site visits as needed and maintaining close contact with research partners throughout the world. The workload is variable and

The Contractor must have the ability to scale up or contract as required to meet needs that change over time and with the stage of ongoing research.

GENERAL

The Support Services for Epidemiology Contractor shall provide epidemiological, scientific, technical, data management, managerial, clerical, and statistical support to PIs within the EB, Division of

Intramural Research, NIEHS. The Contractor shall function in a purely supportive role, carrying out specific tasks as described in Task Orders and shall not engage in independent research.

The Contractor shall provide field research support for a range of studies in varied settings. The

Contractor shall provide oversight for sample collection, processing, and storage; assist in the management of a large biorepository; facilitate collaborative studies and data sharing; provide data management services; support or carry out data analysis, provide statistical support, coordinate or carry out a variety of laboratory assays; and arrange for a wide range of professional consultations as required to carry out specific task orders.

EB studies are carried out throughout the United States and in international settings. The Contractor will be expected to provide oversight for projects in remote locations, conducting visits as needed and maintaining close contact with research partners throughout the world. Access to bilingual staff may be required, depending on the specific research portfolio at any given time.

On occasion, the EB is required to respond to national disaster or other public health issues on short notice. Thus, the Contractor must have the resources to begin work on short notice. The workload is

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December 4, 2023

DRAFT Statement of Work Page 2 of 18 variable, and the Contractor must have the ability to scale up or contract as required to meet needs that change over time and with the stage of ongoing research.

Experience and expertise working with diverse and challenging populations is required as is experience working with community groups and awareness of best practices for sharing research results with community groups and study participants. Success in and knowledge of best practices for recruiting diverse populations and maintaining high retention rates in long‐term studies are mandatory.

The Contractor shall assist the Government by administering, managing, and conducting epidemiological studies designed and supervised by EB PIs alone, or in collaboration with other scientists inside or outside of the NIEHS, and by carrying out directed analyses of the data and biological and environmental samples from such studies for ultimate publication by EB investigators in scientific journals.

TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall furnish on a task order basis all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the following work:

1. Study Support

a. Conduct pilot studies, literature reviews, computer searches, or other activities to determine capabilities of collaborating institutions, numbers of eligible study subjects, exposure information for study site selection; convene focus groups when appropriate; prepare, pretest, evaluate and produce data collection forms; including, but not limited to, computer‐assisted telephone questionnaires, web‐based data collection platforms and capabilities, in person questionnaires, as well as innovations with social media, cell phones, smart phones, tablets, GPS, and other technologies in addition to more traditional technologies for subject recruitment, interview, data collection, and follow‐up; ensure adequacy of inclusion of women, minorities, children and other under‐served groups in research projects, where applicable and appropriate;

b. Arrange and provide support for meetings and teleconferences of relevant individuals, collaborators, consultants, etc. To aid in study design, logistics, or analysis: arrange and provide support for monitoring, oversight, or advisory boards

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c. Prepare training programs, procedure manuals, manuals of operation, and other required materials for abstractors, interviewers and other study personnel;

d. Provide commercial quality graphics support for field study print materials, study communications with participants, and public websites for recruitment, publicity, and general information dissemination;

e. Arrange, provide support, and prepare materials for IRB submissions and continuing reviews, OMB approvals, and Certificates of Confidentiality;

f. Coordinate collection, handling, transport, storage, analysis, tracking, an bar‐code‐ labelling of biological, clinical, agricultural, industrial, dietary and environmental samples in field studies; arrange for shipping and delivery of samples to laboratories for analysis or to facilities for long term storage;

g. Assemble death certificates, medical records, industrial hygiene data, geocoding data, dietary/food frequency histories, reproductive histories, occupational histories, environmental monitoring data, etc., and have records evaluated and coded by appropriate nosologists, pathologists, industrial hygienists, clinicians, or other relevant experts and abstractors;

h. Depending on study design, recruit or trace study subjects, locate them, and obtain any necessary consent for interview and performance of relevant industrial or environmental measurements, biologic specimen collection, physical or other examination; conduct determination of vital status, assessment of disease status, exposures, genetic susceptibility or other information collection as necessary for the study;

i. Conduct study protocol training for, and provide oversight of, abstractors, interviewers, coders, phlebotomists and others who will acquire and assemble data;

abstract, microfilm, photocopy, scan or obtain computer‐based (electronic) or paper records (clinical or office medical records, hospital charts, vital records, employment records, etc.);

j. Arrange for travel (both domestic and international of contract study managers, lab managers and other staff to field study site(s) for staff training. Focus group meetings, study site visits, study audits, lab audits, study collaborator meetings, and other travel as required; for international study travel, prior approval by both NIEHS

Contracts Office and Contracting Officer Representative (COR) is required;

k. Interview subjects or surrogates using mail, telephone, computer‐assisted, web‐

DRAFT Statement of Work Page 4 of 18 based or in‐ person interviews, evaluating the state‐of‐the‐art for technology‐ dependent techniques where appropriate and cost‐effective, and arrange through licensing or subcontract to use the appropriate technique; propose alternative and innovative means of data collection where appropriate using computer‐assisted technologies, web, mobile/cell phones, smart phones, tablet and other handheld devices; identify appropriate strategies to improve participant enrollments and to obtain optimal participation rates and follow‐up rates for longitudinal studies;

l. Arrange for clinical diagnostic studies, confirmation of self‐reported medical diagnoses, laboratory or other clinical evaluation of subjects, consensus diagnoses and standardized review of pathological material or records, and for industrial, agricultural, dietary, or environmental measurements;

m. Staff and run a local contractor site laboratory for receipt, inventory, processing, aliquoting, bar‐code labelling, shipping, storage and tracking of frozen, refrigerated or ambient samples, with ambient, refrigerator (+4°C) and freezer storage at appropriate temperatures (including ‐ 20°C, 80°C, and LN2 at ‐150°C , ‐180°C, ‐

190°C); provide central electronic alarm temperature systems and make provision for staff to respond in temperature emergencies; provide back‐up generator to support laboratory refrigerators and freezers in the event of a long‐term power outage;

n. Staff and run a local contractor site facility for DNA extraction with demonstrated quality performance or arrange appropriate alternative; provide or identify quality sources for samples plating suitable for a variety of products; identify quality facilities for DNA extraction for large scale studies and for genotyping and other "omic” services (e.g. Epigenomics, metabolomics, microbiomics);

o. Identify appropriate analysis laboratories, evaluate quality assurance/quality control of ongoing laboratory analyses, establish databases for the results of laboratory analyses, coordinate data processing for laboratory results for a wide range of studies;

p. Assist with monitoring the availability, and manage the use of, stored biologic samples from historical Epidemiology Branch studies;

q. Enter coded information into computer databases integrating quality assurance and quality of all data collection systems;

r. Design, staff and run a FIPS 199 categorization 'Moderate' computing center and network appropriate NIST, DHHS/NIH, FISMA, OMB, and IRB guidelines, with site

DRAFT Statement of Work Page 5 of 18 and system security, state‐of‐the‐art, secure on‐site, off‐site and/or cloud storage where appropriate, secure archival I backup storage and retrieval, software, hardware, high‐speed internet access, secure email, staff desktop or laptop computers, with backup generator to support datacenter infrastructure in the event of long term power outage; computing system shall have an Information System

Security Plan, an updated Plan of Action & Milestones (POA&M) list, and a

Certification and Accreditation Program; be prepared to complete NTH E‐

Authentication Threshold Analysis (ETA) and NIH E‐Authentication Risk Assessment

(ERA), and maintain HHS Privacy Impact Assessment(s) (PIAs) for information systems; computing center should have technical IT staffing sufficient for management of a system incorporating existing Epidemiology Branch study data files, new studies, data management, freezer monitoring, laboratory inventory, telephone and web‐a5sisted interviewing, call center(s) and associated technologies, study management systems, archival data storage, analysis programming including genetic/bioinformatics programming, and analysis of high dimensional data, while adhering to relevant federal government laws, policies, standards and guidance, and in compliance with NIH enterprise architecture, with protections for PII and PHI, and appropriate risk management and risk mitigation systems in place;

s. Design, develop, test, maintain, and host NIEHS EB study websites, adhering to relevant federal govern policies and guidance regarding website design and management including but not limited to compliance with Section 508, OMB guidance, and the Privacy Act;

t. Perform data linkages with National Death Index, vital statistics, cancer registries, Medicare data, and other national registries and databases;

u. Provide reproducible epidemiologic, statistical, genetic, bioinformatics, descriptive and other data analyses specified by the EB investigator, including analysis of high dimensional data;

v. Provide documentation of each step data analysis, including initial analysis plan, initial archival data set(s), data changes or edits, analysis programs, tabular results, final data set, and evidence of reproducibility of published data;

w. Provide support for, and facilitate receipt of, data for pooling projects and meta‐ analyses;

x. Provide support for analysis and interpretation of high dimensional ''omics" data, including genomics, epigenomics, metabolomics microbiome and other

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y. Provide assistance in developing NIEHS compliant data sharing data polices, develop systems for tracking data requests and data delivery, and monitoring uses of data and samples from EB Studies;

z. Produce publication‐quality graphics, tables, and figures as required for scientific publication of study analyses and findings;

aa. Provide records management: document each step of a study and maintain, in an orderly and accessible manner, all relevant material so that any aspect of the study may be reviewed and evaluated by the EB staff with little or no prior notice;

bb. According to study protocols, provide professional communication materials and interactions with study participants, including letters, newsletters, reports of individual and summary of tests performed, etc.;

cc. Develop and maintain study websites for study data collection and transmission with data and protection of personal identifiers;

dd. Develop and maintain public, commercial quality study websites for study participants and the public for dissemination of study findings, vignettes, study contact information, study related resources, etc.;

ee. Provide expertise in industrial hygiene/occupational exposure coding, specialized clinical testing (e.g. Neurobehavioral or pulmonary function), specific medical subspecialties, medical record abstraction and coding, medication coding, language translation, etc.;

2. Initiation and Liaison

a. Obtain necessary information to determine effective study resources (e.g., capabilities of collaborating institutions, numbers of eligible study subjects, exposure information, etc.).

b. Determine the parties whose cooperation or approval is necessary for implementation of the study (e.g., Federal, state or local government agencies, local institutions such as hospitals, clinics, physicians, private industry, industry associations, labor unions, extramural institutions and collaborators, local and/or state Departments of Health, institutional Review Board(s)).

c. Arrange for communications and meetings as needed between the NIEHS EB investigators, collaborating institutions and/or agent for those whose cooperation or approval is necessary. Arrange for travel for such individuals as

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d. Attend such meetings, provide required background material, keep minutes of such meetings and take appropriate actions on recommendations as applicable.

e. For multi‐center studies, develop procedures to assure that the investigation is being conducted in a standardized way at all sites.

f. Arrange for translations for necessary transactions to initiate studies in foreign settings.

g. Collect, back‐up, and analyze data, environmental samples and biologic specimens;

when necessary, identify individuals or institutions capable of doing the work, and make necessary arrangements (e.g. subcontract, purchase of equipment, other compensation).

h. Assist in development of protocols and completion of forms as may be required for various committees, such as Institutional Review Boards, Office of Management and Budget, Food and Drug Administration, etc. Attend the meetings of such committees if requested by the COR, with approval from the Contracting Officer

(CO). Assist the investigators in obtaining Certificates of Confidentiality as appropriate for the research being conducted.

i. For studies requiring an ongoing advisory committee or data and safety monitoring committee, make necessary arrangements to support communication and meetings with said committee, including making travel arrangements for meetings and site visits and arranging compensation.

j. For studies requiring preliminary workshops, provide sites and support for such workshops.

k. Arrange focus groups as needed.

l. Carry out validation studies, feasibility studies, and studies to determine ranges of exposure and size of exposed population(s).

3. Development of Study Materials and Procedures

a. Prepare pretest, evaluate and produce data collection forms (e.g., abstract forms, coding forms, questionnaires, follow‐up forms, tracking forms, biological specimen collection and processing forms, exposure assessment forms). Questionnaires may be paper, computer‐assisted, telephone‐assisted, and/or web‐assisted. Tailor the expense and complexity of the proposed interview techniques to the size and complexity of the study at hand, while taking into consideration both cost and

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“state of the art” techniques.

b. Prepare training programs and materials for abstractors, interviewers, clinicians, and other study personnel.

c. Prepare procedure manuals for medical abstractors, coders, interviewers, phlebotomists and other medical personnel involved in specimen collection, tracers, data editors, supervisors, and industrial hygienists.

d. Prepare procedure manuals for the collection, processing, and storage of environmental specimens (air, water, soil, dust, carpet, and other indoor materials;

agricultural or industrial settings, etc.); biologic specimens; shipment of specimens, submission of specimens to repositories, bar code labelling and tracking of specimens and laboratory results.

e. Prepare manuals for obtaining, handling, and abstracting medical records, pathology specimens and reports, submission of pathology specimens for review, and collection of death certificates. Arrange for review of these reports, measurements, or specimens.

f. Develop or adapt existing schemes of coding for categorizing demographic, occupational, industrial, nutritional, geographic, medical or other information.

g. Translate data collection instruments or manuals into appropriate languages for foreign studies or for use with non‐English speaking US residents using procedures consistent with current NIEHS IRB SOPs, including back translation of material into

English to assure that the original intent of the material has not been changed by the translation.

h. Perform specific laboratory analyses of biologic and environmental samples. Carry out pilot studies or cross‐laboratory comparisons, identify expert opinion, or use other appropriate means to identify competent laboratories.

i. When available, and under certain circumstances, equipment and materials required for this work may be supplied by the NIEHS; the Contractor shall be required to furnish all other necessary equipment and material. The Contracting

Officer's Representative (COR) will identify new Government Furnished Equipment and materials on a Task Order basis. The Contractor shall inventory and maintain any Government Furnished Equipment. Contractor should assume cost and responsibilities for equipment and materials unless otherwise noted.

j. Assemble individual subjects’ records, which may include death certificates, hospital or physician records, pathology reports, prescriptions, or billing information, etc.

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The Contractor shall have these certificates and record evaluated and coded by appropriate nosologists, pathologists or clinicians.

k. For activities that are similar across studies, design or use systems and approaches that can serve as a "shell" or "template" for future work in order to avoid reinventing such systems for each study or Task Order.

l. Demonstrate extensive experience, use and facility with computerized study management systems in epidemiological studies.

4. Subject Identification, Selection, Tracing, Recruitment, Community Relations

a. Develop methods for identifying, tracing, or recruiting study subjects, including but not limited to minorities, children, pregnant women, migrants, underserved populations, or other groups that have been historically difficult to recruit, and make recommendations on the feasibility of alternative schemes. Typical study groups include:

i. All patients diagnosed with some condition occurring in a particular group of hospitals or clinics or residing in a given geographic area;

ii. Patients diagnosed with designated control diagnoses, free from the subject disease, subjects sampled at random from a given geographic area sometimes matched to cases on age, gender, race, and other characteristics; and

iii. Groups of individuals with selected occupational, dietary or other environmental exposures.

b. Use methods to derive appropriate control series for use in case‐control studies. This could include a variety of different types of controls, including (but not limited to) those derived from hospitals or clinics, random digit dialing (RDD), area surveys, employer personnel, or labor union records or population rosters. Other techniques may be required. Plan to provide appropriate, cost‐effective, innovative technology and effort for subject recruitment, interview, data collection and follow‐up, including innovations with social media, cell phones, smart phones, tablets, GPS, computer‐and web‐assisted designs, and other new technologies in addition to more traditional technologies for subject recruitment, interview, data collection, and follow‐up.

Evidence of clear documentation of approach shall be demonstrated so that precise response rates can be determine for all phases of the telephone screening, and

DRAFT Statement of Work Page 10 of 18 reasons and demographic characteristics can be summarized of subjects who refuse to participate or who are lost to follow‐up.

c. Acquire appropriate population rosters or files to identify selected series of potential study subjects. This will require knowledge of and compliance with current privacy regulations, e.g. HIPAA.

d. Trace study subjects to locate them for interview, environmental measurements, biologic specimen collection, or clinical examination. Determine their vital status and the presence or absence of specific diseases or conditions. Collect information and specimens that will allow for assessment of exposure to specific environmental, dietary, agricultural, industrial, or other agents thought to affect disease status.

Collect information and specimens that will allow laboratory assessment of genetic susceptibility by whatever state‐of‐the‐art methods are used in a specific study. For deceased or incapacitated subjects, it may be necessary to locate next‐of‐kin or other proxy respondents.

e. For retrospectively ascertained subjects, use a variety of tracing techniques to ascertain current vital status. For living subjects, locate their current whereabouts so that they can be included in studies.

f. For prospective studies, monitor and track participants to minimize loss to follow‐up and promote high response and retention rates.

5. Data Collection

a. Train abstractors, interviewers, telephone screeners, coders, phlebotomists, clinicians and others who will be involved with acquiring and assembling data.

b. Oversee field activities.

c. Abstract, microfilm, photocopy, scan, or obtain computer records (clinical or office medical records, hospital charts, vital records, employment records, etc.).

Maintain quality control over the abstracting or copying process. Verify a sample of abstract by independent re‐abstracting.

d. Obtain the necessary permission(s) for data collection.

e. Interview or otherwise collect data from subjects or surrogates using mail, telephone, computer‐assisted, in‐person, or web‐based interviews. Use appropriate techniques to obtain acceptable response rates, including offering financial or other incentives. Record the interviews if specified. Develop procedures to validate questionnaire responses and strategies to minimize errors. Evaluate the state‐of‐ the‐art for technology‐dependent techniques, such as computer assisted telephone

DRAFT Statement of Work Page 11 of 18 interviews, as well as innovations with social media, cell phones, smart phones, tablets, GPS, computer‐and web‐assisted designs, and other new technologies in addition to more traditional technologies for subject recruitment, interview, data collection, and follow‐ up, and arrange through licensing or subcontract (if necessary) to use the appropriate yet innovative techniques.

f. Arrange for clinical diagnostic studies, laboratory evaluation of study subjects and environmental measurements.

g. Monitor quality assurance/quality control of ongoing laboratory analyses, rapidly integrate laboratory results in study databases, car out graphical and statistical analyses as needed, and assist with monitoring the availability of, and managing the use of biologic samples stored in NIEHS Repositories. Perform backups as needed.

h. Obtain all necessary laboratory reports, store all laboratory results, and document their sources.

i. Procure death certificates from state vital records departments, and arrange for proper return or destruction of records as required. Perform data linkages with the National Death Index (NDI).

j. Develop and manage flexible and efficient computerized tracking systems that monitor participation rates for all aspects of a study. The tracking of recruitment and participation must provide the info required for efficient study management, e.g., allow appropriate timing of contacts, permit updating of contact information. The systems must also generate participation and loss rate data for all aspects of a study, from eligibility pool through completion, and permit immediate ascertainment of which parts of a complex study a given subject has completed.

k. Monitor and/or evaluate current and/or environmental exposures or determinants of exposure.

l. Validate exposure or disease histories obtained in interviews by obtaining original records or through other approaches. This includes maintaining a management tracking system for the retrieval of any such records.

m. Develop study management tracking systems that monitor the incoming flow of data, editing of data, back‐ups, and changing or modification of data that can be summarized into descriptive reports.

6. Specimen Collection, Processing and Shipment

a. Arrange for all aspects of biologic, occupational and environmental sample collection, DRAFT Statement of Work Page 12 of 18 handling, transport, storage, analysis, and information processing. The samples may be a component of a Task Order under this contract or under other Government contracts. The Contractor shall subcontract as necessary to complete these tasks.

b. Train phlebotomists, nurses, and others who will be involved in collecting specimens.

c. After obtaining necessary and appropriate informed consent, obtain biologic specimens (peripheral venous blood, urine, buccal cell mouthwash samples, saliva, etc.) from study subjects. Divide or aliquot samples, package them as necessary and ship, transport or deliver them to a designated repository, laboratory or laboratories. Inventory and bar code label all laboratory samples. Pertinent data concerning the specimen donor and processing procedures shall be collected and accompany every biologic specimen.

d. Collect and deliver biologic, industrial or environmental samples to laboratories or other designated sites for storage and/or analysis. Perform other support activities involving collection, storage and/or shipment to laboratories, as requested by COR or designated NIEHS EB investigator, and approved by the CO.

e. Collect, inventory, process, track, store, and transport human biologic materials to laboratories using sterile technique. Typical procedures include collection of urine specimens, transporting specimens on dry ice, collection and centrifugation of blood, division of samples into individual aliquots, and simple cell isolation and culturing techniques; processing human blood cells for long‐term storage (cryopreservation or

DNA extraction), performing lymphocyte counts, receiving and storing tissues; and collection of other biologic materials including hair, feces, semen, amniotic fluid, tissue, toenails, and pathology specimens. Specimens may be collected locally, in the continental US, or from foreign countries.

f. Staff and run a local laboratory facility for DNA extraction with demonstrated quality performance or provide a suitable alternative; provide or identify quality sources for samples plating suitable for a variety of products; identify quality facilities for DNA extraction for large scale studies and for genotyping and other

"omic" services (e.g. epigenomics. metabolomics, microbiomics);

g. Ensure that employees working with materials that present a biological hazard, e.g., human tissues, maintain adequate caution. Safety procedures for laboratory workers, as outlined in the joint NIH/CDC publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, shall be followed.

http://www.cdc.gov/biosafety/publications/bmbl5/index.htm

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Biological research materials shipped domestically and internationally shall comply with Federal, State and Local regulations. Biological Materials shipping shall follow the procedures as outlined by NIH.

http://www.ors.od.nih.gov/sr/dohs/biosafety/shipbio/pages/shipping_biological_mate rial. aspx

h) Develop and implement standard procedures adaptable to each site where work is being performed and utilize such standard approaches at all site where possible in order to minimize variation in handling and processing of specimens.

i) Arrange for onsite storage and/or safe shipment of biologic specimens (on dry ice or other means as appropriate) to NIEHS Government Repository or one or several laboratories, for either immediate assays or storage.

j) Provide, maintain and monitor state‐of‐the‐art monitoring devices for onsite freezers and refrigerators 24 hours/day for failures, notify the COR and CO of need for offsite storage, and ensure the removal of specimens to appropriate backup freezers when necessary. Monitor backup systems of all freezers regularly. Provide backup generators for onsite laboratory in the event of power outages. Notify the COR or

NIEHS EB Investigator(s) of the potential for sample degradation, length of time thawed, etc.

k) Provide laboratory space in Contractor’s facilities for Government Furnished/Owned freezers, refrigerators, and other laboratory equipment. The Contractor shall be responsible for the oversight of freezer and refrigerator units located within their facility and shall make arrangements for the security, maintenance, and repair of the equipment located in their offices.

l) Within 48 hours, report to the COR all irregularities, delays, losses, deteriorations, unplanned defrostings, accidents, mishandlings, errors, discrepancies and significant inefficiencies connected with any specimen collection, delivery or storage activity.

m) Maintain an inventory of specimens from NIEHS EB studies using BSI‐II software

(or other EB‐ approved lab software). Specimens may have arisen from this contract, previous contracts, other Government contracts, or other EB collaborative activities. Monitor inventory discrepancies with field reports, other laboratories, and Government repository laboratory. Prepare Annual Specimen

Inventory Report and submit to the COR for NIH and other needs, as requested and approved by the CO.

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n) Obtain all laboratory reports of results or progress from laboratories doing analyses for NIEHS EB studies and store laboratory reports data in databases suitable for extraction of reports.

o) Develop management systems for tracking results as they derive from various contracting laboratories for rapidly evaluating laboratory performance on blinded quality assurance/quality control samples within and between Jab batches and for rapidly communicating these results to the appropriate NIEHS EB investigator.

p) Obtain all necessary laboratory reports and process and deliver them immediately to the COR. Rapidly merge laboratory results into primary study inventories and databases and carry out initial graphical and statistical analyses as requested.

7. Data Preparation and Processing

a. Code or enter questionnaire responses, clinical and laboratory information, etc., into computer readable form. Verify a sample of the coding by independent re‐coding.

(The size of the sample shall be approved by the COR or NIEHS EB investigator). Re‐ code as necessary. Summarize and describe differences between the two sets of data.

b. Develop documentation of codes used and listings of unusual responses.

c. Enter coded in formation onto suitable electronic devices or computers.

Develop, implement, and monitor appropriate quality control systems.

d. Ensure the quality of all data collected, and the uniform processing thereof.

Routinely run file compare procedures to compare the manually created files to shipment records and to SAS‐ generated files. For studies involving family groups, establish and run person‐checks within appropriate data to ensure correct family groupings. Review questionnaires and data gathering forms and instruments for clarity.

e. Determine the most error‐free and efficient system available for each study, including state‐ of‐the‐art handling of data from in‐person interview, computer‐assisted interviews, web interviews, or scanned documents.

Provide training for and implement such systems.

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8. Computer Programming and Statistical Data Analysis

a. Design and maintain computer databases and associated reporting software including software for enrollment and participation tracking, computer‐assisted interviewing, web‐ based enrollment and interviewing, and other techniques needed for support of studies in the field. Provide expert advice on the most appropriate, cost effective, and efficient data processing system to be used in support of specific requirements, setting up and maintaining a multi‐user computer network with shared software and data backup capabilities. Provide adequate testing and validation when new software is development.

b. Prepare edit programs, edit data, and correct computer files where necessary.

Describe findings in summary form.

c. As directed by the COR or NIEHS EB investigator, update files with follow‐up data, error corrections, etc. Maintain clearly documented history of development and updating of databases.

d. Prepare data sets for secure electronic transfer to NIEHS EB Investigator or others as specified by the COR or NIEHS EB investigator.

e. Produce epidemiological and statistical analyses specified by the EB investigator.

These may include simple descriptive statistics or complex epidemiologic analyses, including cross‐ tabular and graphic presentation of data, statistical analyses with parametric and nonparametric techniques (including multivariate regression, logistic regression, categorical analysis, survivorship procedures, and Bayesian methods), high dimensional data analysis, and genetics/bioinformatics programming. The

Contractor shall have the capability to use a broad range of computer programs (e.g.

SAS, JMP, IBM SPSS Statistics, SigmaPlot, R Programs, SUDAAN, SYSTAT, S Plus, Stata, ArcView, PLINK) as requested by the NIEHS EB investigator for a given study.

f. Provide customized summary of lab assay results and other complex data.

Provide innovative tools for graphically visualizing epidemiologic and laboratory data.

g. Develop and maintain internal record‐keeping procedures for assessing efficiency and quality of data collection, preparation, back up, and entry.

h. Respond rapidly to high priority, unanticipated requests with appropriate activities and use of personnel.

i. Collect and analyze complex survey data (e.g. SUDAAN) and GIS data (e.g. ArcView) and merge GIS or other data with epidemiologic data.

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j. Research, evaluate, procure and test hardware, including servers, backup systems, desktop computers, printers, network devices, etc.

k. At the completion of selected studies, prepare, document and test an archival version of the analytical dataset appropriate for public access. The current realization of such a dataset might be a CD containing data and documentation that could be shipped on request to interested investigators, but the format and the media may change over the course of the contract period of performance. In addition, such "public use data" shall conform to current conventions of privacy, including US privacy laws, OMB and NIST standards of data/information security, encryption, and masking of Personally

Identifiable Information (PII) such that distinguishing individual identify is not revealed.

9. Study Monitoring, Quality Assurance/Quality Control and Reporting

a. Document each step of a study and maintain all relevant material in an orderly manner, so that any aspect of the study may be reviewed and evaluated by the NIEHS

EB staff with little or no prior notice. Activities related to documentation include the following:

i. Prepare letters, forms, and other documents necessary for the conduct of the study. Most studies shall require a Manual of Operation unless the COR or NIEHS EB investigator determines that one is not necessary.

ii. Duplicate study documents when the origin sources cannot be retained except where expressly precluded by law (e.g. Death certificates, which must be destroyed or returned after a certain time limit).

iii. Maintain a file system of all material relevant to the study (including computer analysis programs) cross‐referenced in a manner as to make all of the material easily accessible (these materials shall be maintained under information security in accordance with requirements of the Privacy Act as it applies to Contractors).

iv. Maintain a log of decisions (see d below).

b. Develop procedures to identify appropriate laboratories and to monitor quality assurance/quality control (QA/QC) as the analysis of study samples proceeds. This includes checks such as spiked, blank and duplicate samples. Develop strategies for obtaining ongoing quality QA/QC data and for monitoring laboratory procedures for

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c. Develop internal record keeping procedures for assessing the progress of data collection, data preparation, data entry, and back up.

d. Maintain a log of scientific decisions made during the study that affect the study design, conduct, or analysis. Examples of such decisions are amendments in criteria for matching cases to controls, and selection of job codes for ambiguous job titles.

The log may consist simply of copies of relevant memos, emails, notes from telephone conversations or meetings, but must include, as a minimum, a brief explanation and date of the decision and name of the NIEHS EB investigator responsible for the decision, as well as the NIEHS EB investigator who has overall responsibility for the Task Order. Documentation shall include a record when a specific change was operationalized in the field.

e. Report verification rates, discrepancy rates, and error rates for data collection, preparation and keying following the schedule agreed upon with the COR, with approval from the CO. Any unusual problems shall be brought to the immediate attention of the COR and CO.

f. When necessary, acquire the services of a certified industrial hygienist (CJH), certified by the American Board of Industrial Hygiene, who has access to the appropriate measuring equipment. Samples shall be analyzed by a laboratory certified by the

American Industrial Hygiene Association. When necessary, acquire the services of medical records abstractors and/or nosologists, for ICD coding of records and death certificates.

g. Upon completion of each Task Order, convert all original questionnaires, updated

Manual of Operations, and other relevant study materials to an electronic format suitable for efficient, secure long‐term storage, e.g. CD‐R, DVD‐R, USB hard disks, optical disks. Storage materials shall be labeled with study name, Task Order number, NIEHS Principal Investigator name, and date of completion. The Contractor shall also compile a compendium of study procedures, forms and analyses. The Contractor shall prepare archival data files for transfer to a designated location at study or contract completion.

h. Provide Monthly, Annual (fiscal year), and Final Technical Progress and Budget

Summary Report to the COR, CO and NIEHS EB investigators. All Reports shall be in electronic format.

i. Create and maintain secure websites for studies which comply with all NIH guidelines

DRAFT Statement of Work Page 18 of 18 http://www.hhs.gov/web/building‐and‐managing‐websites/index.html pertaining to hosting, regulations, policies, security, and where applicable, Paperwork Reduction

Act of 1005, Privacy Act 5 USC 552a, Section 508 of the Workforce Investment Act of

1998, Rehabilitation Act of 1973, and which follow HHS IMR Policies for usage of web cookies, HHS web standards for usability, clear language, logos, etc.