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- Assent Informed Consent Guidance for Paediatric Clinical Trials with . . .
Informed consent is a legal and ethical requirement for clinical trial participation which must be documented by means of a written, signed and dated informed consent form (paper or electronic format)
- ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3)
The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities
- Informed Consent of Trial Subjects - ICH GCP
When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be enrolled in the trial with the consent of the subject’s legally acceptable representative (e g , minors, or patients with severe dementia), the subject should be informed about the trial to the extent compatible with the subject’s understanding and, if
- Additional Protections for Children | FDA
FDA's definition of the term guardian is intended to clarify that a guardian must be an individual authorized to consent to a child's participation in research
- Assent Process and Documentation – Human Research Protection Program
Assent is defined as “a child’s affirmative agreement to participate in research ” Passive resignation to submit to an intervention or procedure is not considered assent
- Summary of Key Changes in the ICH E6 (R3) Guidelines
Additional content supports the implementation of key trial design principles, with a strong emphasis on proportionality and fitness-for-purpose, aiming to improve trial efficiency and extend the applicability of GCP to a broader range of trials Transparency in the trial process is also emphasised
- E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human
- Consent or assent – GUIDANCE FOR CLINICAL TRIAL PROTOCOLS
Assent represents a minor’s affirmative agreement to participate in the trial, which typically involves signing a document that provides age-appropriate information about the study
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