№ lp_1_14365
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This checklist outlines the requirements for authors submitting drafts to Cochrane Central Editorial Service, ensuring that all necessary steps, including research integrity and review consistency, are completed before submission.
Year:
2025
Region / City:
Global
Topic:
Research, Cochrane Reviews
Document type:
Checklist
Organization / Institution:
Cochrane
Author:
Cochrane Central Editorial Service
Target audience:
Authors submitting Cochrane reviews
Period of validity:
Not specified
Approval date:
22 May 2025
Date of amendments:
Not specified
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The product description is provided for reference. Actual content and formatting may differ slightly.
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:
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
Subject:
Pharmaceutical Regulation
Document Type:
Form
Organization / Institution:
Drug Control Authority (DCA) Malaysia
Target Audience:
Applicants for pre-submission meetings
Year:
2023
Region / City:
Amsterdam
Topic:
Centralised procedure, Marketing Authorisation Application
Document Type:
Annex to Pre-submission Request Form
Organization / Institution:
European Medicines Agency (EMA)
Author:
Not specified
Target Audience:
Applicants for marketing authorisation
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
USA
Topic:
Medical Device Submission to FDA
Document Type:
Pre-Submission Request
Organization / Institution:
Duke University
Author:
Investigator, PhD, Department of Duke University
Target Audience:
FDA, Medical Device Industry Professionals
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Date:
10 January 2025
Region / city:
EU
Topic:
Veterinary Medicines
Document Type:
Pre-submission meeting request form
Organization / institution:
European Medicines Agency (EMA)
Author:
European Medicines Agency
Target audience:
Marketing authorisation holders, applicants
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Context:
Pre-submission meeting request form to obtain procedural and regulatory advice for veterinary medicinal products subject to variation requiring assessment (VRA).
Year:
2025
Region / city:
Geneva
Theme:
Prequalification assessment, in vitro diagnostics
Document type:
Form
Organization / institution:
World Health Organization
Author:
World Health Organization
Target audience:
Legal manufacturers of in vitro diagnostic devices
Period of validity:
Effective January 2026
Approval date:
2025
Date of changes:
N/A
Year:
2024
Region / City:
Ashfield District
Theme:
Sustainability, Local Planning, Housing
Document Type:
Report, Addendum
Institution:
Ashfield District Council
Author:
Andrew Williamson
Target Audience:
Local government officials, planning professionals, policymakers
Period of Validity:
Until 2025
Date of Approval:
October 2024
Date of Changes:
February 2025
Year:
2017
Region / City:
Europe
Topic:
Pharmaceutical Industry, Regulatory Affairs
Document Type:
Official Response
Organization / Institution:
European Federation of Pharmaceutical Industries and Associations (EFPIA)
Author:
European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE), Vaccines Europe (VE), AESGP
Target Audience:
Regulatory Bodies, Pharmaceutical Industry Professionals
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Region / City:
Canberra, ACT, Australia
Subject:
Pre-submission meeting process for listing medicines on the Pharmaceutical Benefits Scheme
Document Type:
Briefing Paper
Organization / Authority:
Department of Health, Office of Health Technology Assessment Branch
Target Audience:
Pharmaceutical companies and applicants for PBS listing
Submission Deadline:
At least 10 business days before scheduled pre-submission meeting
Meeting Duration:
60 minutes
Required Attachments:
Word format briefing paper, supporting clinical and economic data
Relevant Legislation:
Privacy Act 1988, National Health Act 1953
Guidelines Referenced:
PBAC Guidelines sections 1–4
Meeting Components:
Background, Population, Treatment Algorithm, Clinical Evidence, Economic Evaluation, Estimated Utilisation, Other Discussion Points
Year:
2024
Location:
Springfield, Ohio, USA
Subject:
Affordable housing procurement for manufactured and modular homes
Document type:
Meeting minutes
Organization:
Clark County Land Reutilization Corporation
Coordinator:
Kara Van Zant
Project manager:
Dirk Lackovich-Van Gorp
Target audience:
RFQQ proposers and contractors
Key dates:
Pre-submission meeting June 6, 2024; RFQQ submission deadline June 18, 2024; Letter of intent July 8, 2024
Funding source:
ARPA funding and potential state of Ohio contributions
Housing type:
Single-family modular/manufactured homes
Site specifications:
Infill lots in Springfield, Ohio; improved crawl space foundations; potential previous structures assessed prior to build
Eligibility criteria:
Families below 300% of federal poverty guidelines
Standards:
HUD and Ohio Building Code; Energy Star rating considered
Description:
Official record of the pre-submission meeting outlining project scope, procurement process, housing specifications, site preparation, funding, and schedule for Clark County Land Bank’s affordable housing initiative.
Year:
2025
Type of document:
Application Form Courtesy Document
Event:
Call for Peer Reviews
Organization:
European Urban Initiative Permanent Secretariat
Target audience:
Cities under review, Peer reviewers
Scope:
European Union
Date of issue:
8 October 2025
Purpose:
Guidance for completing Application Forms for EUI Peer Reviews
Year:
2023
Region / City:
Global
Topic:
Product Updates, Technology, Hospitality
Document Type:
Press Release
Organization:
Airbnb
Author:
Airbnb
Target Audience:
Hosts, Guests, Technology Enthusiasts
Effective Date:
2023
Date of Changes:
2023
Description:
Press release announcing new features on Airbnb, including Guest Favorites, revamped ratings & reviews, and the Listings tab for hosts.
Year:
2015
Region / City:
Adelaide, South Australia
Topic:
Systematic Review, Critical Appraisal, Evidence-Based Healthcare
Document Type:
Guideline
Organization / Institution:
JBI (Joanna Briggs Institute)
Authors:
McArthur A, Klugarova J, Yan H, Florescu S
Target Audience:
Healthcare Professionals, Researchers, Policy Developers
Period of Validity:
N/A
Date of Approval:
N/A
Date of Changes:
N/A
Note:
Year
Year:
2020
Region / City:
South Australia
Topic:
Systematic reviews, Critical appraisal, Cohort studies
Document Type:
Research methodology tool
Organization / Institution:
JBI (University of Adelaide)
Author:
Moola S, Munn Z, Tufanaru C, Aromataris E, Sears K, Sfetcu R, Currie M, Qureshi R, Mattis P, Lisy K, Mu P-F
Target Audience:
Researchers, healthcare practitioners, systematic review reviewers
Period of Application:
2020 onwards
Approval Date:
2020
Date of Modifications:
Not specified
Organization:
Joanna Briggs Institute (JBI)
Document type:
Critical appraisal tool / checklist
Topic:
Randomized controlled trials (RCTs)
Target audience:
Researchers conducting systematic reviews
Year:
2020
Source:
JBI Manual for Evidence Synthesis
Format:
Checklist for individual participants in parallel group RCTs
Purpose:
Assess methodological quality and risk of bias in RCTs
Reference:
Tufanaru C, Munn Z, Aromataris E, Campbell J, Hopp L. Chapter 3: Systematic reviews of effectiveness
Program:
Early Intervention Program
Jurisdiction:
New York State
Governing body:
New York City Early Intervention Program (NYCEIP)
Document type:
Progress report
Review type:
6-month and annual IFSP review
Submission deadline:
No later than 2 weeks prior to scheduled review
Primary participants:
Child, parent(s), interventionist, service coordinator
Reporting scope:
Functional outcomes, objectives, service delivery, collaboration, and progress assessment
Preferred format:
Typed report
Required attachments:
Session notes and progress notes provided to parents
Compliance statement:
Certification of service delivery in accordance with IFSP
Source type:
Administrative program documentation
Year:
2016
Region / City:
Nationwide
Subject:
Loan Guaranty Program, Accuracy Reviews
Document Type:
Policy/Procedure Guide
Organization:
Department of Veterans Affairs (VA)
Author:
LoanSTAR Team
Target Audience:
Loan Guaranty Service Personnel, Loan Guaranty Officers (LGO)
Period of Effect:
Ongoing
Approval Date:
January 25, 2016
Amendment Date:
January 25, 2016