№ lp_1_2_47686
File format: docx Character count: 4425 File size: 369 KB
This document summarizes detailed feedback on the draft guidance for protecting personal data (PPD) and commercially confidential information (CCI) in documents uploaded to the Clinical Trial Information System (CTIS).
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
Price: 8 / 10 USD
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Checklist of documents to be submitted for seeking in-principle approval for listing of Non-Convertible Debt Securities (NCDs)/Non-Convertible Redeemable Preference Shares (NCRCPS)/ Perpetual Debt Instruments (PDIs)/ Perpetual Non-Cumulative Preference Shares (PNCPS)/Structured or Market linked securities (MLDs) to be issued on private placement basis(Application to be uploaded on BSE Listing Centre)
Year: 2021
Region / City: Mumbai
Topic: Listing of Non-Convertible Debt Securities
Document Type: Guidelines
Authority / Institution: BSE (Bombay Stock Exchange)
Author: SEBI (Securities and Exchange Board of India)
Target Audience: Issuers of Non-Convertible Debt Securities
Effective Period: Ongoing
Approval Date: N/A
Date of Amendments: N/A
Each solution should be zipped separately and uploaded through your project page on blackboard.
Year: 2026
Region / City: Not specified
Theme: Programming, Object-Oriented Design
Document Type: Code Example
Organization / Institution: Not specified
Author: Not specified
Target Audience: Students / Programmers
Effective Date: Not specified
Date of Changes: Not specified
Application CTIS trial number SM-number (Part I / Part II / Part I + II)
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
Application CTIS trial number SM-number (Part I / Part II / Part I + II)
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.
Application for Substantial Modification in CTIS for Clinical Trial SM-number
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
Application CTIS trial number SM-number (Part I / Part II / Part I + II)
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
Application CTIS trial number SM-number (Part I / Part II / Part I + II)
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
Application CTIS trial number SM-number (Part I / Part II / Part I + II)
Note: Year
Subject: Clinical Trial Application
Document Type: Application
Topics: forEMA uploaded CTIS