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  • Substantial Amendment Form

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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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How to fill out the Substantial Amendment Form online

Filling out the Substantial Amendment Form online is an important step in notifying the competent authorities and ethics committees about changes in a clinical trial. This guide will provide you with clear, step-by-step instructions to help you complete the form accurately and efficiently.

Follow the steps to complete the form online.

  1. Click ‘Get Form’ button to obtain the form and open it in the editor.
  2. In Section A, indicate the type of notification by selecting the appropriate option: authorization to the competent authority, opinion to the ethics committee, or information only. Ensure that you complete A.1 to A.4 based on your specific submission.
  3. Proceed to Section B to identify the trial. Indicate if the substantial amendment concerns multiple trials and provide the EudraCT number and the full title of the trial in fields B.2 and B.3.
  4. In Section C, fill out the identification of the sponsor responsible for the request, including the organization, contact person's name, address, and contact details in C.1.
  5. If applicable, complete Section C.2 for the legal representative of the sponsor, providing the same type of information as in Section C.
  6. Choose your role in Section D, clarifying whether you are the sponsor, legal representative, or an authorized person, and fill out the corresponding details.
  7. In Section E, specify the substantial amendment identification including the sponsor's code number, version, and date. Explain the type of substantial amendment and the reasons for it in subsections E.2 and E.3.
  8. Fill out Section G with a brief description of the changes being made to the trial.
  9. If there are changes to the trial site or investigators, detail these in Section H, providing information on any new or removed sites and their respective principal investigators.
  10. Specify any changes to instructions in Section I and append all relevant documents in Section J before submitting.
  11. Finally, sign and date the applicant section in Section K to confirm that the information provided is accurate and complete.
  12. Save your changes and download, print, or share the completed form as needed.

Ensure your submission is complete and accurate by filling out the Substantial Amendment Form online now.

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An example of an amendment is a change in project scope or budget that requires formal approval. For instance, if a project needs additional funding due to unforeseen circumstances, submitting a Substantial Amendment Form is necessary. This form documents the changes and provides a clear record for all stakeholders involved. Always refer to your specific guidelines to understand what constitutes an amendment.

A substantial amendment constitutes changes that have a significant impact on the project, such as altering funding sources, extending timelines, or modifying goals. These changes require the completion of a Substantial Amendment Form to ensure that all stakeholders are notified and can adjust accordingly. It's important to recognize what qualifies as substantial to maintain the integrity of your project.

The substantive amendment refers to modifications that change the core elements of a project or agreement. These amendments often require a formal process, which includes filling out a Substantial Amendment Form. By doing so, you ensure that all involved parties are informed and that the project remains compliant with regulations.

A substantial modification typically involves significant changes to project objectives, budget allocations, or the scope of work. These modifications can affect the overall effectiveness and compliance of the project. Therefore, when you identify such changes, it is important to utilize the Substantial Amendment Form to document these alterations appropriately.

Submitting a substantial amendment involves filling out the Substantial Amendment Form accurately and thoroughly. After completing the form, you should send it to the appropriate authority or governing body overseeing your project. Be sure to check for any additional submission requirements or deadlines to ensure a smooth process.

To complete a Substantial Amendment Form, you must identify the specific changes being made, provide justification for these changes, and outline their potential impact. Additionally, you may need to include supporting documents that illustrate the necessity of the amendment. It's essential to follow the guidelines set by the governing body overseeing your project to ensure compliance.

A substantive amendment refers to changes that fundamentally impact the content or essence of an agreement or project. This type of amendment requires careful consideration and often necessitates a Substantial Amendment Form for proper documentation. It ensures that all stakeholders are aware of the changes and can respond accordingly.

A substantial modification significantly alters the original terms or conditions of a project, impacting its scope or funding. In contrast, a non-substantial modification involves minor adjustments that do not affect the overall objective or structure. Understanding these differences is crucial when completing a Substantial Amendment Form, as it determines the necessary documentation and approval processes.

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.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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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
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Help Portal
Legal Resources
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
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
altaFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
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