Get the free Annex 2: Substantial Amendment Form

This form is used to notify competent authorities and ethics committees of substantial amendments to clinical trials involving medicinal products for human use, including details of the sponsor and

How to fill out annex 2 substantial amendment

How to fill out Annex 2: Substantial Amendment Form

1. Begin by downloading the Annex 2: Substantial Amendment Form from the relevant authority's website.
2. Read all instructions carefully before filling out the form.
3. Provide your organization's name and contact information at the top of the form.
4. Clearly state the reason for the substantial amendment in the designated section.
5. List the specific changes you are proposing, including any relevant details and justifications.
6. Include any data or evidence that supports your amendment request.
7. Ensure all required signatures are obtained, including those from authorized representatives of your organization.
8. Review the completed form for accuracy and completeness before submission.
9. Submit the form by the specified deadline through the appropriate channels outlined by the authority.

Who needs Annex 2: Substantial Amendment Form?

1. Organizations or entities that are seeking to make substantial amendments to previously approved projects or programs funded by the relevant authority.
2. Any stakeholders involved in projects that require significant changes to their original application or funding agreements.

People Also Ask about

What is a substantial amendment to a CTA?

Substantial Amendments are a legal requirement which is relevant to all trials. This station is part of the 'recruitment phase' group of stations. Amendments are changes made to a research project after approval from a review body has been given.

What is considered a substantial amendment?

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.

What is considered a substantial modification?

A substantial modification (SM) is defined as "any change to any aspect of the clinical trial which is made after notification of a decision referred to in Articles 8, 14, 19, 20 or 23 of the CTR and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and

What does substantially amended mean?

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.

What is a substantial amendment to a clinical trial directive?

Amendments to the trial are regarded as “substantial” where they are likely to have a significant impact on: the safety or physical or mental integrity of the subjects, or the scientific value of the trial, or the conduct or management of the trial, or the quality or safety of any IMP used in the trial.

What is a substantial amendment?

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.

What is a substantive amendment?

Substantive Amendment is defined to include the following: (a) any change to the Term of this Agreement; (b) any changes to the permitted uses of the Project or the density and/or intensity of use of the Project; (c) any changes to provisions in this Agreement or the Project Approvals related to monetary contributions

Do non-substantial amendments need rec approval?

Depending on the nature of the substantial amendment it may mean that it needs to be reviewed by a Research Ethics Committee (REC), reviewed for HRA and HCRW Approval or reviewed by another organisation. A non-substantial amendment does not require REC review but may require other reviews.

For pdfFiller’s FAQs

What is Annex 2: Substantial Amendment Form?

Annex 2: Substantial Amendment Form is a document used to report significant changes to a previously submitted project or proposal, ensuring compliance with regulatory requirements.

Who is required to file Annex 2: Substantial Amendment Form?

Any organization or individual that has previously filed a project proposal and needs to make substantial changes to it is required to file the Annex 2: Substantial Amendment Form.

How to fill out Annex 2: Substantial Amendment Form?

To fill out Annex 2, carefully read the instructions provided, complete the required sections detailing the substantial amendments, and ensure all necessary documentation is attached before submission.

What is the purpose of Annex 2: Substantial Amendment Form?

The purpose of Annex 2 is to provide a formal process for reporting significant changes to projects, allowing regulatory bodies to assess the implications of these changes on the project’s objectives and funding.

What information must be reported on Annex 2: Substantial Amendment Form?

The form must include details of the proposed amendments, justification for the changes, impact assessment on the project's objectives, budget adjustments, and any relevant timelines or milestones.