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T ITS Office Signature: Date: John Williams CDOT ITS Office Signature: Date: Prepared By: CTMS/CTIS Server Detailed Design Version: 1.0 Date: 21-May-04 Revision History Date Version Description Author 21-Apr-04 1.0 First Draft Jason Westra 18-May-2004 1.0 Change Package Diagrams, formatting and some minor changes Pawan Kharbanda 21-May-2004 1.0 Added securit.

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EU-CTD obliges multiple safety submissions to NCAs and ECs, whereas EU-CTR requires all safety reporting via EudraVigilance. A single safety report can be submitted for trials involving more than one IMP, but all unexpected events which affect a trial's benefit-risk balance must be reported within 15 days.

The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission. CTIS went live with a searchable public website on 31 January 2022.

Unlike the Directive, the Regulation will be binding in its entirety and will be directly applicable in all EU/EEA Member States: the 27 EU countries and Iceland, Liechtenstein and Norway – not including, of course, the UK following the Brexit.

Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) is mandatory.

To transition a trial from EudraCT to CTIS, sponsors need to submit an initial CTA marked as a transitional trial. If sponsors create the trial without marking it as transitional, they cannot correct it at a later stage. They will have to create the trial from scratch, marking it this time as transitional.

The following documents must be submitted in electronic format: Investigator's Brochure or Product Monograph. PSEAT-CTA or Submission Rationale / Brief Summary. Study Protocol(s)

All studies falling into the category of CTIMPs require authorisation by the Medicines and Healthcare Products Regulatory Agency. Application is via the Integrated Research Application System (IRAS) and the Research Governance, Ethics & Assurance Team will be happy to advise.

Starting on 31 January 2023, CTIS will replace the EudraCT portal and clinical trial sponsors will be required to use the portal to apply for authorization to run a clinical trial.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232