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E
Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report
Where the sponsor so requests, the… +
Submission of an application
1. In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States … +
Submission of application
In order to obtain an authorisation, the sponsor shall submit an application dossier to the Member States concerned through… +
U
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
[…]
§ 46.203 Duties of IRBs in connection with re… +
Subpart B—Application and Administrative Action
§ 812.20 Application.
(a) Submission.
[…]
(b) Contents
[…]… +
Subpart B—Electronic Records
§ 11.10 Controls for closed systems.
Persons who use closed systems to create, modify, maintain, or transmit electronic r… +
Subpart B—Organization and Personnel
§ 56.106 Registration
[…]
§ 56.107 IRB membership.
[…]… +
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
[…]
§ 46.303 Definitions.
[…]
(c) Pr… +
Subpart C—Electronic Signatures
§ 11.100 General requirements
(a) Each electronic signature shall be unique to one individual and shall not be reused … +
Subpart C—IRB Functions and Operations
[..]
§ 56.109 IRB review of research.
[…]
(a) An IRB shall review and have authority to approve, require modifi… +
Subpart C—IRB Functions and Operations
§ 56.108 IRB functions and operations.
[…]
§ 56.109 IRB review of research.
[…]
(f) An IRB shall conduct contin… +
Subpart D—Additional Protections for Children Involved as Subjects in Research
[…]
§ 46.402 Definitions.
The definitions in § 46.102 of the pre-2018 R… +
Subpart D—Additional Safeguards for Children in Clinical Investigations
[…]
§ 50.50 IRB duties.
[…]
§ 50.51 Clinical investigations not involving grea… +
Subpart D—IRB Review and Approval
§ 812.60 IRB composition, duties, and functions.
An IRB reviewing and approving investigations under this part shall… +
Subpart E—Registration of Institutional Review Boards
[…]
§ 46.501 What IRBs must be registered?
Each IRB that is designated by an institution under a… +
Subpart E—Responsibilities of Investigators
§ 812.100 General responsibilities of investigators.
An investigator is responsible for ensuring that an i… +
Subpart G—Records and Reports
§ 812.140 Records.
(a) Investigator records. A participating investigator shall maintain the following accurate, complet… +
E
Subsequent addition of a Member State concerned
1. Where the sponsor wishes to extend an authorised clinical trial to another Member State (‘additi… +
Substantial modification of aspects covered by Parts I and II of the assessment report
1. Where a substantial modification relates to aspects cover… +
Substantial modifications to clinical investigations
1. If a sponsor intends to introduce modifications to a clinical investigation that are likely… +
