N02CP71011-26_Draft_Statement_of_Work.pdf

Draft Statement of Work Attachment 1 N02CP71011-26 Page 1 of 11

DRAFT STATEMENT OF WORK

Interdisciplinary Studies of Occupational and Environmental Cancer

Independently and not as an agent of the Government, the Contractor shall be required to furnish all of the necessary labor, materials, facilities, equipment, and supplies, not otherwise provided by the Government, as needed to perform the Statement of Work.

SCOPE

The Contractor shall be responsible for simultaneously managing concurrent, multiple, domestic and international studies. The time line or schedule for support activities will be specified by the NCI Contracting Officer’s Representative (COR) (or a designated representative–hereafter referred to only as the COR) based on the study. The Contractor shall inform the NCI COR of any unforeseen circumstances that may delay timely completion or progress of study activities.

All study activities, documents, and procedures must be approved by the COR prior to implementation. The scientific design of studies and oversight of ongoing activities are the responsibility of Occupational and Environmental Epidemiology Branch (OEEB) scientific staff.

TECHNICAL REQUIREMENTS

Task 1 - Transition Activities - Initial Transition

In the event of a new contractor, the Contractor shall ensure the orderly, efficient and safe transition of all contract activities and materials within three (3) months of the inception of the contract. This shall include the following Initial Transition activities and plans:

a) Within fourteen (14) calendar days of the contract effective date, develop and submit, for

Government review and approval, a Draft Initial Transition Plan to ensure full assumption of all contract responsibilities and functions no later than three (3) months following the contract effective date. The Draft Initial Transition Plan shall delineate the transition activities to be undertaken, timelines for the completion of each transition activity, and the staff to be assigned. The Contractor shall revise the Draft Initial Transition Plan to accommodate COR comments, and submit the Final Initial Transition Plan no later than two

(2) weeks after receipt of COR comments.

b) Develop materials and conduct orientation briefings for contract technical and administrative staff within six (6) weeks of the contract effective date. With input from the COR, incorporate into these orientation briefings information on policies and procedures.

c) Contract materials and plans currently in use by the incumbent contractor will be provided to the Contractor within fourteen (14) calendar days of the effective date of the contract.

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This includes: Standard Operating Procedures (SOPs), project management and staffing plan, quality assurance/quality control (QA/QC) plan, training plan, and overall monitoring strategy.

d) Within four (4) weeks of the effective date of contract, participate in a one-day contract kickoff meeting with the COR, the Contracting Officer, other NCI staff designated by the COR, the Program Director, and Contractor key personnel of the new Contractor and, if necessary, the incumbent Contractor at NIH. The purpose of this meeting will be to discuss initial transition plans and to review current and upcoming project deadlines.

Task 2 - Study Initiation and Liaison (New and Existing Studies)

The Contractor shall:

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

b) Determine the parties whose cooperation or approval is necessary for implementation of new, or continuation of ongoing, studies (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, Contractor’s IRB).

c) As requested by the NCI COR, attend weekly face-to-face meetings regarding study development and/or progress; provide required background material; keep minutes of such meetings and provide such minutes, as an email attachment, within seven (7) calendar days; and take appropriate actions on recommendations as applicable.

d) As requested by the NCI COR, arrange for study-related communications and meetings as needed between the NIH investigators (NCI staff), institutions with which NIH investigators are collaborating on specific studies, and/or agents for those whose cooperation or approval is necessary This includes large-scale, multi-center collaborative projects that may include 1-2 dozen studies participating in genome-wide association study (GWAS) efforts. Up to approximately forty (40) researchers involved in these studies from both domestic and international locations will be attending these meetings. Attend such meetings; provide required background material; keep minutes of such meetings and provide, as an email attachment, within seven (7) calendar days; and take appropriate actions on recommendations as applicable.

e) When multiple institutions are involved in a multi-center study, with guidance and input from the COR, develop procedures to assure that the investigation is being conducted in a standardized way at all sites.

f) Make arrangements for translations for necessary transactions to initiate studies in foreign settings.

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g) Negotiate and manage all financial and administrative matters related to the collection of data and biologic and environmental (workplace and general environment) samples, and analysis of biologic and environmental samples, with the various collaborating centers or other institutions or companies (e.g. subcontract, purchase of equipment, other compensation).

h) Provide support to OEEB in completing forms as may be required for various committees, such as Institutional Review Boards and the National Death Index Review Committee.

Task 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, environmental sample and biospecimen collection and processing forms, exposure assessment forms) with guidance, input and approval from the COR. Prepare, pretest, evaluate and produce paper questionnaires with guidance, input and approval from the COR. Prepare, pretest, evaluate, and produce computer-assisted interviews that may be administered in person (computer-assisted personal interview, CAPI) or via telephone (computer-assisted telephone interview, CATI) with guidance, input and approval from the COR. Prepare, pretest, evaluate, and produce self-administered surveys (paper copies, and web, cloud and mobile platforms), with guidance, input and approval from the COR.

b) Under the guidance and approval of the NCI COR, prepare training programs and materials for abstractors, interviewers, and other study personnel.

c) Under the guidance and approval of the NCI COR, prepare procedures manuals for medical abstractors, coders, interviewers, phlebotomists, other medical personnel involved in specimen collection, tracers, data editors, supervisors and industrial hygienists.

d) Under the guidance and approval of the NCI COR, prepare procedures manuals for the collection, processing, and storage of mobile health-related data (data collected from devices including smartphones and wearable sensors).

e) Under the guidance and approval of the NCI COR, prepare procedures manuals for the collection, processing, and storage of biologic specimens and environmental (workplace and general environment) samples of air, water, soil, carpet dust and other media;

shipment of samples; submission of samples to repositories; and tracking of samples and laboratory results.

f) Under the guidance and approval of the NCI COR, prepare manuals for obtaining, handling, and abstracting medical records, pathology specimens and reports; submission

N02CP71011-26 Page 4 of 11 of pathology specimens for review; and collection of death certificates. Arrange for review of these reports, measurements, or specimens by NCI or other parties designated by NCI.

g) Under the guidance and approval of the NCI COR, develop or adapt existing schemes of coding for categorizing demographic, occupational, industrial, nutritional, geographic, medical, or other information.

h) Translate data collection instruments or manuals into appropriate languages for foreign studies. As requested by the COR, back-translate either a portion of the material or all material into English to assure that the original intent of the material has not been changed by the translation.

i) Under the guidance and approval of the NCI COR, arrange and coordinate logistics for specific laboratory analyses of biospecimens and environmental (workplace and general environment) samples of air, water, soil, carpet dust, and other media. Monitor quality control on ongoing laboratory analyses, rapidly integrate laboratory results in study databases, carry out graphical and statistical analyses as needed, and assist with monitoring the availability of, and managing the use of, biologic and environmental samples stored in NCI biorepositories from a wide range of studies.

j) Assemble death certificates and records on cancer incidence. Have these certificates and records evaluated and coded by appropriate nosologists, pathologists or clinicians.

k) Given the similarity of activities 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 project.

Task 4 - Subject Identification, Selection, and Tracing

a) Provide support to OEEB in developing methods for identifying study subjects and make recommendations on the feasibility of alternative sampling schemes. Typical study groups include:

1) All patients newly diagnosed with cancer in a particular group of hospitals, clinics, or tumor registries;

2) Patients diagnosed with designated control diagnoses or free from disease, sometimes matched to cases on age, sex, race, and other characteristics; and

3) Groups of individuals employed in specific industries, with certain jobs, or having selected occupational or environmental exposures.

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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, Medicare files, area surveys, motor vehicle administration lists, employer personnel or labor union records, or population rosters. Other techniques may be required. When such methods as random digit dialing are performed, clear documentation shall be kept so that precise response rates can be determined for all phases of the telephone screening, and reasons and demographic characteristics can be summarized for subjects who refuse to participate or who are lost to follow-up.

c) Acquire appropriate population rosters or files from sources such as motor vehicle departments and Medicare files to identify selected series of potential study subjects.

d) Trace study subjects to locate them for interview, for biospecimen collection, for environmental (workplace or general environment) sampling, to determine their vital status, to assess cancer incidence, to assess exposure, to assess genetic susceptibility, to obtain current address information, or to obtain other information necessary for the 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.

Task 5 - Data Collection

a) Train abstractors, interviewers, telephone screeners, coders, phlebotomists and others who will be involved with acquiring and assembling data using NCI procedures. Provide computer-assisted personal or telephone (CAPI/CATI) interviews.

b) Oversee field activities that result in acquisition of data including identification of appropriate supplies for biologic sample collection, processing, storage, and shipment;

printing 2-D sample ID labels using ID sequences obtained from the BSI II NCI biorepository data base system, and shipment of supplies to study centers, including those located in international study sites including China.

c) Arrange for and oversee activities that result in the transfer of remotely collected data, including self-administered web-based surveys and data collected using mobile health technologies and associated applications and devices.

d) Abstract, microfilm, photocopy, or obtain computer records (e.g., clinical or office medical records, hospital charts, vital records, employment records). Maintain quality control over the abstracting or copying process. Verify a sample of abstracts by independent re-abstracting.

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e) With guidance and approval from the COR, develop data management and tracking systems that monitor the incoming flow of data, editing of data, changing or modification of data, and that can be summarized into descriptive reports.

f) Obtain the necessary permission for data collection from IRB Contractor.

g) Once NCI has obtained the necessary approvals, interview subjects or surrogates using mail, telephone, or personal interviews, including computer-assisted interviews. Use appropriate techniques to obtain acceptable response rates, including offering appropriate financial incentives. Record the interviews if specified by the NCI COR using contractor-provided devices. Verify a sample of completed questionnaires by re-interviewing subjects. If verification indicates a problem, develop and implement ways to correct the problem.

h) Arrange for clinical diagnostic studies and biologic or environmental (workplace or general environment) sample collection at the subject’s (and/or employer’s) convenience.

i) Collect and deliver biologic or environmental samples to laboratories or individuals for storage and/or analysis including managing international shipments of samples. Perform other support activities involving collection, storage and/or shipment to laboratories, as requested by the COR.

j) Obtain all necessary laboratory reports of results or progress.

k) For large scale GWAS efforts (e.g., NHL, lung cancer among never-smoking females in

Asia), cleaning of subject data logs, harmonization of histology data across studies, finalization of data files, close coordination of GWAS efforts with the relevant NCI repositories and laboratories, selection of deoxyribonucleic acid (DNA) samples for analysis based on review of pre-genotyping quality control reports produced by the NCI CGF, coordination of the post-GWAS replication effort including selecting DNA samples for analysis, coordination of data collection and harmonization across studies for subsequent gene-environment interaction analyses, and preparation and QC/QA of GWAS data sets for submission to the NIH Database of Genotypes and Phenotypes (dbGaP) after initial papers are published.

l) Procure death certificates from state vital records departments. The Contractor shall be responsible for determining details and payment for death certificates.

m) Develop tracing management systems to generate participation and loss rates for all data collection efforts. Develop other management systems to describe document control.

n) Monitor and/or evaluate current and/or historic occupational or environmental exposures or determinants of exposure.

o) Purchase other data, materials, and/or services as directed by the COR.

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p) Validate exposure or disease histories obtained in interviews by obtaining original records. This includes maintaining a management tracking system for the retrieval of such records.

Task 6 - Specimen Collection, Processing, Shipment, and Analysis

a) Provide support to OEEB in developing biospecimen-related protocols and providing logistical support to new field studies including purchasing and shipment of supplies to study sites, as well as assisting with management of samples and data generated on the large quantity of biologic samples already collected from previous studies and stored in NCI contract biorepositories. Assist with the selection of samples to be analyzed using the biospecimen inventory (BSI) II NCI biorepository data base system, coordinating with analysis laboratories to ensure receipt of samples, compilation and initial analysis of quality control data from pilot studies, and assisting with processing data received from analysis laboratories.

b) Train phlebotomists and others in NCI protocols/procedures for collecting specimens.

c) After obtaining necessary and appropriate informed consent, obtain biologic specimens

(e.g., peripheral venous blood, urine, buccal cell mouth wash samples, saliva) from study subjects. Divide samples, package them as necessary, and ship, transport or deliver them to a designated biorepository or laboratory(ies). Pertinent data (e.g., personal identifiers, collection date, etc.) concerning the specimen donor and processing procedures shall be collected and accompany every biologic specimen.

d) After obtaining necessary and appropriate informed consent, obtain environmental

(workplace and general environment) samples. This may include air samples in the workplace or home, personal monitoring, dermal exposure monitoring, or samples of carpet dust, water, soil, and other media. Divide samples, package them as necessary, and ship, transport or deliver them to a designated repository or laboratory(ies). Pertinent data (e.g., personal identifiers, collection date) shall be collected and accompany every sample.

e) With COR input and approval, develop and implement standard procedures adaptable to each site where work is being performed and utilize such standard approaches at all sites where possible in order to minimize sample variation. Document procedures to be followed in field manuals, including quality control procedures.

f) Arrange for safe shipment of biologic specimens (on dry ice or other means as appropriate) to an NCI biorepository or one or several laboratories, for either immediate assays or storage, as directed by the COR.

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g) With input from the COR, identify extramural contractors capable of conducting required analyses on biological samples collected by OEEB and establish subcontracts to conduct such analyses.

h) Report to the COR all irregularities, delays, losses, deteriorations, unplanned defrostings, accidents, mishandlings, errors, discrepancies, and inefficiencies associated with any specimen collection, delivery, or storage activity. Such incidents should be reported immediately via email, and included in the Monthly Progress Report.

i) Maintain an inventory and tracking system of specimens sent to laboratories for a wide range of OEEB studies, including laboratory analyses being supported under this contract as well as laboratory analyses being supported through other funding mechanisms.

Monitor discrepancies with field reports. Interface, use, and update the BSI II NCI biorepository database system, the central biospecimen database of the DCEG, to monitor the availability of, and manage the use of, biologic samples stored in NCI biorepositories from a large number of studies with previously collected samples. Documentation for use of the BSI II NCI biorepository database system shall be provided to the Contractor.

j) Obtain all necessary laboratory reports of results or progress.

k) Track laboratory results as they arrive from various contracting laboratories for assisting the COR in evaluating laboratory performance on blinded quality control samples within lab batches and for communicating these results to the appropriate NCI investigator.

l) Obtain all necessary laboratory reports and process and deliver them immediately to the

COR. Within one week of receipt of electronic or paper laboratory reports, enter or merge the electronic laboratory results into primary study databases and analytic data files, and then conduct initial graphical and preliminary statistical analyses, as requested by the

COR.

Task 7 - Data Preparation and Processing

a) Code or enter questionnaire responses and clinical and laboratory information into computer readable form. Edit data generated by CAPI/CATI interview programs. Verify a sample of the coding by independent re-coding. (The size of the sample shall be approved by the COR.) 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 with guidance and input from the COR.

c) Enter coded information onto suitable computer devices. Verify all or at least a 10% sample (at the discretion of the NCI study investigator) by re-entry. Re-enter as needed.

Summarize and describe differences between the two sets of data.

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Task 8 - Computer Programming

a) Modify and maintain computer databases and associated reporting software.

b) Prepare computer driven edit programs, conduct edit checks, edit data files, and correct computer files, where necessary, following a schedule agreed upon with the COR.

Describe findings in summary form in a report delivered as an e-mail attachment.

c) Update files with follow-up data, error corrections, and other revisions, as directed by the

COR. Maintain clearly documented history of development and updating of databases.

d) Prepare data sets for transfer to NCI investigators or others, in a format specified by the

COR.

e) Produce analyses specified by the NCI COR. These may include simple descriptive statistics or complex epidemiologic or other analyses. Most epidemiologic analyses will be performed elsewhere, but occasionally the Contractor may be required to provide such service.

f) Respond to priority requests and changes of direction by appropriate activities and use of personnel.

g) Prepare data sets in response to FOIA requests made to the NCI FOIA office, with special attention to protecting privacy and indirect identification of study subjects.

Task 9 - Study Monitoring, Quality Control and Reporting

Quality control of all aspects of data collection and management is a critical activity. The NCI COR will carefully review studies to ensure that the data are sound. At the outset and throughout the progress of each study, the COR shall approve a plan prepared by the Contractor Study Manager for the schedule and contents of reports needed for quality control. Quality control shall require that the Contractor:

a) Document each step of a study and maintain, in an orderly arrangement, all relevant material so that any aspect of the study may be reviewed and evaluated by the NCI staff at any point in time. Involved are the following:

1) Type letters and prepare forms and other documents necessary for the conduct of the study;

2) Duplicate study documents when the original sources cannot be retained;

3) Maintain a filing system of all materials relevant to the study, cross-referenced in a manner so as to make all of the material easily accessible (these materials shall be maintained under security in accordance with requirements of the Privacy Act as it applies to contractors); and

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4) Maintain a log of decisions made during each study that affect the design, conduct or analysis. Each entry shall include a brief explanation and date of the problem, the decision made.

b) With input and guidance from the COR, develop quality control procedures for carrying out pilot studies to identify appropriate laboratories and for monitoring quality control as the analysis of actual study samples proceeds. This includes checks such as spiked, blank, and duplicate samples, and covers collection, disbursal, and results transmission.

Develop strategies for obtaining blind quality surveillance for monitoring laboratory procedures.

c) With input and guidance from the COR, develop internal recordkeeping procedures for assessing the progress of data collection, data preparation, and data entry. These record systems may be paper files or computer files.

d) Report verification rates, discrepancy rates, and error rates for data collection, preparation, and keying following the schedule agreed upon with the COR. All unusual problems should be brought to the immediate attention of the COR.

e) Monitoring of a wide spectrum of workplace exposures, or estimation of historical exposures, shall be performed by an industrial hygienist 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.

Task 10 - Exposure Assessment

a) Using protocols developed by the COR, provide support to the OEEB by using

Geographic Information Systems (GIS) to develop exposure metrics in studies of the relationship between environmental contaminants and cancer risk. Examples of current projects include risk assessments concerning fugitive agricultural chemicals in California, release of dioxin compounds from incineration facilities, and nitrate and disinfection by-products in private wells and public water supplies.

b) Using approaches developed by the COR, provide support to the OEEB in conducting exposure assessment in the context of epidemiologic studies relating occupational exposures to disease risk, particularly cancer. The studies of occupation-related risk carried out by OEEB include retrospective assessment of historical exposures through industry and questionnaire-based evaluations in case-control and cohort studies; on-site evaluation of exposures through air, dermal, and biological monitoring; remote collection of exposure measurements through the development of mobile health-based technologies and associated devices; and studies of early biologic effects and genetic susceptibility.

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Task 11 - Final Transition

The Contractor shall develop and implement a Final Transition Plan to ensure the orderly, efficient, and smooth transition of all contract activities and materials. Four (4) months prior to the completion date of the contract, a Draft Final Transition Plan shall be submitted to the COR and Contracting Officer for review and approval, delineating the transition activities to be undertaken, timelines for the completion of each transition activity, and the staff to be assigned.

The Draft Final Transition Plan shall include a listing of and plans for transferring contract-generated materials.

The Final Transition Plan shall be submitted to the Government no later than two (2) months prior to the completion date of the contract.

During the first eight (8) weeks of the follow-on contract, the follow-on Contractor shall effect a smooth transition of the management and operations of the existing support provided by the current Contractor to the new Contractor without prolonged interruption of the normal day-to-day provision of support services including: a) initiation, liaison and administrative management;

b) word processing and computing; c) development of the study materials and procedures; d) identifying and tracing study subjects, data collection and monitoring; e) laboratory aspects involving biologic specimens, tests and laboratory data; f) data preparation; g) data processing;

h) data analysis; and i) documentation, monitoring, quality control and priority actions.

During this period, the Contractor shall establish a working relationship with the follow-on Contractor; In particular, transfer of all materials related to each study or study component managed by the Contractor shall occur within four (4) weeks of contract award.

Maintain contract operations at full staffing levels during the final Transition period, unless otherwise directed by the COR.

d) Within four (4) weeks of the effective date of contract, participate in a one-day contract kickoff meeting with the COR, the Contracting Officer, other NCI staff designated by the COR, the Program Director, and Contractor key personnel of the ne...