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3.12 Noncompliance
3.12.1 Noncompliance with the protocol, SOPs, GCP and/or applicable regulatory requirement(s) by an investigator/institution or by… +
3.13.1 Sponsor Review of Safety Information
The sponsor should aggregate, as appropriate, and review in a timely manner relevant safety information. T… +
3.13.2 Safety Reporting
(a) The sponsor should submit to the regulatory authority(ies) safety updates and periodic reports, including changes to the I… +
3.13.2 Safety Reporting
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(c) Safety reporting to regulatory authorities should be undertaken by assessing the expectedness of the reaction in rel… +
3.14 Insurance/Indemnification/Compensation to Participants and Investigators
3.14.1 If required by the applicable regulatory requirement(s), the spo… +
3.14 Insurance/Indemnification/Compensation to Participants and Investigators
3.14.1 If required by the applicable regulatory requirement(s), the spo… +
3.15 Investigational Product(s)
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(d) In blinded trials, the sponsor should implement:
(i) A process to blind individuals, including the sponso… +
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution +
3.16 Data and Records
3.16.1 Data Handling
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For systems used or deployed by the investigator/institution:
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(vii) In situations where clinica… +
3.16.1 Data Handling
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(g) Procedures should be in place to describe unblinding; where applicable; these descriptions should include:
(i) who … +
3.19 device deficiency
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3.2 Ethics committee
The role of the ethics committee (or other board responsible for reviewing the trial) is to ensure the protection of the rights a… +
3.2 Ethics committee
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The ethics committee has an ongoing responsibility for the ethical conduct of research, and therefore must be informed of a… +
3.2 Ethics committee
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The investigator, or the investigator and the sponsor, must consult the relevant ethics committee(s) regarding the suitabil… +
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EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2 +
3.2. When should the notification be made?
Without undue delay and at the latest within 7 calendar days of the sponsor becoming aware of a serious bre… +
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3.2.4 Training and mentoring
Investment in education and training is required in all regions through accessible (practically and financially) fit-for-… +
3.3 Informed consent
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c) The subject must have access to information about insurance, if any, and other procedures for compensation and treatment s… +
3.3 Informed consent
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c) The subject must have access to information about insurance, if any, and other procedures for compensation and treatment s… +
3.3 Informed consent
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e) Careful consideration should be given to ensuring the freedom of consent obtained from members of a group with a hierarchi… +
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3.3.5 Critical to Quality Factors in Operational Practice
The foundation of a successful study is a protocol that is both scientifically sound and ope… +
3.33 malfunction
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