QASP_Attachment_J-9.pdf

ATTACHMENT J-9

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

1. Introduction

a. Since this is a Performance Based Contract, the CDC must effectively validate in a timely manner the performance of the Contractor in meeting the services required. This QASP provides a systematic surveillance method for the services, and describes the methodology by which the Contractor’s performance will be monitored.

b. The principal focus of the surveillance system is the Contractor’s performance of the indicators identified in the Performance-Based Matrix in Section C.7 of the Performance Work Statement.

c. The contract will be surveilled with this Quality Assurance Surveillance Plan. Additional surveillance may be added as needed by the program office.

d. The plan references the Contractor Performance Assessment Reporting System (CPARS). The CPARS system allows the Contracting Officer or the Contracting Officer’s Representative to report Contractor and subcontractor performance on a national, easily accessible database. It requires the CDC to review the database prior to approving the use of a Contractor to ensure that the contractor or subcontractor has done a good job in the past. As a result, it is anticipated that the CPARS system should help motivate the contractor, wishing future work in the Federal Sector, on the current contract toward superior performance.

e. This QASP:

i. Identifies the services and products that will be measured.

ii. Establishes the specific standards of performance for each required output.

iii. Establishes the responsibilities for performing the measurement.

iv. Defines the CDC role in overseeing the performance.

v. Provides for feedback to the contractor regarding quality, quantity, and timeliness of the service outputs.

vi. Establishes timeframes for communicating performance improvements.

2. Methods of Surveillance

a. The Performance Based Matrix in Section C.7 lists the services to be monitored and the standards to be applied.

b. This QASP is based on the premise the CDC desires to maintain a quality standard for services to conduct assessments, studies, research and demonstration projects, consultation and technical assistance, health education activities and related support services.

c. The contractor and not the CDC is responsible for management and quality control actions to meet the terms of the contract. The role of the CDC is quality assurance to ensure contract standards are achieved.

d. In this contract the contractor quality control program is the basis for service quality. The contractor is required to only deliver services that conform to the requirements of the contract as defined in the Performance Work Statement.

3. Roles and Responsibilities

a. The contractor’s primary responsibility is to ensure all requirements are met at the required quality level.

The CDC shall ensure this responsibility has been met before payment is made to the contractor. The primary CDC team members are the Contracting Officer’s Representative (COR) and the Contracting Officer

(CO).

b. The CO has the overall responsibility for overseeing the Contractor’s performance. The CO is responsible for monitoring Contractor performance in the areas of contract compliance, contract management, and the resolution of all issues relative to the language of the contract.

c. The COR and the COR team are responsible for directly monitoring, assessing, recording, and reporting on the technical performance of the Contractor. The COR will have primary responsibility for signing off on all invoices and documenting the inspection and evaluation of the contractor’s performance.

d. The COR will work with staff and the Contractor to ensure good communication and resolve any problems not requiring the CO’s authority.

4. Surveillance

a. The COR will evaluate the performance objectives through periodic inspections during each service month.

b. All performance must be documented, whether acceptable or unacceptable. When unacceptable performance is documented, the COR or Technical Monitor shall take the following actions:

i. If the government actions caused the unacceptable performance, take steps to prevent it in the future.

ii. If the contractor’s performance is unacceptable, inform the contractor’s Program

Director of the unacceptable performance and the reasons why it is unacceptable.

iii. If the contractor wants to dispute the results of the surveillance, refer them to the CO for resolution.

iv. Performance should not be determined unacceptable until all possible contributing factors have been considered.

v. For required tasks not shown on the Performance Based Matrix, the CDC still retains the right to inspect any item included in the contract. These services will be inspected periodically and the results provided to the CO.

5. Standards

a. All standards in the Performance Based Matrix must be met. All deliverable dates and other contractual completion dates must also be met. If any of the standards are not met, the CDC shall receive consideration from the contractor for breach of contract.

b. Late performance is un-excusable unless the contractor can justify all the following:

i. The delay was not the contractor’s fault

ii. The delay was not foreseeable.

iii. It was beyond the contractor’s control to avoid the delay.

c. All work shall be performed in accordance with the Performance Work Statement. The COR shall not consider the services complete until all deficiencies have been corrected.

d. The COR shall determine whether the failure was a minor non-conformance or a substantive non-conformance.

6. Procedures

a. The CDC will inspect performance requirements to ensure contractor compliance and record results of inspection. Unacceptable performance and complaints shall be referred to the CO for investigation and validation. The CO will investigate and validate the unacceptable performance or customer input. The contractor shall be given a reasonable amount of time after notification to correct the unacceptable performance and report to the CO that the deficiency has been corrected. If deficiencies are not corrected the COR will notify the CO and recommend a course of action.

b. The contractor’s overall Monthly Progress Report will be used to provide assurance that the contractor is working to maintain quality control and to keep on schedule.

7. Contract Performance Evaluation

a. FAR 42.15 – Contractor Performance Information establishes the CDC responsibility for recording and maintaining contractor performance information.

b. FAR 42.1501 – Past Performance information is relevant information for future source selection purposes, regarding a contractor’s actions under previously awarded contracts. It includes, for example, the contractor’s record of conforming to contract requirements and standards of good workmanship; the contractor’s record of forecasting and controlling costs; the contractor’s adherence to contract schedules, including the administrative aspects of performance; the contractor’s history of reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the contractor’s business-like concern for the interest of the customers.

c. The general procedures to be used are addressed in FAR 42.1503: Agency procedures for the past performance evaluation system shall generally provide for input to the evaluations from the technical office, contracting office and, where appropriate, end users of the product or service. Agency evaluations of contractor performance prepared under this subpart shall be provided to the contractor as soon as practicable after completion of the evaluation. Contractors shall be given a minimum of 30 days to submit comments, rebutting statements, or additional information. Agencies shall provide for review at a level above the contracting officer to consider disagreements between the parties regarding the evaluation. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, contractor response, and review comments, if any, shall be retained as part of the evaluation.

These evaluations may be used to support future award decisions, and should therefore be marked “Source Selection Information.”

d. The CPARS form will be completed at least annually and more frequently if necessary to motivate or reward the contractor.

8. Performance Based Matrix

Desired Outcomes

Required Services SLA Performance Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level (AQL)

Monitoring Method (Quality Assurance Surveillance Plan/QASP)

Incentives/ Disincentives

The contractor will develop the main study protocol

Per section C.4:

1.1

The contractor shall write a protocol to meet the objectives of the study outlined above in collaboration with the CDC/DVH team, and receive approval from CDC prior to implementation of the protocol.

The protocol will be complete within 90 days of the contract award date. Any requested modifications by CDC will be completed within 15 days from receipt. The study will begin within 15 days of CDC IRB and DVH approval of the protocol, questionnaires, and technical descriptions.

No deviation Review of protocol

Favorable or unfavorable performance evaluation

Development of implementation procedures for the study (study protocol)

Per section C.4:

1.3

The contractor shall develop implementation procedures for the study. Procedures must be approved by the COR and will include conducting interviews to determine subject eligibility, for managing data that tracks enrollment, drop-outs (with reason), vaccination information (e.g., lot number, site of administration), laboratory results (e.g., assay, site sample obtained), subject clinical status at each visit.

Standard data collection forms shall be drafted by the contractor and finalized in collaboration with the CDC/DVH team.

Baseline and ongoing data collection for eligible subjects will include subject demographics, medical diagnoses, medications, previous receipt or non-receipt of hepatitis A vaccine, birth country and travel history, anti- HAV IgG titers at the specified time points, and at each visit, past history of hepatitis A infection and possible sources of HAV infection (e.g., risk factors).

Information on new HAV infections will be reported to state health departments in accordance with routine state reporting

No deviation without COR approval

Deliverables Favorable or unfavorable performance evaluation

Required Services SLA Performance Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level (AQL)

Monitoring Method (Quality Assurance Surveillance Plan/QASP)

Incentives/ Disincentives requirements. (See section C5 for sample data tables.)

Develop data management tools including database and data dictionary (study protocol)

Per section C.4:

1.4

The contractor shall develop data management tools including development of a database and data dictionary and receive CDC approval of such. The contractor shall outline procedures for and perform data entry and data cleaning throughout the study for results obtained by the contractor. The data will be delivered quarterly in CSV and XLS format (Quarterly Data Report). The contractor shall provide CDC with a copy of the final cleaned and de-identified data set (Final Data Report).

Quarterly Data Report is due on a quarterly basis on/before the 15 th of the month. Final Data Report is due on/before the expiration date of the contract.

Data entry will be 95% complete and 100% accurate.

Quarterly Data Report and final cleaned data set will be delivered on time, complete and 100% accurate.

Review of reports and deliverables

Favorable or unfavorable performance evaluation

Identification of study subjects meeting the inclusion criteria

Per section C.4:

1.5

The contractor shall identify and recruit study subjects who meet the inclusion criteria of the study and who do not meet the exclusion criteria. Eligibility will be determined initially based on history and results of the contractor performed anti-HAV total and ALT. All eligible subjects will be vaccinated and entered into the study, even if confirmatory anti-HAV total and HBV or HCV results are not yet known. Subjects later found to be ineligible based on anti-HAV total, HBV, or HCV results performed by CDC Hepatitis Reference Laboratory should not proceed with further blood draws or vaccination after the results are known. All data collected from these subjects and all subjects should be documented, retained, and included in progress reports.

The contractor will recruit sufficient subjects, such that the sample size for the study groups and controls is adequate to demonstrate a statistically significant effect with consideration of loss to follow-up.

Demographic data, past medical and vaccination history will be documented.

The contractor shall report on study enrollment progress at six (6), nine (9) and twelve (12) months after contract award.

No deviation Review of reports and deliverables;

(Enrollment Initiation Report, Enrollment Mid-Period Report, and Enrollment Completion Report.)

Favorable or unfavorable performance

The contractor All sample size estimates and Achieving an Achieving Review of Favorable or

Required Services SLA Performance Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level (AQL)

Monitoring Method (Quality Assurance Surveillance Plan/QASP)

Incentives/ Disincentives shall recruit sufficient subjects such that the sample size for the study groups and controls is adequate to demonstrate a statistically significant effect with consideration of loss to follow-up.

Per section C.4:

1.6 enrollment limits must be reviewed by and discussed with CDC/DVH. The minimum sample size for each age group is 100 and for the control group is 50.

adequate sample size for the study the minimum sample size for each age group is 100 and for the control group is 50.

report of recruited patients unfavorable performance evaluation

Execute activities in accordance with IRB review and approved protocols

Per section C.4:

1.8

The contractor shall conduct all study activities in accordance with the provisions of local IRB review/approved protocols and under the direction of CDC. The contractor shall obtain additional written informed consent as necessary for follow-up or studies conducted at CDC from remaining samples, if not covered in the initial consent for blood sample collection, in accordance with IRB approved protocols. The contract shall receive consent for CDC to use samples for further testing for up to a specified time point after study completion.

Accuracy and quality of questionnaire data and serology results

No deviation Review of informed consents obtained and site visit

Favorable or unfavorable performance evaluation

Create unique identifiers for study data (study protocol)

Per section C.4:

1.9

The contractor shall follow direction from the CDC Hepatitis Reference Laboratory to create procedures for assigning unique identifiers, access to codes for unique identifiers, and management of confidential records. The identifiers and a suffix pertaining to each blood draw will be determined and used by

Follow direction of CDC Hepatitis Reference Laboratory . Delivery of accurate de-identified data to the

CDC.

No deviation Deliverable Favorable or unfavorable performance evaluation.

Documentatio n of violation of IRB protocol

Required Services SLA Performance Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level (AQL)

Monitoring Method (Quality Assurance Surveillance Plan/QASP)

Incentives/ Disincentives the CDC Hepatitis Reference Laboratory for label production. The contractor shall prepare unique codes linking case information and samples to prevent CDC from obtaining case identifiers. Subject information containing identifiers will not be shared with CDC. Master lists linking unique codes and case information will be destroyed by the contractor after the results of the study are published.

Hepatitis A vaccination of all subjects meeting the study inclusion criteria

Per section C.4:

1.11, 1.12

The contractor shall be responsible for the purchase and acquisition of hepatitis A vaccine from one manufacturer (HAVRIX, Smith-Kline Beecham Biologicals, Rixensart, Belgium OR VAQTA, Merck & Co., Inc, Whitehouse Station, NJ).

Vaccine from the same one or two lots from the same manufacturer will be used throughout the study for all participants. Vaccine will be administered intramuscularly in the deltoid area (1mL adult dose of vaccine containing 1440 EL.U. antigen for HAVRIX, or 1.0 mL adult dose containing 50 Units antigen for VAQTA). The contractor shall conduct and oversee hepatitis A vaccination for all subjects meeting the inclusion criteria for the study, on day 0 (first dose) and 6 months (second dose) and document the date of vaccination, type of vaccine, manufacturer, site and route of administration, dose, lot number, and expiration date.

The contractor shall track

The contractor shall ensure that vaccination occurs on day 0 for dose 1 and within 4 days of 6 months for dose 2 and document the date of vaccination, type of vaccine, manufacture, site and route of administration, dose, lot number, and expiration date. The contractor shall ensure that vaccine from the same one or two lots will be used throughout the study. The second vaccination should occur within 7 days after 6 months and no earlier than 4 days prior to 6 months (i.e. vaccine administered >4 days prior to 6 months would be considered invalid).

No deviation Review of reports

Favorable or unfavorable

Required Services SLA Performance Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level (AQL)

Monitoring Method (Quality Assurance Surveillance Plan/QASP)

Incentives/ Disincentives vaccine vials and lot numbers of vaccine administered during the study.

Conduct Medical and Safety assessments including follow-up phone calls

Per section C.4:

1.10

The contractor shall conduct a medical and safety assessment for all subjects prior to study entry and for a defined period after each dose of vaccine.

Additional monitoring will be done by the contractor to identify adverse events during the course of the study. The medical and safety assessment will include taking a medical and vaccination history at the start of the study. The medical history will include diagnoses, medications, past or present hepatitis virus infection (e.g.

serology for HAV, HBV, HCV), chronic liver disease, heart disease, kidney disease, and diabetes. At each visit, changes to the medical history, including new diagnoses and medications should be requested. Assessing local and systemic reactions, medications taken, adverse reactions and serious adverse reactions will be documented throughout the study. A Safety Monitoring Report describing any serious adverse events is required 5 working days after each quarterly conference call.

Phone calls with subjects 5 days after each vaccination will inquire about adverse effects of the vaccine or blood draw. Diary cards will be used and all adverse events will be followed to resolution. The contractor shall report all adverse events to CDC within 5 days, to the regulating IRB in accordance with local requirements, and to VAERS when/if adverse events are judged by the investigators to be possibly vaccine related.

100% completed phone calls to assess safety of vaccination within 14 days of vaccination.

Safety Monitoring Report submitted on time.

Review of reports and deliverables

Favorable or unfavorable performance evaluation.

Failure to meet timely follow-up safety assessments could jeopardize continuation of funding for the study

Evaluate subjects for hepatitis A disease

Per section C.4:

1.13

The contractor shall assess all subjects for signs/symptoms of hepatitis A during the course of the study. Subjects will be asked to report known exposures to hepatitis A or disease during the study period.

Any laboratory confirmed hepatitis A cases must be clearly documented with the appropriate lab work and

Document all cases of hepatitis A disease that occur during the study period

Data entry be will be 100% complete and accurate for subjects completing the study

Deliverables Favorable or unfavorable

Required Services SLA Performance Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level (AQL)

Monitoring Method (Quality Assurance Surveillance Plan/QASP)

Incentives/ Disincentives excluded from further study participation.

Perform blood draws

Per section C.4:

1.14

The contractor shall conduct and oversee blood draws pre-study, day 0 (post-vaccination #1), day 15, day 30, 6 months, and post-vaccination dose 2 at 7 months. The pre-study blood draw will be used to determine anti-HAV total negativity, baseline B, C serology, and liver function tests (e.g., ALT). The contractor shall perform the anti-HAV total and ALT pre-study eligibility testing. Aliquots of the blood sample from anti- HAV total negative subjects will then be sent to the CDC Hepatitis Reference Laboratory for further serology testing.

(See C4: 1.16 for specifics of aliquot size, shipping and storage.)

Timely shipment of samples following the CDC Hepatitis Reference Laboratory protocol.

No deviation without COR approval

Deliverables Favorable or unfavorable performance evaluation

Blood draws and vaccines within specified time frame

Per section C.4:

1.15

The contractor shall ensure that blood draws occur within the specified time frame. Blood draw # 2 must occur within 3 days of the specified time frame (e.g., the day 15 blood draw must occur within day 12-18).

The second vaccination must occur no earlier than 4 days prior to 6 months (i.e. vaccine administered > 4 days prior to 6 months would be considered invalid and should be repeated 6 months later.) If vaccine dose-2 is given too early, data from the subject, including the 7 months blood draw would still be included in the final analysis with early vaccination noted. A Conduction of Study Report documenting the completion of all vaccination and blood draws is due by 19 months after

Accurate recording of the data and time of all vaccinations.

Timely completion of blood draws and vaccines according to the specified schedule and number of days past acceptable range, if applicable.

No deviation Evaluation of documented dates of blood draws and vaccinations.

Review Conduction of Study Report.

Favorable or unfavorable

Required Services SLA Performance Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level (AQL)

Monitoring Method (Quality Assurance Surveillance Plan/QASP)

Incentives/ Disincentives contract award.

Facilitate laboratory blood sample testing

Per section C.4:

1.16

The contractor shall obtain peripheral venous blood samples each containing a minimum of 10 mL of whole blood, and separate blood into

1.5 mL aliquots of serum. The CDC Hepatitis Reference Laboratory will perform the serological testing for all viral hepatitis A antibody titers. The aliquots should be sent to the CDC Hepatitis Reference Laboratory for determination of total anti-HAV for eligibility (pre-study), anti-HAV total, anti- HAV IgG, and anti-HAV IgM following evidence based protocols. The contactor must follow the CDC Hepatitis Reference Molecular/Serology Sample Handling and Shipping instructions for proper labeling, storage, and transport of blood samples to CDC available at:

http://www.cdc.gov/hepatitis/H EV/PDFs/HRL_PCRSampleHndlg Shpg_20080615.pdf Per section 1.10, labels will have a unique number; the contractor shall maintain a copy of each label in the relevant subject’s record to assure samples are accurately attributed to subjects.

Aliquoted samples will be stored at -70C until sent by overnight mail to CDC according to the specifications in the above referenced pdf file. All vials should be discarded at a specified time frame after study completion according to IRB policy and in accordance with the subject’s consent.

Prompt shipping;

verification of receipt of blood samples; ensuring confidential linkage of samples to subject

Timely shipping of blood samples;

shipped within 1 day of blood draw;

Samples received in accordance with CDC Hepatitis Reference Laboratory protocol

Evaluation of sample labeling, storage, transport, and quality by the DVH lab

Favorable or unfavorable performance

Obtain serology The contractor shall be Documentation of No deviation Deliverables Favorable or

Required Services SLA Performance Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level (AQL)

Monitoring Method (Quality Assurance Surveillance Plan/QASP)

Incentives/ Disincentives results from the CDC Hepatitis Reference Laboratory

Per section C.4:

1.17 responsible for obtaining the serology results from the CDC Hepatitis Reference Laboratory.

The contractor shall be responsible for reporting new hepatitis A virus infections to state health departments in accordance with routine state reporting requirements. The contractor shall be responsible for providing the subjects with the results in writing of CDC Hepatitis Reference Laboratory testing.

serology results.

Reporting positive serology results (i.e.

hepatitis A disease) following the appropriate state reporting requirements.

Providing laboratory results to the subject.

without COR approval.

unfavorable performance evaluation

Inform all subjects of laboratory test results

Per section C.4:

1.18

Investigators will document that both ineligible and eligible subjects have been informed of the results obtained in this study, and any referrals made for additional care.

Completeness of subject follow-up

No deviation without COR approval

Deliverables Favorable or unfavorable performance evaluation

Data analysis from questionnaires and antibody titer data

Per section C.4:

1.19

The contractor shall conduct analyses and produce plots of the HAV antibody titer data.

Univariate analysis will include risk factors, demographic information and other key factors included in the standard questionnaire.

Quality of the analyses

Data will be 95% complete and 100% accurate

Deliverables Favorable or unfavorable performance evaluation

Preparation and presentation of data

Per section C.4:

1.20

The contractor shall work with CDC/DVH to prepare and present the analyzed data in an internal and possibly national forum.

Presentation of data No deviation without COR approval

Deliverables Favorable or unfavorable performance evaluation

Monthly Progress Reports Per section C.4:

1.21

The contractor shall be responsible for preparing a monthly progress report

Delivery of monthly progress report within 10 days of the start of the next month.

No deviation without COR approval

Deliverables Favorable or unfavorable performance evaluation

Participation in meetings or conference calls

Per section C.4:

1.22

The contractor shall participate in meetings or conference calls with the CDC technical monitor and other CDC/DVH team members. Calls will occur at the discretion of CDC at least

Adherence with CDC call schedule

No deviation without COR approval

Observation Favorable or unfavorable

Required Services SLA Performance Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level (AQL)

Monitoring Method (Quality Assurance Surveillance Plan/QASP)

Incentives/ Disincentives weekly in order to finalize implementation protocols at regular intervals (TBD) thereafter.

Participation in meetings or conference calls

Per section C.4:

1.23

The contractor shall participate in meetings or conference calls with the CDC technical monitor and other CDC/DVH team members to monitor the progress of the study at the direction of CDC. Calls and meetings will occur no less than once every quarter. The contractor shall present an update of their progress at each meeting. (Quarterly Conference Report)

Meetings will be held at least quarterly.

Quarterly conference reports will be submitted to CDC no less than 5 working days prior to a meeting/conference call. The quarterly conference reports should be updated based on the meeting/conference call within 5 working days after the meeting and delivered to CDC.

Reports must be 95- 100% accurate.

Reports must be 100% on time.

Review of reports;

Observation

Favorable or unfavorable performance evaluation

Preparation of manuscripts

Per section C.4:

1.24

The Contractor shall aid in preparing of two manuscripts,

1) short term response; 2) overall response after the second vaccine dose, for publication in a peer-reviewed journal with CDC co-authors.

The contractor shall make revisions to manuscript as suggested by CDC, including revisions suggested during CDC clearance.

The contractor shall make revisions to manuscript as suggested by CDC, including revisions suggested during CDC clearance. Two

(2) manuscripts should be submitted within 30 months after contract award.

Cleared by

CDC

clearance process

Clearance process;

journal review process

Favorable or unfavorable performance evaluation

Site visit

Per section C.4:

1.26

The contractor shall prepare and perform a site visit in collaboration with CDC personnel

Conduction of the site visit

Capabilities, resources, organization, and facilities consistent with the proposal and protocol

Observation Favorable or unfavorable performance evaluation

Kick-off Meeting

Per section C.4:

1.28

The contractor shall schedule an initial kick-off meeting with CDC and present the preliminary study plan. The kick-off meeting

Kick-off meeting within two weeks of award and timely completion of the

Meeting and report 100% on-time and accurate.

Observation and Deliverable

Favorable or unfavorable

Required Services SLA Performance Standard (completeness, cost, reliability, accuracy, timeliness, quality)

Acceptable Quality Level (AQL)

Monitoring Method (Quality Assurance Surveillance Plan/QASP)

Incentives/ Disincentives must take place within two weeks after award.

Kick-off meeting report by three (3) weeks after contract award.

Preliminary study plan presented clearly.

Final Progress Report

Per section C.4:

1.29

The contractor shall provide a final progress report at the completion of the study, including completion of all activities involved in the study.

Submission of final report by 36 months post contract award.

Meeting and report 100% on time and accurate.

Review of report

Favorable or unfavorable performance evaluation

Technical Research Documentation Report

Per section C.4:

1.30

The contractor shall provide a technical research documentation report, documenting all aspects of the research study, including the study methods, protocols for recruitment, implementation, and includes, but is not limited to, all relevant forms, data dictionaries, IRB submissions, study methods, and protocols.

The final format will be provided upon award of the contract.

Submission of final report by 36 months post contract award.

Meeting and report 100% on time and accurate.

Review of report

Favorable or unfavorable