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What information should be included in a study protocol?… +
What is an Independent Data and Safety Monitoring Board (DSMB, also known as an independent Data Monitoring Committee [DMC])?
An independent data and … +
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GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported +
What needs to be reported?
• Any serious breach of:
(a) The conditions and principles of good clinical practice in connection with that trial (as def… +
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When is unblinding of the trial by the investigator permissible?
How should unblinding be accomplished (in those situations where it would be allowed)… +
Who may administer informed consent?
The person who conducts the consent interview should be knowledgeable about the study and able to answer question… +
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Withdrawal
The sponsor may withdraw the application at any time until the reporting date. In such a case, the application may only be withdrawn with … +
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Any change should be in the form of a protocol amendment, appended to the original protocol and signed by the investigator and the sponsor. Ame… +
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GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I +
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6. For trials that are on-going in the UK, should serious breaches that occur at non-UK sites be reported?
If a serious breach is identified at … +
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9. Responsibilities of the sponsor
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9.3 Outsourcing of duties and functions
The sponsor may transfer any or all of the duties and functions… +
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Adverse Event of Special Interest:
An event (serious or non-serious) of scientific and medical concern specific to the sponsor’s product or prog… +
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Breaking the blind (for a single subject) should be considered only when knowledge of the treatment assignment is deemed essential by the subjec… +
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Case Report Forms Used as Source Documents
Case report forms (CRFs) may be used as source documents if data will be initially recorded on the f… +
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Causality assessment is required for clinical investigation cases. All cases judged by either the reporting health care professional or the spon… +
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Contract research organization means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a s… +
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Data may be broadly classified into two types, and a trial may make use of both types of data (i.e., data generated specifically for the trial (… +
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USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV. +
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For clinical investigations of drug and biological products conducted under an investigational new drug (IND) application, information about adv… +
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation +
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For clinical investigations of drug and biological products conducted under an investigational new drug (IND) application, information about adv… +
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I – DEMANDE D’AUTORISATION D’ESSAI CLINIQUE DE MEDICAMENT AUPRES DE L’ANSM
Préambule
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Préalablement à la mise en place en France d’un essai… +
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USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. +
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III. REPORTING AEs TO IRBs IN CLINICAL TRIALS OF DRUG AND BIOLOGICAL PRODUCTS CONDUCTED UNDER IND REGULATIONS
A. How to Determine If an AE is an… +
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In general, all individuals, including healthy volunteers, who participate as research subjects should be viewed as intrinsically vulnerable.
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