Amendment 7 to RFP NIH-NICHD-NIAAA-2020-01 - correct typo in Attachment 3C.docx.pdf

Amendment 7 to RFP NIH-NICHD-NIAAA-2020-04, “Clinical Research Sites for the NIAAA Medications Development Clinical Investigations Network for the Treatment of Alcohol Use Disorder”

AMENDMENT 7

Request for Proposal (RFP) NIH‐NICHD‐NIAAA‐2020‐04 entitled, “Clinical Research Sites for the

NIAAA Medications Development Clinical Investigations Network for the Treatment of Alcohol

Use Disorder”

Amendment Number: Seven (7)

Amendment Issue Date: August 19, 2020

Proposal Due Date: September 4, 2020 (unchanged)

Issued By: Jason Williams Contracting Officer

DHHS, NIH, NICHD

Office of Acquisitions

NIAAA CMB

Point of Contact: Jason Williams

Contact Email: jason.williams2@nih.gov

THIS AMENDMENT IS ISSUED TO ALL POTENTIAL OFFERORS:

The above numbered solicitation is amended as set forth below. Offerors must acknowledge receipt of this amendment by identifying this amendment number and date on each copy of the offer submitted. Failure to receive your acknowledgement may result in the rejection of your offer.

Except as provided herein, all terms and conditions of the RFP remain unchanged and in full force and effect.

PURPOSE OF AMENDMENT:

To correct a typo contained in Attachment 3C, “Sample Clinical Trial Task Order B‐2 Statement of Work and Deliverables”. Specifically, the last sentence of the Study Design and Duration section of the Draft Protocol Synopsis on page 9 is corrected to read a “1:1” randomization is to be performed (rather than “1:1:1”, which was a typo) for this 2‐arm study.

RFP-NICHD-NIAAA-2020-04: ATTACHMENT 3C – Sample Clinical Trial Task Order B-2 Statement of Work and Deliverables

STATEMENT OF WORK

SAMPLE CLINICAL TRIAL EXECUTION TASK ORDER B-2

Clinical Research Sites for the NIAAA Medications Development Clinical Investigations Network for the Treatment of Alcohol Use Disorder

“Human Laboratory Study of Drug X for the Treatment of Alcohol Use Disorder”

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 NIAAA Medications Development Clinical Investigations Network for the Treatment of Alcohol Use Disorder, consisting of multiple clinical research sites and a CRO/Clinical Coordinating Center has been established to rapidly and efficiently conduct clinical trials of promising compounds to treat alcohol problems.

This Sample Task Order is assumed to be for a cost reimbursement, completion type requirement.

2. Scope

To participate as a clinical site in a multiple-site Phase II clinical trial and perform all site-specific clinical research activities, from protocol development and finalization though clinical trial completion, close-out and report writing in accordance with the final approved protocol for a Human Laboratory Study of Drug X for Alcohol Use Disorder.

3. Objectives

To evaluate the effect of Drug X once-daily (QD), compared with matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after two weeks of QD daily dosing among subjects with moderate Alcohol Use Disorder as confirmed by the Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (DSM-5™).

Secondary objectives include evaluation of Drug X compared with placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, study retention, and safety and tolerability throughout the last 4 weeks of the maintenance phase of the study.

4. Technical Requirements

Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, equipment and facilities not otherwise provided by the Government as needed to conduct the clinical trials as described in the Statement of Work below in accordance with the final NIAAA-approved study Protocol “to be determined” and all subsequent NIAAA-approved revisions thereof.

Specifically, the Contractor shall perform the following:

Start Up Activities: Protocol Development and Finalization (5 months)

1. Work in conjunction with NIAAA staff and the NIAAA CRO to finalize a protocol.

Provide all necessary documentation for the proposed clinical trial to the NIAAA CRO required to secure the IND approval (e.g. Form FDA 1571, Form FDA 1572) and work with NIAAA CRO to submit documents for all requisite regulatory approvals (e.g., IRB and FDA submissions). Provide reliance agreements to the NIAAA CRO to rely on the contracted IRB to be in compliance with the NIH single IRB (sIRB) policy.

2. Provide essential regulatory documents as specified in ICH guidelines. All documents shall be generated and stored in files/folders and be available for monitors upon request. Essential regulatory documents include, but are not limited to: signed IRB approved protocol, informed consent form and advertisement for subject recruitment; IRB approval letter; IRB membership list; PI and sub-investigators curriculum vitae; licenses for PI and sub-investigators; investigator’s brochure, normal laboratory ranges, laboratory certification, financial disclosure documents, conflict of interest declaration, indemnification/insurance documents, Form FDA 1571, Form FDA 1572.

Study Implementation Activities: Study Execution [to be performed upon FDA approval of the IND] (1.5 years)

The clinical trial shall be carried out in a timely fashion and in compliance with all FDA regulations and International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidelines.

A) Protocol Implementation: Compliance and Oversight

1. Activities required prior to clinical trial initiation:

a) Provide contact information to the NIAAA CRO contractor for registration of the clinical trial in the National Library of Medicine’s Clinical Trials registry (http://www.clinicaltrials.gov) http://www.clinicaltrials.gov/

b) Ensure all requisite regulatory approvals are in place (e.g., IRB and FDA submissions) and that the investigational agent has appropriate FDA clearance (i.e., IND) confirming the agent’s suitability for testing in humans prior to initiating recruitment. The FDA IND or IND waiver will be provided by

NIAAA.

c) Prepare and deliver the following specific to your site:

• Trial-specific recruitment and retention plan (e.g., enrollment of a diverse subject pool, including women and minorities, rate of subject accrual, subject retention, plans for deficient enrollment)

• Trial-specific data management plan (DMP) – CRO will provide Data Managmenet system, CRFs and Source Documents to clinical sites. This DMP should focus on in-house data quality and monitoring controls and standard operating procedures.

• Trial-specific pharmacy management plan (e.g., receipt, storage and distribuition of investigational product to study participants, etc.)

• Trial-Specific plan to monitor and track AEs and SAEs, including prompt reporting of SAEs according to the protocol and MOP

• Trial-Specific plan for quality control and quality assurance (e.g.

monitoring plans, data quality plans and internal audits).

d) Participation in a clinical trial initiation meeting or teleconference conducted by the NIAAA CRO contractor (logistics support/costs, inclusive of reimbursement for travel costs [as applicable] absorbed by NIAAA CRO contract). Assume a two-day teleconference with up to five clinical staff members from your site in attendance, inclusive of the PI.

2. Regulatory Compliance

a) Throughout Task Order performance, essential regulatory documents shall be generated and stored in files/folders and be available for monitors upon request and at the end of the clinical trial all essential regulatory documents at the clinical research site shall be placed in the master regulatory file for archiving. Regulatory documents may include but are not limited to: IRB approved protocol, ICF and advertising; IRB approval letter; IRB membership list; PI and sub-investigators curriculum vitae; licenses for PI and sub-investigators; investigator’s brochure, normal laboratory ranges, laboratory certification, financial disclosure documents, indemnification/insurance documents, Form FDA 1572, investigational agent shipment receipts, etc.

During the conduct of the clinical trial, all new relevant information/data must be appended to the essential documents as it becomes available.

b) In conjunction with oversight provided by the NIAAA CRO contractor, ensure that the conduct of the clinical trial performed is in compliance with all FDA and ICH GCP regulations and guidelines.

c) Provide site-specific information to the NIAAA CRO contractor for a complete clinical study report in submission ready format for FDA unless otherwise specified.

d) Ensure the confidentiality of all clinical records and information about subjects enrolled in the clinical trial.

Information and records obtained from subject volunteers who have consented to participate in performance of work under this Task Order will be subject to the provisions of the Privacy Act. The Contractor shall explain to participants exactly how information is to be collected, the purpose and use for which the information is being collected and how the information will be protected pursuant to the Privacy Act of 1974 (P.L. 93-579) and accompanying Privacy Act System Notice made a part of this Task Order via the IDIQ contract terms and conditions, both of which are applicable to the performance of work under this Task Order. All participants must be made to understand, through use of the informed consent form and careful education, that the extent of their participation is entirely voluntary and that they may provide all, some or none of the information which the Contractor is intending to collect. Upon completion of the clinical trial, the system of records generated in performance of this study shall be disposed of in accordance with instructions to be furnished by the COR.

3. Clinical Trial Initiation

The Contractor’s clinical trial team and support staff shall participate in a clinical trial initiation meeting or teleconference at NIAAA (meeting logistical support inclusive of any travel cost reimbursement [as applicable] and conduct of meeting performed by the NIAAA CRO contractor). Assume a two-day teleconference with up to five clinical staff members in attendance from your site, inclusive of the

PI.

4. Protocol Amendments

The NIAAA CRO will prepare all protocol amendments and modifications.

a) Upon sIRB approval (coordinated and supplied via the NIAAA CRO contractor), the amended protocol and/or revised ICF shall be archived in the master regulatory file.

b) The Contractor will ensure that the Manual of Operations, case reports forms and other supporting documents are replaced with updated versions provided by the NIAAA CRO to reflect the protocol amendments.

c) If necessary, the PI or designee will conduct a training session describing the protocol amendment and its impact on clinical trial procedures and assessments.

5. Protocol Oversight

Oversee all clinical activities conducted at the clinical research facility and supporting sites (e.g., research pharmacy, clinical laboratory, and [if applicable] subcontractors).

Ensure that each participant: meets protocol entry criteria; has provided informed consent and has undergone all the screening and baseline assessments as specified in the protocol.

For the Task Order protocol:

1. Track subject enrollment and adherence to defined recruitment goals.

2. Review and assess participant data as specified within the data management plan, protocol requirements and/or quality assurance requirements:

• Promptly provide all participant data for monitor review at scheduled visits;

• Monitor continuously for the validity and integrity of the accumulating data;

• Monitor continuously (i) protocol adherence and (ii) compliance with current

ICH GCP guidelines, DHHS Protection of Human Subjects regulations (45 CFR Part 46) and FDA regulations and report all protocol deviations;

• Report of any serious adverse events and/or unexpected/unanticipated adverse events to FDA, IRB, CRO and COR;

• Report all performance-related issues and proposed resolutions or corrective actions taken;

• Provide recruitment information to the CRO weekly for monitoring and tracking purposes throughout the course.

6. Data Management and Quality Control

a) Provide quality control to ensure initial data entry within 24 hours and to correct or issue a data query within 48 hours and inform promptly the clinical research staff of any missing, incomplete and erroneous data;

b) Alert NIAAA of any indication of research misconduct by Contractor staff.

7. Audit Compliance

The NIAAA at their discretion may undertake an audit of the Contractor’s facility including all supporting sites. The Contractor shall make available all facilities, records and files as related to any activity under this Task Order. The Contractor will submit a report describing the implementation of any corrective actions.

B) Investigational Agents and Clinical Specimens

1. Investigational Agent

a) Maintain inventory records of investigational agent in accordance to the pharmacy SOPs.

b) Maintain documentation that the investigational agent will be stored and quarantined under appropriate conditions in the research pharmacy according to the sponsor and regulatory requirements.

c) Mechanism for the return and/or destruction of investigational material.

2. Clinical Specimens

a) Ensure collection, processing, labeling, temporary storage under appropriate conditions and management of all collected biological specimens.

b) Ensure shipping of biological specimens for testing and/or repository deposition, as specified in the protocol, in compliance with current Good Laboratory Practice (cGLP), cGCP and domestic laws and regulations.

C) Clinical Trial Close-out and Final Clinical Trial Reporting

1. Close-out

Following the last subject’s completion of clinical trial procedures including any outpatient follow-up visits, the Contractor shall:

a) Continue to monitor any residual safety concerns (i.e., AEs & SAEs) until complete resolution.

b) In conjunction with NIAAA CRO, complete data editing/cleanup.

2. Completion

a) Prepare for archiving clinical trial records. Clinical trial records are considered case report forms and detailed documentation necessary to assess the final dataset with specific codes for all variables including all transformation that have been created (i.e., data dictionary).

b) Provide final Task Order Completion report.

D) Facilities, Equipment and Other Resources

The Contractor shall be responsible for the adequacy and availability of all facilities, equipment, and other resources necessary for the conduct of this clinical trial which shall include, but is not limited to, the following.

Provide Outpatient Clinical Research Facility:

a) Accreditation with a national or state accreditation board or equivalent for the conduct of clinical trials.

b) Areas to allow for waiting, check-in and discharge.

c) Private, designated examination rooms to allow for protocol-related assessments.

d) 24-hour staff emergency physician contact and other standard clinical support services as described in individual Task Orders.

e) Capability to recruit a diverse alcohol use disorder population.

f) FISMA-compliant secure computing resources for communication and data management (e.g., entry, editing, quality control).

g) FISMA-compliant secure electronic access to the data management center.

h) Emergency care plan and a definitive plan for management of life-threatening adverse events.

i) Resources for performing routine safety evaluations (e.g., vital signs, ECG), precisely timed phlebotomy, urine and other bodily fluids and blood/breath alcohol concentration measurement.

j) Cognitive testing resources, using paper or computer based systems.

k) Pharmacovigilance resources for composition of serious adverse event reports and narratives.

Provide Clinical Laboratory Facility:

a) Facility suitable for the processing and temporary storage of biological specimens.

b) Facilities and equipment suitable for conducting protocol-required tests and assays

c) On-site sample storage facilities at room temperature, -20 and -70 degrees Celsius.

d) Clinical laboratory support services

e) Have current certification and licensure for the performance of biological specimen assays and analyses.

Provide Research Pharmacy Facility:

a) Research pharmacist with expertise in the preparation, distribution and storage of investigational agents.

b) Facility suitable for processing, storing and dispensing investigational agents under appropriate conditions.

c) FISMA-compliant secure electronic access to the data management system.

d) Have current accreditation and certification for the performance of pharmacy services.

Data Management Resources:

The data management system will be provided by the NIAAA CRO. The Contractor shall provide:

a) FISMA-compliant computing resources to support data collection activities.

b) Data management system reporting procedures to determine irregularities and alert the NIAAA CRO.

E) Insurance

The Contractor and all collaborating sites participating in the conduct of the approved protocol shall provide sufficient malpractice insurance and indemnification for trial related injuries to volunteers. The Government will not provide third party liability insurance or indemnification and will not provide medical care or financial compensation for research-related injuries to clinical trial volunteers.

F) Reporting Requirements and Deliverables

In addition to reporting requirements referenced above, the following Sample Task Order Reporting and Deliverable Requirements are also required in the performance of this Sample Task Order:

a) Trial-Specific Evidence of Annual IRB Review and Approval of Study Protocol

(see “Single Institutional Review Board (sIRB)” and Plan for Single Institutional Review Board (sIRB)” Articles in Section H of the RFP).

b) Trial-Specific Annual Technical Progress Report for Clinical Research Populations (see associated Article in Section C of the RFP for description)

c) Trial-Specific Cumulative Inclusion Enrollment Report (Final).

d) Trial-Specific Data File.

e) Trial-Specific Final Study Report and Summary of Salient Results.

f) Trial-Specific Annual Invention Utilization Report (see “Invention Reporting

Requirement” Article in Section C of the RFP).

g) Trial-Specific Final Invention Statement (see “Invention Reporting Requirement”

Article in Section C of the RFP).

DRAFT PROTOCOL SYNOPSIS

Study Title Human Laboratory Study of DRUG X for Alcohol Use Disorder

Study Number TBD

Study Phase Phase II, Human Laboratory Study

Subject Population At least Moderate Alcohol Use Disorder

Objectives 1. Primary: The primary objective of this study is to evaluate the effect of DRUG X QD compared with matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after two weeks of QD daily dosing among subjects with moderate alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (DSM-5™).

2. Secondary: Secondary objectives include evaluation of DRUG X compared with placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, study retention, and safety and tolerability throughout the last 4 weeks of the maintenance phase of the study.

Study Design and Duration

This study is a 2-arm, double-blind, randomized, placebo-controlled, parallel group, study designed to assess the effects of DRUG X as compared with placebo on responses to in vivo alcohol cue exposure in the human laboratory setting. After signing informed consent, subjects will be screened for eligibility and have other baseline assessments. Screening is permitted over a 14-day period and most baseline assessments will be performed on the day of randomization. Assessments include alcohol breathalyzer test (before signing consent), medical history, physical examination, vital signs, electrocardiogram (ECG), drinking history by the timeline follow-back (TLFB) method, Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA-AR), prior medication use, MINI neuropsychiatric interview, urine drug test, smoking quantity frequency and nicotine use interview, clinical laboratory tests including chemistry, hematology, thyroid function tests, and medical urinalysis, craving responses during cue reactivity session, Columbia Suicide Severity Rating Scale (CSSR-S), drinking goal, Penn Alcohol Craving Scale (PACS), Pittsburg Sleep Quality Index (PSQI), PROMIS Alcohol Negative Consequences short form, Profile of Moods State (POMS), and confirmation that subjects are treatment seeking and desire a reduction or cessation of drinking.

Women of child-bearing potential will have a pregnancy test.

If eligible for the study, 40 subjects will be randomized using a stratified permuted block randomization procedure in an approximate 1:1 to receive either DRUG X QD or matched placebo for 5 weeks.

Inclusion and Exclusion criteria

Main Inclusion/Exclusion: Subjects will be male and female at least 21 years of age with 4 or more DSM-5™ symptoms of AUD (moderate to severe AUD). They must also be seeking treatment for AUD and if male, report drinking an average of at least 35 drinks per week or if female report drinking an average of at least 28 drinks per week prior to consent, and have at least 1 heavy drinking day (4 or more drinks per day for women/5 or more drinks per day for men) during the 7-day period prior to randomization.

Number of Subjects

40 participants per site

Outcome Measures:

Safety

Safety Endpoints: Safety endpoints will be analyzed over the entire treatment and follow-up period.

1. Vital signs

2. Body weight

3. Clinical laboratory parameters

4. BAC by breathalyzer

5. Urine drug tests

6. AEs (included elicited AEs and AEs in subjects taking a CYP 3A4 sensitive substrate)

7. ECG results

8. CIWA-AR scores

9. Frequency of subjects with suicidal ideation at any time during the treatment period (C-SSRS)

10. Concomitant medication use

11. Alcohol Craving Questionnaire – Short Form – Revised

(ACQ-SF-SR) score (pre- and post-cue response sessions)

Primary Outcome Measure

The primary efficacy endpoint is the “strength” of alcohol craving Visual Analog Scale (VAS) score (item 1 below) upon presentation of the first alcohol cue at Week 2 – after one week of investigational product treatment.

Investigational Product

DRUG X and matched placebo will be provided as matched capsules in bottles containing enough study drug until the next study visit.

Instructions for shipping, storage and handling will be provided in the protocol.

RFP-NICHD-NIAAA-2020-04: ATTACHMENT 3C -- SAMPLE CLINICAL TRIAL TASK ORDER B-2 APPENDIX

Table 1: DRUG X Human Lab Study Schedule of Assessments and Procedures

Study Phase Screening Treatment End of Studyi) Follow-up Call

Clinic Visit # 1 2 3 4 5 6 7

Study Week (Days)ii) -2 to -1 (-14 to -1)

(1 to 7)

(8 to 14)

(15 to 21)

(22 to 28)

(29 to 35)

(36 to 42)

(50 to 56)

Informed Consent X Alcohol Breathalyzer X X X X X X X

Urine Drug Testiii) X X X X X X X

Locator Form X Update Update Update Update Update Update Demographics X Medical History X Update Physical Exam X Update Body Weight X X X X X X X

MINI V 7.0 X

C-SSRS X X X X X X

Clinical Chemistryiv) X X X X X X

Hematologyv) X X X

Medical Urinalysis X X X Pregnancy Test X X X X X X X Birth control methods (all subjects) X X X X X X X

Vital Signsvi) X X X X X X X

Eligibility Checklist X X Drinking Goal X

ECG X X X

Prior and Concomitant Meds X X X X X X X X

CIWA-AR X X X X X X X X

Study Phase Screening Treatment End of Studyi) Follow-up Call

Clinic Visit # 1 2 3 4 5 6 7

Study Week (Days)ii) -2 to -1 (-14 to -1)

(1 to 7)

(8 to 14)

(15 to 21)

(22 to 28)

(29 to 35)

(36 to 42)

(50 to 56)

Screening Cue Reactivity Session:

VAS Scales, typical alcoholic beverage

X

Randomization X (Day 1) Blood for Drug Concentration X X Drug compliance/ accountability Dispense

Day 1 X X X X X

AEs (open ended question) and elicited AE questions

X X X X X X X

Brief Telephone Interviewvii) 2 times during the week

As needed if the subject misses a clinic visit

Take Control X X Xviii) X X X

Treatment Cue Reactivity Session:

VAS Scales, typical alcoholic beverage

X

TLFB X X X X X X X

Brief Drinking Questionnaire AS NEEDED Exit Interview X ACQ-SF-R 2X pre/post cue session 2X pre/post cue session

PACS X X X X X X

Smoking quantity/frequency and nicotine use

X X X X X X

PSQI X X

Study Phase Screening Treatment End of Studyi) Follow-up Call

Clinic Visit # 1 2 3 4 5 6 7

Study Week (Days)ii) -2 to -1 (-14 to -1)

(1 to 7)

(8 to 14)

(15 to 21)

(22 to 28)

(29 to 35)

(36 to 42)

(50 to 56)

POMS X X X

PROMIS Alcohol Negative Consequences

X X

Treatment Referral X Follow-Up Telephone Interview X Final Subject Disposition X a EOS - end of study. These assessments are to be done at Week 6 or if the subject discontinues early and agrees to a final clinic visit.

b Within each study week, there should be a least two days elapsed since the visit in the prior week.

c Test for opiates (i.e., morphine test), cocaine, amphetamines, methamphetamine, THC, buprenorphine, methadone, benzodiazepines, oxycodone, barbiturates, 3,4-methylenedioxy-methamphetamine (MDMA – also known as ecstasy), and EtG.

d AST, ALT, alkaline phosphatase, total bilirubin, creatinine, gamma glutamyl transferase (GGT), and albumin. CrCl will also be calculated each time creatine is measured.

e Hematology tests include complete blood cell count with differential.

f Intentially left blank g Sitting blood pressure and heart rate.

h AEs, concomitant medications, CIWA-AR, and drug compliance reminder. Telephone calls during the first week, should be separated by at least one day between calls, and will include assessments for AEs, concomitant medications, CIWA-AR, and a drug compliance reminder. The second call should be several days before the cue session to remind the subject of the planned visit.

i Two Take Control modules will be viewed at this visit.

RFP-NICHD-NIAAA-2020-04: ATTACHMENT 3C – Sample Clinical Trial Task Order B-2 Deliverables and Reporting Requirements

Sample Task Orders B1&B2 Reporting Requirements and Deliverables

[same for both Sample Task Orders]

START UP ACTIVITIES: PROTOCOL DEVELOPMENT AND FINALIZATION

Description Quantity and Recipients Due Date

TECHNICAL DELIVERABLES

Site-Specific Protocol Information and Forms

1 e-copy to NICHD Contracts Portal

On or before the end of the fourth month from the date of Task Order award.

Site-Specific Protocol Information and Form Updates and Amendments

1 e-copy to NICHD Contracts Portal

AND one electronic copy sent directly to the NIAAA CRO Contractor

As applicable, within 5 business days of the update or amendment

STUDY IMPLEMENTATION ACTIVITIES: STUDY EXECUTION [to be performed upon NIAAA and

FDA approval of final Protocol/IND]

Description Quantity and Recipients Due Date

TECHNICAL DELIVERABLES

Evidence of Trial-Specific IRB Approval

(Reference the “Single Institutional

Review Board (sIRB)” and “Plan for Single Institutional Review Board (sIRB)” Articles in Section H)

Prior to recruitment of human subjects

Trial-Specific Recruitment and Retention Plan

1 e-copy to NICHD Contracts Portal

AND one electronic copy sent directly to the NIAAA CRO Contractor

60 days after NIAAA and FDA approval of the final protocol/IND

Trial-Specific Data Management Plan

1 e-copy to NICHD Contracts Portal

AND one electronic copy sent

60 days after NIAAA and

Trial-Specific Pharmacy Management Plan

1 e-copy to NICHD Contracts Portal

AND one electronic copy sent

Trial-Specific SAE/AE Reporting Plan

1 e-copy to NICHD Contracts Portal

AND one electronic copy sent

Trial-Specific Quality Control and Quality Assurance Plan

1 e-copy to NICHD Contracts Portal

AND one electronic copy sent

Trial-Specific Data Collection

Electronic transmission to NIAAA CRO Contractor

Within two weeks from time of collection

Trial-Specific Evidence of Annual IRB Review and Approval Study Protocol

Due annually, 30 days after the anniversary date of the NIAAA and FDA final Protocol/IND approval.

Trial-Specific Annual Technical Progress Report for Clinical Research Study Populations

AND one electronic copy sent

Annually, due 12 months after award date of Task Order

Trial-Specific Cumulative Inclusion Enrollment Report (Final)

1 e-copy to NICHD Contracts Portal

AND one electronic copy sent

On the completion date of the Task Order

Trial-Specific Data File Electronic transmission to NIAAA CRO Contractor

Trial-Specific Final Study Report and Summary of Salient Results

TRIAL-SPECIFIC

ADMINISTRATIVE AND

REGULATORY DELIVERABLES

Trial-Specific Annual Invention Utilization Report

If any inventions to disclose, electronic submission to NIH Interagency Edison reporting system, http://www.iedison.gov and 1 e-copy to NICHD Contracts Portal

If no inventions to disclose, send a negative report via e-copy to NICHD Contracts

Annually, 12 months from the anniversary date of the Task Order.

Trial-Specific Final Invention Statement

If any inventions to disclose, electronic submission to NIH Interagency Edison reporting system, http://www.iedison.gov and 1 e-copy to NICHD Contracts Portal

If no inventions to disclose, send a negative report via e-copy to NICHD Contracts the Task Order.

All electronic reports and deliverables (designated as “e-copy” in the chart above) 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 .

All reports required herein, other than those specifically designated to be submitted by e-mail or other method in the “Quantity and Recipients” column in the chart above, shall be submitted in electronic format via the NICHD Contracts Portal available at the following website:

https://contracts.nichd.nih.gov. The Contractor must provide to the Contracting Officer/Contract Specialist the name of the person(s) submitting electronic reports via the NICHD Contracts Portal in order to initiate access to the Portal http://www.iedison.gov/ http://www.iedison.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 https://contracts.nichd.nih.gov/