№ lp_1_2_22081
File format: docx
Character count: 5168
File size: 31 KB
The document is a Standard Operating Procedure outlining the management process for completing Form FDA 1572 in clinical research.
Year:
Not specified
Region / City:
Not specified
Topic:
Clinical research documentation
Document type:
Standard Operating Procedure
Organization / Institution:
Not specified
Author:
Not specified
Target audience:
Study Investigators, Study Coordinators, Regulatory Affairs, Sponsors
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
[XXXX]
Region / City:
Georgia
Topic:
Human services, public assistance
Document type:
Memorandum of Agreement (MOA)
Organ / institution:
Georgia Department of Human Services
Author:
Georgia Department of Human Services
Target audience:
Contractors and state agencies
Period of validity:
Effective Date to [End Date], with potential renewal options
Approval date:
[Approval Date]
Date of amendments:
[Amendment Date]
Year:
2017
Region / City:
N/A
Theme:
Medical Device Regulation
Document Type:
Fee List
Organization / Institution:
Notified Body XXXX
Target Audience:
Manufacturers of medical devices
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
xxxx
Region / city:
xxxxxx
Subject:
Safety and Security Management
Document type:
Plan
Organization:
XXXX
Author:
xxxxxx
Target audience:
XXXX staff
Period of validity:
From: xxxx, To: xxxx
Approval date:
xxxx
Date of last revision:
xxxxxx
Year:
XX/XX
Note:
Region / City
Subject:
Higher Education, Undergraduate Programmes
Document Type:
Handbook
Target Audience:
Students, Academic Staff
Period of Validity:
Academic Year XX/XX
Note:
Year
Subject:
Continuing Professional Development (CPD)
Document type:
Template
Organization / institution:
FiP, UKCP
Target audience:
Practitioners required to meet CPD standards
Period of validity:
Annual
Context:
A form designed for professionals to record and assess their CPD activities over a 12-month period in order to meet the CPD standards of FiP and UKCP.
Year:
2019
Region / city:
United Kingdom
Subject:
GCE Qualifications, Assessment Strategies
Document Type:
Guidance
Organization:
Ofqual
Author:
Ofqual
Target Audience:
Awarding organisations, schools, and colleges
Period of Validity:
Ongoing
Date of Approval:
2019
Date of Revisions:
2019
Year:
1992
Region / City:
Queensland
Subject:
Legal Documents
Document Type:
Affidavit
Author:
Not specified
Target Audience:
Legal professionals, courts, applicants, and respondents
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
Not specified
Region / City:
Not specified
Topic:
Standard Operating Procedure (SOP)
Document Type:
Template
Organization:
Not specified
Author:
Not specified
Target Audience:
Study Investigators, Study Coordinators, Regulatory Affairs, Sponsors
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2012
Region / City:
Dallas, Texas
Subject:
Utility check for potential conflicts with existing facilities
Document Type:
Official Letter
Organization / Institution:
Bob Smith Engineering
Author:
Bob Smith, PE
Target Audience:
Utility companies and service providers
Effective Period:
Immediate
Approval Date:
August 23, 2012
Amendment Date:
N/A
Year:
2023
Note:
Region / City
Subject:
Internal Environmental Quality (IEQ), building design, educational facilities
Document Type:
Design Report
Organization / Institution:
Ministry of Education
Target Audience:
Architects, Engineers, Ministry Officials, Education Planners
Year:
XXXX
Region / City:
-
Topic:
Production Measurement and Allocation Systems
Document Type:
Technical Standard
Organization / Institution:
-
Author:
-
Target Audience:
Operators, engineers, industry professionals
Validity Period:
-
Approval Date:
-
Modification Date:
-
Year:
2015
Region / City:
Aberystwyth
Subject:
Procurement, Quotation, Supply
Document Type:
Request for Quotation (RFQ)
Institution:
Aberystwyth University
Author:
Aberystwyth University
Target Audience:
Potential Suppliers
Validity Period:
Until XX/XX/2015
Approval Date:
XX/XX/2015
Amendment Date:
N/A
Year:
XXXX
Region / City:
South East London
Topic:
Shared care prescribing
Document Type:
Guideline
Organization:
Health Services
Author:
Not specified
Target Audience:
General Practitioners, Specialists
Period of Application:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2019
Region / City:
Monaco
Theme:
Hydrography, Bathymetry
Document Type:
Technical Specification
Organization:
International Hydrographic Organization
Author:
IHO S-102 Project Team
Target Audience:
Hydrographers, Maritime Data Producers
Period of Validity:
Ongoing
Approval Date:
2019
Modification Date:
2019
Year:
2016
Region / City:
United States
Topic:
Electronic Informed Consent (eIC)
Document Type:
Guidance
Agency / Institution:
Office for Human Research Protection (OHRP), Food and Drug Administration (FDA)
Author:
Office for Human Research Protection (OHRP), FDA
Target Audience:
Researchers, IRBs, Clinical Investigators, and Study Participants
Period of Validity:
Ongoing
Approval Date:
December 2016
Date of Revisions:
Not specified
Year:
2013–2019
Region:
United States
Subject:
Medical device regulatory submissions
Document type:
Regulatory guidance
Program:
FDA Q-Submission (Q-Sub) Program
Regulatory authority:
U.S. Food and Drug Administration
Centers:
Center for Devices and Radiological Health; Center for Biologics Evaluation and Research
Submission types covered:
Pre-Submission; Submission Issue Request; Study Risk Determination; Informational Meeting
Format requirements:
eCopy
Effective requirement date for eCopy:
January 1, 2013
Final rule date for electronic submissions:
December 13, 2019
Intended audience:
Medical device sponsors and applicants
Scope:
Premarket submissions including IDE, 510(k), PMA, HDE, and De Novo requests
Administrative timeline:
15 calendar days acceptance review; meeting scheduling prior to day 75
Year:
2005
Issuing Organization:
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, Division of Immunology and Hematology Devices
Document Type:
Guidance Document
Target Audience:
Industry and FDA Staff
Subject:
AFP-L3% Immunological Test Systems, In Vitro Diagnostic Devices, Class II Special Controls
Date Issued:
October 4, 2005
Contact:
Donna Roscoe, [email protected]
Note:
, 301-796-6183
Year:
2023
Region / City:
Duke University
Theme:
Medical Device Regulation
Document Type:
Instructional Document
Organization / Institution:
Duke Office of Regulatory Affairs and Quality
Author:
Duke University
Target Audience:
Medical device developers, regulatory affairs professionals
Period of validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.