A24. Sample Request for Task Order Proposal.docx

REQUEST FOR SAMPLE TASK ORDER PROPOSAL – 2022 VSD 01

VACCINE SAFETY DATALINK INFRASTRUCTURE TASK ORDER

Subject to FAR 52.232-18 Availability of Funds Department of Health and Human Services Public Health Service Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Division of Healthcare Quality Promotion (DHQP) Immunization Safety Office Atlanta, GA 30333

Date Issued: July11, 2022 Date Response Due: August 12, 2022

Request for Sample Task Order Proposal (SAMPLE RFTP) Number: 2022 VSD 01

Title of Project: VSD Infrastructure Task Order

Contract Reference: This SAMPLE RFTP is consistent with the purposes of the indefinite delivery, indefinite quantity (IDIQ) contract for the CDC’s Vaccine Safety Datalink.

1. Applicability This effort is within the scope of the basic contract discussed in Requirement 2 section C.5.2 of the basic Performance Work Statement (PWS).

2. Order Type The Task Order shall be Cost Reimbursement. Offerors must submit a technical and business proposal for this Task Order. This Task Order is anticipated to be awarded to multiple IDIQ Schedule holders

3. Period Of Performance

The expected period of performance is Year 1: 9/29/2022 – 9/28/2023 Year 2: 9/29/2023 – 9/28/2024 Year 3: 9/29/2024 – 9/28/2025 Year 4: 9/29/2025 – 9/28/2026 Year 5: 9/29/2026 – 9/28/2027

4. Place Of Performance Services will be performed at Contractor specified site in the United States.

4. Performance Work Statement (PWS)

Title: Vaccine Safety Datalink Project, VSD Infrastructure Activities

5.1 Background and Need

The Vaccine Safety Datalink has a long history of conducting rigorous vaccine safety research. Participating sites have provided an administrative and data infrastructure in which adverse events following immunization can be evaluated and can support the enhancement and development of vaccine safety methodologies. The administrative aspects of the VSD that have facilitated this project’s success have included not only efficient project management and the creation and participation of working groups, but also active discussions at site visits, annual conferences, and conference calls. Utilizing existing data sources at health plans has allowed the VSD to create its own data infrastructure to serve as the foundation of the project. Modification to the data infrastructure has also allowed the VSD to adapt to changing environments and needs. For example, the VSD developed a distributed data model to respond to heightened confidentiality concerns and the development of dynamic data files allowed the project to capture near-real time event-based health plan administrative data. As the Government continues the work of the VSD, there is also a need to continue these infrastructure activities so that scientifically rigorous and efficient monitoring of vaccine safety can be conducted.

5.2 Project Objective

The purpose of this task order is for the contractor to contribute to the main functions of VSD. There are three main components of this task order that are considered essential infrastructure activities: administrative tasks, data management, and contribution to vaccine safety assessments. This work will support the management and development of the ongoing work of the VSD. Specific aims surrounding administrative activities include to manage overall project activities and participate on working groups and conference calls, host site visits, and travel to annual conferences. The data management objective is to produce and maintain a high-quality electronic data infrastructure encompassing health plan members of all ages, located at the contractor’s site, and accessible through a distributed data model. Data will be made available routinely through cycle files, created on an annual basis as well as dynamic data files, created and updated on a more frequent basis (weekly or monthly). Contractors will also contribute to vaccine safety assessments through their participation on vaccine safety monitoring and evaluation studies, leading automated studies, and conducting medical record reviews.

5.3 Scope of Work

This task order is to support the essential VSD infrastructure activities. Administrative work, data management, and contribution to vaccine safety assessments are ongoing activities of the VSD. The administrative activities involve programmatic tasks that support the overall work of the VSD, and the main requirements include project management, participation on VSD conference calls, working groups, site visits, and annual conferences. Also included in the overall management of project activities are individual study tracking, maintaining IRB and data use agreement (DUA) documentation, and providing the support for external presentation of ongoing VSD work. This task order is also for the creation and maintenance of a high-quality electronic data infrastructure. This is an ongoing function of the VSD wherein all work performed uses these data as a resource. The main requirements of this task include data preparation, creation of a distributed data model, creation of a study population, data maintenance and merging of files, and adherence to data specifications as outlined in the VSD data dictionary. Data are formatted using SAS vs. 9 (or higher) and are made available through cycle files (created annually) and through dynamic data files (created more frequently, either weekly or monthly). Through this task, a cohort shall be created consisting of all ages from the health’s plan membership base whose entire medical history of health care provider encounters can be accessed electronically. Data assessments through this task order may use automated data to lead or participate on studies. Data assessments through this task order may also involve supporting other task orders through the provision of automated data or limited chart review (depending on availability of resources).

5.4 Technical Requirements

Working closely and collaboratively with CDC and other VSD IDIQ holders, the contractor shall accomplish the following:

A. Administrative tasks:

i. The contractor shall participate and contribute on the following working groups (when active) and associated conference calls:

1. VSD project working group

2. Rapid Cycle Analysis working group

3. Data Management working group

4. Project Manager working group

5. Methodology working group

6. Annual Meeting Working group

7. Data Quality working group

8. Pregnancy working group

9. Principal investigator working group

10. Vaccine Schedule working group

11. Study specific working groups (e.g., COVID-19 RCA working group)

Each working group shall conduct conference calls up to two times per month.

ii. The contractor shall perform tasks related to the general project management of the VSD including study tracking and IRB and DUA documentation.

iii. Each contractor shall host at least one site visit (in-person or virtual) per year for the government to discuss work surrounding the VSD.

iv. Contractor attendance and participation at scientific meetings and conferences (in-person or virtual) for the purposes of presenting VSD study results, collaborating with other vaccine safety researchers and disseminating information, is fundamental to the scientific process and integral to the VSD. Such travel is essential to furthering CDC and VSD’s mission of protecting the public by ensuring the safety of vaccines. The contractor shall send 1-3 staff to attend up to 3 scientific meetings or conferences per year, in addition to the VSD Annual Conference. The Contractor may send up to 9 staff to the VSD Annual Conference, pending CDC approval. The number of staff permitted to attend the Annual Conference will be determined by CDC based on funds available. All travel will be authorized and funded in advance by the Government via a modification to the task order. The contractor shall notify CDC in advance of any travel plans and will adhere to all federal travel policies.

v. Contractors shall routinely update the VSD website regarding any changes in personnel, study progress, study documents or publications. This includes posting proposals, chart review forms and any other study-related documents.

B. Data preparation:

i. The contractor shall provide sufficient technical information about all data collected to facilitate use by the Government, or indicate any special handling needs beyond the provisions outlined in the Statement of Work.

ii. The contractor shall obtain the necessary clearances to begin automated data compilation. This includes, but not limited to, all IRB approvals and overall contractor approvals for data creation and use for VSD studies and activities.

iii. The contractor shall institute the appropriate means of acquiring the information for each of the automated data files indicated below if such procedures are not already in place.

C. Creation of a system in which data can be transferred to and from the Government

i. The contractor shall adopt and maintain the existing “distributed data model” (DDM) system to support VSD activities, such as studies, surveillance, and data management and data quality activities. The DDM allows the contractor to assemble and maintain its computerized data files on a secure server at the site rather than transferring all data files to CDC. Ownership of the data is retained by the contractor and all electronic data are accessed by the Government. The DDM allows all individual level standardized data files to reside at the health plan and should be accessible to the government at a minimum from 5am-midnight ET. The DDM maintains confidentiality of the health plan’s data by utilizing encrypted and secure methods, while limiting access to IRB approved data required for specific studies and data management and data quality checks.

ii. The contractor shall ensure that DDM functions to download SAS programs, transmit emails to the Government, and create and transfer log and output files. Through the DDM, the contractor shall identify Cycle libraries (C20XX), a library housing the DDFs (EVENT), a library housing Medicaid and geocode files (HISTORY), and six permanent libraries for Government use (VSDCDC1-VSDCDC6).

iii. The contractor shall ensure all requirements of the DDM are met. See Attachment 1

D. Data file specifications and creation

i. The contractor shall establish a study population.

a) The contractor shall identify and establish a study population (i.e., VSD cohort) of all ages whose entire medical history of health care provider encounters is readily accessible electronically, including claims from outside providers. This member population is to be followed over the duration of the contract while enrolled in the participating health plan. This population would be a dynamic cohort in which members may enter or leave the health plan.

b) Unique identification numbers are to be maintained. To ensure confidentiality and comply with federal regulations, each person within the VSD is assigned a unique randomized VSD identification number that is not linked to their health plan member identification number. Following the structure outlined in the standardized VSD data dictionary, the unique identification numbers will be found in the CONSTANT files and used as a link between the various VSD files containing demographic and medical services data. Every health plan member in the study population is required to have a record in the CONSTANT file, even if they leave the health plan.

c) The start date for identifying the VSD Cohort will be the date that an electronic vaccination tracking system became fully operational for the contractor’s health plan. At a minimum, contractors are required to include data from January 1, 2007. The contractor shall include their entire enrolled population at the time the study population is established and on any new entrants into the system, including births.

d) The contractor shall develop and manage both annual files and dynamic data files. Both follow the current standardized VSD data dictionary, are longitudinal in nature, and contain all records back to the start date of each participating contractor’s VSD cohort. Annual data files are called cycle files and include all data specified in the VSD data dictionary. Cycle files are longitudinal in nature with data through December 31st of the cycle year. This includes member information obtained from administrative files maintained by the individual health plans such as demographic and medical services on all members, age, gender, health plan enrollment, vaccinations, hospitalizations, outpatient clinic visits, emergency department visits, urgent care visits, mortality data, and additional birth information (when available). Dynamic data files permit the ongoing capture of near real-time event-based health plan administrative data, including data on vaccination, hospitalizations, emergency department visits, clinical visits, health plan enrollment, and certain demographic characteristics. The following files shall be updated weekly or monthly with new data from the health plan depending on the capabilities of the health plan’s data system: inpatient, outpatient, vaccine, constant, procedure, and enrollment.

e) The contractor shall create data files as specified in the current standardized VSD data dictionary. The VSD data dictionary is available upon request.

f) CONSTANT FILE: The contractor shall establish a file that includes basic demographic data that do not change (e.g., birth date, sex, health plan, race) which is derived from membership or enrollment files from the participating health plan. This also includes the VSD ID and is only 1 record per individual. Race/ethnicity data will be included based on the feasibility of collecting such data and the ability of identifying appropriate standardized categories.

g) ENROLL FILE: The contractor shall establish a means of tracking the data of each health plan member. The contractor shall establish a computerized database component, available to be merged with subsequently described files, which is the ENROLL file, containing the unique VSD identification number, the dates that study eligibility begins and ends, and other specified enrollment characteristics as outlined in the current data dictionary. There shall be separate records for each period that persons are enrolled in the health plan.

h) GEOCODE FILE: The contractor shall provide a means for geocoding (i.e., based on tract level linkage of residence with Census data) each member of the study population for further socioeconomic characterization. The data that may change (e.g., zip code, etc.) in the GEOCODE file on an annual basis.

i) HMOBIRTH FILE: The contractor shall identify all infants and newborns that were born during the available data years (at a minimum beginning in 2005) in a MCO -owned hospital (or contract hospital) as an MCO-eligible member from birth). The HMOBIRTH FILE will be created for these infants with variables on birth characteristics (which must include birth weight, gestational age, 5 min apgar scores, race and ethnicity, facility ID code, child’s birth state and county, and the mother’s year of birth. If necessary, sites should link to the state vital records to obtain state birth certificate files in order to populate the variables listed in the HMOBIRTH File.

j) PREG FILE: The contractor shall establish a data file to contain records of pregnancies ending in live births, identified by the Pregnancy Episode Algorithm (PEA). The contractor shall append additional variables not found in the PEA including, but not limited to, episode id, baby id, smoking history, mother’s height, pre-pregnancy weight, delivery weight, education, previous number of live births and other pregnancy outcomes, alcohol history, and marital status. If necessary, the sites should link to the state vital records to obtain state birth certificate files to populate the variables listed in the PREG File.

k) VACCINE FILE: The contractor shall establish a data file to contain records for all vaccines given to all members in the VSD cohort.

i. The contractor shall include information concerning the administration of all vaccines administered in their population per the data dictionary.

ii. The contractor shall include all new vaccines and those that are in routine use in this file, and code the vaccines according to the current data dictionary.

iii. The contractor shall include the following variables in this data file: 1) the vaccine received and vaccination date; 2) the manufacturer; 3) lot number; and 4) facility/clinic id code where vaccination was administered. Other variables to be included, if available are: 1) body site and 2) whether the vaccine was given inside or outside the health plan.

l) INPT and OUTPT Files: The contractor shall establish computerized data files of medical encounters information or alter existing means of recording medical encounters to create such data files, available to be merged with all other study files.

i. The contractor shall include all diagnoses of medical events, using current ICD codes that are made following inpatient admissions for the member population (INPT File).

ii. The contractor shall produce an electronic file of medical encounters that occur in an outpatient setting during the period data are collected for the VSD Project (OUTPT file). The file shall include all diagnoses, using ICD codes that were made following an emergency department visit, urgent care, or clinic visit during the study collection period.

m) MORT and MORTCOD FILE: The contractor shall include a separate electronic data file of all diagnoses, using ICD codes, related to deaths of persons enrolled in the VSD population and related deaths occurring at a minimum of year of an individual member’s termination date as identified in the CONSTANT file. The contractor shall identify deaths from local automated files and provide details of methods for identifying deaths (e.g., hospital discharge data, state death files) and estimates of completeness of ascertainment of deaths in the study population. As some members enrolled in the cohort who die may not receive medical care at their specific MCO, special efforts may be necessary to obtain relevant information from country or state authorities to permit timely evaluation of any potential associations between deaths and vaccinations. The contractor shall describe methods for linking study population with state or local death certificate files directly or by obtaining state death certificate files. It may be necessary to link to state vital statistics data to ensure completeness of capturing all deaths.

n) FAMID FILE: The contractor shall provide a file that contains a single record for the birth mother associated with each VSD study member born as an MCO member during the years covered by the VSD project and include the source of the linkage between birth mother and study member (e.g., birth data, health plan, algorithmic match).

o) PROCDRE FILE: The contractor shall provide a file that contains a record for each ICD or CPT procedure code a member receives during the period of data collection. All procedure codes need to be collected, except for the following CPT codes: 99201-99205, 99211-99215, 99241-99245, 99251-99255, 99271-99275, 99281-99285.

p) MEDICAID FILE: The contractor shall create a file containing the Medicaid status of each study member on an annual basis.

q) The contractor shall provide additional computerized data components that would be available to be merged with other VSD files by unique record identification numbers, if needed in a specific study conducted as an infrastructure study or issued via other task orders. Examples of such files may include, but not limited to laboratory and pharmacy data.

E. Data maintenance and merging of files

i. The contractor shall maintain the integrity of each data file on a continual basis by repeated error checking and editing procedures.

ii. The contractor will develop internal methods to conduct data quality checks. If chart reviews need to be conducted for data quality of the automated immunization data, the contractor may do so and budget for no more than 400 reviews per year. Findings from data quality assessments shall be included in the quarterly technical report.

iii. Allow government to conduct weekly and annual data quality reviews through the DDM.

iv. The contractor will have ability to revise data files as identified through data quality checks by the government and do so when needed. At a minimum, revisions should be conducted within one month, however, there may be times when issues have been identified that are IT related and may take longer than one month. The contractor will be required to notify the Government and provide weekly updates on progress in resolving problems.

v. The contractor will develop a system for tracking changes and corrections to both cycle files and DDFs.

F. Contribution of data to assessments

i. Cycle files and DDFs prepared under this task order will be used for automated assessments led within this task order. This includes contribution of automated data for surveillance assessments, such as RCA, and other automated epidemiologic analysis. The contractor shall prepare automated data for analysis. The contractor shall seek IRB approval and execute necessary DUAs. The contractor shall propose and initiate at least one automated or chart confirmed study per year (beginning in year two for any contractors new to the VSD and awarded their first VSD IDIQ base contract in FY22). Sites shall notify CDC if they are unable to meet this requirement for any reason, or if current CDC priorities and/or pandemic response efforts do not align with this requirement. All final datasets for automated studies conducted under this task order will be archived per the VSD Guidelines for Archival of Datasets (Attachment 2).

ii. The following ancillary files shall be created for assessing the safety of COVID-19 vaccines during or around the time of pregnancy or lactation and maternal and infant outcomes, or for assessing associations between COVID-19 vaccines and reproductive health outcomes:

-Milk choice / breastfeeding status from maternal or infant clinical data -Infant growth (length, weight, and head circumference in first year of life) -Infant development (developmental screening data, when available) -Teratogenic medication file -Contraceptive medication file -Ad-hoc updates to FAMID file, as requested -Ob/Gyn status (e.g., menopausal, peri-menopausal, postpartum, etc.) from clinical data

iii. The contractor shall conduct chart reviews for case verification for studies and other assessments. The contractor shall conduct 500 chart reviews or chart reviews for 0.04% of their total enrolled population per year, whichever is greater, as a necessary part of the VSD infrastructure and as deemed necessary by CDC. The contractor shall perform chart reviews as needed for priority studies, and priority studies for each contract year will be determined by CDC and communicated to VSD Infrastructure sites. These charts reviews performed under this requirement are not intended for data quality work.

G. Clearance requirements

i. The contractor shall adhere to all CDC clearance policies regarding the submission of manuscripts, abstracts, and presentations produced from this task order. All products submitted into clearance must include the following disclaimer: “The findings in this presentation are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.”

6 DELIVERABLES

In order to verify deliverables relating to the creation of the DDM and the associated files, the CDC will run a SAS program to ensure that files are created and available for use. All Deliverables will be provided to the COR by email.

Contractors may propose additional deliverables that enhance the contractor’s ability to manage and successfully complete the work and/or facilitate oversight by CDC

7. Travel Contractor attendance and participation at scientific meetings and conferences (in-person or virtual) for the purposes of presenting VSD study results, collaborating with other vaccine safety researchers and disseminating information, is fundamental to the scientific process and integral to the VSD. The contractor shall send 1-3 staff to attend up to 3 scientific meetings or conferences per year, in addition to the VSD Annual Conference. The Contractor shall send up to 9 staff to the VSD Annual Conference upon CDC approval. The number of staff attending the Annual Conference will be determined by CDC. All conference travel will be authorized and funded in advance by the Government via task order modification. The contractor shall notify CDC in advance of anticipated travel details and costs, and will adhere to all federal travel policies.

8. INSTRUCTIONS TO CONTRACTORS

IAW FAR 16.505(b)(1), this SAMPLE RFTP represents fair opportunity for consideration. Offeror response must be submitted in two parts: a Technical, and a Business proposal. Each part shall be separate and complete in itself so evaluation of one may be accomplished independently of the other.

Required Statements: Your proposal must indicate that it is predicated on the terms and conditions of your VSD contract and is valid for a period of 90 days; and a brief statement indicating current or future commitments during the proposed performance period and any impact the commitments might have on performance of the task order. Proposals shall not include information regarding past performance, letters of reference, or corporate capability. The proposal shall reference only the proposed work and budget for the referenced SAMPLE RFTP. Proposals containing information that is not specific to the proposed task will not be evaluated.

Proposal shall be submitted via email by 3 PM EDT on August 12, 2022. Proposals shall be formatted in editable MS Word. Technical proposal shall not exceed 25 single spaced pages. Business Proposals shall be submitted in editable MS Word, with Pricing spreadsheets formatted in editable MS Excel. PDF files are acceptable but do not replace the Word/Excel requirement. To ensure all pages are included please put a footer in your proposal that includes your company name; SAMPLE RFTP number, your contract number, and Page # of # Pages

All proposals shall be e-mailed to the following address: ins4@cdc.gov Because this RFTP is the sample for the base IDIQ contract, offerors are required to submit a proposal that will be used to evaluate the IDIQ proposal.

The Government shall not pay any cost for the preparation and submission of proposals submitted in response to this SAMPLE RFTP.

All communications concerning this project prior to the award of a task order under this SAMPLE RFTP shall be with the Contracting Officer. Communications with other Government personnel concerning this SAMPLE RFTP prior to award may jeopardize your eligibility for award.

8.1. Technical Approach and Methodology

The Offeror shall clearly describe and demonstrate its approach and understanding, in executing all the requirements of the SOW. The Offeror shall specifically address the sub-factors listed below in their narrative:

1. Provide a detailed and comprehensive statement of purpose and scope of the project to demonstrate complete understanding of the intent and requirements of the contract.

1. Describe the proposed technical approach to comply with each of the requirements specified in the statement of work. The proposal must be consistent with the stated goals and objectives. The Contractor’s proposed approach must ensure plans for quality control, timeliness, and high performance.

1. Describe your ability to collect, manage, transmit, and maintain the security and confidentiality of clinical patient data.

1. Describe your organization’s health plan and its membership base. Specifically, the description shall include information about the following:

3. Size of population

3. Number of enrolled health plan members

3. Demographic info

3. Average number of births per year

1. Description of health plan including types of insurance plans offered as well as types of medical settings in which the Offeror has access to membership information.

1. Description of the proportion of all medical encounters by patients included in the population for which information, including chart review, can be captured.

1. Description on the approach the Offeror will take for human subjects’ protection for the VSD project as well as for multi-site studies and surveillance.

1. Description of DUA execution processes for multi-site studies. Offeror shall include a description of the processes as well as timeliness for initial approval and processes for when modifications to IRB approved protocols are made.

1. The Offeror shall describe their ability to access medical records and medical records management. Specifically, the Offeror shall describe:

8. Description of how medical record abstraction is performed and Offeror’s capacity to do it.

8. Ability to conduct “quick looks” of medical records as part of feasibility assessments and informal validation of cases.

1. Description of electronic medical records (EMR) and how EMRs are used as a method for conducting medical record abstraction.

1. Among the total members enrolled (as indicated above), describe the percentage or proportion among the enrolled population for which medical record review can be conducted.

1. Describe capabilities to utilize other supplemental data collection methods.

8.2. Staffing and Management

The Offeror should provide a description of staff that will conduct work for this task order. It is recommended that your staffing mix include, but not be limited to investigators, project managers, researchers, biostatisticians, SAS/analytical programmers, data consultants, epidemiologists, medical epidemiologists and clinicians. The Offeror should also demonstrate their ability to address administrative and management aspects of this project.

The Offeror shall describe how the overall task order shall be managed and the methods and resources that will be used, including the following:

1. A staffing matrix showing the type and number of staffing resources readily available for the base effort of this task, including breakdown by skill sets and functions of each person.

2. Resumes detailing relevant experience and training for proposed key personnel including the Principal Investigator (PI), who will conduct work.

3. Time and effort (labor hours) of proposed staff on this project and other projects

4. A description of the Offeror’s approach to rapidly obtain and/or replace qualified staffing resources to support existing and new Task Order work and to meet changing workload requirements.

5. Provide a description of the Offeror’s organization, include, the type of facility and the organization’s experience and capability in in developing studies as specified in this project.

6. Describe the method, resources, and tools that will be used to manage this project.

7. The Offeror shall briefly demonstrate their ability to provide appropriate facilities, data management, and other equipment for conducting this project. The plan should include a brief description of the office facilities, record keeping, disaster recovery plans, computer hardware and software, and conferencing equipment available.

8. If subcontractors are proposed, provide information to support their qualifications. The Offeror shall identify any portions of any task that will be performed by subcontractors. This information must include the name of the subcontractor and the specific duties and labor categories that will be performed by them.

8.3. Experience and Expertise

The Contractor shall provide a description of one (1) project awarded or completed within the past three years that clearly demonstrates the Offeror’s experience in performing projects of similar scope, size and complexity to the requirements described in the solicitation. The following information shall be provided for each project reference:

0. Name of contracting organization

0. Contract number

0. Contract type

0. Period of Performance

0. Total contract value

0. Description of the contract work and how the scope for this past contract/task order relates to this effort in scope and complexity

0. Contracting Officer and telephone number

8.4. Business Proposal Instructions, The business proposal shall be comprised of the following elements:

(6) If human subjects will be involved in any research activities, see applicable HHSAR clause, 352.270-4a, Notice to Offerors, Protection of Human Subjects

9. EVALUATION CRITERIA:

This task order shall be awarded to the Offeror whose proposal is considered to be the most advantageous to the Government, price and other factors considered. Technical Factors are more important than cost in this evaluation. The Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance.

9.1 Technical evaluations for this SAMPLE RFTP are as follows:

Criteria Value of Criteria

Total ____ 100_____

The evaluation will be based on demonstrated capabilities of the prospective Offeror in relation to the needs of the project as set forth in this solicitation. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below.

9.2. Business Evaluation: A cost analysis of the business/cost proposal shall be conducted to determine the reasonableness of the proposal.

14. Attachments

1. DDM Requirements

2. Guidelines for Archival Datasets and Documentation from Completed VSD Studies

3. Performance Matrix

Attachment 1 DDM Requirements

Requirements of the VSD Distributed Data Model:

1. SAS v8 Base and SAS v8 Stat or higher.

2. Secure method for transfer of SAS Programs, SAS Logs, SAS Output, and SAS Datasets – SSH2 is currently being utilized

3. “Scheduler” program

· Initiate the “processing job” program every 15 minutes

· Allow for at least 2 job processes occurring at the same time

4. “Processing job”

· Transfer programs to a specified site

· Check for the VSDEOF statement

· Delete the programs from that site after download

· Submit the programs to SAS in order as specified by the *.run file

· Specify the location of the SAS Macros in the SAS Library “vsdcat”

5. SAS Macros installed

· Getref macro - This macro issues a LIBNAME, FILENAME, or CATALOG statement to a pre-existing library, catalog, or file. Currently, the distributed data model requires the set-up of at least 15 pre-existing libraries including the following

· ML macro - This macro simply sends an email with a specified subject line. It uses a lookup table for emails addresses that are valid

· Makefile macro - is macro creates a file and a SAS reference to that file. It can create a SAS output or log file, a SAS XPORT file, or a SAS CPORT file. SAS output (ODS), log, and CPORT files have a SAS FILENAME assigned to the file while XPORT has a SAS LIBNAME assigned.

· Putfile macro - This macro sends the specified file to the CDC output. Currently, this file should be sent through the Secure Hub or other secure method of transfer to the CDC

· Upload macro – Creates upload macro to upload SAS datasets to vendors distributed data model.

6. Specific Requirement Functions of Distributed Data Model

· Programs downloaded from FTP

· Emails received by CDC

· Log files created and transferred

· Cycle Library identified (C2011)

· Output files created and transferred

· Permanent CDC libraries available (VSDCDC1-VSDCDC6) “HISTORY” and “EVENT” libraries available

ATTACHMENT 2 -

Guidelines for Archival Datasets and Documentation from Completed Vaccine Safety Datalink (VSD) Studies

These guidelines address the archival of information from finalized VSD studies for the purpose of making the data available to external researchers. The researchers will use these archives to reanalyze completed VSD studies after obtaining access as described in ‘Guidelines for Data Sharing Proposals from External Researchers: Vaccine Safety Datalink (VSD) Project’.

Conscientious data management practices, if carried out throughout the project’s operation, will simplify the study archiving process. They will provide an ongoing organization to the studies data and computer programs and will provide some of the material that is ultimately needed for archival. For this reason, it is advised that many of these recommendations be implemented before and during the operation period of the study.

Responsibility for providing the datasets and documentation for archival ultimately rests with each study’s principal investigator. A check list of the required elements for archival will be provided to each principal investigator who will assure that each of these elements is included in the archive. This check list in PDF or Word format will be kept at CDC, as well as sent to NCHS for the VSD Data Sharing Program in order to respond to requests for reanalyses as needed.

The required elements for archival will include datasets, programs, and other documentation. These elements along with the check list will be gathered together and placed in an electronic archive. The actual location of the archive will be determined by the study’s principal investigator.

General principles for Archiving Information from a Study:

1. All information for a study will be archived in its own subdirectory on a server specified by the principal investigator. This practice will make it easier to find all relevant files for a given project.

2. All written documentation will be provided either as text files or in PDF format. This will allow them to be read on a variety of platforms. SAS programs and computer programs in other languages are already text files and will be accepted as is. Other forms of documentation such as Word files will be converted to PDF format before archival.

3. The archival data sets should be in SAS format.

The most recent versions of protocols, programs, etc. should be saved in the archive, and reflect analyses conducted.

Contents of the Study Archive:

1. The study protocol. The final study protocol will be included in the archive. The following information should be included as a part of the study protocol:

a. Description of Study Methods and Objectives.

b. Name of Principal Investigator and Collaborating Investigators.

c. The Analysis Plan.

2. IRB and Other Approvals. A copy of the Institutional Review Board approval from each participating institution should be included in the archive. In addition, please note if any of the IRBs from the participating sites require destruction of the datasets. If so, the date(s) that the dataset must be destroyed should be noted

3. The questionnaire or other data collection forms. If a questionnaire or other data collection instrument was used in the study, a copy of this form will be included in the archive.

4. Study Specific Data dictionary. A data dictionary will be included to provide information about each variable in the archival datasets. These datasets will include many variables taken directly from the VSD Cycle or questionnaire datasets. But it will also contain variables created by either combining or categorizing the original variable. The following information should be provided for each variable in the final dataset:

a. Definition of the variable. Each variable should have a label which gives a definition of the variable. It may include some information about the source of the variable.

i. When a variable is computed based on the value of other variables, the formula should be provided.

ii. When categorical variables are created from continuous variables, the cut-offs and a justification for the use of these cut-offs should be documented. Generally cut-off values are either determined based on the medical literature or by creating categories with the equal frequencies.

iii. Variables used to create final dataset variables do not have to be retained in the final dataset, but it is generally a good idea to keep them in the data dictionary to provide their definition and coding.

b. Format of the variables. Formats should be provided for all variables. It is sufficient to provide only the name of the format in the part of the data dictionary when the definitions for the formats are supplied elsewhere.

5. Format names and definition. A separate listing which includes all format names and coding should be included either as a part of the data dictionary or as a separate document. This listing can actually be the SAS program where the formats are created.

6. The archival dataset(s). The dataset used for the final published analysis will be provided in SAS format. This dataset will be shared with external researchers upon request and approval. The original VSD site datasets, the VSD Cycle datasets, and the any intermediate datasets should not be in the archive. This will serve to protect the confidentiality of the VSD site and the participants. However it is important that information be provided to show how this data set was created from the VSD Cycle datasets and/or the data collection forms.

a. Confidentiality issues. Variables retained in this final dataset should be carefully considered to ensure confidentiality. In general, variables which are not essential to the analyses should not be included in the archived dataset.

i. Studyid. Study id should not be on this archival dataset. After the merges and various manipulations to create a final dataset, the study id is generally unnecessary. If some type of id is needed such as to designate clustering within the individual, a sequential numbering could replace the study id.

ii. VSD Site id. Some method for designation of the site will need to be retained in the final data set. It should be done in a way which does not allow the disclosure of an actual VSD site.

iii. Date of birth. The inclusion of date of birth in the final dataset should be carefully considered. There will be cases in which it will have to be retained to facilitate a reanalysis, but when possible it should be removed to make tracing back to an individual patient more difficult.

b. Public Use Dataset: Please state whether a public-use dataset is available for this study. If so, please describe how the dataset was created for public release.

7. Analytic programs. Analytic programs should be provided along with the archival dataset(s) to allow internal researchers to duplicate all statistical results provided in the manuscript. Programs will not be used for the data sharing program, but should be available to VSD researchers for replication purposes.

8. Manuscript(s). A copy of all manuscripts based on the study should be included in the archive in PDF format.

9. Check list. A copy of the check list of the required archival elements that was provided to data management when the information was archived will remain in the archive at all times. The checklist will also be sent to CDC upon completion of archival processes. It will be in PDF format and contain the following information:

a. A check indicating whether each required element is currently in the archive.

b. The date that this requirement was satisfied. If parts of this requirement were added at different times, the date will be the date on which this element was completed. If the element is not complete, the date may be missing.

c. The file names and formats which correspond to each specific required element of the archive.

d. A listing of optional elements included in the archive. This options list will include the same information suggested above for the required elements.

Archival Check List for Completed VSD Studies

VSD Study Number:

Study Name:

PI:

Contact PI at:

Location of Archive:

1. Study Protocol Archive Element Completed: Yes No

File name: Date entered: Comments:

2. IRB Approvals Archive Element Completed: Yes No

File name:

Date entered:

Comments:

Do any of the IRBs from the participating sites require destruction of the dataset, if yes, when? Y N Comments:

3. Questionnaire or other data collection form Archive Element Completed: Yes No N/A

File name: Date entered: Comments:

File name:

Date entered: Comments:

4. Data Dictionary Archive Element Completed: Yes No Includes formats: Yes No File name:

Comments:

5. Format names and definitions Archive Element Completed: Yes No

File name: Date entered: Comments:

File name: Date entered: Comments:

6. Archival Datasets Archive Element Completed: Yes No

File name: Date entered: Comments:

File name:

Comments:

7. Is a public use dataset available for this study Yes No Comments:

8. `Computer Programs Archive Element Completed: Yes No

9. Manuscripts Archive Element Completed: Yes No N/A

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