CLINICAL OPERATIONS & OUTSOURCING To more accurately assess risk based on


impact, probability, and detectability, I use the following grading system. Impact: this refers to the potential negative effects an error in a variable or procedure could have on subject safety, the integrity of the study, and its data. Consideration is given to the status of primary, secondary, and exploratory endpoints when evaluating impact. Impact risk is graded as follows: • High – 3 • Moderate – 2 • Low – 1


Probability: this is an estimate of how likely it is that an error in a variable or procedure might occur. Probability risk is categorized as: • High – 3 • Moderate – 2 • Low – 1 Detectability: this estimates how easily an error can be observed. The risk associated with detectability is inversely related to impact and probability; the more detectable an error, the less risk of it going unnoticed. Detectability is graded as: • High – 1 • Moderate – 2 • Low – 3


Figure 2: Impact, Probability, and Detectability Impact


Probability


1 - Low 2 - Moderate 3 - High


1 - Low 2 - Moderate 3 - High


3 3 2 1 3 2 2 1 3 1 2 1 28 | Outsourcing in Clinical Trials Handbook


Detectability


1 - High 2 - Moderate 3 - Low


3 2 1 3 2 1 3 2 1 3 2 1 3 2 1 3 2 1 3 2 1 3 2 1 3 2 1


Risk Score / Category Score


9 8 7 8 7 6 7 6 5 8 7 6 7 6 5 6 5 4 7 6 5 6 5 4 5 4 3


Category


Critical


Noncritical Critical


Noncritical Noncritical


Critical Critical


Noncritical Critical


Noncritical


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68