Manual v2.0 Changes and DAERS. Lawrence Allan (HJF – DAIDS) Dr. Oluwadamilola Ogunyankin (RSC Safety Office). November 15, 2010 HVTN Network Meeting. Seattle, WA. Objectives. Expedited Reporting Policy Distinguish changes in Manual v2.0 Define key terms New algorithm for reportability
Lawrence Allan (HJF – DAIDS)
Dr. Oluwadamilola Ogunyankin (RSC Safety Office)
November 15, 2010
HVTN Network Meeting. Seattle, WA
Two Reporting Categories:
The protocol (and any applicable Letter of Amendment) will specify which reporting category will be used
SAE - All Serious Adverse Events
SUSAR- OnlySuspected, Unexpected, Serious Adverse Reactions
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose:
Life-threatening refers to an event in which the patient was at risk of death at the time of the event
The following types of hospitalization DO NOT require expedited reporting to DAIDS:
NOTE: Hospitalization is not an AE, but is an outcome
Do not report clinically insignificant physical findings at birth, including those regarded as normal variants.
NOTE: DAIDS clarification
Used for some non-Investigational New Drug (non-IND) studies/trials using U.S. FDA-approved agents with approved dosages for approved indications in typical populations
NOTE: Since the majority of HVTN protocols are for unapproved vaccine products, the SAE reporting category would apply most of the time.
For many HVTN studies, SUSAR reporting is used during the period of extended surveillance, after the main study reporting period has been completed
Hospitalization for lithium overdose, 9 months since last vaccination, 3 months after termination from the study. Assessed by site PI as not related. Identified during Annual Health Contact reporting period, SUSAR category of reporting
Marked injection site muscle atrophy with arm weakness affecting ADLs reported during an annual health contact visit,1 year after last study visit, 18 months since last vaccination. Considered related due to anatomical location and an isolated similar finding in animal toxicity studies. Identified during Annual Health Contact reporting period
NOTE: All SUSARs are SAEs, NOT all SAEs are SUSARs
Additional reporting requirements:
EXPEDITED REPORTING Defect
Sites must follow each AE until the AE is resolved or stable. For each event reported to DAIDS, sites are required to submit an updated report as soon as significant additional information becomes available. The following are examples that must be submitted:
Within 3 reporting days of site awareness that an event fulfills the protocol-defined criteria for expedited reporting to DAIDS
A site physician investigator or sub-investigator listed on the 1572 or the IoR Agreement must:
NOTE: This physician makes the site’s final assessment of the relationship to study agent(s)
For sites where DAERS has been implemented, ALL expedited adverse events and supporting information MUST be submitted to DAIDS using DAERS
ASSESSMENT OF Defect
All events reported to DAIDS in an expedited timeframe must be graded for severity.
The terms used to assess the relationship of an event to study agent are:
Related – There is a reasonable possibility that the AE may be related to the study agent(s).
Not Related– There is not a reasonable possibility that the AE is related to the study agent(s).
When an SAE is assessed as “not related” to study agent(s), an alternative etiology, diagnosis, or explanation for the SAE should be provided.
SCHARP currently has 2 versions of the AE Log CRF.
For those studies using the five category AE Log CRF, but EAE Manual Version 2, please consider the following “mapping” guidance when documenting the SAE relationship in DAERS and on the AE Log CRF
Manual V1.0 Manual V2.0
Definitely related Related
Probably not relatedNot Related
Not related Not Related
Expected AEs are events that have been previously observed with use of the study agent(s). It is not based on what might be anticipated from the pharmacological properties of the study agent.
For unapproved products: Expected AEs are determined on the basis of the IB. Events are unexpected if:
Must submit within 3 ‘reporting days’ of site awareness
Provide information on reported primary AE
NOTE: Any significant information that doesn’t have a field in DAERS can be included in the case narrative (e.g., results of a re-challenge).
Other Events: List other clinically significant signs and symptoms that more fully describe the nature, severity, and/or complications of the primary AE.
Laboratory Tests (include normal range, if known):
NOTE: It’s the site’s responsibility to confirm that the report was in fact submitted.
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