ATTACHMENT_7_-_Sample_Task_Order_1_-_Phase_2_Proof_of_Concept_Medication_Clinical_Trial_CRO_Study_and_Data_Management.pdf

ATTACHMENT 7 -- RFP 75N94025R00008

Sample Task Order #1 – Phase 2 Proof of Concept Medication Clinical Trial CRO Study and Data Management

Sample Task Order #1 – Phase 2 Proof of Concept Study

3.17.2026

SAMPLE TASK ORDER

STATEMENT OF WORK

Project Title: Sample Task Order #1 – Phase 2 Proof of Concept Medication Clinical Trial – Contract Research

Organization Study and Data Management

RFP Number: 75N94025R00008

(NOTE: This “Sample” Task Order #1 is for technical and overall contract proposal evaluation purposes only and will NOT be awarded as an actual task order).

1) Background and Introduction:

Medications development is a high priority program at National Institute on Alcohol Abuse and Alcoholism (NIAAA). Currently, only 3 medications are approved by the Food and Drug Administration (FDA) for the treatment of alcohol problems. These medications have demonstrated small to moderate effect sizes in clinical trials and do not work for everyone.

Thus, the search for new molecular targets and more efficacious drugs is critical. The creation of the NIAAA’s Medications Development program was recommended by the NIAAA Extramural Advisory Board on Medications Development, a subcommittee of Council, February 7-8, 2005 and subsequently approved by the full NIAAA National Advisory Council, June 2005. The Council recognized the urgent need for a rapid and efficient mechanism to conduct clinical trials of promising compounds to treat alcohol problems.

This Statement of Work is for a Contract Research Organization (CRO) for the NIAAA Medications Development Branch Extramural Clinical Program. The Contractor shall serve as the CRO to conduct all aspects of multiple, multi-center, pharmacotherapy clinical trials for the treatment of Alcohol Use Disorder (AUD). The CRO shall develop and have the overall responsibility for the operation of the clinical trial including but not limited to; clinical trial coordination, clinical site oversight and management, preparation of study documents, electronic data capture capabilities, Good Clinical Practice (GCP) monitoring services, acquisition and facilitation of packaging, shipping

Management

Sample Task Order #1 – Phase 2 Proof of Concept Study

3.17.2026 and coordination of study medication, logistical and meeting services, regulatory support, statistical and data analysis, and final clinical study report preparation. It is anticipated that 4-6 trials will be completed during the life of the Indefinite Delivery, Indefinite Quantity (IDIQ) contract.

Conduct of the trials shall be monitored by an independent Data and Safety Monitoring Board (DSMB) chosen by and report to the NIAAA. The CRO shall consult regularly with the DMD staff at NIAAA to establish research priorities and provide on-going updates on the status of the trial(s).

Studies conducted in association with this program are expected to emphasize treatment of AUD with novel or repurposed compounds.

2) Scope:

The Contractor shall provide CRO support for the Phase II, Proof of Concept Clinical Trial conducted at 5 NIAAA contract clinical sites. To achieve this goal, the Contractor shall manage, facilitate, monitor and provide oversight of all aspects of the trial conducted at three east coast universities.

3) Technical Requirements:

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

Assumptions:

Number of Sites – 5 clinical sites - 3 on the east coast, 1 on the west coast and 1 in Colorado Number of Participants – 200 (100 per arm)- 40 per clinical site Study Parameters

• Double – blind, placebo-controlled.

• Active and placebo investigational products are provided but Contractor is responsible for blister packaging (1 capsule per day), kitting, randomization schema, and site distribution/tracking.

• 14-week study with 12 weeks of maintenance (patient treatment) and 2-week follow-up visit.

• 20 monitoring visits – 18 during study, 1 site initiation visit and 1 site close out visit.

• 3 participants randomized per month per site.

• Period of performance is 6 months for start-up activities, 15 months for recruitment, 3 months for data lock, 2 months for analysis and close-out (2 years and 2 months total).

Specifically, the Contractor Shall:

Management

Sample Task Order #1 – Phase 2 Proof of Concept Study

3.17.2026

A) Project Management

Through the issuance of this Task Order, the Contractor shall perform the following:

1) Study Information/Materials Transfer

The Contractor shall receive materials, data, and anything else related to ongoing DMD program. During this period, the Contractor shall establish agreements with any subcontractors necessary for the study.

2) Planning and Preparation of Study Materials

a. The Contractor shall submit to the CO/COR a Regulatory Plan by the end of 1st month after the award outlining trial regulatory support. The CRO is responsible for all regulatory support for the trial including:

1) IND preparation;

2) SAE reporting;

3) protocol amendments;

4) information amendments;

5) annual reports; and

6) FDA requests and/or requirements to acquire the IND

7) and FDA reporting.

b. Submit to the CO/COR a Medication Plan by the end of the 3rd month after the award. The CRO is responsible for all logistics and arrangements to secure study medication including:

1) Study medication packaging and labeling;

2) Drug distribution; and

3) Drug accountability.

3) Study Documents Preparation and Subcontracts

a. In collaboration with the COR and with approval of the CO, the CRO shall format, copyedit, disseminate, and provide FDA and ICH mandated regulatory content for the protocol, and shall revise the NIAAA Program Office developed protocol, the Standard Operating Procedures (SOP) and the core assessment battery that shall include but will not be limited to:

1) Inclusion/Exclusion criteria;

2) Patient enrollment and closure;

3) Data collection and verification;

4) Data entry and verification;

Management

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5) Safety monitoring (including flow chart and timeliness);

6) Analysis and reporting of all the above;

7) Protocol violations and tolerance levels;

8) Training and calibration;

9) Drug handling and monitoring;

10) Quality control and assurance plan;

11) Core collection forms appropriate for screening, enrollment, safety and outcomes assessment.

b. A draft of the Protocol shall be submitted to the CO by the end of the 4th month following the award.

c. After award and in collaboration with the COR, and upon receipt of CO approval, the CRO shall assist in developing, disseminating, and revising, as needed, the Manual of Operations (MOP). The MOP shall include but is not limited to the following:

1) Study governance and contact list of the steering committee;

2) Prohibited drug list;

3) Informed consent procedures;

4) Randomization and un-blinding procedures;

5) Safety monitoring and reporting procedures;

6) Instructions on study documentation and biological sampling/shipping;

7) Payment reporting procedures;

8) Good clinical practice guidelines;

9) Investigational product receipt, dispensing and accountability procedures;

10) clinical data management system user guide;

11) subject recruitment and retention strategies and advertising aids;

12) mandatory staff training and new hire requirements;

13) interactions with regulatory agencies such as the FDA;

14) additional assessment guidelines as needed.

d. A draft of the Manual of Operations shall be submitted to the CO by the beginning of 5th month following the award and the final document by the end of 5th month following the award.

e. In collaboration with the COR, develop study and case report forms (CRF) and set up a data entry system referred to under Conduct of Clinical Trial and Data Collection and Analysis, Data Management and Maintenance.

f. Disseminate to the clinical sites the Manual of Procedures, CRFs, the CRF manual, the protocol, and any source documents by the end of the 6th month after contract award.

g. A draft of the Standard Operating Procedures, related to the conduct of the trial, shall be submitted to the CO by the end of 6th month after award.

h. The CRO shall randomize patients and coordinate with the central pharmacy to distribute the drug to NIAAA’s Contract Clinical Sites and maintain appropriate control records. The

Management

Sample Task Order #1 – Phase 2 Proof of Concept Study

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CRO shall be responsible for all pharmacy support including medication packaging and labeling, study medication distributing and tracking. The CRO shall be responsible for all FDA regulatory requests, IND requirements and reporting.

i. The CRO shall provide a Medical Monitor for safety overview for the study. The CRO shall provide a position description for the Medical Monitor to the CO and NIAAA COR.

j. The CRO shall establish and oversee a Data and Safety Monitoring Board (DSMB) based on the guidelines for the establishment and operation of the DSMB found at https://www.niaaa.nih.gov/research/guidelines-and-resources/guidelines-establishing-and-operating-data-and-safety-monitoring .

Specifically, CRO shall:

1) Obtain the commitments of participation from DSMB members

2) Prepare the DSMB charter

3) Organize the DSMB teleconferences

4) Obtain and maintain the DSMB conflict of interest and confidentiality disclosure agreements.

k. The CRO shall work with the Clinical Sites to obtain and maintain IRB approval.

1) This includes obtaining IRB approvals for any amendments or modifications to the protocol, patient handouts or informed consent forms.

2) The CRO shall keep on file all documentation, including IRB approved protocols, informed consent forms and patient handouts.

3) The CRO shall provide NIAAA with all IRB approvals.

Research involving human subjects shall not be conducted under this contract. Research involving human subjects shall not be conducted at a particular clinical site until the CRO has provided to the COR a certification of IRB review, evidence of human subjects assurance, and approval of the protocol and informed consent at that site.

l. The CRO shall prepare a Monitoring Plan including accompanying SOP’s named in the Plan.

The Plan should detail all monitoring events including the monitoring report shells. Submit the Monitoring Plan to the COR by the end of 6th month after the award.

m. The CRO shall prepare an Analytical Plan, in collaboration with the COR, which includes an adaptive randomization schema, power analysis and sample size determination, Statistical Analysis Plan preparation, SAS programming, and statistical analysis reports and submit to the COR by the end of the 6th month after the award.

B. Coordination of Communications and Meetings

a. The CRO shall respond to NIAAA or Subcontractors telephone and written inquiries within 24 hours of each inquiry.

b. The CRO shall coordinate logistics for study-related meetings and provide reimbursement for travel and per diem expenses for all non-Government employees required to travel.

https://www.niaaa.nih.gov/research/guidelines-and-resources/guidelines-establishing-and-operating-data-and-safety-monitoring https://www.niaaa.nih.gov/research/guidelines-and-resources/guidelines-establishing-and-operating-data-and-safety-monitoring

Management

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c. The CRO shall coordinate a virtual kick-off meeting prior to the beginning of the study.

d. The CRO shall attend other face to face meetings to discuss issues related to the study, conference calls, frequency TBD, between the NIAAA DMD team, CRO, PIs and Coordinators.

e. The CRO shall prepare and disseminate minutes of all Executive Committee, Coordinator, Principal Investigator and DSMB calls or meetings.

f. The CRO shall follow up on all action items discussed during meetings or teleconferences.

C. Data Management Systems

a. The CRO shall produce a Data Management Plan and submit it to the COR by the end of 6th month after award.

b. Upon the effective date of this contract, the CRO shall have the following in place:

1) A secure clinical data management system (CDMS) validated for the capture, review and management of clinical data in compliance with FDA Guidance for Industry: Electronic Source Data in Clinical Investigations*. Security through the use of individual log-on codes, password protection and activity-based permissions.

2) An electronic data capture (EDC) system compatible with the CDMS for use to capture data electronically and accurately at each clinical site.

*Electronic Source Documentation in Clinical Investigations:

https://www.fda.gov/downloads/drugs/guidances/ucm328691.pdf

c. Upon approval of the study protocol and CRFs, the CRO shall design and implement edit systems (data ranges approved by COR) to ensure completeness, quality and uniformity of all data.

d. Upon the effective date of this contract, the CRO shall have, on-line and operational, computing capabilities and all other capabilities necessary to perform the Statement of Work including the above mentioned CDMS. The CRO shall possess a confidential, secure, off- site data storage system for the purposes of backing up all trial data.

Specifically, the CDMS (provided by the CRO) shall:

1) Provide real-time data range and error checking - outstanding data fields/forms, incomplete data fields/forms, delinquent data fields/forms or missing reading center or laboratory data must be recognized by the system so that quality control programs can respond promptly.

2) Provide secure electronic transmission of data from the Clinical Sites;

3) Be accessible to the Sponsor and others designated by the Sponsor.

4) Be regularly updated with manufacturer suggested software updates and validated annually.

https://www.fda.gov/downloads/drugs/guidances/ucm328691.pdf

Management

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e. The CRO shall provide an Enterprise Content Management (ECM) system for the purpose of centrally storing, managing, and accessing clinical trial documents and internally communicating agendas, minutes and updates. The ECM should be tested and operational 30 days prior to the Kick – Off meeting.

f. The CRO shall provide access to the ECM to all study personnel as approved by the COR. All study personnel shall be trained by the CRO on operations of the ECM.

g. The CRO shall provide the COR with all access levels and rights granted to study personnel for the CDMS and ECM system. CRO shall make changes to rights upon request by the COR and in accordance with GCP.

B) Implementation of Treatment

1) Subject Recruitment

The CRO shall closely monitor the recruitment of subjects under the clinical trials contracts and task orders and provide NIAAA with real-time notification of each subject randomized and weekly recruitment reports.

2) Data Collection and Storage

a. The CRO shall prepare and supply the clinical sites with all study forms, copies of the study protocols and other materials; shall receive all data from the study clinical sites and laboratories; and shall be responsible for the inventory and storage of these materials.

Specifically, the CRO shall:

1) Assume responsibility for the reproduction and distribution of all study forms, manuals, and other documentation.

2) Receive and store all data transmitted on the study forms or other media such as the electronic Data Capture (EDC) system by the participating clinical sites and laboratories.

3) Maintain copies of any list of shipments of data, specimens, drugs or materials.

4) Protect against loss of study data and hold all information in confidence and maintain subject confidentiality.

5) Provide NIAAA with electronic copies of all study materials provided to the clinical sites and updates as they occur.

b. The CRO shall be responsible for transmitting accurate data to NIAAA, as required by the schedule of data reports set up by NIAAA. The CRO shall ensure completeness and accuracy of all data received from the clinical sites.

c. The CRO shall collaborate with NIAAA IT support (as specified by the COR and with approval by the CO) on collecting and transmitting data to NIAAA in a format compliant with NIAAA IT standards.

Management

Sample Task Order #1 – Phase 2 Proof of Concept Study

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3) Monitoring and Communications

a. The CRO shall be responsible for tracking protocol violations and shall notify the COR of such violations.

b. The CRO shall be responsible for overseeing the operations of the clinical sites to ensure:

1) Accurate reporting by each site of the number of individuals screened, enrolled and completed in accordance with the approved inclusion/exclusion criteria.

2) Proper data collection/entry through training of clinical site staff during the Kick-Off meeting and as needed.

3) Each site is following the Manual of Operations and all SOPs.

4) Initial and annual IRB approval is obtained, and documentation is provided to the CRO no later than two weeks following the IRB approval date.

5) Appropriate reporting of adverse events in accordance with toxicity monitoring and safety reporting plan.

6) Dissemination of information to (and from) the clinical sites is communicated to the sites and NIAAA in a timely fashion, including changes in SOPs and operations, reporting and regulatory requirements, and IRB and DSMB findings or recommendations.

7) Written informed consent is obtained from all study subjects. Medical and research records are collected and maintained according to institutional requirements and the Manual of Operations.

8) Accurate data is transmitted to the CRO as required by the Manual of Operations.

9) Clinical site staff is trained on reporting data accurately, SOPs and randomization system and calibrations as scheduled; including conducting site visits for quality assurance and control in collaboration with the NIAAA

COR.

4) Quality control and standardization

a. Monitor study activities to determine whether data collection is proceeding uniformly and efficiently.

b. GCP Monitoring services to include site initiation visits, regular monitoring visits, monitoring reports to the Sponsor and the site Investigators as outlined in the Monitoring Plan and site close out visits.

c. Verify medication compliance through blood serum testing and pill count.

Management

Sample Task Order #1 – Phase 2 Proof of Concept Study

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d. Determine and report to NIAAA and clinical sites, verification, discrepancy, and error rates for data collection, preparation and entry.

e. Institute corrective actions when deviations to the protocol are found (i.e. retrain personnel).

f. Monitor the performance and progress of any work done under a subcontract.

5) Reporting and Documentation

a. In collaboration with the NIAAA COR, prepare and submit the annual FDA IND report.

b. Use the clinical data management system (CDMS) to monitor the status of data collection and provide timely reports, as specified by NIAAA, to the COR (See Deliverables attachment).

c. CRO shall provide all aspects of regulatory reporting to include IND preparation and submission (if applicable), Serious Adverse Events reporting, protocol amendments, information amendments.

d. SAE reporting to include setting up a reporting plan/mechanism for the sites to report

Serious Adverse Events to the sponsor and Medical Monitor. Submit SAEs to FDA and others as specified in SAE reporting plan.

e. In collaboration with NIAAA, maintain a Question and Answer table for the sites to refer to throughout the trial that pertains to study design, conduct, data reporting and analysis.

6) Coordination of Communications and Meetings

a. The CRO shall respond to telephone and written inquiries in a timely manner.

b. The CRO shall attend other face to face meetings to discuss issues related to the study, conference calls, frequency TBD, between the NIAAA DMD team, CRO, PIs and Coordinators.

c. The CRO shall write and distribute minutes after all conference calls and face to face meetings, and follow-up on all action items discussed during meetings or teleconferences.

7) Data Management and Maintenance

Management

Sample Task Order #1 – Phase 2 Proof of Concept Study

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a. The CRO shall be responsible for providing training on the EDC system to all Clinical Site staff and NIAAA DMD team.

b. The CRO agrees to cooperate fully with the COR and Contracting Officer, who may periodically review the CRO’s performance in the development of systems for data management, data processing, and data maintenance.

1) The CRO shall provide to the COR and designees access to data and data files whenever requested.

2) The CRO shall provide training to the COR and designees on the CDMS and

EDC system

3) The CRO shall provide the COR requested reports on cumulated blinded data on a monthly basis.

4) The CRO shall provide a monthly report to the Data and Safety Monitoring

Board (DSMB) in a requested format (e.g., blinded or un-blinded) as specified in the DSMB charter.

5) Prepare detailed analyses of cumulated data for the DSMB to monitor the study for adverse and beneficial treatment effects at intervals determined by the Board and the COR. These analyses shall assess positive and negative aspects of the effectiveness of any treatments under this study.

6) Generate any additional analyses as suggested by the DSMB and approved by the COR. Only the COR may direct the CRO to work on such analyses.

c. The CRO shall set up and provide the COR with a Data Dictionary and code book of the data management system 30 days after the 1stsubject is recruited. The Data Dictionary must be acceptable to NIAAA and in accordance with ICH standards of good clinical data management.

d. The CRO shall provide continuous updates of study content to the Enterprise Content Management (ECM). Update study material, meeting minutes, agendas, etc. must be uploaded within 2 business days of receipt.

C) Study Close-Out

1) Data Cleansing and Data Lock

a. The CRO shall completely monitor and inspect data entered into the database for errors, anomalies (data cleansing).

b. After data has been cleansed and audits are complete, the CRO shall lock the database and no further changes should be made to the information in the database.

Management

Sample Task Order #1 – Phase 2 Proof of Concept Study

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2) Analysis

a. The Contractor shall prepare analyses of all data in accordance with an approved data management plan. Specifically,

1) After the database is locked, statistical analysis of the clean, locked data shall be performed by the CRO statisticians in accordance with the Analytical Plan and direction of the COR.

2) Prepare detailed analyses of accumulated data for the DSMB. These analyses shall assess positive and negative aspects of the effectiveness of any treatments under this study.

3) Generate any additional analyses as suggested by the DSMB or COR.

4) Develop new or modified methods of analysis that meet the specific needs of the study.

3) Clinical Study Report

a. Within 2 months after analysis of the data, the CRO shall provide to the Sponsor and submit to the FDA (if applicable) a Final Clinical Study Report in accordance with ICH E3:

Structure and Content of Clinical Study Reports and the Statistical Analysis Plan.

4) Manuscript and Dataset Preparation

a. In collaboration with the COR and the study investigators, prepare analyses of study data for publication.

b. Create tables and graphs suitable for publication.

c. Prepare statistical code and datasets for ready use by other parties and contractors.

RFP 75N94025R00008

ATTACHMENT 7

Sample Task Order #1 Reports and Deliverables

Phase 2 Proof of Concept Medication Clinical Trial – Contract Research Organization Study and Data Management

Reports & Deliverable Due Date Electronic Copy to:

One Time Reports

Regulatory Plan End of Month 1 COR Medication Plan End of Month 3 COR Draft Protocol End of Month 4 COR Manual of Operations – Draft Beginning of Month 5 COR Manual of Operations – Final End of Month 5 COR, CO Final MOP, Protocol, Protocol Manual, source documents and CRFs

End of Month 6 COR, CO

Standard Operating Procedures End of Month 6 COR, CO Monitoring Plan End of Month 6 COR, CO Analytical Plan End of Month 6 COR, CO Kick-off Meeting Agenda 2 months prior to K/O

Meeting with clinical sites

COR, CO

Kick-off Meeting Slides 1 month prior to K/O Meeting with clinical sites

COR, CO

Close-out Meeting Agenda and Slides

2 weeks prior to C/O meeting

COR, CO

Data Management Plan End of Month 6 COR FDA IND Application or Waiver 2 days after finalization of

IND package

COR

Data Dictionary 30 days after 1st subject is recruited

COR

Electronic Content Management System tested and operational

30 days prior Kick-off meeting with clinical sites

COR

Reoccurring Deliverables

Monitoring Reports Within 2 weeks after clinical site visit

COR

Updates to the protocol, CRFs, MOP, or any other study related documents

Within 1 week of finalization COR

FDA IND report Annually COR

Quarterly Study Progress Report Quarterly - by the 5th of the month

COR, CO

Quarterly Financial Report Quarterly - by the 5th of the month

COR, CO

Annual Progress and Financial Report

Annually. No Quarterly Report is due when an Annual Report is due.

COR, CO

Meeting/Teleconference Minutes Within 2 days after call or meeting

Final Reports

Final Clinical Study Report

The Contractor shall submit a final report describing the activities and accomplishments of the Contractor in the performance of this contract.

The final report shall be typed double space or space and a half and shall include all illustrations, tables, drawings, charts, data sheets, and other pertinent material as is necessary and sufficient to comprehensively explain the results achieved under the Task Order.

2 months after analysis of data. No Quarterly or Annual Report Due.

COR, CO

Complete Data Set All data and data sets acquired and maintained by the Contractor under the CRO Task Order shall be returned to the

NIAAA

2 months after analysis of data

COR, CO

Statistical Code and Algorithms used in data analysis

2 months after analysis of data

COR, CO

IT and Administrative Reports Roster of Employees Requiring Suitability Investigations

• Federal Information Processing Standard Publication 199

(FIPS-199)

Assessment

• Boundary Scope Memo (BSM)

30 days following the start date of CRO Study and Data Management Task Order

COR, CO, ISSO

Information Technology System Security Plan (IT-SSP)

• System Security Plan

• Risk Acceptance Waiver*

• Plan of Action and Milestone (POAM)*

90 days following the start date of CRO Study and Data Management Task Order

COR, CO, ISSO

IT Security Authorization (IT-SA) Documentation:

• Privacy Impact Assessment (PIA)

• Contingency Plan

(CP)

• Configuration Management Plan

(CMP)

• Security Assessment Plan

(SAP)

• Security Assessment Report

(SAR)

• E-Authentication Threshold Analysis

(ETA)

• Interconnection Security Agreement

(ISA)*

• Memorandum of Understanding

(MOU)*

*If Applicable

120 days following the start date of CRO Study and Data Management Task Order

Annual Assessment:

Information Technology System Security Plan

(IT-SSP)

• System Security Plan

• Risk Acceptance Waiver*

• Plan of Action and Milestone (POAM)* *If Applicable

Annually after Authority to Operate (ATO) is granted.

COR, CO, ISSO

Reporting of New and Departed Employees

Within 5 business days of a staffing change

COR, CO, ISSO

Contractor-Employee Non- Disclosure Agreements

30 days following the start date of CRO Study and Data Management Task Order

COR, CO

Vulnerability Scanning Reports 90 days following the start date of CRO Study and Data Management Task Order

COR, CO, ISSO

Section 508 Annual Report

Within 30 days after anniversary date of Task Order

COR, CO

Reporting of Financial Conflict of Interest (FCOI)

As applicable, in accordance with 45 CFR Part 94.5(b)

COR, CO

List of Employees Requiring NIH IT Security Awareness Training

30 days following the start date of CRO Study and Data Management Task Order

COR, CO, ISSO

NIH IT Security Awareness Training (provide certificates of completion)

30 days following the start date of CRO Study and Data Management Task Order and Annually for each year the Task Order is active – to be completed each year on or before 30 days from notification of availability of annual training module from

ISSO

Service Contract Annual Report

October 31st of each Task Order year

Submit electronically to

Reference FAR Clause 52.204-15, “Service Contract Reporting Requirements for Indefinite Delivery Contracts” included in full text in the IDIQ base contract, Section L.

Reporting Period is the previous Government Fiscal Year (October 1 through September 30) https://www.SAM.gov

**Data set will be provided in SAS - includes the complete SAS code used to complete all analyses.

All electronic reports and deliverables submitted shall be compliant and in conformance with the Revised Section 508 Standards of the Rehabilitation Act of 1973 (29 U.S.C. 794d). Additional information about testing all deliverables and reports including guidance and specific checklists, by application, as well as completion of VPATs for Section 508 compliance and conformance, can be found at https://www.hhs.gov/web/section-508/index.html under “Making Files Accessible” for checklists and “Contracting” for required appropriate VPAT templates using the ART tool that are to be completed. Information about the ART tool and the needed VPAT statements is located at https://www.itic.org/policy/accessibility/vpat as Word document or using an online tool at https://www.section508.gov/buy/accessibility-requirements-tool .

https://www.sam.gov/ https://www.hhs.gov/web/section-508/index.html https://www.itic.org/policy/accessibility/vpat https://www.section508.gov/buy/accessibility-requirements-tool

ATTACHMENT 7a Deliverables Sample CRO Study Support TO