Manual/Section: Clinical Manual/Other

Policy No. OTH-2

Key Words: Severe Adverse Events, Clinical Trials, Medication Error, Research

1. PURPOSE:

1.01     To ensure that medication error is considered in the differential diagnosis of local SAEs associated with the drugs administered in a clinical trial.

2. POLICY:

2.01       In the event of a local SAE, the QI (Qualified Investigator; or his/her representative) must re-compute the drug dosing and administration using the research protocol as a source document.  The study pharmacist must similarly retrace the steps involved in the drug preparation. 

2.02       The local SAE report submitted to the CHEO REB must be signed and dated by the QI (or his/her delegate) and clearly indicate that the dosing and administration of drugs associated with a local SAE were verified.

2.03       The QI (or his/her delegate) must also notify other research staff (including the study pharmacist) of the occurrence of a local SAE. 

2.04       Given the importance of timely SAE reporting, all health care providers must notify the QI (or his/her representative) of patient symptoms that, to the best of their knowledge, may be related to the drugs administered in the context of a clinical trial.

3. SCOPE:

3.01       This policy applies to all clinical drug trials that are conducted by staff of CHEO or the CHEO Research Institute.

4. DEFINITIONS:

4.01   Serious Adverse Event: A serious adverse event is an untoward medical occurrence that may include, but is not limited to:

• any medical occurrence that results in death

• any life-threatening ailment

• any congenital birth defects or congenital anomaly

• any  ailment that results in persistent or significant disability or incapacity

• any hospitalization or prolongation of existing hospitalization

• any symptom that is unexpected and has a severity grading of 4 or more based on the Common Toxicity Criteria.

In the context of a clinical drug trial, the research protocol specifies both the nature and severity of symptoms that constitute the basis for a ‘serious adverse event’. 

Local SAE: is an SAE occurring within CHEO.