University System Of Maryland

DEVELOP COMPREHENSIVE ASSESSMENTS OF POTENTIAL FORCE PROTECTION THREATS FROM EMERGING ELECTROMAGNETIC TECHNOLOGIES.

ATMOSPHERE OBSERVING SYSTEM (AOS) POLARIMETER PHASE A STUDY

CLOSELY ASSOCIATED IGF::CL::IGF

THE NATIONAL PERFORMANCE MANAGEMENT RESEARCH DATA SET (NPMRDS) AND TECHNICAL AND DATA-SHARING SUPPORT.

MAX TO-26 (RENEWAL OF TO 24 AND 25)

EO 14398 -BROAD AGENCY ANNOUNCEMENT CONTRACT: MACHINE LEARNING-GUIDED 3D NANOPRINTING OF A RETINAL VASCULAR PHANTOM LIBRARY

THE CONTINUUM OF CARE IN HOSPITALIZED PATIENTS WITH OPIOID USE DISORDER AND INFECTIOUS COMPLICATIONS OF DRUG USE (CHOICE)

DIRECT MOLECULAR DETECTION OF T. PALLIDUM USING ANTISENSE OLIGONUCLEOTIDES DIRECTED REDOX ASSISTED ELECTROCHEMICAL BIOSENSOR CHIP; DESIGN AND OPTIMIZATION OF THE MOLECULAR PROBES FOR SIMULTANEOUS TARGETING THREE REGIONS OF T. PALLIDUM GENOME; ELECTROCHEMICAL SENSING PLATFORM FOR SELECTIVE, SENSITIVE AND QUANTITATIVE ONE-STEP DETE...

THE CONTINUUM OF CARE IN HOSPITALIZED PATIENTS WITH OPIOID USE DISORDER AND INFECTIOUS COMPLICATIONS OF DRUG USE (CHOICE)

THE CONTINUUM OF CARE IN HOSPITALIZED PATIENTS WITH OPIOID USE DISORDER AND INFECTIOUS COMPLICATIONS OF DRUG USE (CHOICE)

SCOPE OF WORK: THE CENTER FOR VACCINE DEVELOPMENT AND GLOBAL HEALTH (CVD) WILL FURNISH THE NECESSARY SCIENTIFIC, CLINICAL, ADMINISTRATIVE AND LABORATORY PERSONNEL, AND THE MATERIALS, EQUIPMENT, AND FACILITIES TO EVALUATE A RABIESVECTORED MONOVALENT LASSA FEVER VACCINE IN HUMANS. THIS WORK INCLUDES THE REGULATORY PHASE, THE TRIAL PREPARATORY PHASE, THE EXECUTION PHASE OF THE CLINICAL TRIAL, AND THE ANALYSIS AND RESULTS PHASE. IN THE REGULATORY PHASE, WE WILL COORDINATE ASSEMBLY OF THE PRE-IND BRIEFING PACKAGE, SCHEDULE THE PRE-IND MEETING AND PARTICIPATE IN THE PRE-IND MEETING. WE WILL COORDINATE THE DEVELOPMENT AND FILING OF THE IND PACKAGE, INCLUDING PROVIDING OVERSIGHT OF OUTSIDE VENDORS, AS NEEDED. CVD WILL ACT AS STUDY SPONSOR FOR THE CLINICAL TRIAL. WE WILL DESIGN THE CLINICAL TRIAL PROTOCOL, WITH INPUT FROM ALL PARTNERS. PRIOR TO STARTING THE TRIAL, WE WILL OBTAIN ALL NECESSARY APPROVALS, INCLUDING FROM NIH AND INSTITUTIONAL REVIEW BOARDS; TRAIN STUDY STAFF; DELINEATE ROLES AND TIMELINES; AND ENSURE ADEQUATE FACILITIES AND RESOURCES ARE AVAILABLE TO CONDUCT THE TRIAL ACCORDING TO GOOD CLINICAL TRIAL (GCP) STANDARDS, STANDARD OPERATING PROCEDURES AND OTHER GUIDELINES. WE WILL PERFORM THE CLINICAL TRIAL AS DESIGNED IN THE PROTOCOL, ACCORDING TO ALL ETHICAL, QUALITY AND GCP STANDARDS. THIS WILL INCLUDE STUDY INITIATION; RECRUITMENT, INFORMED CONSENT AND RETENTION OF THE STUDY POPULATION; CONDUCT OF STUDY VISITS PER SCHEDULE; DATABASE CLEANING AND CLOSURE; AND WRITING OF REPORTS AND PUBLICATIONS. WE WILL COMPLY WITH REGULATORY REQUIREMENTS INCLUDING SERIOUS ADVERSE EVENTS (SAES) REPORTING REQUIREMENTS. WE WILL COMMUNICATE AS REQUIRED WITH FUNDERS, AND PARTNERS, AND CONVENE A SAFETY MONITORING COMMITTEE PER THE DETAILS IN THE PROTOCOL. CVD WILL PERFORM ALL DATA RECORDING PROCESSES AND FUNCTIONS, INCLUDING CASE REPORT FORM DESIGN, DATA COLLECTION AND ENTRY, SOURCE DOCUMENTATION. WE WILL ENSURE THAT CLINICAL DATA ARE ACCURATE, COMPLETE AND TIMELY. WE WILL ENSURE THE QUALITY, SECURITY, SAFETY AND RELIABILITY OF ALL DATA ACCORDING TO OUR QUALITY MANAGEMENT PLAN. AFTER DATA LOCK, CVD WILL ANALYZE TRIAL RESULTS ACCORDING TO THE PROTOCOL AND THE STATISTICAL ANALYSIS PLAN, AND PRODUCE A FINAL CLINICAL STUDY REPORT. WE WILL COMPLY WITH ALL NECESSARY REPORTING TO CLINICALTRIALS.GOV, THE FUNDER, AND THE FDA, AS RELEVANT.