№ lp_1_2_69039
File format: docx
Character count: 9829
File size: 913 KB
This document outlines the standard operating procedures for documenting and reporting adverse events (AEs) and serious adverse events (SAEs) during clinical trials at USF, following the guidelines of the USF IRB and ICH.
Year:
Not specified
Region / City:
Not specified
Topic:
Adverse Event Reporting in Clinical Trials
Document Type:
Standard Operating Procedure
Institution / Organization:
USF
Author:
Not specified
Target Audience:
Research team members involved in clinical trials
Period of Effectiveness:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
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.
Note:
Year
Subject:
Medical education, residency program, supervision policy
Document type:
Policy
Organization / Institution:
USF Health Morsani College of Medicine, University of South Florida
Author:
Program Director
Target Audience:
Residents, faculty, medical staff
Period of validity:
Ongoing
Organization:
USF Health Morsani Clinical Research Center
Institution:
USF Health Office of Clinical Research
Document type:
Standard operating procedures
Subject area:
Clinical research governance and Good Clinical Practice
Geographic location:
Tampa, Florida, United States
Regulatory framework:
ICH-GCP, federal regulations
Intended users:
Clinical investigators and clinical research staff
Contact information:
Office of Clinical Research, USF Health
Scope:
Administrative, regulatory, project management, subject management, data management, and quality assurance procedures
Ethical foundations referenced:
Nuremberg Code, Declaration of Helsinki, Belmont Report
Source type:
Institutional policy and procedural manual
Year:
2026
Region / City:
United Kingdom
Topic:
Urban Studies Research Funding
Document Type:
Fellowship Application Template
Organization:
Urban Studies Foundation
Author:
Urban Studies Foundation
Target Audience:
Early to mid-career urban researchers
Application Period:
Rolling based on USF guidelines
Submission Method:
Online application via USF website
Currency:
British Pounds (GBP)
Eligibility:
PhD awarded within the last ten years, nationals of OECD ODA recipient countries, full release from current roles required
Year:
2014
Location:
Tampa, Florida, USA
Type of Document:
Press Release
Institution:
USF Morsani College of Medicine
Organization:
Alpha Omega Alpha Honor Medical Society, Gamma Chapter
Contact:
Catherine M. Lynch, M.D., AOA Councilor
Event:
Induction of Class of 2015 students into AOA
Number of Students:
14
Selection Criteria:
Academic performance, leadership, service, professionalism
Founded:
1902
Chapter Established:
1976
Context:
Press release announcing the election of top-performing USF Morsani medical students to the national Alpha Omega Alpha honor society and listing their names for formal induction.
Year:
Not specified
Region / City:
Not specified
Subject:
Externships, Law Education
Document Type:
Requirements
Organization:
USF School of Law
Author:
Not specified
Target Audience:
Law students
Period of Action:
Summer (not specified)
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2019
Region / city:
OECD
Topic:
Adverse Outcome Pathway, oxidative stress, brain development, neurotoxicity
Document Type:
External Review Report
Author:
OECD EAGMST review manager
Target Audience:
Scientific community, regulators, policymakers
Period of validity:
Not specified
Approval Date:
June 2018
Date of revisions:
17 March 2020
Year:
2024
Region / city:
UK
Topic:
Climate change, extreme weather, workplace safety
Document type:
Policy document
Organization / institution:
UNISON, TUC
Author:
UNISON
Target audience:
Trade union representatives, employers, workers
Period of validity:
2024–2025
Approval date:
Not specified
Date of changes:
Not specified
Note:
Year
Year:
2003
Region / City:
Mount Sinai Hospital
Subject:
Clinical Research
Document Type:
Guideline
Organization / Institution:
Mount Sinai Hospital REB
Author:
REB Chair
Target Audience:
Clinical Investigators, Research Staff
Effective Period:
Ongoing
Approval Date:
November 6, 2003
Revision Date:
July 8, 2015
Year:
2026
Region / City:
Boston, MA
Topic:
Clinical Research, Adverse Event Reporting
Document Type:
Form
Author:
BU Medical Campus
Target Audience:
Clinical research staff
Period of validity:
Ongoing
Approval Date:
2026-01-01
Date of Changes:
Not specified
Year:
2019
Region / City:
International
Subject:
Medical device adverse event reporting
Document Type:
Proposed document
Organ / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, healthcare providers, manufacturers, reporters of adverse events
Period of validity:
Not specified
Approval date:
27th June 2019
Date of Changes:
Not specified
Year:
Not specified
Region / City:
Not specified
Topic:
Adverse events tracking in clinical studies
Document Type:
Template
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Site Monitors, Principal Investigators, study team members
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
2020
Region / City:
International
Topic:
Medical device regulation
Document Type:
Final Document
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, medical device manufacturers, healthcare providers
Period of Validity:
Not specified
Approval Date:
18 March 2020
Date of Changes:
Not specified
Note:
Year
Theme:
Healthcare, Medication Safety, Adverse Drug Event Prevention
Document Type:
Program Evaluation Report
Organization / Institution:
Centers for Medicare & Medicaid Services (CMS)
Target Audience:
Healthcare Providers, Medicare Beneficiaries, Policymakers
Year:
2022
Region / City:
N/A
Topic:
Adverse Reaction Tracking, Drug Allergy Management
Document Type:
User Manual
Institution:
Department of Veterans Affairs
Author:
N/A
Target Audience:
Healthcare professionals in the Veterans Health Administration
Period of Validity:
N/A
Approval Date:
September 2022
Date of Amendments:
N/A
Year:
2025
Region / City:
United States
Subject:
Serious Adverse Event Reporting
Document Type:
Form
Organization / Institution:
National Cancer Institute (NCI)
Author:
National Cancer Institute
Target Audience:
Clinical Investigators, Medical Monitors, Research Staff
Effective Period:
Ongoing
Approval Date:
09/04/2025
Modification Date:
10/01/2024
Note:
Year
Subject:
Health Insurance Appeals
Document Type:
Notification
Target Audience:
Insurance claimants
Year:
2023/2024
Region/City:
Capital, Coast and Hutt Valley
Theme:
Healthcare, Patient Safety
Document Type:
Report
Organization/Institution:
Health New Zealand | Te Whatu Ora
Author:
Health New Zealand | Te Whatu Ora
Target Audience:
Healthcare professionals, policymakers, public health officials
Period of Validity:
1 July 2023 – 30 June 2024
Approval Date:
September 2025
Date of Changes:
Not specified
Year:
2024
Region / city:
Australia
Topic:
Adverse Childhood Experiences, Trauma, Mental Health
Document type:
Factsheet
Organization / institution:
New South Wales Department of Education
Author:
Unknown
Target audience:
Educators, Researchers, Policymakers
Period of validity:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified