№ lp_1_2_22201
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This checklist outlines various considerations and required documents for procurement processes within County APD, including approval requirements for equipment, services, and software.
Note:
Year
Topic:
Procurement, Equipment, Services, Software
Document Type:
Checklist
Organization:
County APD
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Note:
Study Summary 1.1 Please provide a brief summary of the study in the table below. A complete description of the study with detailed information should be provided in the body of the protocol. For sections not applicable to the study, mark them as N/A. Study Title Study Design Primary Objective/Purpose Secondary Objective(s)/Purposes Research Intervention(s) ClinicalTrials.gov NCT # Study Population Sample Size Study Duration for individual subjects Study Specific Abbreviations/ Definitions
Background 3.1 Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how will it add to existing knowledge. :
this section should be limited to only information directly related to the research questions and objectives. Do not include your full dissertation proposal. 3.2 Describe any relevant preliminary data (e.g. pilot data).
Procedures Involved 5.1 Describe and explain the study design. 5.2 Please select the methods that will be employed in this study (select all that apply):
☐ Audio/Video Recording ☐ Psychophysiological Recording ☐ Behavioral Interventions ☐ Record Review - Educational ☐ Behavioral Observations and Experimentations ☐ Record Review - Employee ☐ Deception ☐ Record Review- Medical ☐ Focus Groups ☐ Record Review - Other ☐ Interviews ☐ Specimen Collection or Analysis ☐ Investigational Medical Device – (e.g. Medical Mobile Applications) ☐ Surveys and/or Questionnaires ☐Psychometric Testing ☐ Other Social-Behavioral Procedures Provide a description of all research procedures being performed and when they are performed. (Upload any surveys, questionnaires, interview scripts, focus group scripts, debriefing scripts, psychometric tests, stimulus materials, intervention manuals, and data collection forms on the Local Site Documents page in the IRB application.) 5.3 Describe the procedures or interventions that are going to be conducted as part of the research project, but that would have been conducted anyway, even if the research was not occurring (i.e. standard of care procedures, activities that would occur in a classroom). 5.4 Describe the procedures performed to lessen the probability or magnitude of risks of items selected in 5.2.5. 5 If accessing or collecting existing data, describe: The data that will be collected during the study (e.g. demographics, medical history, etc.). Attach the data capture sheet(s) on the Local Site Documents page in the IRB application. How the data will be obtained, including how you have the authority to access the data. The source or location of the data (e.g. USF Epic, TGH Epic, Hillsborough County School records, CANVAS records, publicly available databases, etc.). 5.6 If collecting and/or analyzing biological specimens, describe: How the biological specimens will be or have been collected. How the biological specimens will be stored. How long the biological specimens will be stored. How the biological specimens will be used. The laboratories that will be used. Whether the collected biological specimens will undergo genetic testing. If so, indicate if this study is part of a Genome Wide Association Study (GWAS) and whether the data will be forwarded to the NIH dbGaP. 5.7 If there are plans for long-term follow-up (once all research related procedures are complete), what data will be collected during this period.
Data and Specimen Storage for Future Research 6.1 If data or specimens will be banked for future research studies, describe where the data or specimens will be stored, how long it/they will b:
the process to request a release, approvals required for release, who can obtain data or specimens, and the data to be provided with specimens.
Year:
2023
State:
Wisconsin
Type of Document:
Questionnaire / Data Collection Form
Institution:
Department of Health Services, Division of Public Health
Program:
Trauma Program
Target Audience:
Hospitals seeking Level IV trauma classification
Reporting Period:
12 months prior to PRQ submission
Submission Deadline:
45 days before scheduled site visit
Contact Email:
[email protected]
Note:
Year
HRP-308 Worksheet: Pre-Review Screening Checklist for Human Research Submissions (February 16, 2026)
Year:
2026
Date:
February 16, 2026
Document Code:
HRP-308
Document Type:
Worksheet
Subject:
Human Research Ethics Review and IRB Pre-Review Screening
Responsible Body:
Institutional Review Board (IRB)
Purpose:
Screening of submission materials for Human Research review
Related Documents:
HRP-309 Ancillary Review Matrix; HRP-330 HIPAA Authorization Worksheet; HRP-024 SOP New Information; HRP-306 Drugs Worksheet; HRP-307 Devices Worksheet; HRP-801 Establishing Reliance Agreements; HRP-815 Institutional Profile Form; HRP-830 Communication and Responsibilities Worksheet
Regulatory Areas Referenced:
Human Research Regulations; EU GDPR; HIPAA; NIH Policy; FERPA; PPRA
Primary Users:
IRB staff conducting submission screening
Scope:
Initial review, modification review, and pSite review for studies relying on the IRB
Key Topics:
regulatory oversight determination, ancillary reviews, ethics training verification, conflict of interest disclosure, consent documentation, research protocol completeness, drug and device oversight, multi-site research coordination, HIPAA authorization review, protection of vulnerable populations
Note:
Year
Context:
This document outlines the process for Clinical Faculty to complete a Pre-Review of Payroll Statements in the PAC system for certification.
Year:
2024
Region / City:
UK
Topic:
Data Protection, Special Category Data, Criminal Offence Data
Document Type:
Policy Document
Organization:
Office for Nuclear Regulation (ONR)
Author:
Data Protection Officer (DPO)
Target Audience:
ONR Staff, Regulatory Bodies, Legal Professionals
Effective Period:
May 2024 - May 2027
Approval Date:
May 2024
Review Date:
May 2027
Year:
2020
Note:
Region / City
Subject:
Medication Administration
Document Type:
Guide
Organization / Institution:
APD
Target Audience:
Medical professionals and caregivers working with APD clients
Year:
Not specified
Region / City:
Not specified
Subject:
Cost allocation methodology for Advance Planning Documents
Document Type:
Certification Process
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
County representatives involved in submitting APDs
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2024
Region / City:
United Kingdom
Theme:
Data protection, law enforcement
Document Type:
Policy
Authoring Body:
Office for Nuclear Regulation (ONR)
Target Audience:
Data Protection Officers, Law Enforcement Agencies
Implementation Period:
May 2024 – May 2027
Approval Date:
May 2024
Review Date:
May 2027
Document Reference No.:
ONR-DPC-POL-004
Record Reference No.:
2024/27109
Revision:
1
Description of Updates:
New policy document as part of wider data protection compliance arrangements
Contextual Description:
A policy document outlining the processing of special category and criminal offence data by ONR for law enforcement purposes, including compliance with the DPA 2018 and the GDPR.
Year:
Not specified
Country:
United States
Program:
Medicaid
Document Type:
Government form template
APD Type:
Planning APD (PAPD); Implementation APD (IAPD); Annual APD Update (APDU); As-Needed APDU
Subject:
Medicaid Enterprise Systems (MES) advance planning and funding request
Related Systems:
Medicaid Management Information Systems (MMIS); Eligibility and Enrollment (E&E) systems
Regulatory Authority:
45 CFR §95.610
OMB Control Number:
0938-1148 (CMS-10398 #94)
OMB Expiration Date:
10/31/2027
Estimated Burden:
60 hours per response
Issuing Agency:
Centers for Medicare & Medicaid Services (CMS)
Submission Address:
CMS, 7500 Security Boulevard, Baltimore, Maryland 21244-1850
Title:
IS AN APD NECESSARY CHECKLIST
Document Type:
Administrative checklist
Subject:
Advance Planning Document (APD) requirements for EDP/ADP acquisitions
Legal References:
45 CFR Part 95 Subpart F; 45 CFR 95.601; 45 CFR 95.605; 45 CFR 95.617; Div. 28-010; Div. 28-105; Action Transmittal Number ACF-AT-93-3
Programs Referenced:
Titles I, IV-A, IV-B, IV-D, IV-E, IV-F, X, XVI (AABD), XIX of the Social Security Act; Title IV Chapter 2 of the Immigration and Naturalization Act
Administering Authorities:
State agencies; CDSS; California Department of Health Care Services; California Department of Child Support Services
Geographic Scope:
County and State level (California)
Funding Scope:
Federal, State, and County funds
Primary Topic:
Prior approval requirements for EDP/ADP equipment, services, and software acquisitions
Intended Audience:
County agencies preparing APDs
Threshold Requirement:
$0 threshold for EDP acquisitions seeking State or federal participation
Exclusions:
Prohibited content including duplication or modification of current systems and certain social services software
Year:
2026
Region / City:
New Zealand
Topic:
Assistive Technology for Students with Auditory Processing Disorder
Document Type:
Application Form
Organization / Institution:
Ministry of Education
Author:
Unknown
Target Audience:
Educational staff, Learning Support Coordinators, Audiologists
Period of Application:
February - November
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Region / City:
Florida
Document Type:
Incident Report Form
Organization / Agency:
Agency for Persons with Disabilities (APD)
Author:
Not specified
Target Audience:
Healthcare and caregiving staff
Date of Report:
Not specified
Date of Incident:
Not specified
Medication Error Type:
Wrong medication, wrong dose, wrong time, wrong route, documentation errors, or other
Involved Personnel:
RN, LPN, caregiving staff
Follow-up Actions:
Retraining, warnings, counseling, policy updates, corrective action plans
Controlled Substances:
Yes / No
Year:
2023
Region / City:
Not specified
Topic:
Fitness promotion, event scheduling, and training
Document Type:
Training Manual
Organization:
Powder Blue Productions
Author:
Chalene Johnson, Christine Dwyer
Target Audience:
Area Promotions Directors (APD), Fitness Professionals
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
May 11, 2023
Note:
Year
Year:
2025
Region / City:
Global
Topic:
Environmental and Social Impact in Evaluations
Document Type:
Consultancy Request
Organization / Institution:
United Nations Evaluation Group (UNEG), Global Environment Facility (GEF)
Author:
UNEG Working Group on Climate Change and Environment
Target Audience:
Consultants, UNEG members, Evaluation Practitioners
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Document type:
Corporate charter commentary
Subject matter:
Corporate governance and venture capital financing
Jurisdiction:
Delaware, United States
Applicable law:
Delaware General Corporation Law
Referenced law:
California Corporations Code
Corporate structure:
Preferred Stock and Common Stock
Intended use:
Venture-backed portfolio company incorporation
Key provisions discussed:
No impairment clause, pay-to-play provision, blank check preferred
Audience:
Corporate counsel and venture capital practitioners
Geographic considerations:
Delaware incorporation with potential California operations
Case law referenced:
Wilson v. Louisiana-Pac. Res., Inc.; VantagePoint Venture Partners 1996 v. Examen, Inc.; Lidow v. Superior Ct.
Time references:
2012
Year:
2024
Region / City:
United States
Topic:
Healthcare Compliance, Pharmaceutical Programs
Document Type:
Policy/Guideline
Organization:
Apexus
Author:
Not specified
Target Audience:
340B-covered entities, Medicaid agencies, healthcare providers
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Region / city:
Global
Topic:
Vaccine Policy, Maternal Health, Group B Streptococcus
Document type:
WHO Guidance
Institution:
World Health Organization (WHO)
Author:
WHO ECVP
Target audience:
Policymakers, Vaccine Developers, Public Health Authorities
Period of validity:
Ongoing
Approval date:
March 11, 2025
Date of changes:
Not specified
Year:
2024
Region / City:
Africa
Topic:
Vector Control, Malaria, Genetically Modified Organisms
Document Type:
Consultancy Announcement
Organization:
African Union Development Agency-NEPAD (AUDA-NEPAD)
Author:
Not specified
Target Audience:
Individual Consultants
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified