CRP 106 Lecture 1

Question 1

Monitor duties (4)

Answer 1

-key point of contact for sites
-scheduling and conducting study visits (site selection, site initiation, routine monitoring, closeout)
-review records of other departments such as pharmacy, labs, etc
-helping QI and site rectify compliance issues (CAPA)

Question 2

Monitoring envrionments (3)

Answer 2

-pharmaceutial companies
-CRO/ARO/hospital CRO
both typically require travel
-Academic centres
less travel requirements

Question 3

Monitoring issues (4)

Answer 3

-non-compliance with GCP, division 5, etc (documentation, informed consent, protocol deviations, data integrity)
-immediate safety risk to participant
-institutional/corporate risks (public percepion, drug approvals)
-fraud/misconduct

Question 4

charateristics of good monitor (8)

Answer 4

-attention to detail
-sense of observation
-maintain focus
-process driven
-effective communicator
-motivator
-adaptive
-problem solving, open to multiple solutions
-ability to learn and integrate new material

Question 5

Food and Drugs Act

Answer 5

-law which enables the food and drug regulations, natural health product regulations, and medical device regulations
-covers practices involved in maintaining safety of food, drugs, cosmetics and devices
-enables inspection, seizure and forfeiture

Question 6

AE reporting

Answer 6

-drugs: serious unexpected adverse drug reaction inside or outside Canada
-Natural health prouct: all SAEs or unexpected adverse drug reaction inside Canada
-medical devices: device deficiencies that may lead to SAE, SAEs, unanticipated adverse device effects (serious and unexpected), public health threats, malfunctions or defects.