№ lp_1_2_39344
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File size: 29 KB
This document outlines the details of substantial modifications (SM) to documents and data fields for a clinical trial application.
Year:
2024
Region / city:
EU
Topic:
Clinical trials
Document type:
Application form
Organ / institution:
Sponsor Name
Author:
Unknown
Target audience:
Applicants for clinical trials
Effective period:
January 2024 - ongoing
Approval date:
Unknown
Modification date:
22 Jan 2024
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Year:
2024
Region / city:
EU
Subject:
Substantial modification details
Document type:
Application
Organization:
Sponsor Name
Author:
Sponsor Name
Target audience:
Trial participants, Regulatory Authorities
Period of validity:
January 2024 onwards
Approval date:
January 2024
Date of changes:
January 2024
Note:
Year
Contextual description:
A document related to the application process for a clinical trial, outlining necessary modifications, submission instructions, and documentation requirements in line with CTR regulations.
Date:
01-01-1900
Subject:
Application CTIS trial number SM-number (Part I / Part II / Part I + II)
Sponsor:
Sponsor Name
EU Trial number:
Trial Number
Application number:
SM-x
Protocol Number:
Protocol Number/Acronym
Protocol Title:
Protocol Title
Document version:
v2.0
Regulation compliance:
Regulation (EU) No 536/2014
Document type:
Substantial Modification Application
Target audience:
Regulatory authorities
Submission portal:
CTIS
Modification scope:
Substantial and non-substantial changes described
Document components:
Protocol, IB, IMPD, SoC, track-changes version
Date of last update:
01-01-1900
Year:
2024
Region / city:
EU
Subject:
Clinical trial documentation
Document type:
Instructions and templates for application submissions
Organ / institution:
Not specified
Author:
Not specified
Target audience:
Applicants for clinical trial modifications
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Note:
Year
Subject:
Clinical Trial Application
Document Type:
Application
Year:
2024
Region / city:
EU
Subject:
Substantial modification details
Document type:
Application
Organization:
Sponsor Name
Author:
Sponsor Name
Target audience:
Trial participants, Regulatory Authorities
Period of validity:
January 2024 onwards
Approval date:
January 2024
Date of changes:
January 2024
Note:
Year
Contextual description:
A document related to the application process for a clinical trial, outlining necessary modifications, submission instructions, and documentation requirements in line with CTR regulations.
Date:
01-01-1900
Subject:
Application CTIS trial number SM-number (Part I / Part II / Part I + II)
Sponsor:
Sponsor Name
EU Trial number:
Trial Number
Application number:
SM-x
Protocol Number:
Protocol Number/Acronym
Protocol Title:
Protocol Title
Document version:
v2.0
Regulation compliance:
Regulation (EU) No 536/2014
Document type:
Substantial Modification Application
Target audience:
Regulatory authorities
Submission portal:
CTIS
Modification scope:
Substantial and non-substantial changes described
Document components:
Protocol, IB, IMPD, SoC, track-changes version
Date of last update:
01-01-1900
Year:
2024
Region / city:
EU
Subject:
Clinical trial documentation
Document type:
Instructions and templates for application submissions
Organ / institution:
Not specified
Author:
Not specified
Target audience:
Applicants for clinical trial modifications
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2022
Region / City:
European Union
Topic:
Protection of personal data and commercially confidential information in clinical trial documents
Document type:
Guidance document
Organization / Institution:
EFPIA
Authors:
Merete Jørgensen, Wendy Wimmer, Julie Holtzople, Brendan Barnes, Silvia Garcia
Target audience:
EMA, industry stakeholders, clinical trial sponsors
Effective period:
Not specified
Approval date:
10/Mar/2022
Date of amendments:
Not specified
Note:
Year
Subject:
Clinical Trial Application
Document Type:
Application
Date:
August 3, 2011
Author:
Lisa Hull
Document type:
Personal letter
Subject:
Support for Anna Stubblefield
Institutions mentioned:
Rutgers University; Essex County Superior Court
Individuals mentioned:
Anna Stubblefield; DMan; Judge Siobhan Teare
Location:
Newark, New Jersey
Related event:
Criminal trial beginning September 9, 2011
Purpose:
Request for awareness, attendance, and support
Funding information:
Defense fund contribution details
Communication medium:
Written correspondence
Jurisdiction:
Australia
Regulatory framework:
Therapeutic Goods Administration (TGA) Clinical Trial Notification scheme
Document type:
Regulatory notification form
Scope:
Clinical trials involving medicines, biologicals, medical and therapeutic devices
Trial phases covered:
Phase I–IV, bioavailability/bioequivalence, device studies
Subjects:
Human participants
Ethics oversight:
Human Research Ethics Committee (HREC)
Approving authority:
Relevant institutional authority
Geographic coverage:
Australian trial sites with optional international sites
Responsible party:
Lead Investigator
Fee responsibility:
Lead Investigator
Related institution:
La Trobe University
Submission requirement:
Completed form and ethics approval
Note:
Year
Topic:
Clinical Trials
Document Type:
Plan
Target Audience:
Study team, sponsors, and regulatory authorities
Year:
2014
Region / City:
Geneva
Topic:
Revision of TGP/8, DUS Trial Design and Data Analysis
Document Type:
Draft Document
Organization / Institution:
International Union for the Protection of New Varieties of Plants (UPOV)
Author:
UPOV Office
Target Audience:
Technical Committees, Working Parties for Vegetables, Agricultural Crops, Fruit Crops, Ornamental Plants, and others involved in plant variety protection
Period of Validity:
Ongoing (as of 2014)
Approval Date:
May 27, 2014
Date of Changes:
N/A
Note:
Year
Year:
2025
Region / City:
Eastern Region, Central Region, Western Region
Subject:
Field Trial Planning and Management
Document Type:
Meeting Minutes
Organization:
English Cocker Spaniel Club of America
Author:
Jack Glinsky, Jonathon Sims, Jeff Lusk, Barb Defalco, Paul McGagh, Mark Mercie, David Williams
Target Audience:
Members of the Field Trial Committee, Judges, Participants
Period of Effect:
2025
Approval Date:
July 15, 2025
Date of Changes:
Not specified
Year:
2025
Region / City:
Shanghai
Topic:
Arbitration, Early Determination
Document Type:
Guideline
Organization:
Shanghai International Economic and Trade Arbitration Commission (Shanghai International Arbitration Center)
Target Audience:
Parties involved in arbitration cases under SHIAC rules
Period of Validity:
Starting June 1, 2025
Approval Date:
June 1, 2025
Note:
Year
Topic:
Clinical Trial Agreement
Document Type:
Contract
Institution / Organization:
Istituto clinico Humanitas
Target Audience:
Medical, Scientific, and Research Professionals