Assessment of Causality. The investigator must use the following classifications and criteria to characterize the relationship or association of the study drug in causing or contributing to the AE:
Assessment of Causality. The investigator’s assessment of an AE’s relationship to study drug is part of the documentation process but is not a factor in determining what is or is not reported in the study. The investigator will assess causality (ie, whether there is a reasonable possibility that the study drug caused the event) for all AEs and SAEs. The relationship will be classified as follows: • Not related: There is not a reasonable possibility of relationship to study drug. The AE does not follow a reasonable temporal sequence from study drug administration or can be reasonably explained by the subject’s clinical state or other factors (eg, disease under study, concurrent diseases, and concomitant medications).
Assessment of Causality. The investigator’s assessment of an AE’s relationship to study drug is part of the documentation process. The investigator will assess causality (i.e., whether there is a reasonable possibility that the study drug caused the event) for all AEs and SAEs. The relationship will be classified as follows: • Not related: There is not a reasonable possibility of relationship to study drug. The AE does not follow a reasonable temporal sequence from study drug administration, or can be reasonably explained by the subject’s clinical state or other factors (e.g., disease under study, concurrent diseases, and concomitant medications). • Related: There is a reasonable possibility of relationship to study drug. The AE follows a reasonable temporal sequence from study drug administration and cannot be reasonably explained by the subject’s clinical state or other factors (e.g., disease under study, concurrent diseases, or concomitant medications), represents a known reaction to the study drug or other drugs in its class, is consistent with the known pharmacological properties of the study drug, and/or resolves with discontinuation of the study drug (and/or recurs with re-challenge, if applicable).
Assessment of Causality. The Investigator is obligated to assess the relationship between the study intervention and each occurrence of each AE or SAE. An Investigator causality assessment must be provided for all AEs (both nonserious and serious). This assessment must be recorded in the CRF and on any additional forms, as appropriate. The definitions for the causality assessments are as follows: − Not related: There is no reasonable possibility the study intervention caused the AE. ▪ The AE has a more likely alternative etiology; it may be due to underlying or concurrent illness, complications, concurrent treatments, or effects of another concurrent drug. ▪ The event does not follow a reasonable temporal relationship to administration of the study intervention. − Related: There is a reasonable possibility the study intervention caused the AE. ▪ The AE has a temporal relationship to the administration of the study intervention. ▪ The event does not have a likely alternative etiology. ▪ The event corresponds with the known pharmaceutical profile of the study intervention. ▪ There is improvement on discontinuation and/or reappearance on rechallenge. • The Investigator will use clinical judgment to determine the relationship. • Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well as the temporal relationship of the event to study intervention administration will be considered and investigated. • The Investigator will also consult the IB and/or Product Information, for marketed products, in his/her assessment. • For each AE/SAE, the Investigator must document in the medical notes that he/she has reviewed the AE/SAE and has provided an assessment of causality. • There may be situations in which an SAE has occurred, and the Investigator has minimal information to include in the initial report to Xxxxxxx. However, it is very important that the Investigator always makes an assessment of causality for every event before the initial transmission of the SAE data to Alexion. • The Investigator may change his/her opinion of causality in light of follow-up information and send an SAE follow-up report with the updated causality assessment. • The causality assessment is one of the criteria used when determining regulatory reporting requirements.
Assessment of Causality. Any occurrence of an AE will be assessed for relationship to the study drug. A causal relationship means that the study drug caused (or is reasonably likely to have caused) the AE. This usually implies a relationship in time between the drug and the AE; for example, the AE occurred shortly after the subject received the study drug. The investigator who examines and evaluates the subject will determine AE causality based on the temporal relationship to administration of the study drug, the pharmacology of the study drug, and their clinical judgment. Terms used to describe the degree of causality between a study drug and an AE are definitely related, probably related, possibly related, unlikely related, or not related. The best estimate at the time of reporting of an event and the degree of certainty about the causal relationship between the study drug administration and the AE will be graded as follows:
Assessment of Causality. The causality assessment shall be undertaken by the responsible investigator and Idenix or its designee, for SAEs for all investigational products (and/or concomitant products) from all clinical trials. Should Idenix or it's designee assess causality as "suspected" (also referred to as "associated with" or "related to" the use of the drug) when the investigator has made an assessment of "not suspected", the "higher" causality (suspected) shall be applied for purposes of expedited and periodic reporting. Novartis will monitor the assessments in the incoming reports and in case of concern, the Parties shall enter into discussion and issue an agreed follow-up report with a re-assessment, if necessary. Any differences in the causality assessment must be documented on the SAE report.
