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E centre trial): D.2.5 Complete below D.2.5.1 Organisation : D.2.5.2 Name : D.2.5.3 Address : D.2.5.4 Telephone number : D.2.5.5 Fax number : D.2.6 E-mail : E SUBSTANTIAL AMENDMENT IDENTIFICATION E.1 Sponsor s substantial amendment code number, version, date for the clinical trial concerned: E.2 Type of substantial amendment 2 3 As stated in Article 19 of Directive 2001/20/EC. According to national legislation. Substantial Amendments Form October 2005 2/6 E.2.1 E.2.2 E.2.3 E.2.3.

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a. The Sponsor is responsible for the decision to make a change, the classification of an amendment as either substantial or non-substantial and the revision of any documentation. b.

Category C - Amendment to a research study that participating NHS organisations are not expected to consider. This category includes any amendment to a research study that has no implications that require management or oversight by the participating NHS organisations hosting the research study.

An amendment is considered as substantial if the modification has a significant impact on: - Security or physical or mental integrity of the subject. - Scientific value of the trial. - Organization and execution manner of the trial.

An amendment must be classified as substantial if it includes an update to the Reference Safety Information (RSI) for the trial (contained within an IB or SmPC). The submission cover letter must indicate that the RSI is being updated.

The addition of a new NHS/HSC site, and the addition or change of a Principal Investigator (PI) in the NHS/HSC for CTIMP studies, will now be classified as non-substantial changes (Please note these changes should still continue to be classed as substantial when relating to non-NHS/HSC settings).

An amendment is considered as substantial if the modification has a significant impact on: - Security or physical or mental integrity of the subject. - Scientific value of the trial. - Organization and execution manner of the trial.

Amendments may be made to the conduct of a clinical trial. These are substantial if they are likely to have an impact on the safety of the trial subjects, on the interpretation of the scientific documents in support of the conduct of the trial, or if they are otherwise significant.

Amendments may be made to the conduct of a clinical trial. These are substantial if they are likely to have an impact on the safety of the trial subjects, on the interpretation of the scientific documents in support of the conduct of the trial, or if they are otherwise significant.

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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