Voisin Consulting Life Sciences Interview Questions and Answers

LAR stands for legally authorized representative, who makes decisions on behalf of a research participant. An impartial witness observes the consent process to ensure it is conducted properly.

• LAR is someone who is legally authorized to make decisions on behalf of a research participant who may not have the capacity to do so themselves.

• An impartial witness is someone who observes the informed consent process to ensure that it is conducted properly and that the participant is n...read more

SAE stands for Serious Adverse Event. It is a severe and unexpected reaction to a medical treatment or intervention.

• SAEs are events that result in death, life-threatening situations, hospitalization, disability, or other serious outcomes.

• There are different types of SAEs including serious unexpected adverse reactions, serious unexpected suspected adverse reactions, and serious unexpected adverse events.

• Examples of SAEs include severe allergic reactions, organ failure, and sev...read more

AE stands for Adverse Event, SAE stands for Serious Adverse Event, ADR stands for Adverse Drug Reaction.

• AE refers to any untoward medical occurrence in a patient or clinical trial subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

• SAE refers to any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitaliza...read more

SAE stands for Serious Adverse Event. Responsibilities include reporting, documenting, and managing adverse events in clinical trials.

• SAEs are unexpected, serious adverse reactions that occur during a clinical trial

• Responsibilities include promptly reporting SAEs to regulatory authorities and ethics committees

• Documenting all details of the SAE, including severity, outcome, and relationship to the study drug

• Managing the SAE by ensuring appropriate medical care is provided to t...read more

LAR and IW play crucial roles in ensuring informed consent is obtained properly.

• LAR (Legally Authorized Representative) can provide consent on behalf of a participant who is unable to provide consent themselves.

• IW (Independent Witness) is a neutral party who observes the informed consent process to ensure it is conducted properly and without coercion.

• Both LAR and IW help protect the rights and welfare of participants in research studies.

• Examples: LAR may be a family member of...read more