№ lp_1_2_20932
File format: docx
Character count: 4634
File size: 35 KB
Clinical trial application source detailing substantial and non-substantial modifications, document versions, and regulatory compliance for submission in the CTIS portal.
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
Price: 8 / 10 USD
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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.
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:
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
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.
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:
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
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
Year:
2018
Region / City:
San Joaquin Valley, California
Topic:
Healthcare, Agricultural Industry
Document Type:
Report
Organization:
Diringer and Associates, California Rural Legal Assistance Foundation
Author:
Joel Diringer, JD, MPH, Noe Paramo, JD
Target Audience:
Agricultural workers, policymakers, public health professionals
Period of Action:
April 2018
Date of Approval:
April 2018
Date of Changes:
N/A
Contextual Description:
A report examining the impact of Medi-Cal expansion on farmworkers in San Joaquin Valley, addressing both health coverage and economic consequences for agricultural employers.
Note:
Year
Theme:
Accreditation
Document Type:
Worksheet
Organization / Institution:
Higher Learning Commission (HLC)
Target Audience:
Institutions seeking accreditation
Year:
2024
Region / City:
California
Subject:
Environmental Defense Fund, compensation, gas revenue requirement
Document Type:
Decision
Authority / Institution:
California Public Utilities Commission
Author:
Environmental Defense Fund
Target Audience:
Public utilities stakeholders, environmental advocacy groups, regulatory bodies
Period of Effectiveness:
January 1, 2024
Approval Date:
December 23, 2024
Date of Last Amendment:
N/A
Year:
2026
Region / City:
California
Topic:
Gas Systems, Public Utilities
Document Type:
Decision
Agency / Organization:
Public Utilities Commission of the State of California
Author:
Not specified
Target Audience:
Not specified
Effective Period:
Not specified
Approval Date:
December 21, 2023
Modification Date:
Not specified
Year:
2024
Region/City:
Texas
Theme:
Floodplain management
Document Type:
Template
Organ/Institution:
Texas Water Development Board
Author:
Texas Water Development Board
Target Audience:
Communities participating in the NFIP
Period of Validity:
Indefinite
Approval Date:
April 2024
Modification Date:
April 2024
Year:
2013
Region / City:
New Zealand
Subject:
Financial Markets Conduct Act, disclosure requirements
Document Type:
Regulatory form
Agency / Institution:
Licensed market operator, listed issuer
Author:
Not specified
Target Audience:
Entities with substantial holdings in financial products
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
Not specified
Year:
2021
Region / City:
Ireland
Subject:
Medical Devices, Clinical Investigation
Document Type:
Notification
Author:
Health Products Regulatory Authority (HPRA)
Target Audience:
Sponsors of clinical investigations
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
Not specified
Note:
Year
Subject:
Clinical Trial Application
Document Type:
Protocol
Year:
2024
Region / City:
European Union
Topic:
Clinical Trial Modifications
Document Type:
Application
Organization / Institution:
European Medicines Agency (EMA)
Author:
Applicant
Target Audience:
Regulatory Authorities
Period of Validity:
Ongoing
Approval Date:
March 19, 2024
Modification Date:
January 1, 1900