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  • Request For Authorisation Of A Substantial Amendment To A Clinical Trial - Ctsu Ox Ac

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Annex 2: Notification of Amendment Form REQUEST FOR AUTHORISATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR THE OPINION.

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a substantial modification (art 2.2. 13); a change relevant to the supervision of the trial (art 81.9) which is a new concept under CTR; a non-substantial modification (changes outside the scope of substantial modifications and changes irrelevant to the supervision 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.

A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.

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.

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.

A substantial amendment is defined as change to the terms of the protocol or any other supporting documentation that is likely to affect to a significant degree: the safety or physical or mental integrity of participants. the scientific value of the research. the conduct or management of the research.

Regulatory bodies (such as the Research Ethics Committee (REC) [7], Medicines and Healthcare products Regulatory Agency (MHRA) [1] and most recently introduced body the Health Research Authority (HRA) [7]) required to review the amendment will depend on the type of clinical trial and amendment being made.

A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on the safety of the subjects or the scientific value of the study.

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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