CARDIA Y30 FINAL AL FC SOW.pdf

ATTACHMENT #3

STATEMENT OF WORK – CARDIA FIELD CENTERS 1

STATEMENT OF WORK – CARDIA FIELD CENTER (BIRMINGHAM, AL)

I. BACKGROUND

The Coronary Artery Risk Development in Young Adults (CARDIA) study was established in 1985 by the National Heart, Lung, and Blood Institute (NHLBI) to study the distribution and evolution of cardiovascular disease risk beginning in young adulthood in four U.S. communities (Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA) (http://www.cardia.dopm.uab.edu/). The original cohort (n=5,115) was selected to have approximately the same number of participants in subgroups of age (18-24 and 25-30), sex, race (black and white), and education (high school or less and more than high school) within each community. Participants were sampled from the total population, selected census tracts or, in the case of one Center, the membership of a large health plan. The baseline examination (Year 0) was conducted over a 14-month period during 1985-86. The examination consisted of questionnaires on sociodemographic characteristics, health behaviors, and psychological factors;

an exercise treadmill test; resting electrocardiography; a diet history assessment; anthropometry;

pulmonary function testing; and resting blood pressure. Fasting blood measurements included total cholesterol and its subfractions, insulin, glucose, liver enzymes and other serum chemistry measurements, and hematology.

Seven additional examinations have been completed every 2-5 years, including a Year 25 examination completed in 2011. Repeat measurements on traditional risk factors, including plasma lipids, blood pressure, anthropometry, smoking behavior, and physical activity have used the same methods at each examination to assess age and secular trends in these factors during young adulthood to middle-age. In selected years, additional measurements have been made, including a treadmill exercise test at baseline and Year 7; diet history at baseline, Year 7, and Year 20; cardiovascular reactivity measurements in Year 2; ambulatory blood pressure monitoring (in a subset) at Year 5; skin reflectance and assessment of the experience of discrimination and other psychosocial measures and urine sodium and creatinine (in a subset) in Year 7; glucose tolerance testing in Year 10, Year 20, and Year 25; microalbuminuria at Year 10, Year 15, Year 20, and Year 25; echocardiography at Year 5, Year 10 (in a subset), and Year 25;

cardiac CT scan in Year 15 and Year 20; carotid ultrasound in Year 20; abdominal CT scan in Year 25; and brain MRI at Year 25 (in a subset). Investigator initiated ancillary studies have also contributed significantly to the CARDIA program of research.

Retention of the surviving cohort was 90, 86, 81, 79, 74, 72, and 72 percent at each of the respective seven follow-up examinations. Cohort members are contacted every six months to obtain information on vital status and current residence. Every other six-month contact also includes speaking with the participant to ascertain information on major illness or injury, and hospitalizations occurring between contacts.

At Year 30 examination, the eighth examination of the cohort, participants will be 48-60 years old, a time when risk factors and subclinical abnormalities are prevalent and clinical events continue to emerge. CARDIA offers the opportunity to address aspects of the development and progression of subclinical and clinical disease that cannot be addressed in older cohorts.

http://www.cardia.dopm.uab.edu/�

STATEMENT OF WORK – CARDIA FIELD CENTERS 2

Specifically, CARDIA offers the opportunity to phenotype early cardiovascular disease, including heart failure in a large cohort of white and black adults. In addition, risk factors for cardiovascular disease can be updated. With risk factor data from previous examinations, CARDIA has the ability to study how the entire trajectory of early adulthood to mid-to-late middle-age risk factors and their control affects development and progression of cardiac dysfunction.

1. Scientific Objectives

This renewal will fund continued follow-up and a limited clinical examination of the CARDIA cohort to address the following three objectives:

1. To determine abnormalities in cardiac structure and function that exist in a community-based sample of mid-to-late middle-aged adults; to utilize novel measures to better understand myocardial dysfunction; to examine 25-year trajectories in cardiac structure and function; and to assess whether these abnormalities and trajectories differ between white and black adults.

2. To assess the impact of timing and varying levels of risk factors acquired throughout young adulthood and middle-age on the occurrence and progression of myocardial dysfunction and early clinical events.

3. To utilize a comprehensive approach to elucidate the basis for racial disparities in the development of cardiovascular disease risk factors, subclinical cardiac abnormalities, and potentially early clinical events.

4. To continue cohort follow-up for cardiovascular events, including heart failure, coronary heart disease, stroke, and atrial fibrillation.

5. To provide a platform for ancillary studies particularly to the cohort examination, a training ground for new investigators, and data sharing.

The final protocol (including any additional scientific objectives and measurements) will be developed in collaboration with the NHLBI Project Office, and will be reviewed and approved by NHLBI in consultation with the existing CARDIA Observational Studies Monitoring Board

(OSMB).

The study will support in-depth ancillary studies that are funded outside of the current contract.

These studies will be operationally integrated into the main study, and the data will be shared across both types of studies, per current CARDIA and NIH data-sharing policies. The study’s data will be provided to interested investigators through a defined process that encourages maximum data utilization but that protects participant confidentiality.

The study will also continue to serve as a training ground for early stage investigators, who will work with senior investigators and be provided with guidance on conducting research.

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2. Study Operations

All surviving and willing members of the CARDIA cohort will be followed up and included in the Year 30 exam during 2015-2016 (approximately 12 months in duration). It is estimated that approximately 3500 participants will be examined. Participants will be contacted every 6 months to ascertain vital status and change in address; every other 6-month contact includes contacting the participant to characterize new clinical events and other changes in health status. A timeline for the study is provided in Table 1.

Collaborating centers will include four Field Centers, a Coordinating Center, and an Echocardiography Reading Center. The Coordinating Center will establish other Reading Center(s) and laboratories as necessary. Principal Investigators from each of the 6 collaborating centers, plus any relevant large subcontracts as determined by the NHLBI Project Office, and the NHLBI Project Officer form the CARDIA Steering Committee. The chairman of the Steering Committee serves through a subcontract with the Coordinating Center.

Data analysis, publications, and cohort follow-up for morbidity and mortality will occur throughout the Base and Option periods. If all periods are exercised, the total contract will be a 5-year requirement.

Base July 1, 2013 – June 30, 2014 Option 1 July 1, 2014 – June 30, 2015 Option 2 April 1, 2015 – August 31, 2016 Option 3 July 1, 2015 – June 30, 2016 Option 4 July 1, 2016 – June 30, 2017 Option 5 July 1, 2017 – June 30, 2018

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Table 1. Timeline according to Base Period and Options Funding Schedule

July '13- June '14

July '14- June '15

April '15- Aug '16

July ’15 – June ‘16

July '16- June '17

July '17- June '18

BASE

Protocol Development

Follow-up and Retention

Analysis and Publications

OPTION 1

OMB Preparation

OMB Submission, clearance

Protocol Review NHLBI and OSMB

OPTION 2

Staff Training and Certification

Pilot Testing

Exam

OPTION 3

OPTION 4

OPTION 5

Close Out

STATEMENT OF WORK – CARDIA FIELD CENTERS 5

Base Period (July 1, 2013 – June 30, 2014)

I. GENERAL REQUIREMENTS AND TASKS FOR THE BIRMINGHAM, AL COHORT

Note: Throughout this statement of work, the terms “Contractor” and “Field Center” are used interchangeably. This statement of work is specific to the Birmingham, AL cohort. The offeror must be able to contact this cohort for examination and follow-up components.

The Contractor shall provide appropriate personnel with expertise in cardiovascular epidemi-ology, clinical and subclinical cardiovascular disease, echocardiography, body composition, obesity, genetics, laboratory measurements, statistics, longitudinal studies, clinic operations, clinical events follow-up, and management to:

A. Participate in and designate staff to lead the study and participate in committees, such as the Steering Committee, Endpoints Surveillance and Adjudication Committee, Laboratory Committee, Imaging Committee, Quality Control Committee, Publications Committee, Clinic Coordination and Retention Committee, and other subcommittees, as appropriate.

B. Conduct surveillance of the cohort for clinical events.

C. Provide formal and/or informal training opportunities for early stage investigators

(assistant professors, fellows, and students). This includes but is not limited to early stage investigator with experience and responsibilities for specific scientific and study management areas and working on data analyses and publications and serving on study subcommittees. Sites are encouraged to apply for supplements from existing NIH programs or include CARDIA.

D. Participate actively in data analysis, presentation, and publication.

E. Encourage investigators from outside the existing CARDIA sites to participate in data analysis and publication of the “public use” data from the NHLBI Data Repository. Also seek outside investigators to work with CARDIA investigators in analyzing the data not yet available through the NHLBI Data Repository. Formalize and expand existing plans to facilitate this to include (but not be limited to) publicizing the availability of Data Repository data, the publication policy, and the ancillary study mechanisms on the CARDIA public website, at scientific meetings, or by letters to investigators. Provide data user support and designated staff to respond to inquiries about data or ancillary studies. See Appendix for description of Ancillary Studies.

F. Provide event ascertainment. Follow-up will be performed for morbidity (acute myocardial infarction, angina, stroke, heart failure, atrial fibrillation; peripheral vascular disease; chronic obstructive pulmonary disease; obstructive sleep apnea); mortality; and any cardiovascular disease interventions received. In addition, all hospitalizations will be

STATEMENT OF WORK – CARDIA FIELD CENTERS 6

identified and data collected on discharge diagnoses. All participants, including those who have refused participation and unequivocally expressed the desire not to be re-contacted, will be followed through the National Death Index and other commercial databases as appropriate.

Events will be classified in a standard manner and consistent with current CARDIA practice, as developed by the Endpoints Surveillance and Adjudication Subcommittee.

Refinements to the protocol and Manual of Operations for event ascertainment should to the extent possible be comparable to other NHLBI-sponsored large cohort studies such as the Atherosclerosis Risk in Communities (ARIC) Study and the Multi-Ethnic Study of Atherosclerosis (MESA). Types of data to be collected include:

Dates of deaths and hospitalizations Interview data from participants or proxy Hospital discharge diagnosis and ICD codes Data collected from hospital inpatient and outpatient records

G. Prepare and submit technical and financial reports as specified herein.

II. SPECIFIC REQUIREMENTS AND TASKS

Note: Throughout this statement of work, the terms "Contractor" and "Field Center" are used interchangeably to facilitate description of the tasks to be performed.

The Contractor shall:

1. Designate key personnel to lead and manage the study who have the appropriate qualifications.

a. A principal investigator with the following:

i. Training and experience in cardiovascular epidemiology

ii. Demonstrated excellence as a manager and collaborator

iii. Experience successfully recruiting participants into an epidemiology study

b. Co-investigator(s)* knowledgeable in scientific areas relevant to the study and skilled in study design and data analysis (*Include the designation of one co-investigator who is qualified to temporarily serve in the place of the principal investigator as needed.)

[Note to Offerors: The NHLBI Project Office must approve key personnel.]

2. Provide other staff as follows:

a. Investigators

b. Data analysts

c. Surveillance, follow-up contacts investigations staff

STATEMENT OF WORK – CARDIA FIELD CENTERS 7

d. Data management staff

3. Participate in and designate staff to participate in the Steering Committee and other committees, as appropriate. Subcommittees include, but are not limited to:

a. Genetics Committee

b. Clinic Coordination and Retention Committee

c. Quality Control Committee

d. Laboratory Committee

e. Imaging Committee

f. Endpoints Surveillance and Adjudication Committee

g. Publications and Presentations Committee

Note: The final composition of subcommittees will be determined during protocol development.

4. Conduct surveillance of the cohort for clinical events, collecting information as specified in the Manual of Operations.

a. Information to be collected includes: occurrence of cardiovascular events, other significant illnesses and hospitalizations, including information from participants, proxies, hospital records, and death certificates, and according to a standard protocol developed by the Endpoints Surveillance and Adjudication Committee and approved by the Steering Committee.

b. As part of the Endpoints Surveillance and Adjudication Committee, participate in classification of type and severity of cardiovascular events.

c. Perform and/or coordinate searches using commercial databases to find participants who are lost to follow-up.

5. Analyze and publish data from the study.

a. Perform data analysis, write and present abstracts, and write and publish manuscripts based on CARDIA data.

b. Submit at least three (3) manuscripts for publication in each year of the contract with an investigator from the site as the first author.

c. Submit abstracts and manuscripts proposed for presentation or publication to the Publications and Presentations Committee, per study policy, prior to submitting to scientific meetings or journals.

d. Provide publications and presentations emanating from the Field Center in a timely manner, for a data base to be managed by the Coordinating Center.

6. Provide early stage investigators with experience and responsibilities for specific scientific and study management areas and data analysis and publication. Contribute to new scientific developments within the study and work collaboratively with all centers to support early investigators in training.

a. In collaboration with the other centers, or within the Coordinating Center, propose new ideas for analyses, testing, and scientific directions.

STATEMENT OF WORK – CARDIA FIELD CENTERS 8

b. Propose new collaborations to achieve the goal of advancing new scientific objectives.

c. Support training of and providing experience for early stage investigators.

i. Both at the Field Center and at collaboration centers, provide assistance to develop new research projects

ii. Encourage early stage investigators to apply for programs to bring support for training.

iii. Provide informal training experiences.

iv. Provide guidance in accessing the data set, proposing manuscripts, analyzing data, interpreting findings, preparing manuscripts, identifying next steps for research, and proposing ancillary studies.

7. Protocol Development:

a. Participate in the study protocol development of the Year 30 Exam.

b. Assist the Coordinating Center as necessary in identifying and establishing reading centers and laboratories as needed.

8. Prepare and submit technical and financial reports, including the following:

a. Semi-annual progress reports that describe main operational activities during the period, problems encountered and how they were resolved, an accounting of personnel, including levels of effort and changes during the period, and scientific productivity.

b. Periodic financial reports, as required by NIH, specific to your institution.

9. Implementation of Transition Plan Activities as applicable:

a. Implement plan for smooth and seamless transition of Field Center’s responsibilities from existing Field Contractor.

b. Implement plan for obtaining IRB approval with appropriate consideration for conditions that have been established and existing in the previous contract. This should include informed consent conditions agreed to by the participants, and existing IRB approved conditions at the original Coordinating Center.

c. Implement plan for the transition of all data from the existing Contractor, including care of the confidentiality and security of all data.

d. Implement plan for transition of all exiting protocols, document, minutes, and reports from the current Contractor.

STATEMENT OF WORK – CARDIA FIELD CENTERS 9

Option Period 1 (July 1, 2014 – June 30, 2015) interchangeably. This statement of work is specific to the Birmingham, AL cohort. The offeror must be able to contact this cohort for examination and follow-up components.

The Contractor shall provide appropriate personnel with expertise in cardiovascular epidemi-ology, clinical and subclinical cardiovascular disease, echocardiography, body composition, Laboratory Committee, Imaging Committee, Quality Control Committee, Publications stage investigator with experience and responsibilities for specific scientific and study management areas and working on data analyses and publications and serving on study seek outside investigators to work with CARDIA investigators in analyzing the data not yet available through the NHLBI Data Repository. Formalize and expand existing plans to facilitate this to include (but not be limited to) publicizing the availability of Data Repository data, the publication policy, and the ancillary study mechanisms on the CARDIA public website, at scientific meetings, or by letters to investigators. Provide

STATEMENT OF WORK – CARDIA FIELD CENTERS 10

identified and data collected on discharge diagnoses. All participants, including those who have refused participation and unequivocally expressed the desire not to be re-contacted, will be followed through the National Death Index and other commercial databases as appropriate. Events will be classified in a standard manner and consistent with current CARDIA practice, as developed by the Endpoints Surveillance and Adjudication Subcommittee. Refinements to the protocol and Manual of Operations for event ascertainment should to the extent possible be comparable to other NHLBI-sponsored large cohort studies such as the Atherosclerosis Risk in Communities (ARIC) Study and the Multi-Ethnic Study of Atherosclerosis (MESA). Types of data to be collected include:

Note: Throughout this statement of work, the terms "Contractor" and "Field Center" are used interchangeably to facilitate description of the tasks to be performed.

a. A principal investigator with the following:

i. Training and experience in cardiovascular epidemiology

ii. Demonstrated excellence as a manager and collaborator

iii. Experience successfully recruiting participants into an epidemiology study

b. Co-investigator(s)* knowledgeable in scientific areas relevant to the study and skilled in study design and data analysis

b. Data analysts

d. Data management staff

STATEMENT OF WORK – CARDIA FIELD CENTERS 11

3. Participate in and designate staff to participate in the Steering Committee and other committees, as appropriate. Subcommittees include, but are not limited to:

a. Genetics Committee

b. Clinic Coordination and Retention Committee

c. Quality Control Committee

d. Laboratory Committee

e. Imaging Committee

a. Information to be collected includes: occurrence of cardiovascular events, other significant illnesses and hospitalizations, including information from participants, proxies, hospital records, and death certificates, and according to a standard protocol developed by the Endpoints Surveillance and Adjudication Committee and approved by the Steering Committee.

b. As part of the Endpoints Surveillance and Adjudication Committee, participate in classification of type and severity of cardiovascular events.

manuscripts based on CARDIA data.

b. Submit at least three (3) manuscripts for publication in each year of the contract with an investigator from the site as the first author.

c. Submit abstracts and manuscripts proposed for presentation or publication to the Publications and Presentations Committee, per study policy, prior to submitting to scientific meetings or journals.

scientific and study management areas and data analysis and publication. Contribute to new scientific developments within the study and work collaboratively with all centers to support early investigators in training.

a. In collaboration with the other centers, or within the Coordinating Center, propose new ideas for analyses, testing, and scientific directions.

STATEMENT OF WORK – CARDIA FIELD CENTERS 12

b. Propose new collaborations to achieve the goal of advancing new scientific objectives.

c. Support training of and providing experience for early stage investigators.

i. Both at the Field Center and at collaboration centers, provide assistance to develop new research projects

ii. Encourage early stage investigators to apply for programs to bring support for training.

iii. Provide informal training experiences.

iv. Provide guidance in accessing the data set, proposing manuscripts, analyzing data, interpreting findings, preparing manuscripts, identifying next steps for research, and proposing ancillary studies.

7. Protocol Development:

a. Participate in the study protocol development of the Year 30 Exam.

b. Assist the Coordinating Center as necessary in identifying and establishing reading centers and laboratories as needed.

c. Develop an informed consent prototype with common language for all Field

Centers.

d. Develop local recruitment procedures, while cooperating in common efforts and sharing ideas as coordinated by the Clinic Coordination and Retention Committee.

8. Prepare and submit technical and financial reports, including the following:

a. Semi-annual progress reports that describe main operational activities during the period, problems encountered and how they were resolved, an accounting of personnel, including levels of effort and changes during the period, and scientific productivity.

9. Work cooperatively with other study centers, including other Field Centers, Coordinating Center, Reading Centers, Laboratories, and the NHLBI Project Office staff in all relevant aspects of study development and execution.

STATEMENT OF WORK – CARDIA FIELD CENTERS 13

Option Period 2 (April 1, 2015 – August 31, 2016) interchangeably. This statement of work is specific to the Birmingham, AL cohort. The offeror must be able to contact this cohort for examination and follow-up components.

The Contractor shall provide appropriate personnel with expertise in cardiovascular epidemi-ology, clinical and subclinical cardiovascular disease, echocardiography, body composition, A. Obtain IRB approval and plan and participate in central training and pilot testing.

B. Recruit and re-examine the local established CARDIA cohort for CARDIA Year 30

Exam.

Designate key personnel to lead and manage the study who have the appropriate qualifications.

a. A principal investigator with the following:

i. Training and experience in cardiovascular epidemiology

ii. Demonstrated excellence as a manager and collaborator

iii. Experience successfully recruiting participants into an epidemiology study

Provide other staff as follows:

a. Clinic operations staff, including a manager/coordinator, recruiters, technicians and interviewers

1. Obtain IRB approval and plan and participate in central training and pilot testing

a. Obtain approval from the Institutional Review Board to conduct the study.

b. Based on draft protocols developed and approved by the Steering

STATEMENT OF WORK – CARDIA FIELD CENTERS 14

Committee, plan and participate in central training sessions for clinic staff.

c. Perform pilot testing for the examination after training is complete, consisting of performing all of the components of the Year 30 Exam according to the draft Manual of Operations, in at least 9 volunteers per Field Center who are not study participants. The pilot tests also are to include shipping blood samples to the appropriate laboratories.

Results will be reviewed by the Steering Committee.

d. Redesign and implement changes in protocol, as recommended by the

Steering Committee, based on pilot testing results.

e. Assist the Coordinating Center in making final modifications to the Manual of Operations based on the pilot test results at the direction of the Steering Committee.

2. Recruit and re-examine the local established CARDIA cohort for the Year 30 Exam.

a. Obtain informed consent from each participant.

b. Perform clinic examinations.

c. Obtain other measurements, as determined by the Steering Committee and Project Office.

d. Provide samples to the proper laboratories for assays or long-term storage.

e. Provide for refrigerated centrifugation, temporary storage at low temperature, laboratory procedures for sample preparation, and shipping with dry ice for blood and urine specimens, as appropriate.

f. Perform data entry and initial verification and correction of the entered data using software provided by the Coordinating Center.

g. In collaboration with the Coordinating Center, provide clinically relevant results of each examination and an indication of any abnormalities of clinical significance to the participant, and, with consent, to his/her physician.

Provide recommendations for follow-up of abnormalities as appropriate.

h. Oversee local quality assurance and quality control activities, according to established study procedures, as recommended by the Quality Control Committee to assure high quality data collection.

i. Enter and edit the results from study interviews, examinations and quality assurance activities, including blind duplicates, into a computer, using software designed in cooperation with the Coordinating Center, and

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transmit the data to the Coordinating Center on a regular basis, as specified in the study protocol.

ii. Transmit quality control data to the Coordinating Center according to specifications of the study protocol.

iii. Perform repeat measurements and send repeat lab samples for quality control, per the protocol. For planning purposes, estimate 5% repeat measurements and samples.

3. Examination Components

Data to be collected are approximated by the following list of components, which may be modified during protocol development. Unless there is a strong rationale, procedures should be similar to those used for previous data collections in CARDIA. The final protocol as approved by the NHLBI in consultation with the OSMB shall constitute the final content and schedule of the data to be collected.

• Consent

List of Year 30 Exam components

• Demographic information

• Anthropometry

• Blood pressure

• Smoking history

• Medical history, including medications

• A limited number of questionnaires, including but not limited to perimenopause, behavioral factors related to weight gain and weight loss, and physical activity

• Fasting phlebotomy for whole blood, serum, plasma, and DNA collection

• Spot urine collection for albumin and creatinine

• M-mode and 2-D echocardiography with tissue doppler and speckle tracking

4. Laboratory Measures

The following specific types or classes of measurements will be made. The final protocol for lab measurements will be determined by the Steering Committee.

a. Established clinical measures of metabolism, renal function, and lipid metabolism.

b. Urine creatinine and albumin.

c. Collection and storage of DNA, serum, plasma, and urine.

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Option Period 3 (July 1, 2015 – June 30, 2016) interchangeably. This statement of work is specific to the Birmingham, AL cohort. The offeror must be able to contact this cohort for examination and follow-up components.

The Contractor shall provide appropriate personnel with expertise in cardiovascular epidemi-ology, clinical and subclinical cardiovascular disease, echocardiography, body composition, Laboratory Committee, Imaging Committee, Quality Control Committee, Publications stage investigator with experience and responsibilities for specific scientific and study management areas and working on data analyses and publications and serving on study seek outside investigators to work with CARDIA investigators in analyzing the data not yet available through the NHLBI Data Repository. Formalize and expand existing plans to facilitate this to include (but not be limited to) publicizing the availability of Data Repository data, the publication policy, and the ancillary study mechanisms on the CARDIA public website, at scientific meetings, or by letters to investigators. Provide

STATEMENT OF WORK – CARDIA FIELD CENTERS 17

identified and data collected on discharge diagnoses. All participants, including those who have refused participation and unequivocally expressed the desire not to be re-contacted, will be followed through the National Death Index and other commercial databases as appropriate.

Events will be classified in a standard manner and consistent with current CARDIA practice, as developed by the Endpoints Surveillance and Adjudication Subcommittee.

Refinements to the protocol and Manual of Operations for event ascertainment should to the extent possible be comparable to other NHLBI-sponsored large cohort studies such as the Atherosclerosis Risk in Communities (ARIC) Study and the Multi-Ethnic Study of Atherosclerosis (MESA). Types of data to be collected include:

a. A principal investigator with the following:

ii. Training and experience in cardiovascular epidemiology

iii. Demonstrated excellence as a manager and collaborator

iv. Experience successfully recruiting participants into an epidemiology study

b. Co-investigator(s)* knowledgeable in scientific areas relevant to the study and skilled in study design and data analysis

b. Data analysts

STATEMENT OF WORK – CARDIA FIELD CENTERS 18

3. Participate in and designate staff to participate in the Steering Committee and other committees, as appropriate. Subcommittees include, but are not limited to:

a. Genetics Committee

b. Clinic Coordination and Retention Committee

c. Quality Control Committee

d. Laboratory Committee

e. Imaging Committee participants, proxies, hospital records, and death certificates, and according to a standard protocol developed by the Endpoints Surveillance and Adjudication Committee and approved by the Steering Committee.

b. As part of the Endpoints Surveillance and Adjudication Committee, participate in classification of type and severity of cardiovascular events.

manuscripts based on CARDIA data.

b. Submit at least three (3) manuscripts for publication in each year of the contract with an investigator from the site as the first author.

c. Submit abstracts and manuscripts proposed for presentation or publication to the Publications and Presentations Committee, per study policy, prior to submitting to scientific meetings or journals.

scientific and study management areas and data analysis and publication.

Contribute to new scientific developments within the study and work collaboratively with all centers to support early investigators in training.

a. In collaboration with the other centers, or within the Coordinating Center, propose new ideas for analyses, testing, and scientific directions.

b. Propose new collaborations to achieve the goal of advancing new scientific

STATEMENT OF WORK – CARDIA FIELD CENTERS 19

objectives.

c. Support training of and providing experience for early stage investigators.

i. Both at the Field Center and at collaboration centers, provide assistance to develop new research projects

ii. Encourage early stage investigators to apply for programs to bring support for training.

iii. Provide informal training experiences.

iv. Provide guidance in accessing the data set, proposing manuscripts, analyzing data, interpreting findings, preparing manuscripts,

7. Prepare and submit technical and financial reports, including the following:

a. Semi-annual progress reports that describe main operational activities during the period, problems encountered and how they were resolved, an accounting of personnel, including levels of effort and changes during the period, and scientific productivity.

STATEMENT OF WORK – CARDIA FIELD CENTERS 20

Option Period 4 (July 1, 2016 – June 30, 2017) interchangeably. This statement of work is specific to the Birmingham, AL cohort. The offeror must be able to contact this cohort for examination and follow-up components.

The Contractor shall provide appropriate personnel with expertise in cardiovascular epidemi-ology, clinical and subclinical cardiovascular disease, echocardiography, body composition, Laboratory Committee, Imaging Committee, Quality Control Committee, Publications stage investigator with experience and responsibilities for specific scientific and study management areas and working on data analyses and publications and serving on study seek outside investigators to work with CARDIA investigators in analyzing the data not yet available through the NHLBI Data Repository. Formalize and expand existing plans to facilitate this to include (but not be limited to) publicizing the availability of Data Repository data, the publication policy, and the ancillary study mechanisms on the CARDIA public website, at scientific meetings, or by letters to investigators. Provide

STATEMENT OF WORK – CARDIA FIELD CENTERS 21

identified and data collected on discharge diagnoses. All participants, including those who have refused participation and unequivocally expressed the desire not to be re-contacted, will be followed through the National Death Index and other commercial databases as appropriate. Events will be classified in a standard manner and consistent with current CARDIA practice, as developed by the Endpoints Surveillance and Adjudication Subcommittee. Refinements to the protocol and Manual of Operations for event ascertainment should to the extent possible be comparable to other NHLBI-sponsored large cohort studies such as the Atherosclerosis Risk in Communities (ARIC)

H. Provide guidance in accessing the data set, proposing manuscripts, analyzing data, interpreting findings, preparing manuscripts, identifying next steps for research, and proposing ancillary studies.

b. A principal investigator with the following:

i. Training and experience in cardiovascular epidemiology

ii. Demonstrated excellence as a manager and collaborator

iii. Experience successfully recruiting participants into an epidemiology study

c. Co-investigator(s)* knowledgeable in scientific areas relevant to the study and skilled in study design and data analysis

b. Data analysts

STATEMENT OF WORK – CARDIA FIELD CENTERS 22

3. Participate in and designate staff to participate in the Steering Committee and other committees, as appropriate. Subcommittees include, but are not limited to:

a. Genetics Committee

b. Clinic Coordination and Retention Committee

c. Quality Control Committee

d. Laboratory Committee

e. Imaging Committee participants, proxies, hospital records, and death certificates, and according to a standard protocol developed by the Endpoints Surveillance and Adjudication Committee and approved by the Steering Committee.

b. As part of the Endpoints Surveillance and Adjudication Committee, participate in classification of type and severity of cardiovascular events.

c. Perform and/or coordinate searches using commercial databases to find participants who are lost to follow-up.

5. Analyze and publish data from the study.

a. Perform data analysis, write and present abstracts, and write and publish manuscripts based on CARDIA data.

b. Submit at least three (3) manuscripts for publication in each year of the contract with an investigator from the site as the first author.

c. Submit abstracts and manuscripts proposed for presentation or publication to the Publications and Presentations Committee, per study policy, prior to submitting to scientific meetings or journals.

6. Provide early stage investigators with experience and responsibilities for specific scientific and study management areas and data analysis and publication. Contribute to new scientific developments within the study and work collaboratively with all centers to support early investigators in training.

a. In collaboration with the other centers, or within the Coordinating Center, STATEMENT OF WORK – CARDIA FIELD CENTERS 23 propose new ideas for analyses, testing, and scientific directions.

b. Propose new collaborations to achieve the goal of advancing new scientific objectives.

c. Support training of and providing experience for early stage investigators.

i. Both at the Field Center and at collaboration centers, provide assistance to develop new research projects

ii. Encourage early stage investigators to apply for programs to bring support for training.

iii. Provide informal training experiences.

7. Prepare and submit technical and financial reports, including the following:

a. Semi-annual progress reports that describe main operational activities during the period, problems encountered and how they were resolved, an accounting of personnel, including levels of effort and changes during the period, and scientific productivity.

b. Periodic financial reports, as required by NIH, specific to your institution.

STATEMENT OF WORK – CARDIA FIELD CENTERS 24

Option Period 5 (July 1, 2017 – June 30, 2018) interchangeably. This statement of work is specific to the Birmingham, AL cohort. The offeror must be able to contact this cohort for examination and follow-up components.

The Contractor shall provide appropriate personnel with expertise in cardiovascular epidemi-ology, clinical and subclinical cardiovascular disease, echocardiography, body composition, Laboratory Committee, Imaging Committee, Quality Control Committee, Publications stage investigator with experience and responsibilities for specific scientific and study management areas and working on data analyses and publications and serving on study seek outside investigators to work with CARDIA investigators in analyzing the data not yet available through the NHLBI Data Repository. Formalize and expand existing plans to facilitate this to include (but not be limited to) publicizing the availability of Data Repository data, the publication policy, and the ancillary study mechanisms on the CARDIA public website, at scientific meetings, or by letters to investigators. Provide

STATEMENT OF WORK – CARDIA FIELD CENTERS 25

identified and data collected on discharge diagnoses. All participants, including those who have refused participation and unequivocally expressed the desire not to be re-contacted, will be followed through the National Death Index and other commercial databases as appropriate. Events will be classified in a standard manner and consistent with current CARDIA practice, as developed by the Endpoints Surveillance and Adjudication Subcommittee. Refinements to the protocol and Manual of Operations for event ascertainment should to the extent possible be comparable to other NHLBI-sponsored large cohort studies such as the Atherosclerosis Risk in Communities (ARIC)

a. Designate key personnel to lead and manage the study who have the appropriate

c. A principal investigator with the following:

i. Training and experience in cardiovascular epidemiology

ii. Demonstrated excellence as a manager and collaborator

iii. Experience successfully recruiting participants into an epidemiology study

d. Co-investigator(s)* knowledgeable in scientific areas relevant to the study and skilled in study design and data analysis

b. Provide other staff as follows:

b. Data analysts

c. Participate in and designate staff to participate in the Steering Committee and other committees, as appropriate. Subcommittees include, but are not limited to:

a. Genetics Committee

STATEMENT OF WORK – CARDIA FIELD CENTERS 26

b. Clinic Coordination and Retention Committee

c. Quality Control Committee

d. Laboratory Committee

e. Imaging Committee

d. Conduct surveillance of the cohort for clinical events, collecting information as

i. Information to be collected includes: occurrence of cardiovascular events, participants, proxies, hospital records, and death certificates, and according to a standard protocol developed by the Endpoints Surveillance and Adjudication Committee and approved by the Steering Committee.

ii. As part of the Endpoints Surveillance and Adjudication Committee, participate in classification of type and severity of cardiovascular events.

iii. Perform and/or coordinate searches using commercial databases to find

e. Analyze and publish data from the study.

manuscripts based on CARDIA data.

b. Submit at least three (3) manuscripts for publication in each year of the contract with an investigator from the site as the first author.

c. Submit abstracts and manuscripts proposed for presentation or publication to the Publications and Presentations Committee, per study policy, prior to submitting to scientific meetings or journals.

f. Provide early stage investigators with experience and responsibilities for specific scientific and study management areas and data analysis and publication.

Contribute to new scientific developments within the study and work collaboratively with all centers to support early investigators in training.

a. In collaboration with the other centers, or within the Coordinating Center, propose new ideas for analyses, testing, and scientific directions.

b. Propose new collaborations to achieve the goal of advancing new scientific objectives.

c. Support training of and providing experience for early stage investigators.

STATEMENT OF WORK – CARDIA FIELD CENTERS 27

i. Both at the Field Center and at collaboration centers, provide assistance to develop new research projects

ii. Encourage early stage investigators to apply for programs to bring support for training.

iii. Provide informal training experiences.

iv. Provide guidance in accessing the data set, proposing manuscripts, analyzing data, interpreting findings, preparing manuscripts,

g. Prepare and submit technical and financial reports, including the following:

a. Semi-annual progress reports that describe main operational activities during the period, problems encountered and how they were resolved, an accounting of personnel, including levels of effort and changes during the period, and scientific productivity.

b. Periodic financial reports, as required by NIH, specific to your institution.

c. A final report, due June 30, 2018, documenting and summarizing the results of the entire contract work, including salient results, recommendations and conclusions based on both the general experience and the individual viewpoint of the Field Center.

STATEMENT OF WORK – CARDIA FIELD CENTERS 28

Appendix:

Description of Ancillary Studies

Investigators may propose ancillary studies to be conducted in one or more study Centers.

An ancillary study is an investigation which, although not part of the core exam protocol, will yield additional information related to study objectives. An ancillary study is a study not funded by contract funds. They may include all or a subgroup of the cohort at a given center, and may involve additional interviews or examinations of study participants as well as analysis of blood or tissue samples, tapes, or images collected previously.

Participation in ancillary studies requires NHLBI Project Office approval and will be contingent upon successful and up-to-date fulfillment and completion of the main study contract requirements and deliverables, including participant recruitment and follow-up, report development, and analysis and publication activities.

Ancillary studies are subject to the same policies, reviews and approvals as the core protocol. Ancillary study data, collected under a grant mechanism or other funding mechanism, will become part of the public use data set; these data will be incorporated into the study data set after an appropriate period of time (generally 12 months after completion of data collection). In addition, ancillary study data are required to become part of the limited access data set in accordance with the NHLBI Limited Access Policy (https://biolincc.nhlbi.nih.gov/home). Investigators conducting ancillary studies are to be viewed as collaborating investigators of the primary study, with appropriate access to the full data set and to analytic resources of the study.

Ancillary studies will be evaluated by the Steering Committee. Highest priority will be given to studies which: 1) Do not interfere with the main CARDIA objectives, 2) Have the highest scientific merit, 3) Produce the smallest burden on CARDIA participants and the least demand on CARDIA resources, such as blood samples, and 4) Require the unique characteristics of the CARDIA cohort.

Investigators must define the hypotheses to be investigated and the methodology to be used, and estimate the cost and burden on participants. Study data collection must not interfere with the conduct of the core examination. All studies with participant burden, confidentiality, direct clinical implications for participants, or safety issues must be approved by the Steering Committee, the CARDIA Monitoring Board, and the NHLBI Project Office before initiation.

DELIVERABLES – CARDIA FIELD CENTERS ATTACHMENT #4

Item # Description Quantity Schedule Delivery information

1 Plan for transition between contractors

1 July 31, 2013 Send electronically to Project Office

2 Data from pilot study of clinical examination, including phlebotomy

~9 non-

CARDIA

participants

Prior to June 1, Coordinating Center

3 Human Subjects Certification from IRB

1 Prior to recruitment

Project Office and Office of Acquisitions

4 Examination consent forms

1 or as required by IRB

Prior to recruitment

Project Office and Office of Acquisitions

5 Examination data For each participant in local CARDIA cohort

Weekly and completed by July 1, 2016

Coordinating Center

6 All blood and other specimens, tapes, collected as per the approved protocol

1 Weekly or as directed by the protocol

Laboratories and reading centers as appropriate

7 Notification of participant clinical events

1 per clinical event

Within 30 days of learning of event

Coordinating Center

8 Morbidity and mortality investigation data

1 set per clinical event

Within 90 days of learning of event

Coordinating Center

9 Clinical findings 1 set per participant

As per study protocol

Participant and, if appropriate, his/her health care provider

10 Staffing Report 1 (email) September 30, December 31, March 31, and June 30 each year

Project Office and Office of Acquisitions

11 Progress Report 1 (email) Semi-annually, December 31 and June 30

Project Office and Office of Acquisitions

12 Abstracts 1 (email) As directed prior to submission to scientific meeting

CARDIA P&P

Committee (through the

Coordinating Center)

13 Draft manuscripts 1 (email) As directed prior to submission to scientific journal

CARDIA P&P

Committee (through the

Coordinating Center)

14 Data analysis programs, as requested by the Coordinating Center

1 per manuscript

As directed Coordinating Center

15 Raw data 1 set per participant

Weekly or as requested

Coordinating Center

16 Financial Reports 1 set Monthly (invoice) or Quarterly

(letter of credit)

NHLBI Office of Acquisitions

17 Final Report 1 (email) June 30, 2018 NHLBI Project Office and Office of Acquisitions

Deliverables according to base period and options funding schedule. The contract will be funded using a base period with four option periods. Funding for the next period will be contingent upon successfully meeting the delivery requirements during the current period.

Base and Option Periods

Time Period Reports/ Deliverables

Base Period July 1, 2013-June 30, 2014

1, 8, 10-16

Option Period 1 July 1, 2014-June 30, 2015 2-4, 8, 10-16 Option Period 2 April 1, 2015-August 31, 2016 5-7, 9 Option Period 3 July 1, 2015-June 30, 2016 8, 10-16 Option Period 4 July 1, 2016-June 30, 2017 8, 10-16 Option Period 5 July 1, 2017-June 30, 2018 8, 10-17