ATTACHMENT_4_Base_IDIQ_SOW.pdf

ATTACHMENT 4 – RFP 75N94025R00008

RFP 75N94025R00008

IDIQ Base SOW Dated 1.16.2026

BASE IDIQ CONTRACT

STATEMENT OF WORK

Project Title: Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder –

Contract Research Organization

RFP Number: 75N94025R00008

I. 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 (MDB) 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 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) 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.

IDIQ Base SOW Dated 1.16.2026

II. Scope:

The Contractor shall provide Contract Research Organization (CRO) support services for study development and study and data management of clinical trials performed by NIAAA clinical site contractors. To achieve this goal, the Contractor shall, through Task Orders issued under this indefinite delivery/indefinite quantity contract, provide support services to assist NIAAA in managing, facilitating, monitoring and providing oversight of all aspects of the NIAAA pharmacotherapy clinical trials conducted at NIAAA contract clinical sites.

III. 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 technical requirements identified below. All work will be assigned via individual task orders issued under this indefinite delivery/indefinite quantity contract.

The CRO shall have a Principal Investigator with an appropriate advanced academic degree, such as a Ph.D. for M.D. all task orders issued. Through the issuance of Task Orders, the Contractor shall perform any/all the following:

A) Core and Study Development Support

1) Literature Review

The Contractor shall review and analyze new literature related to investigational products for alcohol use disorder and to synthesize the relevant findings in support of the development of possible new studies.

2) Protocol Development

The Contractor shall assist the NIAAA in development of new clinical protocols for potential new studies to be conducted under the NIAAA Medications Development Clinical Trials Network in accordance with the FDA and International Conference on Harmonization (ICH) guidelines for clinical trials.

3) Regulatory Affairs

The Contractor shall prepare and submit pre-IND meeting packages, develop FDA presentation materials, and submit all required documents to the FDA or other

IDIQ Base SOW Dated 1.16.2026 regulatory agencies for potential new studies. The Contractor shall also submit regulatory requests on behalf of the NIAAA and shall prepare an Investigator’s Brochure, if required.

4) Queries and Meetings

The Contractor shall respond to inquiries regarding potential new studies and coordinate logistics for virtual meetings to discuss information related to the proposed investigational product.

B) Project Management

The CRO shall have a Principal Investigator with an appropriate advanced academic degree, such as a Ph.D. or MD. Through the issuance of Task Orders, the Contractor shall perform any/all the following:

1) Study Information/Materials Transfer

The Contractor shall receive materials, data, and anything else related to the NIAAA Medications Development Program clinical trial. During this period, the Contractor shall establish agreements with any subcontractors necessary to the clinical trial infrastructure including data security, medication procurement and distribution, and material analysis and regulatory reporting.

2) Study Documents Preparation and Subcontracts

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 (for example: Alcohol interaction study or Human Laboratory study) 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) Purchasing study medication;

IDIQ Base SOW Dated 1.16.2026

2) Purchasing matching placebo;

3) Over-encapsulation (as needed);

4) Study medication packaging and labeling;

5) Drug distribution; and

6) Drug accountability.

The NIAAA Study Manger shall work with the CRO to finalize medication packaging prior to distribution to the sites and be in attendance during the CRO’s QC visit to the pharmacy.

c. 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 will 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;

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.

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

e. After award and in collaboration with the COR, and upon receipt of CO approval, the CRO shall assist in developing, shall disseminate, and shall revise as needed the Manual of Operations. 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.

IDIQ Base SOW Dated 1.16.2026

f. 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.

g. 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.

h. 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.

i. 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.

j. NIAAA will hold the IND for the study drug. 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 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, requirements and reporting.

k. 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.

l. The CRO shall establish and oversee a Data and Safety Monitoring Board (DSMB), with support from the COR, based on the guidelines for the establishment and operation of the DSMB found at http://www.nidr.nih.gov/clinicaltrials/datasafetyguidelines.asp. 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.

m. The CRO shall work with the Clinical Sites to obtain and maintain single 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.

n. The CRO shall prepare a Monitoring Plan including details of all monitoring events including the monitoring report shells. Submit the Monitoring Plan to the COR by the end of 6th month after the award.

http://www.nidr.nih.gov/clinicaltrials/datasafetyguidelines.asp

IDIQ Base SOW Dated 1.16.2026

o. 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. A two-day virtual “kick-off” meeting attended by the NIAAA DMD team, Co-Investigators, Clinic PIs and Coordinators and the CRO. CRO shall submit an agenda at least 2 months prior to this meeting to the NIAAA COR and the meeting Power Point slides and other materials to the COR at least 1 month prior to the meeting.

c. A one-day virtual “close-out” meeting to be determined in collaboration with NIAAA, attended by the NIAAA Medications Development team, Co-Investigators, Clinic PIs and Coordinators and the CRO.

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: Electronic Source Data in Clinical Investigations

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 https://www.fda.gov/media/85183/download https://www.fda.gov/media/85183/download

IDIQ Base SOW Dated 1.16.2026 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.

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.

C) Implementation of Treatment

1) Subject Recruitment

The CRO shall closely monitor the recruitment of study participants 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.

IDIQ Base SOW Dated 1.16.2026

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 approve by the CO) on collecting and transmitting data to NIAAA in a format compliant with NIAAA IT standards.

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

IDIQ Base SOW Dated 1.16.2026

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.

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. 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

IDIQ Base SOW Dated 1.16.2026

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.

D) 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.

2) Analysis

a. The Contractor shall prepare analyses of all data in accordance with an approved data management plan. Specifically, IDIQ Base SOW Dated 1.16.2026

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

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.

E) Transition

1) Transition Plan

Within 150 calendar days of the task order’s expiration date, the Contractor shall submit to the COR and the Contracting Officer (CO) a written draft transition plan outlining the following activities with dated milestones for completion of each. A final transition plan shall be agreed upon by the COR, CO, and Contractor within 45 calendar days of the draft’s submission. The transition plan shall be written to accomplish all activities therein during the final 90 calendar days of the task order’s period of performance (i.e. prior to the task order’s expiration date).

a. Status of any ongoing contract projects with anticipated completion dates

b. Plan for transferring all contract-related electronic data to the NIAAA COR

c. Plan for transferring all contract-related hard copy data to the NIAAA COR

d. Plan for final disposition of all contract Materials to the NIAAA COR