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2 To the Ethics committee B TRIAL IDENTIFICATION When the amendment concerns more than one trial repeat this form as necessary. B. 1 Does the substantial amendment concern several trials involving the same IMP yes no B. 1. 1 If yes repeat this section as necessary. According to national legislation. 2/6 E.2. 1 E.2. 2 E.2. 3 E.2. 4 Amendment to information in the CT application form Amendment to the protocol If yes specify E.2. 4. 1 If yes specify E.2. 5 This amendment concerns mainly urgent...
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What is substantial amendment form?
The substantial amendment form is a document used to make significant changes to a previously filed form or application.
Who is required to file substantial amendment form?
Any individual or organization who needs to make substantial changes to a previously filed form or application is required to file a substantial amendment form.
How to fill out substantial amendment form?
To fill out a substantial amendment form, you must provide the necessary information and details about the changes being made, including the reasons for the amendments.
What is the purpose of substantial amendment form?
The purpose of the substantial amendment form is to ensure that any significant changes made to previously filed forms or applications are properly documented and reviewed.
What information must be reported on substantial amendment form?
The substantial amendment form requires reporting of the specific changes being made, the reasons for the amendments, and any relevant supporting documentation.
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