In the Clinical Study Report, we will summarize the number of participants who experience each type of adverse event (AE). To ensure consistent AE terminology across study sites and enable accurate analysis of similar events, AE terms entered by sites are standardized using the MedDRA dictionary.

As part of this process, you may receive queries regarding AE terminology to help ensure events are coded, standardized, and counted appropriately. Common queries may include:

• Please record each term on a separate log line.  MedDRA coding assumes one symptom/diagnosis per line, so terms such as “Redness and Swelling” should be recorded as two separate log lines as “Redness” and “Swelling” 

• Please combine terms that represent signs and/or symptoms of a single diagnosis into one unifying diagnosis. Per the CRF Completion Guidelines, individual signs and symptoms that are attributable to a confirmed diagnosis should be reported under the diagnosis whenever possible. 

• If a symptom is later determined to be part of an underlying diagnosis, please update the start date of the diagnosis to reflect the earliest onset date of any symptom that can be definitively attributed to that diagnosis.  Any individual symptoms covered by the overarching diagnosis should be inactivated in EDC. 

• If an abnormal laboratory value is considered clinically significant, please record the diagnosis as the AE whenever possible rather than describing the laboratory abnormality itself (e.g., record “anemia” rather than “decreased hemoglobin”).

Additionally, CTCAE grading is used to standardize reporting of event severity.  The full CTCAE dictionary is available online. In general, CTCAE grades are defined according to the descriptions below.  If an event term and/or interventions given (or not given) do not appear consistent with the assigned CTCAE grade, you may receive a query.

• Grade 1: Mild; asymptomatic or mild symptoms; clinical diagnostic observations only; intervention not indicated 

• Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting instrumental ADL. 

• Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL 

• Grade 4: Life-threatening consequences; urgent intervention indicated 

• Grade 5: Death related to AE

Click here to visit the CTCAE Dictionary

Source documents for adjudication must be collected and submitted through the WCG AIMS Portal. Over 20 sites currently have outstanding uploads. Timely submission is critical, so endpoint adjudication can proceed as required by the protocol. Please ensure that you upload any outstanding source ASAP.  

Need help? AIMS portal issues: see the AIMS external user guide on Longboat or contact aimssupport@wcgclinical.com

Questions on the adjudication process: reach out to your PSI CRA and copy Marci.Parks@prokidney.com