№ lp_2_3_61514
File format: docx
Character count: 6508
File size: 266 KB
Standard operating procedure outlining responsibilities, regulatory requirements, and institutional processes for preparing, conducting, and completing clinical study close-out visits and related follow-up activities at Kent State University.
Organization:
Kent State University
Related Institution:
USF Health
Related Bodies:
USF IRB; CIRP
Document Type:
Standard Operating Procedure
Field:
Clinical Research
Subject:
Study Close-Out Visit Procedures
Scope:
Key Research Personnel
Effective Date:
01/29/2017
Approval Date:
01/29/2017
Related Policy:
SOP #201 Regulatory Documentation
Appendix:
Appendix W Site Close-Out Checklist
Regulatory References:
21 CFR 312.50; 21 CFR 312.59; 21 CFR 312.60; 21 CFR 312.62; 21 CFR 312.64; 21 CFR 312.66; 21 CFR 312.68; FDA Guidelines for Monitoring of Clinical Investigations January 1988; ICH Good Clinical Practice May 1997
Governing Framework:
USF HRPP Policy and Procedure Manual Records Retention and Accessibility
Revision History:
Running history of all revision dates
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2025
Region / City:
Queensland
Topic:
Contract Management
Document Type:
Template
Institution:
Department of Housing and Public Works
Author:
Not specified
Target Audience:
Government agencies
Effective Period:
Not specified
Approval Date:
Not specified
Date of Amendments:
June 2025
Year:
2023
Region / city:
Bern, Switzerland
Theme:
Clinical Trials Monitoring
Document Type:
Report Template
Organization:
Swiss Clinical Trial Organisation (SCTO)
Author:
Monitoring Platform of the SCTO
Target Audience:
Clinical trial monitors, researchers, study coordinators
Approval Date:
April 2023
Changes Date:
N/A
Note:
Year
Theme:
Financial management, Reporting
Document type:
Policy
Organization / Institution:
PHA
Target audience:
Public Housing Authorities
Institution:
George Washington University
Department:
Office of the Vice President for Research (OVPR)
Related Office:
GCAS SPFA
Document Type:
Administrative checklist
Subject:
Sponsored project award close-out procedures
Timeframe:
90 days prior to award end date through close date
Related Process:
No Cost Extension (NCE)
Referenced Systems:
Concur, EPAF
Policy References:
OVPR Handbook (Close-Out, page 42); Award Management and Close-out Policy
Audience:
Principal investigators, research staff, departmental administrators
Reporting Requirements:
Final Technical Report; Patent and Property Report; Final Invention Statement; Disposition of Fixed Assets
Financial Requirements:
Verification of expenditures; cost share confirmation; subaward closeout; encumbrance liquidation; final invoices submission
Year:
2023
Region / City:
United States
Topic:
Immigration, Security, International Visitors
Document Type:
Questionnaire
Organization / Institution:
U.S. Department of Energy
Author:
U.S. Department of Energy
Target Audience:
Foreign nationals visiting or assigned to the Department of Energy
Period of validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Region / City:
East Sussex
Topic:
Offsite Educational Visits
Document Type:
Policy
Organization:
East Sussex County Council
Author:
Leanne Bentley
Target Audience:
Educational establishments
Period of Validity:
Ongoing
Approval Date:
2025
Date of Amendments:
Ongoing
Year:
2024
Region / City:
USA
Subject:
Medical Education Accreditation
Document Type:
Guidelines
Organization:
Liaison Committee on Medical Education (LCME)
Author:
Association of American Medical Colleges (AAMC) and American Medical Association (AMA)
Target Audience:
Medical schools, accreditation teams, healthcare professionals
Period of Validity:
Not specified
Approval Date:
December 2024
Date of Changes:
Not specified
Institution:
Gwenfro Community Primary School
Document type:
School policy
Topic:
Educational visits and outdoor learning
Academic year:
2024/2025
Governing body approval:
Autumn 2024
Chair of Governors:
D. Jacks
Authors:
Simon Lancaster-Jones; Mike Rosser
Last revision date:
July 2024
Date of issue:
September 2024
Review cycle:
Annual
Geographical scope:
North Wales
Regulatory framework:
OEAP National Guidance for Educational Visits
Approval system:
EVOLVE online visit planning and approval system
Language availability:
English; Welsh
Year:
2014
Topic:
Spiritual care, chaplaincy
Document Type:
Guidelines
Author:
Not specified
Target Audience:
Chaplains, healthcare providers
Effective Period:
June 2014
Approval Date:
June 2014
Last Revised:
June 2014
Year:
2023
Region / City:
Victoria, Australia
Topic:
Occupational Health and Safety, Workplace Safety
Document Type:
Procedure
Department / Institution:
Department of Education and Training
Author:
Not specified
Target Audience:
Employees of the Department of Education and Training
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
United States
Topic:
Telehealth, Patient Care
Document Type:
Informational Document
Organization:
American Medical Association
Author:
American Medical Association
Target Audience:
Patients considering telehealth visits
Effective Date:
2023
Modification Date:
N/A
Note:
Year
Year:
2021
Region / City:
United States
Topic:
Medical Education Accreditation
Document Type:
Checklist
Organization / Institution:
LCME (Liaison Committee on Medical Education)
Author:
LCME
Target Audience:
Medical Schools, Faculty, Accreditation Coordinators
Validity Period:
Ongoing
Approval Date:
May 2021
Date of Changes:
N/A
Year:
2015
Region / City:
Not specified
Topic:
Clinical Research, Monitoring, SOP
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
CRC (Clinical Research Center)
Author:
Not specified
Target Audience:
Clinical research personnel, investigators, study monitors
Period of Validity:
Not specified
Approval Date:
01/01/2015
Effective Date:
01/01/2015
Revision Date:
06/01/2016
Year:
2026
Region / City:
Oxfordshire
Subject:
Educational visits, off-site activities, corporate parenting
Document Type:
Policy
Organization:
Oxfordshire County Council
Author:
Mike Fawcett
Target Audience:
OCC staff, educational institutions, service providers
Effective Period:
2026
Approval Date:
2026
Amendment Date:
N/A
Note:
Year
Subject:
Legal/Official Visits
Document Type:
Directory
Agency / Institution:
HM Prison Service (HMPS)
Target Audience:
Legal representatives, individuals scheduling visits
Context:
A directory of contact information and booking details for legal and official visits to several North West HM prisons, including available time slots and procedures.
Document type:
Practice guide
Subject:
Home visits to children in care
Focus:
Safety, belonging and wellbeing of children in care
Key roles:
Child Safety Officer (CSO), carers, families
Legislation referenced:
Child Protection Act 1999 (section 122)
Framework referenced:
Framework for Practice
Target audience:
Child Safety Officers and child protection practitioners
Population addressed:
Children in care, including Aboriginal and Torres Strait Islander children and children with disability
Practice context:
Case plan cycle implementation phase
Associated tools:
Child strengths and needs assessment, case plan, cultural support plan, placement agreement, child health passport, Foster care matching tool, Placement risk assessment tool, The Three Houses Tool, The Future House, The Safety House Tool
Values outlined:
Family and community connection; participation; partnership; cultural integrity; strengths and solutions; fairness; curiosity and learning
Year:
2022
Region / City:
Not specified
Subject:
Medical coding and documentation
Document type:
Coding portfolio project
Institution / Organization:
Not specified
Author:
Rodney Balbo (patient case)
Target audience:
Healthcare coding students or professionals
Period covered:
Weeks 2–6
ICD-10-CM Codes:
S01.01XA, W18.2XXA, G44.309, I10, R53.83, R40.0, S06.5X0A, Z48.811
CPT Codes:
12002, 99215, 70552, 61312, 61316, 00211, 62146, 62148, 00215
HCPCS Level II Codes:
N/A, A9585
APC Codes:
19991
Procedures described:
Laceration repair, office visit for headache, MRI brain with contrast, craniectomy, cranial bone graft, cranioplasty with autograft
Medical conditions:
Traumatic head injury, brain hematoma, post-traumatic headache, controlled hypertension, drowsiness