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Substantial modifications to performance studies
1. If a sponsor intends to introduce modifications to a performance study that are likely to have … +
Suitability of clinical trial sites
The facilities where the clinical trial is to be conducted shall be suitable for the conduct of the clinical tria… +
Suitability of individuals involved in conducting the clinical trial
The investigator shall be a medical doctor as defined in national law, or a pers… +
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GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 - +
Summarized in "Electronic Execution of Documents - Industry Working Group Interim Report" (01-Feb-2022)
https://assets.publishing.service.gov.uk/media… +
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Suspected Unexpected Serious Adverse Reaction (SUSAR):
an adverse reaction that meets three criteria: suspected, unexpected and serious.
• Suspected… +
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Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purpose… +
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Suspension or termination of clinical trial
31.—(1) If, in relation to a clinical trial—
(a)the licensing authority have objective grounds for cons… +
GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 System Security +
System Security
[...]
There should be the implementation of robust security procedures by the sponsor and investigator site/institution, such as; pass… +
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Temporary halt or early termination by the sponsor for reasons of subject safety
1. For the purposes of this Regulation, the temporary halt or early… +
The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, otherwise kno… +
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The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under devel… +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13 +
The level of security should be proportionate to the sensitivity and confidentiality of the data (e.g. nominative data in electronic medical records a… +
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The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures and data collec… +
These essential records should be maintained in or referred to from repositories held by the sponsor and by the investigator/institution for their res… +
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USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 - +
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for … +
Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services
Subchapter A—General
Part 56 Institutional R… +
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Traceability, storage, return and destruction of investigational medicinal products
1. Investigational medicinal products shall be traceable. They … +
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Transcelerate GCP mutual recognition programm FAQ… +
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Unauthorised investigational and unauthorised auxiliary medicinal products
1. The following information shall appear on the outer packaging and on … +
Unblinding treatment allocation
17. The investigator shall only unblind the treatment allocation of a subject in the course of a clinical trial if un… +
