WSU22164S
YEAR 1 SITE RESPONSIBILITIES PRE-ENROLLMENT KICKOFF MEETING (BY TELECONFERENCE) O JUSTIFICATION: REQUIRED FOR COMMUNICATION OF PROJECT GOALS AND EXPECTATION ESTABLISHMENT OF THE SURVEILLANCE PROTOCOL AND CASE REPORT FORM INCLUDING RUDIMENTARY TEXT IDENTIFICATION FOR VACCINATION STATUS. O JUSTIFICATION: SET-UP TIME AND EFFORT COSTS REQUIRED FOR INFORMATION TRANSFER FROM EACH SITE FOR ALL GOALS, WHICH REQUIRES FACE TO FACE MEETINGS, MULTIPLE ZOOM CALLS WITH THE PRIME SITE, AND MULTIPLE TEST RUNS. REQUIRED TO COMMUNICATE WITH OTHER SITES TO BALANCE FEASIBILITY AND RIGOR. ESTABLISH OR AMEND AGREEMENTS WITH EDNS REPORT ESTIMATES OF POPULATIONS SERVED BY EACH HOSPITAL/HOSPITAL NETWORK. O JUSTIFICATION: REQUIRES SEVERAL MEETINGS TO ESTABLISH SEARCH PARAMETERS AND REVIEW RESULTS. IRB APPROVAL OF THE SURVEILLANCE PROTOCOL. O PROTOCOL PREPARATION, SUBMISSION AND REVISION (RA + IRB FEES $2500 PER SITE) O JUSTIFICATION: FOR ALL GOALS, EACH SITE WILL NEED TO MAINTAIN IDENTIFYING INFORMATION ON EACH PATIENT, AND THIS WILL REQUIRE FULL IRB REVIEW. DEVELOP OR MODIFY EXISTING DATA COLLECTION TOOLS AND PROTOCOLS TO SUPPORT THE DATA COLLECTION. O JUSTIFICATION: REQUIRED TO ESTABLISH FEASIBILITY OF ENSURING COMPLIANCE WITH FEDERAL RULES ON PRIVACY, WHILE ALLOWING LOCAL IDENTIFICATION, AND ENSURING INTERNAL SYSTEMS FOR SWAB TRANSFER TO APPROPRIATE AUTHORITIES. SUBMIT DRAFT DATA MANAGEMENT PLAN O JUSTIFICATION: TWO ONE-HOUR ZOOM CALLS TO CREATE METHODS OF API EXTRACTION, DEFINITIONS OF DATA QUALITY, METHODOLOGY FOR TRAINING OF ABSTRACTORS FOR GOAL [6], METHODS FOR REAL- TIME DATA COLLECTION IN GOAL [4], AND PROCEDURES FOR HANDLING OF MISSING DATA. GOAL [2-3] WEEKLY API MAINTENANCE, UPDATING AND TROUBLESHOOTING, PRE-EXPORT DATA REVIEW, CLEANING AND VERIFICATION AND EXPORT TO REDCAP. GOAL [5] RUDIMENTARY WEEKLY TRACKING OF THE SWAB TRANSFERS TO LOCAL/STATE HEALTH DEPARTMENTS. GOAL [6] CASE ACQUISITION, STRING VARIABLE AND CHART REVIEW AND DATA ENTRY FOR UP TO 5400 CASES PER YEAR, BY A RESEARCH ANALYST.
Integrative Emergency Services Physician Group, Pa
Definitive Contract 75D30121C11813
$50.1k 11/21/22 WSU22166S
YEAR 1 SITE RESPONSIBILITIES Â ¢ ESTABLISHMENT OF THE SURVEILLANCE PROTOCOL AND CASE REPORT FORM INCLUDING RUDIMENTARY TEXT IDENTIFICATION FOR VACCINATION STATUS. Â ¢ ESTABLISH OR AMEND AGREEMENTS WITH EDNS INSTITUTIONAL REVIEW BOARD (IRB) NON-RESEARCH N/A. Â ¢ REPORT ESTIMATES OF POPULATIONS SERVED BY EACH HOSPITAL/HOSPITAL NETWORK. Â ¢ SUBMIT DRAFT DATA MANAGEMENT PLAN. YEAR 2/3 SITE RESPONSIBILITIES REGULATORY Â ¢ IRB APPROVAL OF THE SURVEILLANCE PROTOCOL. O JUSTIFICATION: FOR ALL GOALS, EACH SITE WILL NEED TO MAINTAIN IDENTIFYING INFORMATION ON EACH PATIENT, AND THIS WILL REQUIRE FULL IRB REVIEW. DEVELOP OR MODIFY EXISTING DATA COLLECTION TOOLS AND PROTOCOLS TO SUPPORT THE DATA COLLECTION. O JUSTIFICATION: REQUIRED TO ESTABLISH FEASIBILITY OF ENSURING COMPLIANCE WITH FEDERAL RULES ON PRIVACY, WHILE ALLOWING LOCAL RE-IDENTIFICATION, AND ENSURING INTERNAL SYSTEMS FOR SWAB TRANSFER TO APPROPRIATE AUTHORITIES GOAL [2-3] WEEKLY API MAINTENANCE, UPDATING AND TROUBLESHOOTING, PRE-EXPORT DATA REVIEW, CLEANING AND VERIFICATION AND EXPORT TO REDCAP. GOAL [5] RUDIMENTARY WEEKLY TRACKING OF THE SWAB TRANSFER TO LOCAL/STATE HEALTH DEPARTMENTS. GOAL [6] CASE ACQUISITION, STRING VARIABLE AND CHART REVIEW AND DATA ENTRY FOR UP TO 5400 CASES PER YEAR, BY A ARCH ANALYST.
The Regents Of The University Of California. San Francisco
Definitive Contract 75D30121C11813
$73.6k 10/7/22 WSU22037S
YEAR 1 GOAL 1/PRE-ENROLLMENT - UPON COMPLETION OF SITE INITIATION ACTIVITIES (INCLUDING IRB APPROVAL, ESTABLISHMENT OF THE SURVEILLANCE PROTOCOL, SUBMISSION OF BASELINE DATA, AND DATA MANAGEMENT PLAN. GOALS 2, 3 - UPON COMPLETION OF QUARTERLY API MAINTENANCE, UPDATING AND TROUBLESHOOTING, PRE-EXPORT DATA REVIEW, CLEANING AND VERIFICATION AND EXPORT TO REDCAP. GOAL 4 NA GOAL 5 UPON COMPLETION OF QUARTERLY TRACKING OF THE SWAB TRANSFER TO LOCAL/STATE HEALTH DEPARTMENTS. GOAL 6 UPON QUARTERLY COMPLETION OF CASE ACQUISITION AND ENTRY INTO THE DATABASE.
Centura Health Corporation
Definitive Contract 75D30121C11813
$785.7k 7/6/22 WSU22010S
YEAR 1 SITE RESPONSIBILITIES: Â ¢ KICKOFF MEETING (BY TELECONFERENCE) O JUSTIFICATION: REQUIRED FOR COMMUNICATION OF PROJECT GOALS AND EXPECTATION Â ¢ ESTABLISHMENT OF THE SURVEILLANCE PROTOCOL AND CASE REPORT FORM INCLUDING RUDIMENTARY TEXT IDENTIFICATION FOR VACCINATION STATUS. O JUSTIFICATION: SET-UP TIME AND EFFORT COSTS REQUIRED FOR INFORMATION TRANSFER FROM EACH SITE FOR ALL GOALS, WHICH REQUIRES FACE TO FACE MEETINGS, MULTIPLE ZOOM CALLS WITH THE PRIME SITE, AND MULTIPLE TEST RUNS. REQUIRED TO COMMUNICATE WITH OTHER SITES TO BALANCE FEASIBILITY AND RIGOR Â ¢ ESTABLISH OR AMEND AGREEMENTS WITH EDNS INSTITUTIONAL REVIEW BOARD (IRB) NON-RESEARCH N/A Â ¢ REPORT ESTIMATES OF POPULATIONS SERVED BY EACH HOSPITAL/HOSPITAL NETWORK. O JUSTIFICATION: REQUIRES SEVERAL MEETINGS TO ESTABLISH SEARCH PARAMETERS AND REVIEW RESULTS Â ¢ IRB APPROVAL OF THE SURVEILLANCE PROTOCOL. O JUSTIFICATION: FOR ALL GOALS, EACH SITE WILL NEED TO MAINTAIN IDENTIFYING INFORMATION ON EACH PATIENT, AND THIS WILL REQUIRE FULL IRB REVIEW. DEVELOP OR MODIFY EXISTING DATA COLLECTION TOOLS AND PROTOCOLS TO SUPPORT THE DATA COLLECTION. O JUSTIFICATION: REQUIRED TO ESTABLISH FEASIBILITY OF ENSURING COMPLIANCE WITH FEDERAL RULES ON PRIVACY, WHILE ALLOWING LOCAL IDENTIFICATION, AND ENSURING INTERNAL SYSTEMS FOR SWAB TRANSFER TO APPROPRIATE AUTHORITIES Â ¢ SUBMIT DRAFT DATA MANAGEMENT PLAN O JUSTIFICATION: TWO ONE-HOUR ZOOM CALLS TO CREATE METHODS OF API EXTRACTION, DEFINITIONS OF DATA QUALITY, METHODOLOGY FOR TRAINING OF ABSTRACTORS FOR GOAL [6], METHODS FOR REAL- TIME DATA COLLECTION IN GOAL [4], AND PROCEDURES FOR HANDLING OF MISSING DATA. WEEKLY API MAINTENANCE, UPDATING AND TROUBLESHOOTING, PRE-EXPORT DATA REVIEW, CLEANING AND VERIFICATION AND EXPORT TO REDCAP. YEAR 2/3 SITE RESPONSIBILITIES Â ¢ IRB APPROVAL OF THE SURVEILLANCE PROTOCOL. O 2 HOURS. PROTOCOL PREPARATION, SUBMISSION AND REVISION O JUSTIFICATION: FOR ALL GOALS, EACH SITE WILL NEED TO MAINTAIN IDENTIFYING INFORMATION ON EACH PATIENT, AND THIS WILL REQUIRE FULL IRB REVIEW. DEVELOP OR MODIFY EXISTING DATA COLLECTION TOOLS AND PROTOCOLS TO SUPPORT THE DATA COLLECTION. O JUSTIFICATION: REQUIRED TO ESTABLISH FEASIBILITY OF ENSURING COMPLIANCE WITH FEDERAL RULES ON PRIVACY, WHILE ALLOWING LOCAL RE-IDENTIFICATION, AND ENSURING INTERNAL SYSTEMS FOR SWAB TRANSFER TO APPROPRIATE AUTHORITIES. WEEKLY API MAINTENANCE, UPDATING AND TROUBLESHOOTING, PRE-EXPORT DATA REVIEW, CLEANING AND VERIFICATION AND EXPORT TO REDCAP.
IHC Health Services Inc.
Definitive Contract 75D30121C11813
$429.9k 4/18/22 WSU22012S
Year 1 Site Responsibilities: â ¢ Kickoff meeting (by teleconference) o Justification: required for communication of project goals and expectation â ¢ Establishment of the surveillance protocol and case report form including rudimentary text identification for vaccination status. o Justification: Set-up time and effort costs required for information transfer from each site for all goals, which requires face to face meetings, multiple zoom calls with the prime site, and multiple test runs. Required to communicate with other sites to balance feasibility and rigor â ¢ Establish or amend agreements with EDNs Institutional Review Board (IRB) non-research N/A â ¢ Report estimates of populations served by each hospital/hospital network. o Justification: requires several meetings to establish search parameters and review results â ¢ IRB approval of the surveillance protocol. o Justification: For all goals, each site will need to maintain identifying information on each patient, and this will require full IRB review. Develop or modify existing data collection tools and protocols to support the data collection. o Justification: Required to establish feasibility of ensuring compliance with Federal rules on privacy, while allowing local identification, and ensuring internal systems for swab transfer to appropriate authorities â ¢ Submit draft data management plan o Justification: Two one-hour Zoom calls to create methods of API extraction, definitions of data quality, methodology for training of abstractors for goal [6], methods for real- time data collection in goal [4], and procedures for handling of missing data. Weekly API maintenance, updating and troubleshooting, pre-export data review, cleaning and verification and export to REDCap. Year 2/3 Site Responsibilities â ¢ IRB approval of the surveillance protocol. o 2 hours. Protocol preparation, submission and revision o Justification: For all goals, each site will need to maintain identifying information on each patient, and this will require full IRB review. Develop or modify existing data collection tools and protocols to support the data collection. o Justification: Required to establish feasibility of ensuring compliance with Federal rules on privacy, while allowing local re-identification, and ensuring internal systems for swab transfer to appropriate authorities. Weekly API maintenance, updating and troubleshooting, pre-export data review, cleaning and verification and export to REDCap.
Icahn School Of Medicine At Mount Sinai
Definitive Contract 75D30121C11813
$473.6k 4/15/22