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Unerwünschte Ereignisse
§ 22. Die Meldungen gemäß Art. 80 Abs. 2 der Verordnung (EU) Nr. 745/2017 oder Art. 76 Abs. 2 der Verordnung (EU) Nr. 746/2017… +
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Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.,… +
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Unexpected adverse event or unexpected suspected adverse reaction. An adverse event or suspected adverse reaction is considered “unexpected” if it is … +
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Urgent safety measures
1. Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall … +
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Urgent safety measures
30.—(1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical… +
Urgent safety measures
30.—(1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical… +
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V. FREQUENTLY ASKED QUESTIONS
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1. What are some considerations for enrolling a child into a clinical investigation?
[...]
2. Are there any addition… +
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI C. +
VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY
[...]
C. Delegation of Monitoring Responsibilities to a CRO
If a sponsor of an IND study delegates … +
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D. +
VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY
[…]
D. Clinical Investigator and Site Selection and Initiation
In addition to regulatory requiremen… +
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VIII.B.4.3. Study reports
VIII.B.4.3.1. Progress report and interim report of study results
The progress report is meant to include relevant informati… +
VIII.B.4.3. Study reports
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VIII.B.4.3.2. Final study report
[...]… +
VIII.B.5. Publication of study results
For studies that are fully or partially conducted by investigators who are not employees of the marketing auth… +
Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
1. The rep… +
Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report
1. Within six day… +
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Vulnerable Participants
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justifie… +
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WARNING LETTER - Purolea Cosmetics Lab
MARCS-CMS 722591
[…]
Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing.
During the … +
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WHO Good Practices for Clinical Trial Design and Implementation
This course supports understanding and application of key ethical, scientific princip… +
WHO Principles of GCP
Principle 1:
Research involving humans should be scientifi cally sound and conducted in accordance with basic ethical principl… +
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CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18 +
WOMEN AS RESEARCH PARTICIPANTS
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Vulnerability of women.
Despite the current general presumption that favours the inclusion of women in research, … +
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What about financial reimbursements to research subjects?
Financial reimbursements to subjects are distinct from any benefi ts contributing to the ris… +
